- Japan Regenerative Medicine Market Trends and Forecasts to 2035 Featuring Astellas Pharma, Fujifilm, JCR Pharmaceuticals, Sumitomo Pharma, Takeda, and Terumo
May 13, 2026
Company Logo
Japan's regenerative medicine market offers opportunities driven by an aging population, progressive regulations, and demand for novel therapies targeting chronic and cosmetic conditions. Innovations in stem cell and gene-editing technologies, alongside robust R&D investments and clinical collaborations, further bolster growth potential.
Dublin, May 13, 2026 (GLOBE NEWSWIRE) -- The "Japan Regenerative Medicine Market - Distribution by Type of Product, Type of Therapeutic Area, End User and Key Geographical Regions: Industry Trends and Global Forecasts, till 2035" has been added to ResearchAndMarkets.com's offering.
The Japan regenerative medicine market is poised for substantial growth, projected to expand from USD 13.06 billion in the current year to USD 24.01 billion by 2035, with a CAGR of 7.0%
This expansion is fueled by advancements in repairing damaged tissues and organs, a focus enhanced by the increasing adoption within aesthetic medicine. Regenerative medicine offers promising therapies for chronic illnesses such as Alzheimer's, Parkinson's, diabetes, and renal disorders, integrating cellular therapies, medical devices, and tissue engineering.
The integration of regenerative therapies in cosmetic procedures, such as facial rejuvenation and breast reconstruction using stem cell therapies derived from adipose tissue, is expected to continue driving market growth. Japan's regulatory support, aging population, and key product approvals contribute to this strong market momentum. The sector is further bolstered by expedited commercialization efforts through supportive government initiatives like accelerated review pathways, promoting innovative treatments and therapies.
Japan's regenerative medicine market is enriched by developments in induced pluripotent stem cells, mesenchymal stem cells, gene-editing technologies, nanotechnology, and 3D bioprinting, which expand applications and improve treatment effectiveness. Significant funding from government and private sectors, alongside growing acceptance of personalized medicine, underscores this growth trajectory. Emerging public awareness and financial dynamics, such as export potential for domestic therapies, strengthen Japan's competitive positioning globally.
However, the market faces challenges such as high treatment costs due to complex manufacturing and stringent quality regulations, restricting access for many patients. A shortage of tissue donors further complicates research and product development, creating significant supply chain vulnerabilities. These hurdles, alongside seasonal fluctuations in donor availability, pose critical barriers to progress.
Story Continues
In terms of therapeutic areas, oncological disorders capture the largest market share, driven by regenerative treatments like cell and gene therapies in cancer management. Particularly, the focus on CAR-T cell therapy is propelling this segment forward due to its effectiveness in treating hematological malignancies. As for end users, hospitals dominate due to their capability to utilize advanced technologies necessary for administering regenerative therapies, catering to various diseases including oncological, orthopedic, and cardiovascular conditions.
The Japan regenerative medicine market segments encompass products like gene therapies, cell therapies, and tissue engineering. The therapeutic areas range from dermatological to oncological disorders, while end users include hospitals, commercial industries, and research institutes. Leading market players include Astellas Pharma, Fujifilm Holdings, and Takeda Pharmaceutical, among others. The report explores fundamental questions concerning market size, key trends, growth drivers, and challenges encountered by developers, presenting comprehensive insights beneficial for stakeholders and new entrants alike.
Reasons to invest in this report include its thorough market analysis and insights into revenue projections across market sub-segments. It provides stakeholders with a comprehensive market overview, assisting in data-driven decision-making and the identification of future opportunities. The report helps in understanding customer demand while equipping businesses, particularly new entrants, with critical market knowledge to devise successful strategies.
Complementary benefits of the report include access to PPT insights, Excel data packs, content customization options, and an in-depth walkthrough with the research team, alongside complimentary updates for reports older than six months.
Companies Featured
Astellas Pharma Fujifilm Holdings JCR Pharmaceuticals Sumitomo Pharma Takeda Pharmaceutical Terumo
For more information about this report visit https://www.researchandmarkets.com/r/mvz948
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
View Comments
- Takeda Announces FY2025 Full Year Results and FY2026 Outlook, Highlighted by Excellent Pipeline Progress and Solid FY2025 Results
May 13, 2026
FY2025 Pipeline Successes Set the Stage for Pivotal Product Launches Achieved Latest FY2025 Management Guidance Takeda is Entering a New Era & Transforming for Growth Acceleration
OSAKA, Japan, May 13, 2026--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the fiscal year 2025 (period ended March 31, 2026). The Company delivered solid results in line with its latest FY2025 Management Guidance, reflecting strong OPEX savings, mitigating revenue headwinds while continuing to invest in future growth.
Key Highlights for FY2025
Revenue decreased by 1.7% YoY at actual exchange rates (AER), resulting from the loss of exclusivity for VYVANSE® which was partially mitigated by Growth and Launch Products. On a Core basis, Revenue decreased by 2.6% at Constant Exchange Rate (CER). Core Operating Profit increased by 0.8% YoY at AER and declined by 0.9% at CER, protected by OPEX savings, while still investing for growth. Reported Operating Profit increased by 19.3% YoY at AER, also reflecting a step-down in amortization expenses for VYVANSE and lower restructuring expenses. Core EPS increased by 5.2% YoY at AER and by 3.1% at CER, while reported EPS increased by 78.1% YoY. Adjusted Free Cash Flow amounted to JPY 684.5 billion, in line with forecast, and the Company ended fiscal year with strong cash balance. Delivered key milestones for oveporexton, rusfertide, and zasocitinib, with positive Phase 3 readouts; completed regulatory submissions for oveporexton and rusfertide, and launch preparations underway.
Takeda Chief Executive Officer (CEO)-elect, Julie Kim, commented: "FY2025 was a pivotal year, validating the strength of our execution against demanding development and regulatory milestones, the resilience of our commercial portfolio and our strong position with three major launches planned in the next 12 months and the most robust late-stage pipeline in our history. Our growth roadmap is built around two strategic horizons: transforming for growth through near-term launches and strengthening competitiveness and accelerating growth by transitioning to a new cohort of blockbuster brands, together positioning us for long-term profitable growth and patient impact."
Takeda Chief Financial Officer, Milano Furuta, commented: "In FY2025, despite topline headwinds, we delivered solid profit and cash flow through disciplined cost control, while directing growth investment toward new product launches and the pipeline. In FY2026, we will continue to focus on transforming operations and protecting profitability while delivering successful launches and advancing our pipeline. Strong cash flow generation and deleveraging will support long-term investment for growth acceleration and ensure competitive returns for our shareholders."
Story Continues
Full-year FY2026 Forecast and Guidance Based on the current business outlook and planned investment profile, Takeda issued the following FY2026 forecast and management guidance.
(Billion yen, except percentages and per share amounts) Item FY2026
FORECAST FY2026
MANAGEMENT GUIDANCE
Core Change at CER
(Non-IFRS) Revenue 4,640.0 --- Core Revenue (Non-IFRS) 4,640.0 Low- single digit % decline Operating Profit 420.0 --- Core Operating Profit (Non-IFRS) 1,160.0 5% ~ 8% decline Net Profit 166.0 --- EPS (Yen) 104 --- Core EPS (Yen (Non-IFRS) 472 Mid-teens % decline Adjusted Free Cash Flow (Non-IFRS) 650.0-750.0 --- Annual Dividend per Share (Yen) 204 ---
Pipeline Achievements Set the Stage for Future Growth Our three leading late-stage assets are positioned for regulatory approvals in the U.S. and other geographies in FY2026-2027. We expect this will be a pivotal period for launches and investment with clear near-term wins and proof points over the next 12–24 months.
oveporexton:
Oveporexton is potentially a first-of-its-kind orexin agonist designed to address the underlying orexin deficiency that causes narcolepsy type 1. Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for oveporexton in the second half of 2026 and has also completed regulatory filings in Japan and China.
rusfertide:
Rusfertide is a potential first‑in‑class hepcidin mimetic that has demonstrated rapid, stable, and durable hematocrit control in patients with polycythemia vera, or PV, and has the potential to shift the standard of care in this blood cancer. Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for rusfertide in the second half of 2026.
zasocitinib:
Zasocitinib is poised to be a leading oral treatment option for psoriasis patients with the potential to significantly expand the oral segment in a growing psoriasis market. Takeda is making decisive investments to support a planned regulatory filing in 2026 and a commercial launch in the first half of 2027.
FINANCIAL HIGHLIGHTS for FY2025 Ended March 31, 2026 (Billion yen, except percentages and per share amounts) Item FY2025
(Billion JPY) FY2024
(Billion JPY) YoY Growth
(AER) Revenue 4,505.7 4,581.6 -1.7% Operating Profit 408.8 342.6 +19.3% Margin 9.1% 7.5% +1.6pp Net Profit 191.8 107.9 +77.7% EPS (Yen) 122 68 +78.1% Operating Cash Flow 1,041.4 1057.2 -1.5% Adjusted Free Cash
Flow (Non-IFRS) 684.5 769.0 -11.0%
Core (Non-IFRS) (Billion yen, except percentages and per share amounts) Item FY2025
(Billion JPY) FY2024
(Billion JPY) YoY Growth
(AER) YoY Growth
(CER) Revenue 4,505.7 4,579.8 -1.6% -2.6% Operating Profit 1,172.5 1,162.6 +0.8% -0.9% Margin 26.0% 25.4% +0.6pp --- Net Profit 814.1 775.6 +5.0% +2.9% EPS (Yen) 517 491 +5.2% +3.1%
Capital Allocation and Shareholder Returns Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation to drive growth and enables the company to deliver returns to shareholders under its progressive dividend policy. In FY2025, the proposed annual dividend was JPY 200 per share, and year-end adjusted net debt/adjusted EBITDA was 2.6x.
Additional Information About Takeda’s FY2025 Results Takeda will host a conference call for investors and analysts on Wednesday, May 13, 2026, at 7:00 PM JST / 6:00 AM EDT to discuss its full-year 2025 financial results.
A live webcast of the conference call, along with presentation materials, will be available on the investor relations section of Takeda’s website at www.takeda.com/investors. The presentation will contain further details on Takeda’s FY2025 results, commercial progress, pipeline updates, and other financial information, including key assumptions for the FY2026 forecast and definitions of non-IFRS measures.
About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit https://www.takeda.com.
Important Notice For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners.
Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could", "anticipates", "estimates", "projects", "forecasts", "outlook" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
Financial information and Non-IFRS Measures
Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards ("IFRS").
This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate ("CER") change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as "reported" measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2025 Q4 investor presentation (available at www.takeda.com/investors).
Medical information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
Please refer to slide 14 of Takeda’s FY2025 Q4 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260510786927/en/
Contacts
Investor Relations
Christopher O’Reilly
Christopher.oreilly@takeda.com
+81 (0) 90-6481-3412
Media Relations
Media_relations@takeda.com
View Comments
- Takeda Pharmaceutical (TSE:4502) Valuation Check After Recent Share Price Pullback
May 11, 2026
Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide.
Recent share performance and business snapshot
Takeda Pharmaceutical (TSE:4502) has recently been on investors’ radar after a period in which the stock fell around 10% over the past month and about 7% over the past 3 months.
The company reports annual revenue of ¥4,464,578 and net income of ¥112,926, with both figures showing positive annual growth. The stock’s total return is positive over the past year, 3 years, and 5 years.
Takeda generates revenue primarily from pharmaceutical products, with sizeable geographic exposure to the United States, Europe and Canada, Japan, and Latin America. This gives the business a broad international footprint.
See our latest analysis for Takeda Pharmaceutical.
At the current share price of ¥5,173, Takeda’s recent pullback, with the 30 day share price return down 9.75% and the 90 day share price return down 7.31%, contrasts with a much stronger 1 year total shareholder return of 34.61%. This suggests shorter term momentum has cooled while longer term holders have still seen solid gains.
If recent pharma volatility has you reassessing your watchlist, it can help to widen your scope and check out 8 healthcare AI stocks
So, with revenue and net income both growing, a value score of 2, and the stock trading below the average analyst price target, is Takeda still trading at a discount, or is the market already pricing in future growth?
Most Popular Narrative: 14.3% Undervalued
Takeda’s most followed narrative points to a fair value of ¥6,036.87, which sits above the last close of ¥5,173, and frames the recent pullback as a potential valuation gap based on long term forecasts.
The anticipated moderation and eventual stabilization of VYVANSE generic erosion after FY2025 will remove a major headwind for revenues, allowing Takeda's core growth and launch products to drive top-line and earnings recovery going forward.
Read the complete narrative.
Curious what earnings trajectory, margin shift, and long term revenue path need to line up for that fair value to hold up over time.
Result: Fair Value of ¥6,036.87 (UNDERVALUED)
Have a read of the narrative in full and understand what's behind the forecasts.
However, this narrative can still be knocked off course if generic and biosimilar competition bites harder than expected, or if key late stage pipeline assets disappoint.
Find out about the key risks to this Takeda Pharmaceutical narrative.
Another View: Earnings Multiple Sends a Different Signal
While the SWS DCF model suggests Takeda is trading well below estimated future cash flow value at ¥18,813.75 versus a share price of ¥5,173, the current 72.4x P/E is far above the JP Pharmaceuticals industry at 15.4x and a fair ratio of 37.4x. That mix of deep DCF upside and rich earnings multiple raises a simple question: which set of assumptions do you trust more?
Story Continues
Look into how the SWS DCF model arrives at its fair value.4502 Discounted Cash Flow as at May 2026
Next Steps
With sentiment looking mixed, this is a moment to move quickly, review the underlying data yourself, and weigh up the 2 key rewards and 4 important warning signs.
Looking for more investment ideas?
If Takeda has sharpened your focus on quality, do not stop here. Broaden your opportunity set with focused stock lists built from clear, transparent criteria.
Spot potential mispricings early and size up companies with strong fundamentals by scanning through 15 high quality undervalued stocks. Strengthen the defensive side of your portfolio and reduce portfolio shocks by searching for 45 resilient stocks with low risk scores. Get ahead of the crowd and hunt for future standouts using a screener containing 54 high quality undiscovered gems.
This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include 4502.T.
Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com
View Comments
- DNLI Q1 Loss Narrower Than Expected, Avlayah Approval Boosts Prospects
May 8, 2026
Denali Therapeutics DNLI reported a first-quarter 2026 loss of 69 cents per share, narrower than the Zacks Consensus Estimate of a loss of 73 cents. The company had incurred a loss of 78 cents in the year-ago quarter.
In late March, Denali secured a major regulatory win with the FDA approval of lead pipeline candidate tividenofusp alfa-eknm, under the brand name Avlayah, for the treatment of Hunter Syndrome (MPS II). The FDA granted accelerated approval to Avlayah, marking the first new treatment option in nearly 20 years for patients with Hunter syndrome, a rare lysosomal storage disorder. It is also the first approved therapy in a new class of biologics designed to cross the blood-brain barrier by targeting the transferrin receptor. The continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory study.
Avlayah is an enzyme replacement therapy indicated for pediatric patients with MPS II, targeting neurological symptoms when initiated early. However, the drug is yet to be commercially launched in the United States, and therefore, Denali did not generate any revenues in the reported quarter. The Zacks Consensus Estimate for revenues was pegged at $10 million. The company also periodically recognizes collaboration revenues.
Following Avlayah approval, the FDA granted Denali a Rare Pediatric Disease Priority Review Voucher, which can be used to secure priority review for a future marketing application or transferred to another sponsor.
Highlights of DNLI’s Q1 Results
Research and development expenses decreased 11% to $103.8 million due to the timing of manufacturing of Avlayah commercial supply in the first quarter of 2025, as well as lower external expenses related to small molecule programs.
General and administrative expenses increased 14% to $33.5 million primarily due to higher personnel-related expenses resulting from increased headcount in the first quarter of 2026, reflecting staffing additions made throughout 2025 to support Avlayah’s post-launch activities.
As of March 31, 2026, cash, cash equivalents, and marketable securities amounted to approximately $1.05 billion compared with $966.2 million as of Dec. 31, 2025.
Shares of DNLI have gained 19.4% year to date against the industry’s 0.2% decline.Zacks Investment Research
Image Source: Zacks Investment Research
DNLI’s Key Pipeline Updates
Denali’s ongoing global phase II/III COMPASS study is expected to provide confirmatory data and support regulatory filings for tividenofusp alfa-eknm worldwide, including in young adult patients with Hunter syndrome. Positive outcomes from this study could further expand the drug’s commercial potential and reinforce DNLI’s position in the rare neurodegenerative disease market.
Story Continues
Denali is evaluating DNL126 for the treatment of Sanfilippo syndrome type A (MPS IIIA). It is an investigational intravenously administered ETV-enabled SGSH replacement therapy, being developed to target the neurological and systemic manifestations of the disease by delivering the enzyme to both the brain and body. Per DNLI, the phase I/II MPS IIIA study is ongoing, while start-up activities for a global phase III confirmatory study for this indication are also underway. A regulatory submission with potential accelerated approval is anticipated in 2027.
Denali is also developing other candidates in partnership with Biogen BIIB and Sanofi SNY.
Denali and Biogen continue co-development of BIIB122/DNL151.
Biogen is leading the global phase IIb LUMA study, evaluating BIIB122's impact on disease progression in early-stage Parkinson’s disease (PD). Data is expected in mid-2026. Denali is conducting the phase IIa BEACON study, specifically enrolling participants with LRRK2-associated PD to assess how LRRK2 inhibition may impact this disease.
Sanofi is developing eclitasertib for moderate to severe ulcerative colitis. Data from the phase II study is expected in the first half of the year.
Denali Therapeutics Inc. Price, Consensus and EPS SurpriseDenali Therapeutics Inc. Price, Consensus and EPS Surprise
Denali Therapeutics Inc. price-consensus-eps-surprise-chart | Denali Therapeutics Inc. Quote
Denali is also developing DNL952, an ETV-enabled therapy designed to enhance the delivery of the missing GAA enzyme to muscle tissues and across the blood-brain barrier into the brain, with phase I study start-up activities currently underway.
Last month, Denali announced that former partner Takeda TAK decided to terminate their collaboration agreement to co-develop and co-commercialize DNL593 (PTV: PGRN). Per DNLI, Takeda’s decision was based on strategic priorities and not on any efficacy or safety issues. Following the termination of the co-development agreement, Denali regained full ownership of DNL593 along with its intellectual property.
Denali is conducting a phase I/II study evaluating DNL593, an investigational, intravenously-administered progranulin replacement therapy that uses its PTV platform to deliver progranulin across the blood-brain barrier into the brain for patients with frontotemporal dementia caused by GRN mutations. Enrollment in the study is complete with 40 participants, and results are expected by the end of 2026.
Another candidate in Denali Therapeutics’ pipeline is DNL628, an investigational OTV-enabled therapy for Alzheimer’s disease designed to cross the blood-brain barrier and reduce tau protein levels by targeting the MAPT gene. The first patient was dosed in the phase Ib study in March 2026, with data expected in the first half of 2027.
Our Take on DNLI’s Performance
The approval of Avlayah has significantly boosted DNLI’s growth prospects. The company’s progress with DNL126 is encouraging as well.
The company’s sound cash position is a positive and underscores its ability to fund ongoing programs.
DNLI’s Zacks Rank
Denali currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Sanofi (SNY) : Free Stock Analysis Report
Biogen Inc. (BIIB) : Free Stock Analysis Report
Denali Therapeutics Inc. (DNLI) : Free Stock Analysis Report
Takeda Pharmaceutical Co. (TAK) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
Zacks Investment Research
View Comments
- Timothy P. Walbert Joins Patient Square Capital as a Senior Advisor
May 6, 2026
MENLO PARK, Calif., May 06, 2026--(BUSINESS WIRE)--Patient Square Capital, a leading health care investment firm, today announced that Timothy P. Walbert has joined the firm as a Senior Advisor.
Mr. Walbert brings more than three decades of biopharmaceutical leadership experience and currently serves as Managing Partner of HRZN Partners LLC and a Senior Advisor to Amgen. Most recently, he was Chairman, President, and Chief Executive Officer of Horizon Therapeutics, which he grew to approximately $4 billion in annual sales prior to its $28.3 billion acquisition by Amgen in 2023; earlier, he led IDM Pharma Inc. through its acquisition by Takeda and held senior roles at Abbott (now AbbVie), where he led the global launch of HUMIRA®, as well as at G.D. Searle & Company, Merck & Co., and Wyeth.
"Patient Square Capital has built a highly differentiated platform and a strong record of partnering with management teams to create enduring value in health care," said Tim Walbert. "I’m pleased to join the firm as a Senior Advisor and look forward to contributing my experience in support of the team and its portfolio companies as they advance innovations that improve patient outcomes."
"Tim is an extremely accomplished leader and business builder with a proven history of delivering impactful therapies to patients and creating significant long-term value," said Jim Momtazee, Managing Partner of Patient Square Capital. "We have known Tim for a long time and believe that his depth of experience will be an exceptional resource to our team and our portfolio companies as we expand our investment activities in the therapeutics sector."
Mr. Walbert currently serves on the boards of several public and private companies, including Mirum Pharmaceuticals, Sagimet Biosciences, BioMarin Pharmaceutical, Odyssey Therapeutics, Cour Pharmaceuticals, Catalent, Crystalys Therapeutics, and Latigo Biotherapeutics, where he serves as Chairman. His prior board experience includes Aurinia Pharmaceuticals, Exicure (Chairman), Assertio (Chairman), Raptor Pharmaceutical Corp., Century Therapeutics, XOMA Corporation, and Sucampo Pharmaceuticals. Mr. Walbert earned a Bachelor of Arts in Business from Muhlenberg College.
About Patient Square Capital
Patient Square Capital is a dedicated health care investment firm with over $18 billion in assets under management. The firm aims to achieve strong investment returns by partnering with growth-oriented companies and top-tier management teams whose products, services, and technologies improve health. Patient Square utilizes deep industry expertise, a broad network of relationships, and a partnership approach to make investments in companies that will grow and thrive. Patient Square invests in businesses that strive to improve patient lives, strengthen communities, and create a healthier world. For more information, visit www.patientsquarecapital.com.
Story Continues
View source version on businesswire.com: https://www.businesswire.com/news/home/20260506009468/en/
Contacts
Prosek Partners
pro-PatientSquareCapital@prosek.com
View Comments
- Protagonist Reports First Quarter 2026 Financial Results and Provides Corporate Update
May 5, 2026
ICOTYDE™ (icotrokinra) approved by FDA in March for moderate-to-severe plaque psoriasis, triggering a $50 million milestone payment; Protagonist receives tiered royalties of 6% to 10% and is eligible for up to $580 million in future milestone payments
Rusfertide NDA accepted and granted Priority Review by FDA, with a Prescription Drug User Fee Act target action date in the third quarter of 2026
Protagonist exercised its rusfertide opt-out right under the Takeda collaboration on April 28, triggering a $200 million opt-out fee payable to the Company; eligible for additional $200 million opt-out and $75 million milestone payments upon NDA approval, sales milestones of up to $775 million and worldwide royalties ranging from 14% to 29%
PN-881 (oral IL-17 antagonist peptide) Phase 1 study completion by mid-2026 and Phase 2 initiation anticipated by year-end; PN-477sc and PN-477o (sc and oral triple GLP/GIP/GICG agonist) Phase 1 initiation expected in mid-2026 and Q1 2027, respectively
Cash, cash equivalents and marketable securities of $620 million as of March 31, 2026, anticipated to provide cash runway through at least 2028
NEWARK, CA / ACCESS Newswire / May 5, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.
"The first quarter of 2026 marked a series of landmark achievements for Protagonist, highlighted by the U.S. approval of ICOTYDE, FDA granting Priority Review for rusfertide, and advancement of our highly differentiated and fully-owned peptides PN-881 and PN-477," said Dinesh V. Patel, Ph.D., the Company's President and Chief Executive Officer. "These accomplishments, together with the additional financial resources afforded by our rusfertide opt-out election and future milestones and royalty payments from ICOTYDE and rusfertide, position Protagonist for meaningful near-, medium and long-term value creation through rapid progression of clinical stage assets and further expansion into new internal discovery programs. In addition, we look forward to implementing an efficient capital return strategy at the appropriate time."
First Quarter 2026 Recent Developments and Upcoming Milestones
Rusfertide
On March 2, Takeda and Protagonist announced that the U.S. FDA accepted the New Drug Application for rusfertide and granted Priority Review. The application is supported by data from the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized VERIFY study, as well as four-year efficacy and safety data from the Phase 2 REVIVE study and long-term extension THRIVE study. The FDA set a PDUFA goal date in August 2026.
Story Continues
On April 28, Protagonist announced that it exercised its right to opt out of the U.S. profit and loss sharing arrangement under the terms of its collaboration agreement with Takeda for rusfertide. The opt-out election triggers a $200 million payment to Protagonist, with an additional $200 opt-out fee and a separate $75 million milestone for FDA approval of rusfertide. The opt-out election also increases downstream economics payable to Protagonist, including up to $775 million in sales milestone payments and tiered worldwide royalties ranging from 14% to 29%. At $1.5 billion in annual net sales, the weighted-average royalty rate is approximately 21%, with the 29% tier applying to annual sales above $1.5 billion.
ICOTYDE™ (icotrokina)
On March 18, Protagonist announced that Johnson & Johnson received U.S. Food and Drug Administration approval for ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The FDA approval triggered a $50 million milestone payment to Protagonist in the first quarter of 2026. Under the collaboration, Protagonist remains eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as tiered royalties ranging from 6% to 10% on global net sales with an approximate 7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier applying to the incremental annual sales above $4 billion. ICOTYDE is the first and only FDA-approved targeted oral peptide for moderate-to-severe plaque psoriasis
On March 28, Protagonist announced presentation of new one-year Phase 3 ICOTYDE results at the 2026 American Academy of Dermatology Annual Meeting. Data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies further supported the potential of ICOTYDE as a differentiated oral therapy for patients with moderate-to-severe plaque psoriasis, demonstrating durable efficacy and a favorable safety profile in a once-daily pill.
Wholly-Owned Clinical and Discovery Programs
PN-881 (oral IL-17 antagonist peptide): The Company expects completion of Phase 1 study by mid-2026 and initiation of a Phase 2 study by end of 2026. PN-477 (triple-G GLP/GIP/GCG agonist peptide): Phase 1 initiation of PN-477sc and PN-477o anticipated in mid-2026 and Q1 2027, respectively. PN-458 (dual GLP/GIP agonist peptide): IND-enabling studies in progress with PN-458sc and PN-458o PN-8047 (oral small molecule hepcidin functional mimetic): IND-enabling studies in progress Discovery: Oral IL-4Rα antagonist and amylin oral mono/poly agonists are high-priority discovery programs.
First Quarter 2026 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2026, were $620.3 million as compared to $646.0 million as of December 31, 2025.
Three Months Ended March 31, (in thousands, except per share amounts) 2026 2025 (Unaudited) License and collaboration revenue $ 56,368 $ 28,321 Research and development expense $ 46,739 $ 35,893 General and administrative expense $ 13,277 $ 11,738 Income tax benefit $ 1,502 $ - Net income (loss) $ 3,783 $ (11,655 ) Basic earnings (loss) per share $ 0.06 $ (0.19) Diluted earnings (loss) per share $ 0.05 $ (0.19)
License and Collaboration Revenue: License and collaboration revenue of $56.4 million for the period ended March 31, 2026 consisted of (i) a $50.0 million milestone earned from JNJ in Q1 26 upon FDA approval of ICOTYDE, (ii) $3.3 million allocated to development services provided by us under the Takeda agreement during the period and (iii) $3.1 million cost reimbursement from Takeda for rusfertide clinical trial supplies. License and collaboration revenue of $28.3 million for the period ended March 31, 2025 consisted of (i) $22.8 million related to proportional recognition of a $25.0 million milestone earned in Q1 2025, and (ii) $5.5 million allocated to development services provided by us under the agreement during the period.
Research and Development ("R&D") Expense: The increase in R&D expense from the prior year period was primarily due to increases related to our Phase 1 study for PN-881 and pre-clinical and drug discovery research expenses, including our obesity product candidates, partially offset by a decrease in rusfertide expenses related to the Phase 3 VERIFY clinical trial.
General and Administrative ("G&A") Expense: The increase in G&A expense from the prior year period was primarily due to an increase in personnel-related expenses, including wages and benefits and stock-based compensation.
Income Tax Benefit: Income tax benefit was $1.5 million for the period ended March 31, 2026 and included a discrete credit for stock-based compensation expense specific to the current quarter.
Net Income (Loss): Net income was $3.8 million, or $0.06 per basic share and $0.05 per diluted share, for the first quarter of 2026 as compared to net loss of $11.7 million, or $0.19 per basic and diluted share, for the first quarter of 2025.
About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026, is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the treatment polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.
More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding potential revenue from the Company's collaborations with Johnson & Johnson and Takeda, timing of regulatory actions and clinical trial completion, and advancement of the Company's discovery and clinical pipeline. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone and royalty payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.
Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577
Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1
PROTAGONIST THERAPEUTICS, INC.
Consolidated Statements of Operations
(Amounts in thousands except share and per share data)
Three Months Ended March 31, 2026 2025 License and collaboration revenue $ 56,368 $ 28,321 Operating expense: Research and development (1) 46,739 35,893 General and administrative (1) 13,277 11,738 Total operating expense 60,016 47,631 Loss from operations (3,648 ) (19,310 ) Interest income 5,876 7,573 Other income, net 53 82 Income (loss) before income tax benefit 2,281 (11,655 ) Income tax benefit 1,502 - Net income (loss) $ 3,783 $ (11,655 ) Net income (loss) per share, basic $ 0.06 $ (0.19 ) Net income (loss) per share, diluted $ 0.05 $ (0.19 ) Weighted-average shares used to compute net income (loss) per share, basic 65,087,847 62,963,806 Weighted-average shares used to compute net income (loss) per share, diluted 70,492,618 62,963,806
(1) Amount includes non-cash stock-based compensation expense.
Stock-based Compensation
(In thousands)
Three Months Ended March 31, 2026 2025 Research and development $ 7,769 $ 7,991 General and administrative 6,750 5,811 Total stock-based compensation expense $ 14,519 $ 13,802
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
March 31, December 31, 2026 2025 Cash, cash equivalents and marketable securities$ 620,334 $ 646,002 Working capital 578,906 532,133 Total assets 697,459 668,188 Deferred revenue 6,282 9,550 Accumulated deficit (466,888 ) (470,671 ) Total stockholders' equity 655,473 614,707
SOURCE: Protagonist Therapeutics
View the original press release on ACCESS Newswire
View Comments
- Will the Label Expansion of Asceniv Boost ADMA's Top-Line Growth?
May 5, 2026
ADMA Biologics (ADMA) recently announced that the FDA has approved a supplemental biologics license application for its lead drug Asceniv.
Asceniv (immune globulin intravenous, human – slra 10% liquid), a plasma-derived, polyclonal, intravenous immune globulin (IVIG), was initially approved by the FDA in April 2019.
It was earlier indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age).
The regulatory body recently expanded Asceniv’s label to include pediatric immune compromised patients two years of age and older.
The label expansion meaningfully broadens Asceniv’s addressable market, enabling earlier-line use in younger PI patients. This should support incremental volume growth and strengthen ADMA’s competitive positioning within the IVIG market, particularly given Asceniv’s differentiated, patent-protected plasma sourcing and formulation.
The pediatric approval also removes a regulatory overhang tied to post-marketing commitments, improving the product’s lifecycle visibility. Management’s focus now shifts to driving adoption in the newly eligible patient population, which could serve as a near- to medium-term revenue catalyst.
Total revenues of $510.2 million in 2025 were up 20% from 2024, driven by higher Asceniv sales due to continued growth in physician, payer and patient adoption. Asceniv delivered record utilization in 2025, with revenues climbing 51% year over year to $363 million on strong demand and growing prescriber adoption. The trend is likely to have continued in the first quarter (results are expected later in the week).
Third-party suppliers outperformed expectations in 2025, and newly executed agreements now provide access to more than 280 plasma collection centers, significantly strengthening Asceniv’s long-term supply outlook.
ADMA expects 2026 revenues to exceed $635 million.
The company is positioned to benefit in 2026 from a continued shift in product mix toward higher-margin IVIG therapies, supporting further gross margin expansion. Hence, margins have likely improved in the first quarter.
Competition in the Plasma Therapy Market
ADMA Biologics competes with Grifols GRFS and Takeda TAK for plasma-derived products.
GRFS is a leading producer of plasma derivatives globally, ranking among the three largest producers in the industry in terms of total sales, alongside Takeda and CSL Group. The main plasma products that Grifols manufactures are IG, Factor VIII, Alpha 1 (A1PI) and albumin. Grifols also manufactures intramuscular (hyperimmune) immunoglobulins (IGs), ATIII, Factor IX and plasma thromboplastin component.
Story Continues
GRFS has a strong presence across key segments of the plasma derivatives industry, including A1PI, IG, and albumin, supported by its leading position in plasma collection centers and robust fractionation capacity.
Takeda’s broad immunoglobulin portfolio includes Hyqvia, Cuvitru, Gammagard Liquid and Gammagard Liquid ECR. The company is developing next-generation IG products with 20% facilitated SCIG (TAK-881). It is also pursuing other early-stage opportunities (e.g., hypersialylated Immunoglobulin [hsIgG]) that would diversify its portfolio further.
ADMA’s Price Performance, Valuation & Estimates
ADMA shares have plunged 43.5% year to date compared with the industry’s decline of 3.2%.Zacks Investment Research
Image Source: Zacks Investment Research
From a valuation perspective, ADMA is expensive at this moment. ADMA’s shares currently trade at 3.70x forward sales, lower than its mean of 3.73x but higher than the industry’s 2.05x.Zacks Investment Research
Image Source: Zacks Investment Research
Earnings estimates for 2026 have decreased to 93 cents per share from 96 cents over the past 60 days, while those for 2027 have declined to $1.34 from $1.38.Zacks Investment Research
Image Source: Zacks Investment Research
ADMA currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Grifols, S.A. (GRFS) : Free Stock Analysis Report
ADMA Biologics Inc (ADMA) : Free Stock Analysis Report
Takeda Pharmaceutical Co. (TAK) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
Zacks Investment Research
View Comments
- Model N Appoints Thomas Gibbs to Board of Directors
May 5, 2026
Seasoned pharmaceutical executive brings over 25 years of commercial leadership to Model N board
REDWOOD CITY, Calif., May 05, 2026 (GLOBE NEWSWIRE) -- Model N, a leading end-to-end commercialization, revenue optimization, and compliance platform for life sciences companies, announced the appointment of Thomas Gibbs to the company’s board of directors.
Gibbs has over 25 years of leadership experience across Executive Management, Marketing, Sales, Commercial Operations, and Finance at small, mid-size, and large pharmaceutical companies. He is the Executive Vice President and President of Lundbeck US, a biopharmaceutical company focused exclusively on brain health. Throughout his career, Gibbs has held senior commercial and general management roles at Johnson & Johnson, Novartis, Bristol Myers Squibb, Takeda, Endo Pharmaceuticals, Vanda Pharmaceuticals, OptiNose, and Sunovion. These include Chief Commercial Officer positions overseeing U.S., Canadian, and European markets for companies with leading central nervous system (CNS) franchises.
“Tom brings deep pharmaceutical leadership and extensive experience scaling complex, global organizations while driving measurable business impact,” said Bret Connor, CEO of Model N. “His strength lies in integrating strategy, analytics, and cross-functional collaboration to help drive sustainable growth. As Model N continues to advance its offerings and expand globally, we believe his expertise will play an important role in our continued momentum.”
“Life sciences companies face increasing pressure to modernize operations and enable sustainable, data-driven growth, and Model N is uniquely positioned to support that journey,” said Gibbs. “I look forward to bringing my experience to help advance Model N’s strategy and deliver greater value for its customers.”
Gibbs’ role was sourced through the external board program operated by Vista Equity Partners, a global technology investor that specializes in enterprise software and is a majority investor in Model N. Launched in 2017, the board program leverages Vista’s ecosystem and additional resources to identify, train, and appoint qualified board candidates for its portfolio companies. The program works to create a pipeline of highly talented board candidates through programs and partnerships that will drive results for the corporate world at large.
For more about Model N, visit www.modeln.com.
###
About Model N
For more than 25 years, Model N has been the leader in end-to-end commercialization, revenue optimization, and compliance for pharmaceutical, medtech, and high-tech innovators. With a focus on innovation and customer success, Model N helps manufacturers streamline their revenue operations and remain compliant, empowering them to deliver life-changing products to the world. Our intelligent platform, purpose-built solutions, and advanced analytics and AI automation are trusted by more than 150 of the world’s leading companies across more than 120 countries. For more information, visit www.modeln.com.
Story Continues
CONTACT: PANBlast for Model N modeln@panblastpr.com
View Comments
- Zifo's SiEE Boston Summit Charts New Roadmap for 'Practical AI' in Life Sciences, Bridging the Gap Between Business Vision and Lab Reality
May 5, 2026
BOSTON, May 5, 2026 /PRNewswire/ -- Trading the abstract allure of AI hype for a technical implementation roadmap, Zifo's 2026 Scientific Informatics Experience Exchange (SiEE) in Boston concluded with heavyweights from Sanofi, Takeda, AbbVie, Regeneron, Biogen, Eli Lilly, Novo Nordisk, J&J, and Broad Institute establishing that the industry's digital future now rests on the 'first mile' of lab data integrity.Zifo's SiEE Boston 2026
As the industry grapples with the transition from experimental digital pilots to enterprise-wide AI scaling, Zifo's SiEE Boston summit served as a critical decision-making forum. The primary outcome was a unified consensus: it is time to move beyond the theoretical underpinnings of what is possible and focus on solving the thorny problems that scientists and informaticians face on a day-to-day basis.
"SiEE Boston 2026 proved that the industry is ready to stop asking 'what' AI can do and start solving 'how' it can be implemented with regulatory rigor," said Margaret DiFilippo, Vice President of Customer Success at Zifo. "The exchange established that the future of science depends on democratizing data access and ensuring that our digital transformation projects are built on a foundation of yesterday's data quality combined with tomorrow's automation."
Future-Focused Outcomes and Expert Highlights the summit featured a heavy-hitting agenda of 16 industry practitioners who provided actionable insights into the future of scientific informatics:
Defining the New Scientific Method:Leah O'Brien (Sanofi) challenged the traditional research status quo, outlining how the digital lab revolution is fundamentally accelerating and removing friction from the scientific method for the next generation of researchers. AI Implementation at Scale:Mike Crowe (formerly Colgate) delivered critical considerations for AI-assisted product development, while Kelly Desino (AbbVie) showcased how graph analytics are now being used to drive clinical asset prioritization. The Data-Identity Nexus: A headline panel featuring Ragavi Shanmugam (Zifo), Will Weiss (Eli Lilly), Sovanda Kaing (Takeda), and David Nirschl (J&J) debated that AI-ready data is certainly a prerequisite for AI, but the way to get there will be a combination of mining historical high-value data with for-cause regeneration of new data, with all the right controls and metadata. Translational Outcomes:Vinayagam (Vinu) Arunachalam (Takeda) bridged the gap between computational biology and the clinic, discussing the journey from biomarker insight to clinical decisions under regulatory scrutiny.
Story Continues
Deep-Dive Breakout Success The afternoon sessions divided the collective expertise into two specialized tracks to solve technical hurdles in the drug development journey:
R&D Track:Cathy Kuang (Formerly Takeda) spoke on how data, AI, and automation are reshaping life sciences; Ricardo Schiavo (Regeneron) detailed the democratization of lab data; and Chris Perkins (Broad Institute) shared strategies for operationalizing the 'first mile' of lab data flow in complex research environments. QA/CMC Track:Lira Mishra (Biogen) addressed the rising urgency of laboratory cybersecurity; Diana Bowley (AbbVie) mapped the digital transformation of bioprocess labs; Clark Leininger (Formerly Moderna) shared lessons on 'Failing Successfully' to ensure project delivery; and Nara Aravamudhan (Zifo) tackled the specific challenges of AI-assisted LIMS rollouts.
A High-Commitment Exchange
The exclusivity of the event was underscored by the high level of engagement from the scientific community. The summit hosted a focused group of nearly 120 attendees. Notably, registered partner organizations showed a remarkable 84% attendance rate, reflecting the critical importance of the SiEE platform in the current technology landscape.
Watch the Sessions
If you missed the debate or want to revisit the technical deep dives, the full event recording is now available. To watch the recording, click here: https://zifornd.com/event/siee-boston-2026-ondemand/
What's Next?
The energy from Boston is moving across the Atlantic. Zifo will host its next global dialogue (SiEE) in Basel on June 2, 2026. https://zifornd.com/event/siee-basel-2026/
About Zifo
Zifo is the leading global enabler of AI and data driven enterprise informatics for science driven organizations. With extensive solutions and services expertise spanning research, development, manufacturing, and clinical domains, we serve a diverse range of industries, including Pharma, Biotech, Chemicals, Food and Beverage, Oil & Gas, and FMCG. Trusted by over 190 science-focused organizations worldwide, Zifo is the partner of choice for advancing digital scientific innovation. https://zifornd.com
Photo: https://mma.prnewswire.com/media/2972740/Zifo_SiEE_Boston_2026.jpg
Logo: https://mma.prnewswire.com/media/2731415/5953595/Zifo_Technologies_Logo.jpgZifo Technologies Logo (PRNewsfoto/Zifo Technologies)Cision
View original content to download multimedia:https://www.prnewswire.com/news-releases/zifos-siee-boston-summit-charts-new-roadmap-for-practical-ai-in-life-sciences-bridging-the-gap-between-business-vision-and-lab-reality-302762651.html
View Comments
- British Columbia reimburses REVESTIVE® (teduglutide for injection) for the treatment of Short Bowel Syndrome
May 5, 2026
TORONTO, May 5, 2026 /CNW/ - Takeda Canada Inc. ("Takeda") announced that REVESTIVE® (teduglutide for injection) will now be reimbursed by BC PharmaCare for eligible pediatric and adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.1 Coverage is subject to specific criteria.2Takeda Canada (CNW Group/Takeda Canada Inc.)
For people living with SBS, reimbursed access can help reduce reliance on parenteral support, which includes intravenous administration of nutrition, fluids, and electrolytes.
"We welcome the Government of B.C.'s decision to reimburse REVESTIVE for people living with Short Bowel Syndrome. This decision is an important step toward improving equitable access to care and supporting better health outcomes," said Gail Attara, CEO and Co-founder of the Gastrointestinal Society and President of the Canadian Society of Intestinal Research. "Patient organizations have long engaged with provincial governments on the need for timely access to therapies for rare digestive disorders. We look forward to continuing to work collaboratively with policymakers and partners to strengthen access to appropriate treatments for Canadians living with complex GI conditions."
SBS occurs when the small intestine is unable to absorb enough nutrients and fluids – often due to surgical removal, damage, or disease.3 People living with SBS may experience dehydration, malnutrition, fatigue, and weight loss, among other serious health impacts.3 Management can include medications, surgery, and significant dietary changes.4 SBS affects approximately 800 Canadians and has an estimated mortality rate of almost 40 per cent. 5
"Many people living with SBS rely on parenteral support delivered intravenously (IV). While lifesaving, IV support can be associated with serious complications and can significantly affect quality of life for patients and caregivers," said Dr. Andrea Martinez, Medical Director, Complex Feeding and Nutrition Service, BC Children's Hospital. "REVESTIVE has been shown to help some patients reduce their need for parenteral support, which can translate into meaningful improvements not only in day-to-day life but also in long-term outcomes."
Health Canada issued a Notice of Compliance for REVESTIVE in 2015 for the treatment of adult patients with SBS who are dependent on parenteral support. It was approved in Canada for pediatric patients one year of age and above for the same indication in 2019.
"This reimbursement is another step forward for people in B.C. living with Short Bowel Syndrome, improving access to a therapy that can help eligible patients reduce reliance on parenteral support," said Thiago Magalhães, Business Unit Head, GI² and Mature Brands. "REVESTIVE reflects Canadian innovation, rooted in the discovery of Glucagon-like peptide-2 (GLP-2) at the University of Toronto and advanced through Canadian research, development, and clinical participation."
Story Continues
About REVESTIVE® REVESTIVE® (teduglutide for injection) is currently indicated in Canada for the treatment of adults and pediatric patients one year of age and above with Short Bowel Syndrome who are dependent on parenteral support.1
About Short Bowel Syndrome with Intestinal Failure Short bowel syndrome–associated intestinal failure (SBS-IF) is characterized by reduced gut absorptive function below the minimum necessary for absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation (parenteral nutrition and/or IV fluids/electrolytes) is required to maintain health. When intestinal adaptation is inadequate following extensive intestinal resection or injury, patients may require chronic parenteral support to maintain hydration and nutrient balance.6,7,8
About Takeda Canada Inc. Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: https://www.takeda.com/en-ca/.
_______________________________________ 1 REVESTIVE (Teduglutide for injection), Submission Control 296120, Product Monograph, Takeda Canada Inc. (SEP 19, 2025). Available at: https://takeda.info/en-ca-revestivepm. 2 Drug Coverage Decision for BC PharmaCare. Available at: https://www2.gov.bc.ca/assets/gov/health/health-drug-coverage/pharmacare/decisions/4109_teduglutide_revestive_dds.pdf (accessed April 2026). 3 GI Society, Canadian Society of Intestinal Research. Short Bowel Syndrome. Available at: Short Bowel Syndrome | Gastrointestinal Society. 4 O'Keefe SJD, Buchman AL, Fishbein TM, Jeejeebhoy KN, Jeppesen PB, Shaffer J. (2006). Short bowel syndrome and intestinal failure: Consensus definitions and overview. Clin Gastroenterol Hepatol; 4:6-10. 5 Amin S, Pappas C, Lyengar H, Maheshwari A. Short Bowel Syndrome in the Nicu. Clin Perinatol. 2013 Jan 17;40(1):10.1016/j.clp.2012.12.003. doi: 10.1016/j.clp.2012.12.003. PMID: 23415263; PMCID: PMC3886240. Available at: Short Bowel Syndrome in the Nicu - PMC. 6 Pironi L, et al. ESPEN guideline on chronic intestinal failure in adults – Update 2023. Clinical Nutrition. 2023 Oct;42(10):1940–2021. doi:10.1016/j.clnu.2023.07.019. PMID: 37639741. (guidelinecentral.com). 7 Wauters L, Joly F. Treatment of short bowel syndrome: Breaking the therapeutic ceiling? Nutr Clin Pract. 2023 May;38(Suppl 1):S76–S87. doi:10.1002/ncp.10974. PMID: 37115030. (pubmed.ncbi.nlm.nih.gov). 8 Bering J, DiBaise JK. Short Bowel Syndrome in Adults. Am J Gastroenterol. 2022 Jun 1;117(6):876–883. doi:10.14309/ajg.0000000000001763. PMID: 35383576. (pubmed.ncbi.nlm.nih.gov).Cision
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2026/05/c1100.html
View Comments
