Gossamer Bio, Inc. engages in discovering, acquiring, developing, and commercializing therapeutics in the disease areas of immunology, inflammation, and oncology. Its primary product candidate, GB001, is intended for the treatment of moderate-to-severe eosinophilic asthma and other allergic conditions. The company was founded by Faheem Hasnain and Sheila Gujrathi in 2015 and is headquartered in San Diego, CA.
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- Gossamer Bio's Phase 3 PROSERA trial of seralutinib missed its primary endpoint with a p-value of 0.032, failing to meet the pre-specified alpha threshold of 0.025. - The company's stock lost more than 60% of its value following the trial failure announcement in February 2026. - Management had expressed optimism about positive results in May 2025 but did not disclose the heightened statistical threshold that was twice as stringent as conventional levels. - The trial would have succeeded under standard statistical criteria (alpha = 0.05) but failed the more rigorous 0.025 requirement built into the study design.
- Gossamer Bio expects to announce topline results from its Phase 3 PROSERA trial evaluating seralutinib for pulmonary arterial hypertension (PAH) before the end of February 2026. - The fully enrolled study includes 390 WHO Functional Class II and III PAH patients, with the primary endpoint measuring change in six-minute walk distance after 24 weeks of treatment. - Seralutinib is an inhaled small molecule inhibitor targeting PDGFR, CSF1R, and c-KIT receptors, designed to address the underlying mechanisms of PAH through a dry powder inhaler. - The company has also initiated the Phase 3 SERANATA trial for pulmonary hypertension associated with interstitial lung disease, potentially expanding seralutinib's market opportunity.
- The global pulmonary arterial hypertension pipeline comprises over 55 companies developing 55+ therapeutic candidates across all clinical phases, representing significant industry investment in this rare disease. - Merck's WINREVAIR (sotatercept-csrk) demonstrated a 76% reduction in relative risk of major morbidity and mortality events in high-risk PAH patients during Phase 3 ZENITH trial results. - Recent regulatory milestones include FDA Fast Track designation for Cereno Scientific's CS1 and IND clearance for VASTHERA's VTB-10, highlighting accelerated development pathways for novel PAH therapies. - AllRock Bio secured $50 million in Series A funding to advance ROC-101, a first-in-class pan-ROCK inhibitor, into Phase 2 trials for PAH and pulmonary hypertension associated with interstitial lung disease.
- XOMA Royalty Corporation reported robust financial performance in Q3 2025, receiving $43.9 million in royalties and milestones from partners in the first nine months of 2025, including $14.3 million in Q3 royalties. - The company completed strategic acquisitions of Turnstone Biologics and HilleVax while announcing planned acquisitions of LAVA Therapeutics and Mural Oncology to expand its royalty portfolio. - Key pipeline developments include Zevra Therapeutics submitting a Marketing Authorization Application to the EMA for arimoclomol in Niemann-Pick Type C disease and Rezolute Bio expecting Phase 3 ersodetug trial results in December 2025. - XOMA Royalty achieved net income of $14.1 million in Q3 2025 compared to a net loss of $17.2 million in the same period of 2024, demonstrating improved operational performance.
- Gossamer Bio completed enrollment of 390 patients in the pivotal PROSERA Phase 3 study evaluating seralutinib for pulmonary arterial hypertension, with topline results expected in February 2026. - The company activated the first clinical site for the registrational SERANATA Phase 3 study in pulmonary hypertension associated with interstitial lung disease, planning to enroll approximately 480 patients. - Seralutinib, an inhaled PDGFR, CSF1R and c-KIT inhibitor, is being developed in collaboration with Chiesi Group for two distinct pulmonary hypertension indications. - The company maintains $180 million in cash reserves as of September 30, 2025, sufficient to fund operations into 2027.
- Gossamer Bio entered into an option agreement to acquire Respira Therapeutics and its lead candidate RT234, an investigational inhaled vardenafil therapy designed for on-demand use in pulmonary hypertension patients. - RT234 addresses a significant unmet medical need as no approved PRN therapies currently exist for PAH or PH-ILD, with the majority of patients continuing to struggle with debilitating symptoms despite existing treatments. - The capital-efficient deal structure requires no upfront cash and minimal dilution, with Gossamer issuing 2.5 million shares at signing and funding pre-agreed development expenses for up to two years. - Phase 2 clinical data demonstrated RT234's rapid hemodynamic and functional improvements, including reductions in pulmonary vascular resistance and improvements in six-minute walk distance.
• XOMA Royalty doubled its portfolio to over 120 royalty assets through five strategic transactions in 2024, strengthening its position as a biotech royalty aggregator. • The company completed two whole company acquisitions and celebrated FDA approvals for Day One's OJEMDA™ (tovorafenib) and Zevra's MIPLYFFA™ (arimoclomol), generating significant milestone payments. • Despite reporting a net loss of $13.8 million for 2024, XOMA Royalty received $46.3 million in cash receipts and maintains over $100 million in cash, positioning it for sustainable cashflow from royalties.
• Long-term seralutinib treatment demonstrated continued improvement in pulmonary vascular resistance through 72 weeks in PAH patients, with responders showing a median 32% reduction. • Patients classified as responders exhibited superior outcomes in cardiac output (19.6% vs 1.8%) and mean pulmonary arterial pressure reduction (-11.8% vs -7.7%) compared to the total cohort. • The treatment maintained a favorable safety profile over the extended period, with common side effects including COVID-19, headache, and epistaxis.
- Gossamer Bio will showcase multiple analyses of seralutinib from the TORREY Phase 2 open-label extension study at the Pulmonary Vascular Research Institute 2025 Annual Congress. - The presentations will focus on sustained treatment benefits and biomarker effects of seralutinib in pulmonary arterial hypertension patients. - The data presentations represent important steps in Gossamer Bio's mission to advance seralutinib as a potential treatment option for pulmonary hypertension.
• XOMA Royalty Corporation acquired Pulmokine for $20 million, gaining rights to seralutinib, a Phase 3 asset for pulmonary arterial hypertension (PAH). • The acquisition adds seralutinib to XOMA's portfolio, which already includes six commercial royalty assets, enhancing its late-stage pipeline. • XOMA Royalty stands to gain up to $25 million in milestone payments and a low to mid-single digit royalty on seralutinib's commercial sales. • Phase 3 study results for seralutinib, co-developed by Gossamer Bio and Chiesi Farmaceutici, are expected in the fourth quarter of 2025.
