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FDA clears Waskyra — nonprofit wins first gene therapy approval
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome, marking the first time a non‑profit applicant secured authorization for a genetic medicine. Regulators cited the program’s...
ARPA‑H backs AI toxicity project — Inductive Bio leads human‑centric safety models
Inductive Bio won an up‑to‑$21 million ARPA‑H award to develop next‑generation AI models for drug toxicity prediction, partnering with Amgen, Baylor, Cincinnati Children’s, and Torch Bio. The...
Scaling single‑cell atlases and sequencing firms double down on multiomics
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300‑million‑cell perturbation atlas—expanding on Tahoe’s prior Tahoe‑100M dataset—to train AI models for predicting...
Lilly’s triple agonist sets new bar — 28.7% mean weight loss
Eli Lilly reported Phase 3 results showing its triple‑agonist retatrutide produced a mean 28.7% body‑weight reduction at 68 weeks in the trial population. The data, from the program’s high‑dose...
Next‑gen malaria drug passes Phase 3: Novartis’ GanLum cures 97.4%
Novartis and the Medicines for Malaria Venture (MMV) announced positive Phase 3 KALUMA results for GanLum, a ganaplacide–lumefantrine combination that cured 97.4% of participants with...
Teva recalls >500,000 prazosin bottles after nitrosamine impurity found
Teva Pharmaceuticals voluntarily recalled more than half a million bottles of prazosin hydrochloride after testing detected N‑nitroso prazosin impurity C above acceptable intake limits. The FDA...
AC Immune posts promising Parkinson’s biomarker signals — regulator engagement planned
AC Immune reported interim biomarker data from a mid‑stage Parkinson’s study suggesting the company’s immunotherapy may slow disease progression, and said it will seek regulatory feedback to...
Rezolute stock collapses after Phase 3 flop — ersodetug misses primary endpoints
Rezolute disclosed that its Phase 3 trial of ersodetug in congenital hyperinsulinism failed to meet the primary efficacy endpoint, triggering a catastrophic market reaction and an immediate...
Apple Tree Partners files Chapter 11 amid funding fight to keep portfolio afloat
Venture firm Apple Tree Partners filed for Chapter 11 to implement a restructuring plan intended to ensure continued funding for its biotech portfolio amid a months‑long dispute with primary...
Parse and Tahoe to build 300M‑cell perturbation atlas to train biology AI
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300‑million‑cell single‑cell perturbation atlas using Parse’s GigaLab services and Tahoe’s Mosaic perturbation...
Inductive Bio lands ARPA‑H award to build next‑gen AI toxicity models with Amgen
Inductive Bio received an award worth up to $21 million from ARPA‑H to lead DATAMAP, a consortium that will develop AI models predicting drug toxicity using data from human organoids, ex vivo...
Moderna taps Nanexa’s PharmaShell to pursue long‑acting injectables — deal could hit $500M
Moderna signed a collaboration and option deal with Swedish formulation firm Nanexa to test PharmaShell coatings for sustained‑release injectable therapies, paying $3 million upfront and keeping...
FDA clears Waskyra — first gene therapy approved from a nonprofit sponsor
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome developed by Fondazione Telethon, marking the first regulatory green light for a gene therapy originating from a nonprofit...
Lilly’s triple agonist: blowout efficacy, tolerability questions
Eli Lilly reported pivotal Phase 3 data showing its triple-agonist obesity candidate delivered unprecedented weight loss but drove higher-than-expected discontinuation rates. Company-released and...
Rezolute’s Phase 3 flop: hypoglycemia drug fails, stock collapses
Rezolute said its Phase 3 study of ersodetug in congenital hyperinsulinism missed the primary efficacy endpoint, prompting an immediate, severe market reaction and management to seek regulatory...
Parse and Tahoe commit to 300M-cell atlas to train biology AI
Parse Biosciences and Tahoe Therapeutics announced a collaboration to generate a 300 million single-cell perturbation atlas to train AI models that predict therapeutic outcomes. Parse will use its...
Natera buys Foresight to boost MRD sensitivity and enter hematology
Natera agreed to acquire Foresight Diagnostics for $275 million upfront plus up to $175 million in milestone earnouts to integrate Foresight’s phased-variant PhaseED-seq technology into Signatera...
Moderna taps Nanexa’s PharmaShell to pursue long‑acting injectables
Moderna struck a heavily back‑loaded collaboration with Swedish formulation specialist Nanexa to assess the PharmaShell platform for up to five injectable drug programs. Moderna paid $3 million...
Novartis and Relation agree $1.7B AI‑driven drug discovery pact
Novartis signed a strategic collaboration with UK AI‑driven biotech Relation Therapeutics to discover and advance drug targets for atopic diseases, with up to $1.7 billion in preclinical,...
FDA approves Waskyra: first gene therapy cleared from a nonprofit sponsor
The FDA approved Waskyra, a gene therapy for Wiskott‑Aldrich syndrome, marking the first U.S. authorization of a gene therapy developed and filed by a nonprofit applicant, Fondazione Telethon. The...