Section
Capital, M&A, and what biotech is worth this week.
PhRMA sued CMS on October 7 over the GLOBE most-favored-nation rule for Medicare Part B. The final rule covers as few as four manufacturers and $440 million in projected savings. The suit's real target is the CMMI test authority beneath it.
CSL is paying $355 million upfront for an antibody whose best evidence is a 26-patient interim readout. The deal prices claudin-1 biology, not proven data, across kidney and liver fibrosis.
Celcuity's REVTORPYK became commercially available September 30, claiming the PIK3CA wild-type corner of second-line HR-positive breast cancer no approved PI3K or AKT label covers. The launch must now overcome an immature survival read, heavy stomatitis, and a weekly IV schedule.
Lilly's once-weekly insulin Onswik is the second FDA approval in a six-month window, after Novo's Awiqli. Both won on non-inferiority data, leaving the real question open: whether weekly dosing actually improves insulin initiation and adherence.
Praxis Precision Medicines bypassed non-selective sodium channel toxicity in SCN2A and SCN8A DEEs by targeting persistent current. Now the FDA is examining its pivotal trial.
BigHat Biosciences raised $75 million as BHB810, a CDH17 VHH-Fc ADC, entered a Phase 1/2 gastric cancer trial. The round tests whether wet-lab data can fix AI drug discovery's translation problem.
FDA cleared lirafugratinib (Lyrfigtu) for FGFR2-altered cholangiocarcinoma after ReFocus posted a 46% response rate. The clinical argument is FGFR1 sparing. The cost is months of mandatory retinal monitoring.
Barzolvolimab cleared hives in about half of Phase 3 CSU patients by week 24, including many Xolair failures, but two anaphylaxis cases sent Celldex shares down 13% ahead of a 2027 BLA.
Iambic Therapeutics filed for a Nasdaq IPO the same morning it announced an AbbVie collaboration. Public markets will still judge the company on whether its brain-penetrant HER2 inhibitor holds up against Enhertu and Tukysa.
Curium’s Bexlutry is the first 505(b)(2) radioligand equivalent. The regulatory shortcut is done. Hospital clocks, isotope supply, and a pending $8 billion merger now decide whether Novartis’s NET franchise actually erodes.
Solstice Oncology launched with a $225 million Series A led by RA Capital to advance Harbour BioMed-licensed porustobart into neoadjuvant MSS colon cancer.
Del-desiran missed its primary endpoint in myotonic dystrophy type 1, wiping 13% off Novartis, pulling rival Dyne down 22%, and casting doubt over TfR1 RNA delivery.