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Gossamer Bio Submits New Drug Application to U.S. FDA for Seralutinib for the Treatment of Pulmonary Arterial Hypertension

Key Takeaway: Gossamer Bio has submitted a New Drug Application to the U.S. FDA for seralutinib, aimed at treating pulmonary arterial hypertension (PAH). This marks a significant step in the drug's development and potential commercialization. The application reflects the company's commitment to addressing serious health conditions associated with pulmonary hypertension.

Market Sentiment Analysis

POSITIVE FACTORS

  • Gossamer Bio submitted a New Drug Application for seralutinib.
  • The drug targets pulmonary arterial hypertension, a significant health issue.
  • FDA submission indicates progress in the drug development process.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+53%
120-day peak, hindsight
Typical move
5.3%
average across 6 past catalysts
Cash runway
~3 mo
High dilution risk
Lead asset
GB001
Phase 2 · Asthma

Full Press Release Details

SAN DIEGO--(BUSINESS WIRE)---- $GOSS--Gossamer Bio, Inc. (Nasdaq: GOSS) (the “Company” or “Gossamer”), 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 that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in September 2026 for seralutinib for the treatment

Frequently Asked Questions

What is seralutinib used for?

Seralutinib is being developed for the treatment of pulmonary arterial hypertension.

When was the NDA for seralutinib submitted?

The NDA for seralutinib was submitted in September 2026.

Which company submitted the NDA for seralutinib?

Gossamer Bio submitted the NDA for seralutinib.

What does NDA stand for?

NDA stands for New Drug Application.

Last updated: Sep 23, 2026