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Daily Roundup | Zenbexus Approval Tests a New Endpoint: What BMS Still Owes the FDA
BMS won FDA accelerated approval for Zenbexus on a 41% versus 21% MRD-negative complete response — with no survival data required. We break down what…
1 month ago
Daily Roundup | Taiho and Cullinan Stop Lung Cancer Trial Early — Data Too Good to Stay Blinded
Taiho and Cullinan halt their first-line EGFR exon 20 lung cancer trial early with zipalertinib — the data was too good to stay blinded — raising the…
1 month ago
Daily Roundup | Definium's LSD Pill Wins Phase 3 in Anxiety — What It Means for Psychiatry
DT120 beat placebo by 5.4 points on the Hamilton Anxiety scale twelve weeks after a single dose — the first new mechanism in generalized anxiety diso…
1 month ago
Daily Roundup | WuXi AppTec Wins Injunction: Pentagon's Military Label Halted for Now
A federal judge blocked the Pentagon's Chinese military designation of WuXi AppTec, finding the DoD's case rested on a misreading. Plus: Sionna Thera…
1 month, 1 week ago
Daily Roundup | Jazz Buys Actio Biosciences in $1.3B Rare Epilepsy Deal
Jazz Pharmaceuticals is paying $820 million upfront — up to $1.3 billion total — for Actio Biosciences and its first-in-class KCNT1 epilepsy drug ABS…
1 month, 1 week ago
Week in Review | Takeda's Orzeyful Approval Opens the Orexin Market — and a Payer Fight
FDA approved Takeda's Orzeyful, a first-in-class orexin-2 agonist for narcolepsy type 1, with peak sales seen near $2B. Also: Replimune's Tudriqev wi…
1 month, 1 week ago
Daily Roundup | Vedanta's $60M Lifeline: What VE303 Must Prove in C. diff Phase 3
Vedanta Biosciences raised $60M, including $20M from BARDA, to finish the Phase 3 that decides its microbiome bet on VE303 in recurrent C. difficile …
1 month, 1 week ago
Daily Roundup | Replimune Wins FDA Approval for Melanoma Drug After Two Rejections
FDA approved Replimune's Tudriqev for advanced melanoma after two rejections - and over its own reviewers' written objections. Plus Moderna's mRNA fl…
1 month, 1 week ago
Daily Roundup | Merck's 2028 Keytruda Cliff: The Oral PCSK9 Bet
Merck posted $16.61B in Q2 revenue and $8.37B in Keytruda sales — then cut profit guidance on acquisition charges. Alex and Maya break down the oral …
1 month, 2 weeks ago
Daily Roundup | Curium Buys Lantheus for Up to $8B in Cash-and-CVR Deal
Curium will pay up to $8.0 billion for Lantheus — Asubstantial cash payment per share plus additional contingent value rights tied to milestones stre…
1 month, 2 weeks ago