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ILiAD raises $115M to push intranasal pertussis vaccine into pivotal testing
ILiAD Biotechnologies closed an oversubscribed $115 million Series B led by RA Capital to advance BPZE1, a live attenuated intranasal pertussis vaccine, toward Phase III development and a pivotal...
Evommune and Nektar post mid‑stage wins — rivals to Dupixent gain steam
Two mid‑stage readouts in atopic dermatitis moved markets: Evommune reported EVO301 achieved its phase IIa primary endpoint with competitive EASI reductions, sending shares sharply higher, while...
CMS grants Medicare coverage for Personalis MRD test in lung cancer surveillance
The Centers for Medicare & Medicaid Services granted coverage for Personalis’ NeXT Personal molecular residual disease (MRD) assay for surveillance of stages I–III non‑small cell lung cancer. CMS...
Generate Biomedicines files IPO to bankroll Phase III for AI‑designed asthma antibody
Generate Biomedicines filed for an initial public offering to fund global Phase III programs for GB‑0895, an AI‑designed anti‑TSLP antibody now entering pivotal trials in severe asthma. The...
Capsida confirms cerebral edema in halted AAV trial, cause remains unresolved
Capsida Biotherapeutics confirmed that the fatality in its suspended SYNRGY trial resulted from cerebral edema but said the underlying trigger for the swelling remains undetermined. The company...
Post‑Hoc Live: biotech vs FDA — public tensions escalate
Biopharma leaders and commentators are publicly debating whether relations with the FDA have reached a breaking point after a wave of controversial regulator decisions, including the agency’s...
Lilly buys Orna: $2.4B push into in‑vivo CAR‑T
Eli Lilly agreed to acquire Orna Therapeutics for up to $2.4 billion, securing Orna’s circular RNA platform and a Phase 1–ready in‑vivo CAR‑T candidate, ORN‑252, which targets CD19 for B‑cell...
FDA refuses to review Moderna flu shot: agency flags comparator in trial
The U.S. Food and Drug Administration declined to file Moderna’s application for its mRNA seasonal influenza vaccine, citing concerns with the trial’s control arm and arguing the comparator did...
Atopic dermatitis shakeup: Evommune and Nektar post mid‑stage wins
Two midstage readouts moved market expectations in atopic dermatitis: Evommune reported phase IIa success with its long‑acting IL‑18 fusion (EVO301) and saw a steep stock rally, while Nektar said...
FDA issues CRL to Regenxbio: Hunter syndrome gene therapy setback
Regenxbio received a complete response letter for RGX‑121, its gene therapy for mucopolysaccharidosis II (Hunter syndrome), the company disclosed after the FDA reviewed the biologics license...
Capsida confirms cerebral edema in gene‑therapy trial fatality
Capsida Biotherapeutics reported that an autopsy confirmed cerebral edema as the cause of death in the halted SYNRGY trial participant who received CAP‑002, its AAV gene therapy for STXBP1...
Gilead slips as Yeztugo falls short of lofty expectations
Gilead reported a strong quarter in product sales but its stock fell after investors reacted to guidance and mixed early uptake of Yeztugo, a recently launched long‑acting HIV prevention product....
Medicare expands coverage: Personalis MRD test cleared for lung‑cancer surveillance
CMS granted coverage for Personalis’ NeXT Personal MRD assay to monitor stages I–III non‑small cell lung cancer in the surveillance setting, the company announced. The decision follows clinical...
Takeda taps Iambic AI: $1.7B pact to accelerate small‑molecule discovery
Takeda signed a multiyear, up‑to‑$1.7 billion collaboration with Iambic Therapeutics to deploy Iambic’s AI discovery platform across oncology, GI and inflammation targets. The deal pairs Takeda’s...
Generate Biomedicines files IPO as Phase III asthma program advances
Generate Biomedicines filed for an initial public offering days after dosing its first patient in Phase III studies for GB‑0895, an AI‑designed anti‑TSLP antibody for severe asthma. The company...
NIH director Bhattacharya outlines grant and funding overhaul
NIH Director Jay Bhattacharya announced plans to reform grant review and institutional funding, emphasizing streamlined peer review with fewer key questions, a push to fund higher‑risk research,...
Atopic dermatitis... New biologics dent Dupixent's lead
Evommune and Nektar released clinical data showing prolonged and meaningful skin improvements in patients with moderate-to-severe atopic dermatitis. Evommune reported that EVO301, an IL-18–binding...
Lilly buys Orna – in vivo CAR‑T race accelerates
Eli Lilly agreed to acquire Orna Therapeutics in a deal worth up to $2.4 billion to secure Orna’s circular RNA platform and an in‑vivo CAR‑T candidate, ORN‑252. Orna’s technology pairs engineered...
FDA issues CRL to Regenxbio – gene therapy setback deepens
Regenxbio received a complete response letter (CRL) from the U.S. Food and Drug Administration for RGX‑121, its gene therapy for Hunter syndrome (MPS II), and the agency has placed related...
Moderna’s flu shot spat with FDA: review refused
Moderna said the FDA refused to file (refuse‑to‑file) its application for an mRNA influenza vaccine, citing trial design issues centered on the comparator used in the pivotal study rather than...