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CAR-T access expansion via allogeneic platforms
Caribou Biosciences said it is preparing to widen access to donor-derived CAR T by moving a pivotal Phase III study forward, leveraging its genome editing strategy and product optimization. The...
Definium’s LSD therapy posts additional Phase 3 win in anxiety
Definium Therapeutics reported success in the first of two planned Phase 3 trials of its orally dosed LSD-based therapy for generalized anxiety disorder. The company said the treatment...
Neuro-oncology signal: intranasal NEO100 reaches Phase 2a endpoint
NeOnc Technologies said its intranasal NEO100 met the primary endpoint in a Phase 2a study in recurrent IDH1-mutant high-grade glioma. The company reported six-month progression-free survival of...
Rare disease finance: Vaderis raises to advance engasertib into pivotal testing
Vaderis Therapeutics closed an oversubscribed $152 million Series B to advance engasertib into Phase 3 for hereditary hemorrhagic telangiectasia (HHT). The financing coincided with the initiation...
FDA action: Freenome’s SimpleScreen lung test earns Breakthrough device status
Freenome received U.S. FDA Breakthrough Device Designation for its blood-based SimpleScreen lung cancer screening assay. The designation covers the proposed use in adults ages 50 to 80 with at...
Diagnostics and MRD expansion: Natera moves deeper into early cancer detection
Natera said it is preparing to expand beyond minimal residual disease (MRD) and into early cancer detection as regulatory wins add indications for its Signatera liquid biopsy platform. Over the...
Immunotherapy-industry dealmaking: Innate and Sobi expand toward accelerated CTCL filing
Innate Pharma secured a large partnership with Sobi to fund and expand development of lacutamab in cutaneous T-cell lymphoma. Sobi will pay $75 million upfront and $40 million tied to near-term...
CDMO scale and manufacturing reshoring: BMS commits $2.3B Houston campus
Bristol Myers Squibb said it will build a $2.3 billion multi-modal manufacturing campus in Houston to support drug product manufacturing across modalities. The project, designed for late...
Funding for new platforms: Infinimmune raises to enter atopic dermatitis clinic
Infinimmune raised $75 million in a Series A to advance two antibody programs targeting IL-22 and IL-13 for atopic dermatitis. The company says it has identified mechanisms designed to achieve...
Biotech financing and corporate growth: Epicrispr raises $90M for FSHD epigenetic therapy
Epicrispr Biotechnologies raised $90 million in a Series C after sharing early data for a new epigenetic approach to facioscapulohumeral muscular dystrophy (FSHD). The company said the funding...
Thermo Fisher exits microbiology
Thermo Fisher Scientific has completed the sale of its microbiology business to European private equity firm Astorg, with the unit now operating as an independent company serving clinical,...
Phase III funding jump for hereditary hemorrhagic telangiectasia
Vaderis Therapeutics closed an oversubscribed $152 million Series B to advance engasertib (VAD-044) for hereditary hemorrhagic telangiectasia (HHT) and initiated its global Phase III HEROIC study...
Natera expands ctDNA monitoring into skin cancer
Natera partnered with Kupando Therapeutics to use Natera’s Latitude circulating tumor DNA (ctDNA) molecular residual disease assay in a Phase I skin cancer trial in Germany. The study will track...
FDA approval clears first oral orexin therapy for narcolepsy type 1
The FDA has approved Takeda’s first-in-class oral orexin receptor 2 agonist Orzeyful (oveporexton) for adults with narcolepsy type 1. Takeda said the therapy is designed to address an underlying...
Ambitious rare-disease financing and Phase III start
Vaderis was not the only company pushing toward late-stage execution this week—Definium’s psychedelic program also notched another Phase 3 win, while separate funding news highlighted continued...
Definium’s late-stage anxiety readout draws attention
Definium Therapeutics said its LSD-derived therapy eased generalized anxiety disorder symptoms in the first of two planned Phase 3 studies. The randomized trial enrolled 214 patients receiving a...
FDA rejects ITM Isotope radiopharma manufacturing
The FDA rejected ITM Isotope Technologies Munich’s radiotherapeutic ITM-11 (177Lu-edotreotide) due to manufacturing problems, issuing a complete refusal to approve. The decision delays a potential...
Moderna becomes first to win FDA approval for an mRNA flu shot
The FDA approved Moderna’s mRNA-1010 (mFLUSIVA), marking the first FDA-authorized flu vaccine designed as an mRNA product. Company and regulator materials tied the decision to positive Phase III...
Lundgren-style innovation: new microbiology distribution expansion
N6 Tec expanded distribution for its IconPCR thermocyclers across Europe, the Middle East and Africa, adding new partners and extending existing ones. The company said it broadened Morpho...
Next-generation oncology automation and expanded trial access funding
Separate healthcare investments signaled continued scaling of research infrastructure and clinical access initiatives. In Houston, Bristol Myers Squibb selected the site for a $2.3 billion...