Intismeran plus Keytruda cut melanoma recurrence or death risk by 42% versus Keytruda alone, a first Phase 3 win for a personalized mRNA vaccine. Moderna still fell as much as 25%.
Top stories
Newsletter
Pipeline, markets, policy, and science. Once a week.
Its $1.275 billion upfront commitment to a Phase 1 program puts the spotlight on oral peptide developers, including Entera as it approaches Phase 3 in osteoporosis.
Merck KGaA is paying $1.3 billion for a Phase 2 siRNA that has not started Phase 3, entering a polycythemia vera market the FDA opened with Takeda's weekly injection two months ago. The bet rests on quarterly dosing and durable hematocrit control.
Lilly's Jaypirca just won frontline CLL with a large survival edge, but only over chemoimmunotherapy the field is retiring. Lilly itself says the drug belongs in second line, and that sequencing logic shapes what the new label is really worth.
In depth
The FDA's 321-page review of Rasonque documents the survival win that earned a broad pancreatic cancer label, and the mutation subgroups whose response data ran against the drug.
Read the storyIntellia's lonvo-z is on a priority-review track to March 10, 2027 with no advisory committee planned. The one-dose gene edit cut HAE attacks 87% in Phase 3, and the debate over permanence, competition, and price will happen largely out of view.
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.
The FDA granted accelerated approval to AstraZeneca’s camizestrant based on ctDNA resistance signals before radiographic progression, overruling a 6-3 advisory committee vote and betting on a new oncology paradigm.
Conjugating antisense oligonucleotides to transferrin receptor transport vehicles achieves fifty-fold deeper brain penetration, challenging the standard of invasive spinal punctures.
