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FDA moves to reduce friction in early-phase trial starts
The U.S. FDA launched a pilot program intended to speed up Phase I investigational new drug (IND) preparation by pairing sponsors with prequalified research institutions. Once matched, sponsors...
Grail’s mult-cancer blood test draws FDA advisory committee scrutiny
Shares in Grail jumped after the FDA posted documents ahead of an advisory committee meeting on its mult-cancer blood test, Galleri, signaling the agency may take a favorable view. The panel...
Ocular gene therapy steps closer to review for XLRP
Beacon Therapeutics reported positive pivotal phase II/III results for its ocular gene therapy laruparetigene zovaparvovec (laru-zova) in X-linked retinitis pigmentosa (XLRP), marking another step...
Immunology drugdata lifts Cue’s chronic hives program despite share drop
Cue Biopharma said its Phase 2 trial in chronic spontaneous urticaria (CSU) met key endpoints with CUE-221, its humanized anti-IgE IgG1 monoclonal antibody designed for a dual mechanism involving...
FDA approves second rare-disease indication for Intrabio’s ataxia-telangiectasia therapy
The FDA approved Intrabio’s Aqneursa (levacetylleucine) as the first treatment for ataxia-telangiectasia (AT), according to reports. The approval extends the company’s rare-disease platform beyond...
Regulatory and policy threat to NIH grant oversight becomes a focal point
Reports described a plan to establish a committee that could oversee—and potentially veto—science grants issued by the U.S. National Institutes of Health. Advocates and scientists warned the...
Novo doubles down on launch pipeline as investors question strategy
Novo Nordisk’s rebrand to “Novo” and its 2030 strategy at a Capital Markets Day failed to convince some investors, according to analysts cited in coverage. Executives led by CEO Maziar Doustdar...
Reimbursement-focused decision meeting for blood-based cancer detection
Ahead of an FDA advisory committee meeting on Grail’s Galleri, additional reporting indicated the agency is providing limited commentary in its materials while still framing questions around...
Biopharma finance leadership reshuffles at multiple clinical-stage companies
Multiple biopharma companies announced new finance leadership roles, underscoring continued emphasis on capital strategy and runway management across clinical-stage development. AdvanCell...
Radiopharmaceuticals M&A reshapes supply and scale
Telix Pharmaceuticals moved to lock in manufacturing capacity and an R&D pipeline by agreeing to buy ITM Isotope Technologies Munich in a deal worth $1.65 billion upfront, with additional...
Rare disease gene therapy scores pivotal win toward submission
Beacon Therapeutics reported that its gene therapy for X-linked retinitis pigmentosa (XLRP) improved visual acuity in a pivotal trial, setting up a path toward FDA review. The company framed the...
Ataxia-telangiectasia gets first approval under new mechanism
The FDA approved Aqneursa, a treatment for ataxia-telangiectasia, marking a key regulatory milestone for a rare genetic disorder with limited options. The therapy comes from IntraBio, a privately...
ADHD signal emerges for orexin agonists in early clinical data
Alkermes disclosed early Phase 1 randomized data suggesting its orexin agonist ALKS 7290 may treat attention-deficit/hyperactivity disorder (ADHD). The company reported the drug was well tolerated...
Midstage immunology win for chronic hives competitor effort
Cue Biopharma said its chronic spontaneous urticaria program cleared a Phase 2 primary endpoint, advancing the company’s Xolair-challenger plans to a Phase 2b/3 study. The update follows Cue’s...
Immunology reverse mergers push public-market alternatives
Two biotech reverse mergers landed within hours of each other, reflecting continued experimentation with alternate routes to public-company platforms as IPO windows thaw. Lisata Therapeutics...
Precision immune therapy funding accelerates late preclinical work
Electra Therapeutics raised $350 million in an upsized IPO to advance its lead program for secondary hemophagocytic lymphohistiocytosis (sHLH). The financing is aimed at continuing development of...
Precision gene modulation advances for chronic HBV
Chinese researchers reported engineering a compact CRISPR protein system designed to silence genes without cutting DNA, and packaged the approach into a single adeno-associated virus (AAV) vector....
Oral metabolic assets: low-dose CagriSema data ahead of key decision
Novo released low-dose data for CagriSema during a capital markets day in London as an approval decision looms. The company said the investigational metabolic drug appears competitive with Eli...
IPO pipeline continues with siRNA Phase 3 plans
ADARx Pharmaceuticals disclosed plans to raise about $319 million in a proposed IPO as it advances an siRNA program in Phase 3. The company is part of a broader IPO ramp in biopharma, with the...
Radiopharmaceutical M&A escalates
Telix Pharmaceuticals agreed to acquire German radiopharmaceutical manufacturer ITM Isotope Technologies Munich SE in a deal valued at $1.65 billion upfront, with potential additional milestone...