Gossamer Bio files FDA application. Gossamer Bio stock sits at USD 54.3 million market value.
Published on 10/16/2026 at 05:21 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWSRegulatory path and valuation
- Gossamer Bio submitted its first NDA for seralutinib on September 23, 2026.
- Chardan maintained a Buy rating and a USD 160.00 target on October 13, 2026.
- Gossamer Bio had a USD 54.3 million market value as of October 15, 2026.
Gossamer Bio (ISIN US38341P2011) submitted its first New Drug Application for seralutinib to the U.S. Food and Drug Administration on September 23, 2026, according to Gossamer Bio. The filing seeks approval for pulmonary arterial hypertension and is the clinical-stage company's first NDA. The FDA is expected to decide later in 2026 whether to accept the application for filing.
Seralutinib enters regulatory review
The application is supported by the Phase 3 PROSERA study, the Phase 2 TORREY study and additional analyses. Gossamer said FDA meeting minutes treated the statistical significance and treatment effect in PROSERA as review issues rather than filing issues, leaving the agency's assessment of the full evidence package as the next major step.
The clinical record also carries a measurable risk factor. Mugglehead reported on September 24, 2026 that the trial produced a 13.3-meter placebo-adjusted gain on the six-minute walk test, while its p-value of 0.0320 missed the prespecified 0.025 threshold.
Three dated steps for Gossamer
Gossamer appointed Greg Ciongoli to its board on September 16, 2026, according to MarketScreener. It submitted the first NDA on September 23, 2026. On October 13, 2026, Chardan maintained its Buy rating with a USD 160.00 price target, as reported by TradingView.
What does the target mean?
The USD 160.00 target is an analyst view rather than a regulatory outcome. It also sits against a sharply reduced operating base: Gossamer reported USD 9.24 million of revenue and USD 16.90 million of net income for the second quarter of 2026, according to Yahoo Finance. The figures describe a clinical-stage company whose valuation depends heavily on seralutinib's regulatory path.
Next reported date
MarketBeat estimates that Gossamer will report third-quarter 2026 results on November 4, 2026. The FDA filing decision is the separate regulatory milestone expected later in 2026.
Market value reflects binary risk
Gossamer Bio had a market capitalization of USD 54.3 million as of October 15, 2026. The company is listed on Nasdaq under GOSS and is developing seralutinib for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The combination of a USD 160.00 analyst target and a clinical endpoint that missed its preset statistical threshold highlights the wide range of possible outcomes.
The company's market capitalization was USD 54.3 million as of October 15, 2026.
Market context: Market report Nasdaq Composite.
