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- 🚨Biotech's Big FDA July!💊
🚨Biotech's Big FDA July!💊
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Anthony Ao
July 26, 2025
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Biotech Stocks Await Crucial FDA Decisions in July 2025
July 2025 is significant for biotech stocks, with several critical FDA decisions pending. These approvals could significantly impact treatments across various diseases, including cancers and rare disorders.
Dizal: Awaiting FDA decision for Sunvozertinib, an oral drug targeting non-small cell lung cancer patients with specific genetic mutations. Already approved in China, it could become the first treatment of its kind in the U.S.
Regeneron Pharmaceuticals: Two drugs are pending approval:
Linvoseltamab, targeting multiple myeloma, previously denied due to manufacturing concerns, with a decision expected on July 10.
Odronextamab, intended for follicular lymphoma, previously denied due to enrollment issues in clinical trials, now awaiting approval by July 30.
Otsuka Holdings: REXULTI, already used for depression and schizophrenia, seeks FDA approval for PTSD treatment when combined with Sertraline. An advisory committee review is scheduled for July 18.
Roche: Seeking label expansion for Columvi, combined with chemotherapy, to treat certain lymphoma patients. Despite promising results, an FDA panel has expressed concerns over the trial's applicability to U.S. patients. Decision expected by July 20.
Replimune: RP1, combined with Opdivo, targeting advanced melanoma, awaits a priority review decision on July 22.
GSK: Seeking FDA approval for combinations involving Blenrep for multiple myeloma, after previously withdrawing it from the market due to failed confirmatory trials. Decision due on July 23, following an FDA panel review on July 17.
Swedish Orphan Biovitrum: Seeking expanded use approval for DOPTELET, treating pediatric immune thrombocytopenia, with a decision expected by July 24.
Ascendis Pharma: Awaiting approval for expanded use of Skytrofa in adults with growth hormone deficiency by July 27.
Apellis Pharmaceuticals: EMPAVELI is under priority review for two rare kidney diseases, with a decision expected July 28.
PTC Therapeutics: Sepiapterin, a novel treatment for phenylketonuria, is awaiting FDA approval by July 29.
These FDA outcomes could significantly influence biotech markets, investor sentiment, and patient treatment options in oncology and rare disease therapies.
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The PhDLevel Team
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