Friday: FDA angst and fat GLP-1 checks

Upfront Briefing

Tape Action

Instrument Last close 1D % YTD % S&P 500 6,901.0 0.2% 17.3% Nasdaq 100 25,686.7 (0.3%) 22.2% Russel 2000 2,590.6 1.2% 16.2% XBI 123.0 0.8% 36.6% NBI 5,726.7 0.8% 32.8% Clinical Trials ETF (BBC) 40.0 0.6% 67.3%

• Biotech kept outpacing the tape, with XBI and NBI both up 0.8% vs the S&P’s 0.2%, as BBC’s equal‑weight basket stayed the YTD rocket at 67.3%.
• Risk-on vibes at the smaller end: the Russell 2000 gained 1.2%, handily beating the Nasdaq 100, which slipped 0.3%.

The Big 3

1 FDA leadership and bureaucracy concerns impact biopharma Concerns are rising about FDA leadership instability and bureaucracy, which could hinder drug development and approvals, affecting biopharma innovation. A recent survey reflects industry distress. Why it matters: If FDA leadership keeps churning and staff confidence erodes, review timelines get noisier, guidance gets harder to trust, and late-stage assets carry a higher “regulatory risk” discount in models. Source: BioSpace More: BioCentury; STAT; BioCentury

2 Dyne, Kymera Therapeutics close upsized public offerings Dyne Therapeutics and Kymera Therapeutics have successfully closed upsized public offerings, with Kymera raising $602 million. These financings demonstrate strong investor confidence in the clinical-stage biopharma companies. Why it matters: Dyne and Kymera pulling off jumbo, upsized raises says the window is still open for high-conviction stories — and that investors are willing to fund muscular, multi-year development plans rather than drip-feeding cash. Source: PR More: PR; BioWorld

3 AC Immune's Parkinson's vaccine shows promising biomarker data AC Immune's Parkinson's vaccine is advancing after showing promising biomarker data. This positive development could accelerate its path to approval, offering a new therapeutic option for the disease. Why it matters: A cleaner biomarker profile in Parkinson’s doesn’t just de-risk this program — it helps validate a broader α-synuclein vaccine strategy in neuro, which could support partnering interest, pricing power, and a future franchise if the clinical data hold up. Source: BioCentury More: BioPharma Dive

Everything Else that broke

• Lilly’s retatrutide, a triple agonist, is emerging as a strong contender for best-in-class obesity treatment, positioning the company for further impact in the weight loss market. — BioCentury
• Geron is cutting one-third of its staff to refocus on turning around the launch of Rytelo, underscoring challenges in the drug’s commercial trajectory. — Endpoints
• The EU reached a deal on major pharmaceutical legislative changes that could reshape development, pricing, and access across the European drug market. — Endpoints
• GSK won approval for a new antibiotic to treat gonorrhea, adding a needed option against a growing public health concern. — Endpoints
• Rezolute suffered a major setback as its only drug failed in a Phase 3 trial, highlighting the high stakes of single-asset strategies and the risks embedded in clinical development. — Endpoints
• Rhythm reported key weight loss data for Imcivree in a Phase 2 Prader–Willi study, providing initial signals that could offer hope in this rare disease. — Endpoints
• MAIA kicked off a pivotal Phase 3 lung cancer trial for ateganosine, marking a significant advance for the oncology program. — PR
• AB Science highlighted new data on masitinib showing clinical benefit in ALS patients prior to complete loss of function, offering a measure of optimism in a devastating disease. — PR
• Biotech venture firm Apple Tree Partners filed for bankruptcy amid a dispute with a billionaire backer, signaling stress in a corner of the sector’s capital stack. — BioPharma Dive
• Umoja delayed the first readout for its in vivo CAR‑T program, pushing out timelines for a closely watched cell therapy approach. — Endpoints
• Boehringer Ingelheim is pairing a new drug with an AI-driven strategy to tackle pulmonary fibrosis, aiming to improve outcomes in a severe lung disease. — Labiotech
• The outlook for cell and gene therapy remains strong despite recent turbulence, with scientific potential still seen as a driver of future growth. — BioCentury
• A new CDC report underscored the benefits of COVID‑19 vaccines in children, a datapoint that could influence public health policy and uptake. — Endpoints
• A prominent lawyer is urging the US Supreme Court to revisit a decision on “skinny” generic drug labels, with big implications for how generics come to market. — Endpoints
• Io Therapeutics presented preclinical data on a CAR‑T approach for HER2+ breast cancer, pointing toward potential future combination strategies. — PR

Deal Flow

M&A / BD&L

• Genmab completed its tender offer for outstanding common shares of Merus N.V., marking a notable M&A milestone in the biopharma space. — PR

VC / Private Financings

• China-based innovators D3 Bio and Sanegene each secured funding rounds topping $100 million, underscoring sustained venture appetite for the region’s biotech stories. — BioCentury

IPOs / Follow-Ons

• Kymera Therapeutics Announces Closing of Upsized $602 Million Public Offering. — PR
• Dyne Therapeutics Announces Closing of Upsized Public Offering. — PR

Academic Corner

• FDA pitched a new pathway for rare genetic diseases, highlighting evolving regulatory thinking around how to get ultra-rare therapies to patients. — Nature Biotech
• A novel anti-malarial cleared Phase 3, adding momentum to global efforts to update the anti-infective toolkit. — Nature Biotech
• FDA approved a triglyceride-lowering siRNA drug, reinforcing RNA-based medicines as a maturing modality beyond LDL lowering. — Nature Biotech
• A stepped-wedge trial across 56 US clinics showed that a multifaceted primary care intervention can improve patient weight outcomes versus usual care. — Nature Medicine
• A review detailed current and emerging methods for evaluating influenza vaccine performance, including how to assess durability outside of classic RCTs. — NEJM
• A Nature Medicine review mapped how liquid biopsies can be integrated across the cancer care continuum, from detection to response monitoring. — Nature Medicine
• An overview of upcoming FDA decisions in Q1 2026 flagged the next wave of approvals biotech should be watching. — Nature RDD