One Missed, One Published the Arm That Failed, One Disclosed a Verb
Three Phase 3 toplines in one day, and the detail released runs inversely to the strength of the result. One company disclosed no number at all.
By technology
Two TROP2 Conjugates Reached the Same Patients Ten Weeks Apart, and Payers Finally Have a Choice to Make
Until this summer every approved ADC held its indication alone. Two TROP2 conjugates now share one first-line population, and payers finally have a comparator.
The Effect Size Is 0.81. The Number That Decides the Business Is 6.4 Hours.
Effect size 0.81 settles the efficacy question. The number that decides the business is 6.4 hours of supervised monitoring per dose.
Lilly Can Sue the Sellers. It Can Only Ask the Payment Networks.
Six suits against small peptide sellers is not a strategy for a market spanning a hundred countries. It is a demonstration attached to an appeal.
The Year’s Two Largest Conjugate Deals Were Not ADCs, and Not Cancer Drugs
Buyers stopped paying for conjugate drugs and started paying for conjugate chemistry. The year’s two biggest cheques bought neither an ADC nor a cancer drug.
ITM’s Complete Response Letter Names No Clinical Concern. It Names a Third-Party Facility.
COMPETE hit its endpoint and is published in The Lancet. The FDA did not touch any of it. What stopped the approval is a facility ITM does not own.
MoonLake Says IZAR-1 Met Every Endpoint and Will Not Show You the Placebo Arm
MoonLake disclosed 42.1% ACR50 and withheld the placebo arm. An absolute response rate without a comparator is a number, not a result.
Jazz Paid $820 Million Upfront for a Phase 1b/2a Because the FDA Pathway Came With It
QuickDeal read/Rare Diseases/Small Molecule Jazz Paid $820 Million Upfront for a Phase 1b/2a Because the FDA Pathway Came With It Athithi Verma· 11 August 2026· 3 min read· Synopulse Jazz Pharmaceuticals will acquire privately held Actio Biosciences for $820 million upfront plus up to $500 million in approval and sales milestones, a maximum of $1.32 … Read more
RiboX’s China Trial Data Bought It an Accelerated Dose Titration and a Subcutaneous Route
RiboX filed its Chinese investigator-initiated data with the IND. FDA granted faster escalation and a subcutaneous route on the strength of it.
Replimune Won Accelerated Approval on 91 Evaluable Patients and a 24% Response Rate
CBER took a 24% response in 91 evaluable patients, one day after the same committee voted nine to three against Capricor. Measurement, not size.