Press release
Gossamer Bio Announces Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
- First PAH Patient Dosed in Ongoing Registrational Phase 3 PROSERA Study - - Inclusion of Japan in Phase 3 PROSERA Study Following CTN Acceptance by PMDA -
About this update from Gossamer Bio, Inc.
[{"type":"text","content":"\n- First PAH Patient Dosed in Ongoing Registrational Phase 3 PROSERA Study -\n\n\n- Inclusion of Japan in Phase 3 PROSERA Study Following CTN Acceptance by PMDA -\n\n\n- Cash, cash equivalents and marketable securities totaled $296 million at year-end 2023 -\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nGossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update.\n\n\n“We were thrilled to enroll the first patient in the registrational PROSERA Study last year, and we are pleased with the pace of site activations and enrollment into the study,” said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer Bio. “This advancement marks a significant milestone in Gossamer’s journey, and it was made possible due to the tireless efforts of the Gossamer team. We are excited to be one step closer to bringing seralutinib to patients.\n\n\n“Additionally, we believe Gossamer is one of the first companies to take advantage of new Japanese regulatory guidelines, formally issued at the end of last year, to allow for the inclusion of Japanese subjects in our global registrational study of seralutinib without performing a pharmacokinetic bridging study. Subject to final results, PROSERA could form the basis of a Japanese New Drug Application, accelerating the potential commercial availability of seralutinib to PAH patients in Japan and unlocking a valuable geographic market for Gossamer.\n\n\n“Beyond PAH, we remain excited about the potential of seralutinib to treat patients living with other forms of pulmonary hypertension, including pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Patients with PH-ILD are in desperate need of safe and efficacious therapies, with just one therapy approved in the US and no approved therapies available in the rest of the world. We believe seralutinib holds great promise for these patients, and our team is eagerly working through a clinical development plan.”\n\n\nSeralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor\n\n\n\nThe first PAH patient in the ongoing Phase 3 PROSERA Study was dosed in the fourth quarter of 2023. Th...