Biotech
Biotechnology companies, trials, and applied biological innovation.
Biopharma divides over how to respond to China
U.S. biopharma is split over whether to restrict China ties or keep licensing and development links open, as Congress and HHS step up competing policy moves.
China’s Biotech Ascent Is Forcing U.S. Venture Capitalists to Adapt
Wall Street Journal reporting says China’s biotech sector is drawing a larger share of global capital and forcing U.S. venture investors to rethink how they fund, run and value drug development.
Takeda, InSilico strike AI drug-discovery deal worth up to $600 million
Takeda is reported to have struck an AI drug-discovery partnership with InSilico Medicine worth up to $600 million, with InSilico handling early discovery and Takeda taking on later development and commercialization.
Abivax Shares Jump on Expanded Safety Data for Ulcerative Colitis Drug
Abivax shares rose after the company said expanded safety data for obefazimod, its experimental ulcerative colitis drug, showed cancer rates in a larger patient set remained within expected ranges. The update also added remission data in harder-to-treat patients and kept a 2026 regulatory filing plan on track.
Ipsen agrees to buy Kartos Therapeutics for up to $1.75 billion
Ipsen said it will acquire Kartos Therapeutics for $450 million upfront and up to $1.3 billion more in milestone payments, adding the late-stage myelofibrosis drug navtemadlin to its oncology pipeline.
Moderna Shares Rise After Investor Day Reveals First In Vivo CAR-T Autoimmune Program
Moderna shares rose after the company used its investor day to unveil its first in vivo CAR-T autoimmune program, with clinical development of mRNA-6007 planned for 2027 and an initial focus on systemic lupus erythematosus.
3 People Have Gotten Cancer-Detecting Implants in Their Brains
Coherence Neuro says it temporarily implanted a brain-computer interface in three patients during tumor surgery in Melbourne to test short-term safety before a planned glioblastoma trial next year.
FDA to reverse Regenxbio rejection of Hunter syndrome gene therapy, WSJ reports
Regenxbio says the FDA has agreed to reverse its earlier rejection of Navsunli, a Hunter syndrome gene therapy, and may review the filing within about two months after a July meeting.
Biotech Stocks Surge After FDA Allows uniQure AMT-130 Refiling
uniQure said the FDA will let it refile for AMT-130 using three-year Phase 1/2 data, reversing an earlier rejection and sending the stock sharply higher.
Paradromics implants first brain-chip device in a human patient
Paradromics says it has implanted its Connexus brain-computer interface in a human patient for the first time in an FDA-approved study at University of Michigan Health. The patient, a Michigan woman with a motor neuron disease affecting speech, is recovering at home and is expected to begin training for speech-decoding tests once she is ready.
uniQure Surges After FDA Reverses Course on Huntington's Gene Therapy Filing
uniQure shares soared after the company said the FDA will let it pursue a Biologics License Application for AMT-130, its Huntington’s disease gene therapy, using existing Phase 1/2 data and a three-year analysis rather than requiring a new placebo-controlled trial.
uniQure Shares Surge After FDA Reverses Course on Huntington's Gene Therapy Filing
uniQure shares jumped after the company said the FDA reversed its earlier stance on AMT-130, its Huntington's disease gene therapy, and will now allow a filing using limited clinical data. The change could accelerate the program's regulatory timeline, though questions remain about a confirmatory study and the exact data package.
Eli Lilly Acquires 4E Therapeutics to Expand Pain Pipeline
Eli Lilly acquired Austin-based 4E Therapeutics, a neuroscience company developing nonaddictive chronic-pain treatments, including oral MNK inhibitors. The companies did not disclose terms.
London startup begins NHS trial aimed at preventing cancer immunotherapy side effects
Poolbeg Pharma is starting a six-hospital NHS trial of POLB 001, an oral pre-treatment meant to prevent cytokine release syndrome in patients receiving teclistamab.
Apotex shares rally after C$1.3 billion IPO pricing
Apotex Health priced its Canadian IPO at C$24 a share, raising about C$1.3 billion and sending the stock to an opening gain of 17% on debut. The offering, one of the largest Canadian IPOs in years, was upsized amid strong demand.
Parabilis Medicines Rockets After Record Biotech IPO
Parabilis Medicines raised $670 million in the largest biotech IPO on record and closed its first day of trading up 58%, a sign of renewed investor appetite for development-stage drugmakers.
Tango Therapeutics reports 92% objective response rate for vopimetostat combination in pancreatic cancer
Tango Therapeutics said its vopimetostat and daraxonrasib combination produced a 92% objective response rate in response-evaluable patients with previously treated MTAP-deleted pancreatic ductal adenocarcinoma, alongside a 90% six-month progression-free survival rate and no new safety signals.
Amneal Announces U.S. FDA Approval of Romidepsin Injection Solution
Amneal said the FDA approved its romidepsin injection solution, a ready-to-use vial presentation for adult cutaneous T-cell lymphoma. Wire coverage said the product may qualify for 180 days of Competitive Generic Therapy exclusivity.
Pharming says FDA accepted resubmitted Joenja sNDA for children 4 to 11 with APDS
Pharming said the U.S. FDA accepted its resubmitted sNDA for Joenja in children aged 4 to 11 with APDS, setting a PDUFA date of October 24, 2026.
BioVie completes Phase 2 SUNRISE-PD trial in early-stage Parkinson's disease
BioVie said it has completed the last patient evaluation visit in its Phase 2 SUNRISE-PD trial of bezisterim in early-stage Parkinson’s disease. Topline data are targeted for Q3 2026.
Anthill launches US availability of Anthill Cloud for life sciences
Anthill said Anthill Cloud is now available in the US for pharmaceutical, biotech and medtech commercial and medical teams. The company describes the platform as an AI-powered content-excellence system for life sciences.
Dogwood Therapeutics starts Halneuron Phase 2b extension study
Dogwood Therapeutics said it has started a 12-week open-label extension study of Halneuron after a positive interim assessment in its ongoing Phase 2b chemotherapy-induced neuropathic pain trial. The company said the follow-on study will add safety and efficacy data for its planned FDA submission package and future Phase 3 program.
Lakewood-Amedex reports positive data for lead diabetic-foot-ulcer candidate
Lakewood-Amedex said its lead candidate Nu-3 produced positive development and manufacturing data supporting advancement toward a planned Phase 2 trial in mildly infected diabetic foot ulcers.
Daré Bioscience initiates Phase 2 study of DARE-HPV
Daré Bioscience said it has started a Phase 2 clinical study of DARE-HPV, its investigational vaginal insert containing lopinavir and ritonavir for persistent high-risk HPV infection. The program follows earlier FDA clearance of the IND and is supported by ARPA-H funding.