Episode 166 - December 12, 2025

What It Covers

Biotech Hangout Episode 166 examines the 2026 National Defense Authorization Act's biotech provisions, BioSecure Act implications, ASH conference data on CAR-T therapies and bispecifics in multiple myeloma, ESMO Asia oncology updates, Dyne's positive DMD exon skipper data, obesity pipeline developments, and industry sentiment heading into 2026 with optimism scores averaging 7.5-8 out of 10.

Key Questions Answered

• •Defense Funding Shift: DOD creates new biotech office to fund synthetic biology, biomanufacturing, AI drug development, and infectious disease research as NIH faces cuts. Companies touching federal funding must avoid "companies of concern" lists managed by DOD (1260h list) and White House OMB. BioSecure provisions now prohibit federal agencies from purchasing from designated Chinese biotech equipment or service providers, with watered-down flow-through provisions affecting SBIR recipients.
• •Multiple Myeloma CAR-T Competition: Johnson & Johnson's CARTITUDE shows 83% overall survival at 36 months versus 65% for standard triple therapy in second-line treatment. Gilead's Aniracel demonstrates cleaner safety profile without Parkinsonism or immune enterocolitis seen with CARTITUDE, positioning it as preferred option once approved beyond fourth-line. AstraZeneca's dual-targeting BCMA/CD19 CAR-T achieves 89% overall survival at 36 months in high-risk newly diagnosed patients.
• •Bispecific Breakthrough Data: Johnson & Johnson's Tecvayli plus daratumumab combination achieves 83% overall survival at 36 months in relapsed/refractory multiple myeloma, matching CAR-T efficacy with different toxicity profile. Main concern involves infection risk from chronic B-cell depletion, manageable with subcutaneous IVIG. FDA approval expected 2026 for second-line setting, creating direct competition with CAR-T therapies and ArcelorMitex later-line options.
• •CML Allosteric Innovation: Turns Pharma's TERN-701 demonstrates 43% major molecular response in prior Tasigna-exposed CML patients and 50% in prior TKI-exposed patients. Once-daily oral dosing with or without food, no dose-limiting toxicities, and no pancreatic toxicity positions it ahead of Novartis's Tasigna standard. Phase one data strength drives $750 million financing (versus $650 million target), with phase three trial next step before potential partnership or acquisition.
• •Regulatory Uncertainty Impact: Dyne Therapeutics reports 3% normal dystrophin production at six months (10x standard of care) with functional endpoint separation versus placebo in DMD exon 51 skipper trial. Despite data exceeding Sarepta precedent for accelerated approval, investor response remains muted due to FDA philosophical uncertainty under new administration. SBIR/STTR reauthorization remains blocked over foreign funding debates, with next opportunity January 30th government funding deadline.