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.
By technology
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.
Scholar Rock Filed With Two Fill-Finish Sites. One Just Failed, and the Date Held.
Catalent Indiana failed its FDA inspection. Scholar Rock had named a second fill-finish site in the same BLA, so the PDUFA date did not move.
Tau does its damage inside mitochondria, independent of tangles and microtubules. The field’s imaging toolkit was built to see neither.
Tau does its damage inside mitochondria, independent of tangles and microtubules. The field’s imaging toolkit was built to see neither.
The FDA Approved Orzeyful and Handed the Approval Date to the DEA
FDA’s letter says the approval date is whenever the DEA publishes scheduling. Takeda holds a first-in-class approval it cannot sell yet.
NICE Backed Acalabrutinib and Venetoclax Without Obinutuzumab, and the Omission Is the Decision
AMPLIFY tested acalabrutinib and venetoclax with and without obinutuzumab. NICE recommended the doublet, which is a decision about infusions.
Argenx’s $2.2 Billion Bought a Phase 1b With Ten Patients on Placebo
FB102’s entire human efficacy dataset in vitiligo is 42 patients, ten of them on placebo. argenx paid $2.2 billion in cash, with no milestones.
Lilly’s Volume Rose 60%, Its Realized Prices Fell 13%, and the Top of Its EPS Range Came Down
QuickAccess read/Cardio-Metabolic/Peptide Lilly’s Volume Rose 60%, Its Realized Prices Fell 13%, and the Top of Its EPS Range Came Down Athithi Verma· 6 August 2026· 3 min read· Synopulse Eli Lilly reported Q2 2026 revenue of $23.0 billion, up 48%, driven by a 60% increase in volume and partially offset by a 13% decrease in … Read more