TYK2

ACELYRIN stockholders to receive increased ownership in the combined company through revised exchange ratio; Alumis and ACELYRIN stockholders to now own approximately 52% and 48%, respectively, of the combined company on a fully diluted basis Merger maximizes the potential value for ACELYRIN stockholders and creates a stronger combined company, best-positioned to realize long-term value of multiple late-stage assets ACELYRIN files investor presentation highlighting benefits of proposed merger and comprehensive Board process Special Meeting of Stockholders for both companies to be held May 13, 2025 SOUTH SAN FRANCISCO, Calif. and LOS ANGELES, April 21, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, and ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced an amendment to the existing terms of their previously announced merger agreement. Under the terms of the amended agreement, ACELYRIN stockholders will now receive 0.4814 shares of Alumis common stock for each share of ACELYRIN common stock owned, representing a meaningful increase in the ownership percentage of the combined company over the original definitive merger agreement. With the amended exchange ratio, Alumis stockholders will own approximately 52% of the combined company and ACELYRIN stockholders will own approximately 48% on a fully diluted basis. Martin Babler, President, Chief Executive Officer and Chairman of Alumis, said, “In recognition of the current market conditions and evolving investor expectations for a successful combination, we have revised the terms of our agreement with ACELYRIN, enabling enhanced value creation opportunities for our respective stockholders. This was carefully considered by our Board of Directors and we continue to firmly believe in the merits of the transaction. This merger provides Alumis the best opportunity to significantly enhance our financial flexibility and runway to advance an expanded late-stage pipeline with multiple near-term development milestones and build commercial capabilities to maximize the value of our portfolio for patients and stockholders. We will continue to work closely with ACELYRIN to successfully complete the transaction and deliver on its significant benefits.” Bruce Cozadd, Chair of the ACELYRIN Board of Directors and member of the Board Transaction Committee, said, “Since announcing the merger, we have had extensive conversations with our stockholders who have expressed an understanding of the strategic rationale for this transaction, while also sharing their perspectives on the value provided to ACELYRIN stockholders. This amended agreement reflects this dialogue with stockholders and meaningfully builds upon the previously announced agreement, which was the result of a rigorous, objective, and competitive process facilitated by the ACELYRIN Board. Because of the Board’s continued efforts, our stockholders now stand to benefit from a greater interest in Alumis’ long-term upside potential. We continue to believe that this combination is the most value-maximizing path forward for ACELYRIN stockholders and that Alumis is the right partner to optimize development of lonigutamab.” ACELYRIN also filed today an investor presentation with the U.S. Securities and Exchange Commission (“SEC”) highlighting additional details and benefits of the amended merger agreement, including: The Alumis merger provides significant potential upside for ACELYRIN stockholders; The combination creates a leading clinical-stage immunology company with a diversified portfolio of product candidates; ACELYRIN’s Independent Board Committee ran a thorough process to review multiple alternatives and optimize terms from Alumis; and With a pro forma cash position of approximately $737 million as of December 31, 2024, and continued operating discipline, Alumis expects runway to advance the combined company’s pipeline through multiple planned key data readouts across several clinical trials and to fund operating expenses and capital expenditure requirements into 2027. The presentation is available on ACELYRIN’s investor relations website at https://investors.acelyrin.com/. Additional Details The amended merger agreement was unanimously recommended and approved by the disinterested directors of each company’s Board. As previously announced, Stockholders representing approximately 62% of Alumis voting common stock and approximately 24% of ACELYRIN common stock have entered into voting agreements in support of the transaction. Alumis and ACELYRIN intend to file supplemental proxy materials with the Securities and Exchange Commission promptly. The companies continue to expect to close the transaction during the second quarter of 2025, subject to the approval by both companies’ stockholders and satisfaction of other customary closing conditions. As previously disclosed, Alumis and ACELYRIN will hold its respective Special Meeting of Stockholders on May 13, 2025, and stockholders of record as of the close of business on April 1, 2025, are entitled to vote at the Special Meetings. Advisors Morgan Stanley & Co. LLC is serving as financial advisor to Alumis, and Cooley LLP is serving as its legal counsel. Guggenheim Securities, LLC is serving as financial advisor to ACELYRIN and Fenwick & West LLP and Paul Hastings LLP are serving as legal counsel.  About Alumis Alumis is a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases. Leveraging its proprietary precision data analytics platform, Alumis is building a pipeline of molecules with the potential to address a broad range of immune-mediated diseases as monotherapy or combination therapies. Alumis’ most advanced product candidate, ESK-001, is an oral, highly selective, small molecule, allosteric inhibitor of tyrosine kinase 2 that is currently being evaluated for the treatment of patients with moderate-to-severe plaque psoriasis and systemic lupus erythematosus. Alumis is also developing A-005, a CNS-penetrant, allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases. Beyond TYK2, Alumis’ proprietary precision data analytics platform and drug discovery expertise have led to the identification of additional preclinical programs that exemplify its precision approach. Incubated by Foresite Labs and led by a team of industry veterans experienced in small-molecule compound drug development for immune-mediated diseases, Alumis is pioneering a precision approach to drug development to potentially produce the next generation of treatment to address immune dysfunction. About ACELYRIN ACELYRIN, INC. (Nasdaq: SLRN) is focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN’s lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease. Forward-Looking Statements This communication contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon current plans, estimates and expectations of management of Alumis Inc. (“Alumis”) and ACELYRIN, Inc. (“ACELYRIN”) in light of historical results and trends, current conditions and potential future developments, and are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as “anticipate,” “expect,” “project,” “intend,” “believe,” “may,” “will,” “should,” “plan,” “could,” “continue,” “target,” “contemplate,” “estimate,” “forecast,” “guidance,” “predict,” “possible,” “potential,” “pursue,” “likely,” and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than statements of historical facts, including express or implied statements regarding the proposed transaction; the conversion of equity interests contemplated by the agreement and plan of merger, dated as of February 6, 2025, as amended on April 20, 2025, by and among the parties (as amended, the “merger agreement”); the issuance of common stock of Alumis contemplated by the merger agreement; the expected filing by Alumis with the Securities and Exchanges Commission (the “SEC”) of a registration statement on Form S-4 (the “registration statement”) and a joint proxy statement/prospectus of Alumis and ACELYRIN to be included therein (the “joint proxy statement/prospectus”); the expected timing of the closing of the proposed transaction; the ability of the parties to complete the proposed transaction considering the various closing conditions; the expected benefits of the proposed transaction; the sufficiency of the combined company’s capital resources; the combined company’s cash runway, which is preliminary, unaudited and subject to change; the competitive ability and position of the combined company; the clinical pipeline of the combined company; and any assumptions underlying any of the foregoing, are forward-looking statements. Risks and uncertainties include, among other things, (i) the risk that the proposed transaction may not be completed in a timely basis or at all, which may adversely affect Alumis’ and ACELYRIN’s businesses and the price of their respective securities; (ii) the potential failure to receive, on a timely basis or otherwise, the required approvals of the proposed transaction, including stockholder approvals by both Alumis’ stockholders and ACELYRIN’S stockholders, and the potential failure to satisfy the other conditions to the consummation of the transaction; (iii) the effect of the announcement, pendency or completion of the proposed transaction on each of Alumis’ or ACELYRIN’s ability to attract, motivate, retain and hire key personnel and maintain relationships with partners, suppliers and others with whom Alumis or ACELYRIN does business, or on Alumis’ or ACELYRIN’s operating results and business generally; (iv) that the proposed transaction may divert management’s attention from each of Alumis’ and ACELYRIN’s ongoing business operations; (v) the risk of any legal proceedings related to the proposed transaction or otherwise, or the impact of the proposed transaction thereupon, including resulting expense or delay; (vi) that Alumis or ACELYRIN may be adversely affected by other economic, business and/or competitive factors; (vii) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement , including in circumstances which would require Alumis or ACELYRIN to pay a termination fee; (viii) the risk that restrictions during the pendency of the proposed transaction may impact Alumis’ or ACELYRIN’s ability to pursue certain business opportunities or strategic transactions; (ix) the risk that the anticipated benefits and synergies of the proposed transaction may not be fully realized or may take longer to realize than expected; (x) the impact of legislative, regulatory, economic, competitive and technological changes; (xi) risks relating to the value of Alumis securities to be issued in the proposed transaction; (xii) the risk that integration of the proposed transaction post-closing may not occur as anticipated or the combined company may not be able to achieve the growth prospects expected from the transaction; (xiii) the effect of the announcement, pendency or completion of the proposed transaction on the market price of the common stock of each of Alumis and ACELYRIN; (xiv) the implementation of each of Alumis’ and ACELYRIN’s business model and strategic plans for product candidates and pipeline, and challenges inherent in developing, commercializing, manufacturing, launching, marketing and selling potential existing and new products and product candidates; (xv) the scope, progress, results and costs of developing Alumis’ and ACELYRIN’s product candidates and any future product candidates, including conducting preclinical studies and clinical trials, and otherwise related to the research and development of Alumis’ and ACELYRIN’s pipeline; (xvi) the timing and costs involved in obtaining and maintaining regulatory approval for Alumis’ and ACELYRIN’s current or future product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product; (xvii) the market for, adoption (including rate and degree of market acceptance) and pricing and reimbursement of Alumis’ and ACELYRIN’s product candidates, if approved, and their respective abilities to compete with therapies and procedures that are rapidly growing and evolving; (xviii) uncertainties in contractual relationships, including collaborations, partnerships, licensing or other arrangements and the performance of third-party suppliers and manufacturers; (xix) the ability of each of Alumis and ACELYRIN to establish and maintain intellectual property protection for products or avoid or defend claims of infringement; (xx) Alumis’ ability to successfully integrate ACELYRIN’s operations and personnel; and (xxi) potential delays in initiating, enrolling or completing preclinical studies and clinical trials. These risks, as well as other risks related to the proposed transaction, will be described in the registration statement and the joint proxy statement/prospectus that will be filed with the SEC in connection with the proposed transaction. While the list of factors presented here and the list of factors to be presented in the registration statement are considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. For additional information about other factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to Alumis’ and ACELYRIN’s respective periodic reports and other filings with the SEC, including the risk factors identified in Alumis’ and ACELYRIN’s most recent Annual Reports on Form 10-K. The risks and uncertainties described above and in the SEC filings cited above are not exclusive and further information concerning Alumis and ACELYRIN and their respective businesses, including factors that potentially could materially affect their respective businesses, financial conditions or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. Readers should also carefully review the risk factors described in other documents Alumis and ACELYRIN file from time to time with the SEC. The forward-looking statements included in this communication are made only as of the date hereof. Alumis assumes no obligation and does not intend to update these forward-looking statements, even if new information becomes available in the future, except as required by law. Additional Information and Where to Find It In connection with the proposed merger, Alumis intends to file with the SEC the registration statement, which will include the joint proxy statement/prospectus. After the registration statement has been declared effective by the SEC, the joint proxy statement/prospectus will be delivered to stockholders of Alumis and ACELYRIN. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, SECURITY HOLDERS OF ALUMIS AND ACELYRIN ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS (INCLUDING ALL AMENDMENTS AND SUPPLEMENTS THERETO) AND OTHER DOCUMENTS RELATING TO THE MERGER THAT WILL BE FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER. Investors and security holders will be able to obtain copies of the joint proxy statement/prospectus (when available) and other documents filed by Alumis and ACELYRIN with the SEC, without charge, through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by Alumis will be available free of charge under the SEC Filings heading of the Investor Relations section of Alumis’ website at https://investors.alumis.com/. Copies of the documents filed with the SEC by ACELYRIN will be available free of charge under the Financials & Filings heading of the Investor Relations section of ACELYRIN’s website at https://investors.acelyrin.com/. Participants in the Solicitation Alumis and ACELYRIN and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information about Alumis’ directors and executive officers is set forth in the registration statement, which includes the joint proxy statement/prospectus. Information about ACELYRIN’s directors and executive officers is set forth in ACELYRIN’s Annual Report on Form 10-K, which was filed with the SEC on March 19, 2025. Stockholders may obtain additional information regarding the interests of such participants by reading the registration statement and the joint proxy statement/prospectus and other relevant materials filed with the SEC regarding the proposed merger when they become available. Investors should read the joint proxy statement/prospectus carefully before making any voting or investment decisions. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Alumis Contacts Investor Relations Teri Dahlman Red House Communications teri@redhousecomms.com Or MacKenzie Partners, Inc. proxy@mackenziepartners.com (800) 322-2885 Media Jim Golden / Jack Kelleher / Tali Epstein Collected Strategies Alumis-CS@collectedstrategies.com ACELYRIN, INC Contacts Investor Relations and Media Tyler Marciniak Vice President of Investor Relations and Corporate Operations tyler.marciniak@acelyrin.com or Sodali & Co SLRN@investor.sodali.com (800) 662-5200

With the introduction of a subcutaneous formulation, ENTYVIO has expanded patient convenience and global accessibility. Continued growth is supported by rising IBD prevalence and ongoing geographic expansion. LAS VEGAS, April 15, 2025 /PRNewswire/ -- DelveInsight's " ENTYVIO Market Size, Forecast, and Market Insight Report" highlights the details around ENTYVIO, a gut-selective biologic developed by Takeda Pharmaceutical. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of ENTYVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Takeda Pharmaceutical's ENTYVIO (vedolizumab) Overview Vedolizumab is a biologic medication approved for both intravenous (IV) and subcutaneous (SC) use, with regulatory approvals varying by region. The SC formulation is authorized for use in the United States, European Union, and over 50 other countries, while the IV formulation has received approval in more than 70 countries, including the US and the EU. Collectively, vedolizumab IV and SC have accumulated over one million patient-years of global exposure. Vedolizumab is a humanized monoclonal antibody that selectively targets the alpha4beta7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule 1 (MAdCAM-1) — a protein primarily found on blood vessels and lymph nodes in the gastrointestinal tract. This integrin is present on certain white blood cells involved in the inflammatory processes of ulcerative colitis and Crohn's disease. By disrupting the binding between alpha4beta7 integrin and MAdCAM-1, vedolizumab may reduce the migration of these immune cells into the gut, thereby decreasing inflammation. ENTYVIO Dosage For adults with ulcerative colitis, the advised dosage of ENTYVIO is 300 mg given through intravenous infusion at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks. Treatment should be discontinued if no clinical improvement is observed by week 14. Learn more about ENTYVIO projected market size for Crohn's disease and ulcerative colitis @ ENTYVIO Market Potential Crohn's disease is a progressive type of inflammatory bowel disease (IBD) that results in chronic inflammation throughout the gastrointestinal tract, most commonly affecting the terminal ileum and colon. This inflammation can lead to complications such as strictures, fistulas, and ulcers. In 2024, there were 1.1 million diagnosed prevalent cases of Crohn's disease in the United States. Current treatment approaches primarily include biologics such as adalimumab (HUMIRA and its biosimilars), ustekinumab (STELARA), infliximab (REMICADE and biosimilars), along with systemic corticosteroids, immunosuppressants, 5-aminosalicylic acid (5-ASA), and other therapies. Among these, adalimumab held the largest market share in the 7MM in 2024, generating around USD 4 billion in revenue for Crohn's disease treatment. In 2024, the market size of Crohn's disease was highest in the US among the 7MM, accounting for approximately USD 8 billion, which is further expected to increase at a CAGR of 4.5%. The Crohn's disease market is projected to expand due to the introduction of novel therapies with improved efficacy and more convenient routes of administration, broader use of biologics in pediatric populations, growing commercial opportunities in biologic-treated patients, advancements in biomarker development for early diagnosis, and the overall rising prevalence of the disease. Discover more about the Crohn's disease market in detail @ Crohn's Disease Market Report Ulcerative colitis is one of the primary types of chronic inflammatory bowel disease (IBD) affecting the gastrointestinal tract. It is an idiopathic and long-standing inflammation of the colonic mucosa, typically presenting with symptoms like diarrhea, abdominal discomfort, and rectal bleeding. In 2023, there were an estimated 3.1 million diagnosed prevalent cases of ulcerative colitis across the 7MM, with numbers expected to rise over the forecast period. According to current US treatment guidelines, mild-to-moderate cases are initially managed with aminosalicylates or by using corticosteroids for induction followed by maintenance therapy with aminosalicylates. For patients with moderate-to-severe disease, maintenance treatment may involve immunosuppressants like azathioprine or 6-mercaptopurine after corticosteroid induction. Alternatively, biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside immunosuppressants to achieve and sustain remission and mucosal healing. The treatment landscape across the 7MM is categorized into commonly used drug classes, including conventional therapies, anti-TNF agents, anti-adhesion molecule therapies, JAK inhibitors, and others, reflecting some variations in prescribing practices. Looking ahead, the anticipated introduction of novel therapies, increased focus on early detection, enhanced use in secondary care, improved implementation strategies, and growing disease awareness are likely to contribute to more effective management of ulcerative colitis. As a result, the ulcerative colitis market will grow from USD 8.4 billion in 2023 at a significant CAGR by 2034. However, the high costs of new treatments and the financial burden of disease complications may pose challenges to widespread adoption. For a comprehensive view of the ulcerative colitis market, check out the Ulcerative Colitis Market Assessment Emerging Competitors of ENTYVIO Despite the presence of biosimilars, innovation in Crohn's disease and ulcerative colitis treatment remains strong, with several emerging therapies exploring new inflammatory pathways to improve efficacy and long-term outcomes. RHB-104, a combination macrolide antibiotic, is in Phase III trials targeting potential mycobacterial involvement. VELSIPITY, an S1P receptor modulator, works by limiting lymphocyte migration and reducing inflammation. TREMFYA, which inhibits IL-23, is under evaluation for its immune-modulating effects, while ABBV-154, a TNF inhibitor conjugated with a steroid, aims to enhance TNF suppression. Additional pipeline therapies include Merck's TL1A inhibitor Tulisokibart (PRA023/MK-7240) in Phase III and Pfizer's JAK3 inhibitor LITFULO in Phase II. Teva and Sanofi are also developing Duvakitug, a monoclonal antibody targeting TNFSF15. These investigational drugs represent significant progress for patients unresponsive to current treatments. A range of other promising candidates are in development, each targeting unique pathways. Landos Biopharma's Omilancor (BT-11) is in Phase II and acts via LANCL2, while AVB-114 from Avobis Bio/Alimentiv is also in Phase II. Abivax S.A.'s Obefazimod (ABX464) is being studied for its ability to upregulate miR-124. Roche's RVT-3101 (RG6631), an anti-TL1A antibody, is in Phase II trials, and Mesoblast's RYONCIL (Remestemcel-L), a mesenchymal stem cell therapy, is progressing in Phase III, offering regenerative potential. Other noteworthy agents in Phase II include Zasocitinib (TAK-279) from Takeda, a TYK2 inhibitor; AZD7798 from AstraZeneca, targeting CCR9; Sanofi's Balinatunfib (SAR441566), which blocks TNFR1 signaling; AGMB-129 from Agomab Therapeutics, targeting ALK5/TGFβR1; MBF-118 by Medibiofarma, a PPARγ partial agonist; and MORF-057 by Eli Lilly and Morphic Therapeutic, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline. To know more about the number of competing drugs in development, visit @ ENTYVIO Market Positioning Compared to Other Drugs Key Milestones of ENTYVIO In April 2024, Takeda announced that the FDA has approved the subcutaneous (SC) formulation of ENTYVIO (vedolizumab) for maintenance treatment in adults with moderately to severely active Crohn's disease who have previously received induction therapy with the intravenous (IV) form of ENTYVIO. In September 2023, Takeda announced that the FDA has approved the SC formulation of ENTYVIO to be used as maintenance therapy in adults with moderately to severely active ulcerative colitis following induction treatment with the IV version of ENTYVIO. In September 2023, Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active Crohn's disease, following induction therapy with the intravenous version of ENTYVIO. In April 2023, Takeda announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active ulcerative colitis following induction therapy with the intravenous version of ENTYVIO. In March 2023, Takeda announced that Japan's Ministry of Health, Labour, and Welfare has approved ENTYVIO Pens and prefilled syringes (108 mg for subcutaneous injection) for use as maintenance therapy in patients with moderate to severe ulcerative colitis. In May 2020, Takeda announced that the European Commission has approved the subcutaneous formulation of ENTYVIO, a gut-targeted biologic, for maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2019, Takeda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved for an expanded indication of ENTYVIO, allowing its use in treating adult patients with moderately to severely active Crohn's disease. In May 2019, Takeda announced that the FDA has accepted for review the BLA for a SC formulation of vedolizumab, intended for maintenance treatment in adults with moderately to severely active ulcerative colitis. In November 2018, Takeda announced the launch of ENTYVIO in Japan for the treatment of patients with moderately to severely active ulcerative colitis. In June 2014, Takeda announced that ENTYVIO is now commercially available in the United States for treating adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2014, Takeda announced that the European Commission (EC) has granted Marketing authorization for ENTYVIO. It is the first and only biologic approved at the same time for treating adults with moderately to severely active ulcerative colitis and Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional therapies or TNF-alpha inhibitors. In May 2014, Takeda announced that the FDA had granted simultaneous approval of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Discover how ENTYVIO is shaping the Crohn's disease and ulcerative colitis treatment landscape @ ENTYVIO Infusion ENTYVIO Market Dynamics ENTYVIO has established itself as a leading biologic therapy in the treatment of moderate to severe ulcerative colitis and Crohn's disease. As a gut-selective integrin antagonist, ENTYVIO offers a differentiated mechanism of action compared to anti-TNF therapies, which contributes to its positioning as a safer long-term option, particularly for patients at risk of systemic immunosuppression. Its favorable safety profile and efficacy in inducing and maintaining remission have led to its widespread adoption, particularly among patients who have failed previous therapies. The biologics market for inflammatory bowel disease is highly competitive, with key players including HUMIRA, REMICADE, STELARA, and newer entrants like SKYRIZI and RINVOQ. ENTYVIO has managed to capture significant market share by appealing to both gastroenterologists and patients seeking gut-targeted treatment. Its intravenous formulation, though initially a barrier, has been partially offset by the 2019 launch of the subcutaneous version in global markets, enhancing patient convenience and adherence. However, uptake in the US for the SC version has been slower due to regulatory timelines and physician inertia. Biosimilar competition is also a factor shaping ENTYVIO's future market dynamics. While biosimilars of anti-TNFs are gaining traction, ENTYVIO currently remains insulated due to patent protections, with biosimilar entry expected post-2026. This provides Takeda a limited window to maximize revenue, expand its patient base, and reinforce brand loyalty. Strategic moves such as expanding indications, enhancing real-world evidence, and increasing global access will be crucial to maintaining its competitive edge. Moreover, the shift in payer dynamics and healthcare cost containment efforts are increasingly influencing biologic prescribing behavior. Takeda must continue to demonstrate value through outcome-based contracts and cost-effectiveness data. As newer agents with novel mechanisms enter the market, maintaining differentiation and proving long-term value will be central to ENTYVIO's sustained success. Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @ ENTYVIO Market Drug Report Table of Contents Related Reports Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Crohn's disease companies including Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, Landos Biopharma, Janssen, Roche, Eisai, Bristol-Myers Squibb, Iltoo Pharma, Suzhou Connect Biopharmaceuticals, Theravance Biopharma, TaiwanJ Pharmaceuticals, Celularity, Cerecor, GlaxoSmithKline, KangStem Biotech, Immunic, Alpha Cancer Technologies, Koutif Therapeutics, Tract Therapeutics, Trio medicines, ChemoCentryx, Algernon Pharmaceuticals, Neuclone, JHL Biotech, Innovative Pharmacological Research (IPHAR) Co Ltd, Innovation Pharmaceuticals, Exeliom Biosciences SAS, AbbVie, Finch Therapeutics, Akeso Biopharma, Draconis Pharma, MakScientific, Engitix, Origo Biopharma, Navidea Biopharmaceuticals, Orchard Therapeutics, Xbrane, Thetis Pharmaceuticals, Temisis Therapeutics, Synedgen, Synlogic, Morphic Therapeutic, Metacrine, Curacle, Commence Bio Inc, Cloud Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp, Avobis Bio LLC, Avexegen Therapeutics, Assembly Biosciences, Aibios Co Ltd, Aclaris Therapeutics, Athos Therapeutics, Denali Therapeutics, Educell doo, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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If approved, sebetralstat would be the first oral on-demand treatment for hereditary angioedema available in Japan.\n As KalVista Pharmaceuticals awaits an FDA decision on its hereditary angioedema (HAE) treatment sebetralstat, the company has sold the Japanese rights to the drug to Kaken Pharmaceutical for $11 million upfront.Alongside the upfront fee, Tokyo-based Kaken has also agreed a further $11 million payment if a regulatory milestone is hit next year. There are additional commercial milestone payments tied to the deal should sebetralstat get approved in Japan, but KalVista didn’t go into details in its April 8 release.Royalties tied to the deal would be based on the drug’s price in Japan, with a royalty rate “as a percentage of sales approximately in the mid-twenties,” KalVista explained.HAE is a genetic disease marked by low levels or dysfunction of the C1 inhibitor. Patients can be struck with bouts of severe swelling across the body, and attacks can be fatal if they impact the lungs.The FDA is expected to make a call on whether to approve sebetralstat, an oral plasma kallikrein inhibitor, in the U.S. in June as an on-demand treatment for HAE attacks in adult and pediatric patients aged 12 years and older. The application was based on a phase 3 study last year that showed patients who received either a 300-mg or 600-mg dose of sebeltralstat experienced quicker symptom relief by roughly four hours each compared to placebo.KalVista has also submitted sebetralstat to regulators in Japan. If approved, it would be the first oral on-demand treatment for HAE available in the country, the biotech noted. Kaken already markets an array of products in Japan, including hyaluronate sodium for osteoarthritis and Fiblast for skin ulcers. The company has also licensed a number of drugs from other companies, including seladelpar for primary biliary cholangitis from CymaBay Therapeutics, tildacerfont from Spruce Biosciences for congenital adrenal hyperplasia and—most recently—Alumis’ late-stage TYK2 inhibitor as a dermatology treatment“We are pleased to partner with Kaken, whose expertise and demonstrated success in the region make them well-suited to work alongside our exceptional team to bring sebetralstat to the HAE community in Japan,” KalVista CEO Ben Palleiko said in the release.“This collaboration is an important part of our strategy to expand the global reach of sebetralstat as we prepare for several commercial launches starting this year,” Palleiko added.Even if sebetralstat gets the nod from the FDA in the June, it may only have a few weeks’ headstart on donidalorsen, Ionis Pharmaceuticals’ RNA-targeted medicine for preventing HAE attacks, which is expecting a decision in August. Meanwhile, CSL secured EU approval for its prophylactic HAE drug garadacimab in February, while Intellia has a CRISPR-based gene editing candidate in development.