BioBucks—FDA shake-up, ACIP stalls, CNS and oncology data land

Upfront Briefing

Market Moves

Instrument	Last close	1D %	YTD %
S&P 500	6,857.12	0.11%	16.58%
Nasdaq 100	25,581.70	-0.10%	21.75%
Russell 2000	2,531.16	0.76%	13.50%
SPDR S&P Biotech (XBI)	123.25	1.17%	36.85%
Nasdaq Biotechnology Index (NBI)	5,764.74	Flat	33.73%

Top 3 Headlines

1 FDA leadership changes, vaccine policy face scrutiny Significant leadership changes are underway at the FDA's drug office, with a new head appointed. This comes amid controversy and scrutiny over the agency's vaccine policy. Why it matters: Significant leadership changes at FDA's drug office and controversy over vaccine policy could impact drug approvals and public health trust. Source: BioCentury More: STAT · Endpoints News · BioPharma Dive ·

2 ORIC Pharma presents positive Enozertinib data at ESMO Asia ORIC Pharmaceuticals presented positive data for Enozertinib at the ESMO Asia Congress 2025, highlighting its potential best-in-class profile for NSCLC patients with HER2 Exon 20 and EGFR atypical mutations. Why it matters: Positive data for Enozertinib in NSCLC with HER2 Exon 20 mutations and EGFR atypical mutations could boost ORIC Pharmaceuticals. Source: GlobeNewswire

3 CDC panel delays vote on hepatitis B birth dose The CDC's vaccine advisory panel has again delayed its vote on recommendations for the hepatitis B birth dose, pushing the decision to Friday amid ongoing debate. Why it matters: Repeated delays by the CDC's vaccine advisory panel on hepatitis B birth dose recommendations signal ongoing debate and uncertainty. Source: Endpoints News More: BioPharma Dive · Fierce Pharma

More Headlines

• FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma — FDA
• Ascentage Pharma cleared for global registrational Phase III study of olverembatinib in first-line Ph+ ALL — GlobeNewswire
• CervoMed reports late-breaking CTAD data showing neflamapimod significantly slows clinical progression in Dementia with Lewy Bodies — GlobeNewswire
• Eisai stays confident in its anti-tau Alzheimer’s asset despite Johnson & Johnson’s recent failure in the space — BioSpace All News
• Transcenta Therapeutics posts updated efficacy data from Phase I/II Transtar102 of Osemitamab + Nivolumab + CAPOX in first-line G/GEJ cancer at ESMO Asia — GlobeNewswire
• ImPact Biotech shares updated preliminary Phase 3 ENLIGHTED data for Padeliporfin VTP in low-grade upper tract urothelial cancer at SUO 2025 — GlobeNewswire
• Galimedix Therapeutics reports compelling Phase 1 data at CTAD 2025 for oral small molecule GAL-101, showing excellent safety and pharmacokinetics — GlobeNewswire
• UniQure faces a challenging regulatory path for its Huntington’s gene therapy, per newly released FDA minutes — BioSpace All News

Deal Flow

M&A & BD&L

• Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement — Company PR

VC & Private Financings

• SciNeuro Pharmaceuticals raises $53M to advance its neurodegeneration pipeline — BioPharma Dive

IPOs & Follow-Ons

• Capricor Therapeutics announces a proposed public offering of common stock — GlobeNewswire

Academic Corner

• First-in-class APRIL inhibitor secures approval for rare kidney disease — Nature Reviews Drug Discovery
• A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus — The New England Journal of Medicine
• Trial of Pegcetacoplan in C3 Glomerulopathy and Immune-Complex MPGN — The New England Journal of Medicine
• Updated Evidence for Covid-19, RSV, and Influenza Vaccines for 2025–2026 — The New England Journal of Medicine
• Small Steps, Big Ventricles: Idiopathic Normal-Pressure Hydrocephalus — The New England Journal of Medicine
• Empyema Necessitans — The New England Journal of Medicine
• Clouded by Smoke — The New England Journal of Medicine
• A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA — The New England Journal of Medicine