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Month: August 2026

DealPulse Signal Wk 31: One Buyer Paid Everything, Another Paid a Fifth

August 3, 2026August 3, 2026 by Athithi Verma
DealPulse Signal Wk 31: One Buyer Paid Everything, Another Paid a Fifth

Two immunology deals, five days apart. argenx paid 100% on signing for Phase 1b. J&J paid 22% for preclinical. Both are correctly priced.

Categories DealPulse, DealPulse Signal, Reports, The beats

OrphanPulse Wk 31: The Panel Voted on a Process, Not a Drug

August 3, 2026 by Athithi Verma
OrphanPulse Wk 31: The Panel Voted on a Process, Not a Drug

FDA advisers voted 9 to 3 against Capricor’s deramiocel, three weeks before PDUFA. The argument was not about biology. It was about which SAP counted.

Categories OrphanPulse, The Pulse

NeuroPulse Wk 31: An Open-Label 77% Could Not Rescue a Missed Endpoint

August 3, 2026 by Athithi Verma
NeuroPulse Wk 31: An Open-Label 77% Could Not Rescue a Missed Endpoint

FDA told NeuroPace its generalized epilepsy expansion is not approvable as filed. An open-label 77% cannot rescue a randomized endpoint that missed.

Categories NeuroPulse, The Pulse

Congress Exempted the Medically Frail. The Coding System Cannot Find Them.

August 2, 2026 by Athithi Verma
Congress Exempted the Medically Frail. The Coding System Cannot Find Them.

Fewer than 500 of 10,000 rare diseases have an ICD-10 code. The Medicaid frailty exemption is verified against codes most patients never had.

Categories Access Read, Editor's Pick, Legal & Policy, Market Access, Rare Diseases, The Brief Tags Market Access
Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24 2025

Synopulse Weekly Pulse – November 24, 2025

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