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Biohaven Popped Champagne on a $795M Deal. The FDA Showed Up Nine Days Later.
Nine days after signing a global licensing deal worth up to $795 million with SK Biopharmaceuticals, Biohaven got a partial clinical hold from the FDA on its epilepsy drug opakalim (BHV-7000). The culprit: a metabolite found in rodent studies that the agency wants more data on before new patients can enroll. Shares dropped 13% to 17% on the news. One pivotal trial is already fully enrolled and unaffected, but the other is frozen until Biohaven delivers additional nonclinical studies. The big question: did SK know about the rodent findings before inking the deal? Biohaven says the data came up in diligence, but the deal hadn't even closed yet.
Why it matters: It's a textbook reminder that regulatory risk doesn't respect deal timelines. No amount of due diligence can fully insulate a transaction from the FDA's next phone call, and this one will reshape how partners think about contingency clauses in biotech licensing deals.
Read more →Clinical Trials and Pipeline Moves
What If You Could Kill Cancer Before It Even Starts?
A CAR-T trial just went 20-for-20. Every patient with high-risk smoldering myeloma (the "check engine" light for blood cancer) hit MRD negativity, meaning zero detectable precancerous cells. Zero patients progressed to active myeloma at 15 months. No grade 3 or higher cytokine release syndrome events were reported, though side effects including cytokine release syndrome in all patients, cranial nerve palsies, and prolonged neutropenia were common. It's the first real evidence that cell therapy could prevent cancer, not just treat it. The sample is tiny, but the concept is enormous.
Read more →BMS Says Its New CAR-T Worked. It Just Won't Say How Well.
BMS announced that arlo-cel, its GPRC5D-targeting CAR-T therapy, met all endpoints in its pivotal myeloma trial. Then it declined to prominently share the actual response rates. Phase 1 data showed an 87-91% response rate; whether Phase 2 held up remains a mystery until a future medical conference. In a space this competitive, the silence is deafening.
Read more →BridgeBio Abandoned the Biggest Prize in KRAS Cancer
BridgeBio pulled its lead KRAS drug out of the lucrative first-line lung cancer race, significantly narrowing its addressable patient population. Shares of its oncology subsidiary BBOT cratered 18%, while BridgeBio Pharma (BBIO) fell roughly 4-5%. The later-line data looks solid (75% response rate in pretreated patients), but biotech valuations are built on first-line ambitions, not niche retreats.
Read more →Kailera's Obesity Pill Works. The Side Effects? Yikes.
Kailera's oral obesity pill delivered about 11% weight loss in Phase 3, which is respectable for a pill. The problem: roughly 70% of patients experienced nausea and nearly as many had vomiting. Novo and Lilly are pushing oral alternatives with similar efficacy and far gentler side effect profiles, making Kailera's path to market look uncomfortably narrow.
Read more →AbbVie Found a $6 Billion Problem Nobody Was Solving
More than 6 million American women get menstrual migraines, and no drug has ever carried a specific approval to prevent them. AbbVie's atogepant (Qulipta) just aced its Phase 3 LUNA trial, hitting the primary endpoint and sweeping all eight secondary endpoints. If approved, it would be the first dedicated preventive for this population.
Read more →Deals, Capital, and Corporate Shakeups
Novartis's Worst Month Just Got Worse. Shareholders Want Heads to Roll.
After back-to-back trial failures (including a drug from its roughly $12 billion Avidity acquisition) and three patient deaths in a CAR-T program, major shareholder Artisan Partners is demanding a Novartis board overhaul. The target isn't the CEO; it's the directors who greenlit billions in deals that are now blowing up.
Read more →Biotech's Funding Winter Has a $1.1 Billion Exception
Frazier Life Sciences just closed $1.1 billion for its public biotech fund while early-stage startups can barely get a meeting. First-half 2026 seed and Series A funding dropped about 15% from a year earlier, to roughly $4.4 billion. The money exists in biotech; it's just concentrating at the top of the food chain.
Read more →Biotech's Backdoor to Wall Street Is Running Out of Keys
With the IPO window still barely cracked open, roughly two dozen biotech reverse mergers have been announced in 2026, backed by about $2 billion in financing. The problem: the supply of clean shell companies is thinning fast, and SEC rules keep tightening. Plan B is becoming Plan A, and it's getting crowded.
Read more →An Oncology Company Just Launched a Diabetes Startup. Seriously.
Kura Oncology spun out a diabetes company called Caspian Therapeutics with $50 million in Series A funding and Eli Lilly as an investor. The science connects: Kura's menin inhibitors, built for leukemia, also appear to regenerate insulin-producing beta cells. Kura kept 49% of Caspian, turning a non-core asset into equity upside without spending a dime on diabetes trials.
Read more →The Man Who Taught Big Pharma to Date Startups Is Leaving
Andy Plump, the architect of Takeda's R&D transformation, will retire in June 2027 after roughly twelve years of turning the company into big pharma's most prolific biotech matchmaker. He built over 200 partnerships, narrowed the pipeline's focus, and created a model that half the industry now copies. The question: can the culture survive without him?
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