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Lilly acquires Orna for up to $2.4B — accelerates in vivo CAR‑T strategy
Eli Lilly agreed to acquire Orna Therapeutics in a deal worth up to $2.4 billion to add Orna’s circular RNA and LNP delivery platform and a clinic‑ready in vivo CAR‑T candidate targeting CD19....
Medicare covers Personalis NeXT Personal MRD test for lung cancer surveillance
The Centers for Medicare & Medicaid Services granted Medicare coverage for Personalis’s NeXT Personal molecular residual disease (MRD) assay for surveillance of stages I–III non‑small cell lung...
Precision Biosciences cleared to start PBGENE‑DMD trial — IND accepted
Precision Biosciences received FDA clearance of an Investigational New Drug application for PBGENE‑DMD, enabling site activation for a Phase I/II trial (FUNCTION‑DMD) in ambulatory patients with...
OncoDNA rolls out fragmentomics liquid biopsy OncoXplore for therapy guidance
OncoDNA will begin early‑access roll‑out of OncoXplore, a fragmentomics‑based cell‑free DNA sequencing assay, to research and early access customers while pursuing CE‑IVDR certification for...
FDA refuses review of Moderna's mRNA flu shot: regulator flags trial design
The FDA has refused to start a review of Moderna’s application for its standalone mRNA influenza vaccine, citing flaws in the pivotal trial’s control-arm design rather than explicit safety or...
FDA issues complete response to Regenxbio’s Hunter syndrome gene therapy — approval paused
The FDA issued a complete response letter for Regenxbio’s RGX-121 gene therapy for Hunter syndrome, concluding that the submission did not adequately demonstrate clinical benefit using the trial’s...
Lilly buys Orna... in vivo CAR‑T bet expands pharma playbook
Eli Lilly agreed to acquire Orna Therapeutics in a deal worth up to $2.4 billion to obtain Orna’s circular RNA platform, LNP delivery expertise, and an in vivo CAR‑T therapy poised for Phase I...
Madrigal pays $60M upfront — $4.4B deal for siRNA programs to bolster MASH strategy
Madrigal Pharmaceuticals agreed to acquire six preclinical siRNA programs from Ribo Life Science in a deal with $60 million upfront and as much as $4.4 billion in contingent payments. The programs...
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....