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After signing a deal worth up to $486 million with Italian biopharma Chiesi to develop the pulmonary arterial hypertension candidate seralutinib in 2024, Gossamer Bio has ended the collaboration and licensing agreement. The termination allows Gossamer to regain worldwide development and commercial rights to seralutinib as it prepares to seek FDA approval despite the drug missing the prespecified statistical threshold for the primary endpoint in a phase 3 trial, according to a Monday release . Under the original agreement, Chiesi paid Gossamer $160 million as a development reimbursement. Gossamer was also eligible for up to $146 million in regulatory milestone payments and $180 million in sales milestones. PAH is a rare, rapidly progressing disease in which the blood vessels in the lungs narrow, increasing pressure in the pulmonary arteries and potentially leading to heart failure. Roughly 40,000 people in the United States have the disorder. In February, Gossamer announced that seralutinib produced a placebo-adjusted improvement of 13.3 meters in patients’ six-minute walk distance after 24 weeks. Although the result had a p-value of 0.032, it missed the trial’s prespecified significance threshold of 0.025. Results favored seralutinib on four secondary endpoints, including measures involving intermediate- and high-risk patient subgroups. Gossamer chairman, co-founder and CEO Faheem Hasnain expressed disappointment after the trial missed what he called “the stringent prespecified statistical threshold for our primary endpoint,” but he remained hopeful. “We believe these data clearly demonstrate seralutinib is an active drug in patients with PAH,” Hasnain said in the February release. “These data support the conclusion that seralutinib demonstrated greater activity in patients with more advanced disease.” The termination ends the companies’ agreement to split U.S. profits equally and returns ex-U.S. rights to Gossamer. Chiesi will make a one-time $5 million payment to Gossamer, with no upfront payment required from Gossamer, and the companies will have no other outstanding obligations under the collaboration. Chiesi will be entitled to a capped royalty on worldwide net sales of seralutinib and payments tied to specified regulatory and commercial milestones. Hasnain said regaining the rights will help Gossamer realize seralutinib’s full potential in PAH and other possible indications. “We enter the second half of 2026 with increased clarity on our planned regulatory path, worldwide rights in hand, a healthier balance sheet and real momentum behind us,” he said in Monday’s statement. “There has never been a more exciting time in Gossamer’s history, and we look forward to the milestones ahead.” The company went all-in on seralutinib in 2023, laying off a quarter of its workforce to help fund the phase 3 trial. Before the workforce reduction, Gossamer had experienced a string of setbacks that included the failure of an asthma prospect, the discontinuation of an ulcerative colitis candidate and the end of a lymphoma trial. Despite the phase 3 results and the end of the Chiesi collaboration, Gossamer remains bullish after holding a pre-NDA Type B meeting with the FDA in June. According to Gossamer, the FDA’s official meeting minutes characterized the statistical significance and magnitude of the treatment effect observed in the phase 3 trial as review issues rather than barriers to filing the application. If approved, seralutinib would enter a PAH market that has received considerable attention from Big Pharma. Johnson & Johnson markets Uptravi, Opsumit and the combination therapy Opsynvi for patients with PAH. Merck & Co.’s Winrevair joined the market in 2024, with the company positioning it as the first therapy designed to target an underlying cause of the disease. Encouraged by the FDA meeting, Gossamer plans to submit an NDA in September based on the phase 3 Prosera study, confirmatory evidence from the phase 2 Torrey study and other supporting analyses. If the FDA accepts the application, seralutinib could be eligible for an approval decision in the third quarter of 2027. “This is a defining moment for Gossamer,” Hasnain said in the release. “After years of disciplined execution, we are now closer than ever to bringing forward what we believe can be a first-in-class, important new medicine for PAH patients who need better options.”

BRIDGEWATER, N.J., June 23, 2026 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced the appointment of Samuele Butera as Senior Vice President, General Manager, Global Respiratory, effective today. In this new role, Mr. Butera will assume responsibility for leading Insmed's Respiratory Therapeutic Area. Mr. Butera will report to Will Lewis, Chair and Chief Executive Officer, and serve as a member of Insmed's Executive Committee. "We are thrilled to welcome Samuele to Insmed," said Will Lewis, Chair and Chief Executive Officer of Insmed. "His depth of commercial expertise and proven ability to lead high-performing teams in some of the most complex and competitive therapeutic areas in our industry will be invaluable as he assumes leadership of our Respiratory Therapeutic Area. I am confident that Samuele's experience and passion for patients will be instrumental as we continue to execute on the launch of BRINSUPRI, the potential expansion of ARIKAYCE's label, and our broad TPIP development program." Mr. Butera joins Insmed with more than two decades of commercial leadership experience across global and U.S. markets. Most recently, he served as President, Pulmonary Hypertension & Retina, at Johnson & Johnson, where he led the significant growth of the multi-billion-dollar business unit and launch of OPSYNVI® (macitentan and tadalafil). While at Johnson & Johnson, he also served as Worldwide Vice President, Infectious Diseases & Vaccines, where he built the global commercial organization and co-led the company's expansion into vaccines (including COVID) and therapeutics. Prior to Johnson & Johnson, Mr. Butera held several senior leadership roles at Novartis, including Global Head of Cell & Gene Therapies, where he led the worldwide launch of KYMRIAH® (tisagenlecleucel), the first CAR-T therapy. He also served as Vice President & Head of Oncology CAR-T U.S. and as Vice President & Head of North America for Sandoz Biopharmaceuticals. Earlier in his career, Mr. Butera held roles at McKinsey & Company, Goldman Sachs, and the United Nations, providing him with a uniquely broad foundation across strategy, finance, and global health. Mr. Butera holds a Master in Public Policy from Harvard University and a Bachelor of Science in International Economics from Università Bocconi in Milan, Italy. "I am incredibly excited to join Insmed and lead the Respiratory Therapeutic Area at such a defining moment for the Company," said Mr. Butera. "Insmed has built a respiratory portfolio and pipeline that have the potential to meaningfully change the lives of patients. I look forward to working with the talented Insmed team to advance the already successful launch of BRINSUPRI, accelerate the growth of ARIKAYCE through the potential label expansion, and continue developing TPIP and other promising candidates for the patients who need them most." About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines—including two approved therapies to treat chronic, debilitating lung diseases—as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit  to learn more or follow us on LinkedIn, Instagram, YouTube, and X. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE in the U.S., Europe or Japan or failure to successfully commercialize BRINSUPRI in the U.S. or Europe, or to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or European approval for BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside of the U.S., Europe and Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage, or for BRINSUPRI outside of the U.S. and Europe; failure to successfully conduct future clinical trials for our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; and risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC). The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Bryan Dunn Vice President, Investor Relations (646) 812-4030 [email protected] Media: Claire Mulhearn Vice President, Corporate Communications (862) 842-6819 [email protected] SOURCE Insmed Incorporated 21% more press release views with Request a Demo