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Record biotech IPO capital formation
Parabilis Medicines priced what it is described as the largest-ever U.S. IPO by a drug developer, raising $770.5 million in gross proceeds after an upsized offering that began with 33.5 million...
FDA rare-disease pathway financing via priority review voucher
Rocket Pharmaceuticals said it received $180 million by selling an FDA drug review priority review voucher tied to the accelerated approval of Kresladi in March for a pediatric rare disease. The...
Cell therapy expansion at EHA: off-the-shelf CAR T with no lymphodepletion
Legend/Legend Biotech presented first-in-human data for LB-2501, a CD19/CD20 dual-targeting CAR T designed for an off-the-shelf approach with no lymphodepletion, at EHA2026. Investigators reported...
Checkpoint combination approval for high-risk clear cell RCC
The FDA approved an adjuvant regimen combining pembrolizumab with belzutifan for adults with high-risk clear cell kidney cancer following surgery. The approval is supported by a Dana-Farber study...
Biotech IP and manufacturing risks tied to US government action
WuXi AppTec filed a lawsuit in U.S. District Court for the District of Columbia contesting its designation as a Chinese military company. The company argues the 1260H listing has already caused...
Rare disease genetics: long-read sequencing implementation in the Netherlands
Researchers in the Netherlands reported early implementation results suggesting that long-read genome sequencing as a first-tier test can reduce time to diagnosis and follow-up testing, even if...
Long-read rare disease testing: new comprehensive test and published evidence
Radboud University Medical Center and Maastricht UMC+ published results describing clinical long-read genome sequencing as a route to more accurate and efficient diagnosis of rare genetic...
Ebola vaccine R&D: Moderna mRNA candidate accelerated with CEPI funding
Moderna and CEPI said they are advancing an investigational mRNA vaccine targeting Bundibugyo virus—the species driving an ongoing Ebola outbreak in the Democratic Republic of the Congo and...
AI in endocrine care: screening for underdiagnosed primary aldosteronism
Mayo Clinic researchers reported an AI-driven screening model designed to detect primary aldosteronism (PA), a frequently underdiagnosed cause of hypertension that can drive cardiovascular...
Hematology - off-the-shelf CAR T with outpatient intent
Legend Biotech’s LB-2501 is showing early efficacy with a safety profile that is enabling investigators to frame a future outpatient CAR T approach. At EHA2026, Lei Fan of First Affiliated...
Hematology - BCMA CAR T with MRD-negative outcomes
Kelonia Therapeutics’ KLN-1010 expanded early clinical results in multiple myeloma with high response rates and rapid MRD clearance. At EHA2026, Andrew Spencer of Monash University and the...
Regulatory approval - FDA clears adjuvant pembrolizumab plus belzutifan in kidney cancer
The FDA has approved an adjuvant regimen combining pembrolizumab and belzutifan for high-risk clear cell renal cell carcinoma following surgery. Dana-Farber researchers cited in the report...
Regulatory approval - Merck’s Welireg plus Keytruda gains kidney cancer indication
Merck’s pembrolizumab (Keytruda) and belzutifan (Welireg) combination received approval as an adjuvant treatment for kidney cancer after surgery. The approval expands the use of the dual regimen...
Cell & gene therapy - first patient treated in partial reprogramming glaucoma trial
Life Biosciences has treated the first participant in a gene therapy trial designed to partially reprogram aged cells as a glaucoma treatment. The approach turns on three genes intended to drive...
Oncology - oncolytic VSV targets metastatic ovarian cancer through engineered signaling
Researchers unveiled ErbB-OSV, an engineered vesicular stomatitis virus designed to selectively ablate metastatic ovarian cancer cells by exploiting rewired signaling. The report describes an...
Infectious disease - CEPI accelerates Moderna single-dose mRNA vaccine for Andes hantavirus
A new preclinical report indicates a single-dose mRNA vaccine can fully protect against lethal Andes hantavirus challenge in a Syrian hamster model. Researchers at UTMB tested intramuscular mRNA...
Vaccines - CEPI backs Moderna and others on Bundibugyo mRNA vaccine push
Moderna is developing an investigational mRNA vaccine against Bundibugyo virus with CEPI funding to enable early human trials. The effort is aimed at addressing a gap in available vaccines for...
Financing & IPOs - record-breaking Parabilis listing fuels biotech public-market momentum
Parabilis Medicines’ blockbuster IPO underscores a renewed surge in biotech listings, with record-sized capital raising despite ongoing macro uncertainty. The story reports that Parabilis secured...
Biopharma transactions - SonoThera raises Series B for ultrasound-mediated genetic medicines
SonoThera raised $125 million in an oversubscribed Series B to advance ultrasound-mediated genetic medicines for Duchenne muscular dystrophy and autosomal dominant polycystic kidney disease. The...
Rare disease immuno-oncology and regulatory risk around approved therapies
Amgen moved to defend Tavneos after the FDA signaled possible withdrawal, according to MedCity News. The rare-disease drug, developed by ChemoCentryx and approved for treating a form of...