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.
Athithi Verma
Teledyne Put Its Antitrust Argument in the Press Release, Product by Product
Mehrabian spent a paragraph itemising exactly how the two businesses do not overlap. Executives do that when a competition authority is reading.
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
DealPulse Signal Wk 32: Private Equity Took the Week and Paid Cash for All of It
Two listed healthcare companies agreed to go private before lunch on Monday. Eighty seven cents of every announced dollar was paid at signing.
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.
Imvanex Now Covers European Two-Year-Olds. The Children Carrying the Burden Are in Africa.
A type II variation in Brussels does nothing directly for a child in Kinshasa. What it does is unlock the procurement channels that reach one.
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.
Sphere-9 Can Ablate VT in Europe While Its US Pivotal Is Still Enrolling
Medtronic can sell Sphere-9 into ventricular tachycardia in Europe while the trial meant to prove it works in the US is only now enrolling.