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• CRL Limited to Manufacturing, Not Clinical Data: The FDA's rejection centered solely on unresolved CMC issues at a third-party facility, with no new clinical or safety concerns raised.
• Primary Endpoint Missed: Fasedienol showed a -9.5 SUDS change versus -11.4 for placebo, a statistically insignificant difference (p=0.427).
• $21 Million Secured: Decoy Therapeutics closed a private placement at $5.91 per share with a dedicated healthcare investor.
• Primary Endpoint Met With Strong Effect Size: Epcoritamab plus lenalidomide significantly improved PFS over R-GemOx in relapsed/refractory DLBCL.
• $100 Million Raised at $20.00 Per Share: Nuvectis priced a public offering to bolster its balance sheet and fund pipeline expansion.
• Seeking Global Endpoint Harmonization: OS Therapies requested an FDA Type B meeting to align OST-HER2 trial endpoints with international (FDA-EMA) standards.
• Manageable Safety Profile: Treatment-related adverse events were limited to Grade 1–2 severity, with no dose-limiting toxicities reported.
• Strong Response in Induction Non-Responders: 37.2% of patients who did not respond during induction achieved clinical remission with continued obefazimod treatment.
• Monopar Therapeutics released new Phase 3 data for ALXN1840, showing improved neurologic and global clinical outcomes in Wilson disease patients.
• The new director will sit on key committees.
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