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H.C. Wainwright maintains Buy on Gossamer Bio after FDA feedback

Analysts cite positive regulatory outlook for seralutinib NDA as shares gain 10% following FDA meeting minutes. Price target raised to $2 from $5.

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Priya Anand · Equities & Earnings Desk · 2 Sept 2026 · 06:55 · 2 min read
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H.C. Wainwright maintains Buy on Gossamer Bio after FDA feedback

H.C. Wainwright reiterated a Buy rating on Gossamer Bio Inc. shares, maintaining a price target of $2.00 after the company received positive feedback from U.S. regulators regarding its seralutinib program.

The analyst’s outlook follows a July 27 Type B pre-NDA meeting with the FDA, during which officials characterized the statistical significance and treatment effect of the Phase 3 PROSERA study as review issues rather than filing obstacles. Leerink also upgraded Gossamer Bio to Outperform from Market Perform, citing the same regulatory development. Analyst price targets for the stock now range between $0.28 and $4.00, according to InvestingPro data.

Gossamer Bio’s shares, listed on the NASDAQ under the ticker GOSS, were trading at $0.17 on July 27, up 10% for the week and 8.91% in pre-market activity. Year-to-date, the stock has declined approximately 94%.

The company plans to submit a New Drug Application (NDA) for seralutinib, intended for the treatment of pulmonary arterial hypertension, in September 2026. If accepted for review, the FDA could render a decision in the third quarter of 2027. The NDA submission will be supported by the PROSERA study, confirmatory evidence from the Phase 2 TORREY study, and additional supportive analyses.

Gossamer Bio also completed a restructuring of its seralutinib rights agreement with Chiesi on July 27. The company repurchased global development and commercialization rights for the drug without an upfront cash payment, replacing a previous 50/50 U.S. profit-sharing and ex-U.S. royalty structure with a capped royalty on worldwide net sales and milestone payments tied to clinical outcomes.

The company executed a convertible notes exchange on July 1, reducing its debt principal by approximately $115.9 million. Under the exchange, $181.1 million in 5.00% Senior Convertible Notes due 2027 were tendered for new 7.50% First Priority Secured Convertible Principal Debt due 2030 and other securities, with an initial conversion rate of 5,347.5936 shares per $1,000 of principal.

Gossamer Bio also entered a securities offering on August 21, with plans to sell up to $250 million in restricted securities. The company received an initial $25 million at the first closing and expects an additional $125 million upon FDA acceptance of the seralutinib NDA, along with warrants providing up to $100 million more upon exercise following potential approval. As of the second quarter of 2026, Gossamer Bio reported $57.0 million in cash and investments, while trailing twelve-month leveraged free cash flow was negative $162.6 million.

This article was produced with AI assistance and edited by a Finance Review Daily journalist.
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Written by
Priya Anand
Equities & Earnings Desk

Priya covers listed equities and corporate earnings, reading quarterly results and guidance for what they signal about sector health and forward valuations.

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