1️⃣ Chiesi is buying a working HAE launch
Chiesi agreed on April 29 to buy KalVista for $27 a share in cash, about $1.9B, adding Ekterly, the first oral on-demand HAE treatment, after $49M in 2025 sales.
Why it matters
Rare disease buyers are paying for commercial traction, not just scarcity. Oral HAE has become an exit market before the category settles.
Coffee talk
If the launch is already working, how long before Pharvaris or BioCryst get the same call?
2️⃣ GSK’s progranulin bet has run out of excuses
Alector said on April 29 that the Phase 2 PROGRESS-AD trial of nivisnebart will stop after an IDMC found it unlikely to meet its primary endpoint.
Why it matters
GSK paid $700M upfront for Alector’s AL001 and AL101 in 2021. Both have now failed key trials, and the next CNS pitch shifts to brain delivery.
Coffee talk
How many CNS deals still price the target before anyone has solved brain exposure?
3️⃣ FDA just froze Newron’s US enrolment
Newron said FDA has placed a hold on new US patients in ENIGMA-TRS 2 after a sudden death outside the US, while the safety board said studies should continue.
Why it matters
Treatment-resistant schizophrenia remains investable after Cobenfy, but one safety event can still move the timetable. Q4 data now carries more process risk.
Coffee talk
Does a CNS asset still get full credit when one FDA information request can move the launch clock?