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MaterialPDUFA date set

Gossamer Bio: Pre-NDA FDA meeting set for mid-June; NDA for seralutinib in PAH targeted for September 2026

The company confirmed an in-person Pre-NDA Type B meeting with FDA in mid-June 2026 to discuss the totality of PROSERA data. Subject to meeting outcomes, Gossamer plans to submit an NDA for seralutinib in PAH in September 2026. If accepted, approval could occur in Q3 2027.

Key facts

Filed
May 18, 2026, 11:06 AM
Event
PDUFA date set
Direction
Positive
Company
GOSSGossamer Bio
Asset
seralutinib
Source
SEC 8-K
Confidence
Sourced
Calendar
Trial readout · Sep 1, 2026
p fractal
0.0435
N substudy
162
p arterial
0.0200
p fibrosis abs
0.0260
p venous small
0.0341
p venous total
0.0155
p fibrosis norm
0.0250

Source excerpt

EX-99.1 4 goss-20260518xexx991xearni.htm EX-99.1 Document Exhibit 99.1 Gossamer Bio Announces First Quarter 2026 Financial Results and Provides Business Update - FDA Confirms In-Person Pre-NDA Type B Meeting in Mid-June - - Positive PROSERA CT FRI Results Demonstrated Multiple Statistically Significant Treatment Effects, Including Novel Signals Correlated with Clinical Outcomes - - Gossamer Announces Commencement of Exchange Offer and Consent Solicitation for Outstanding 5.00% Convertible Senior Notes Due 2027 - - Cash, cash equivalents and marketable securities totaled $99 million as of March 31 - SAN DIEGO—(BUSINESS WIRE)— May 18, 2026 — Gossamer 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) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced its financial results for the first quarter ended March 31, 2026, and provided a business update. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. "We are executing across multiple fronts at Gossamer," said Faheem Hasnain, Chairman, Co-Founder, and CEO of Gossamer Bio. "We have secured an in-person Pre-NDA Type B meeting with the FDA, reflecting our conviction in both the breadth of the PROSERA dataset and in the totality of evidence supporting seralutinib. Subject to the outcomes of that

SEC 8-K

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