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What’s in Today’s Brief? (September 11th Preview)
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FDA regulatory decisions – oncology/neurology
The FDA extended Exelixis’ review timeline for its metastatic colorectal cancer drug candidate after the company submitted new safety and efficacy data, according to the company’s filings. Separately, the agency delayed an approval decision for Exelixis’ colorectal cancer tyrosine kinase inhibitor in combination with Roche’s Tecentriq. On the neurology side, FDA placed a partial hold on Biohaven’s epilepsy drug BHV-7000 days after the asset was tied to a pending $350 million deal. The hold followed regulator requests for additional preclinical safety information. Taken together, the actions highlight how late-stage data and preclinical package completeness continue to drive timetable risk across oncology and CNS drug development.
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FDA regulatory decisions – manufacturing quality
The FDA issued a second complete response letter (CRL) to Seikagaku for its resubmitted BLA for condoliase (SI-6603), a therapy aimed at radicular leg pain associated with lumbar disc herniation. Seikagaku said the agency cited unresolved deficiencies tied to drug substance manufacturing after a prior inspection, and it also identified new deficiencies during a cGMP inspection of the contract manufacturing facility for the drug product. The second CRL underscores how manufacturing controls and facility quality remain gating items for reviews, even after resubmission, and it can push companies back into remediation and revalidation work before any potential approval path reopens.
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Cancer immunotherapy financing and scaling
Solstice Oncology exited stealth with a $225 million series A to advance porustobart, a next-generation CTLA-4 antibody intended to expand immunotherapy reach into microsatellite-stable colon cancer. The financing, led by RA Capital Management and joined by Canaan Partners and Forbion among others, is anchored on a phase II study planned with porustobart plus pembrolizumab in stage II–III MSS colon cancer. The company said enrollment is expected to begin in the fourth quarter of 2026, with an initial readout targeted for the second half of 2027—positioning CTLA-4 strategy as a potential counter to limited checkpoint responsiveness in MSS disease.
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Gene therapy funding momentum
Encoded Therapeutics raised $275 million in a Series F to push its lead gene therapy ETX101 into clinical trials for Dravet syndrome. The financing will also fund development work for a second program, ETX301, planned for a 2027 IND filing. The company is also enrolling young children in a registration-directed study and expanding into adolescents, with additional manufacturing scale-up underway rather than relying solely on contract production—an operational choice aimed at reducing throughput constraints for gene therapy assets.
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Biopharma company moves – M&A and strategic partnerships
Revvity signed an agreement to acquire Human Cell Design (HCD), a France-based developer of human cell models used in preclinical research. Revvity said the deal is expected to add HCD’s human pancreatic beta cell models to its Life Sciences portfolio, including the EndoC-βH5 platform. The acquisition is positioned to support drug discovery and screening in diabetes and obesity research, with anticipated cross-usage alongside Revvity’s assay and screening workflows. The transaction is targeted to close in Q4 2026.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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