Biotech
Biotechnology companies, trials, and applied biological innovation.
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.
Quince Therapeutics says it acquired Orphai and lined up up to $187 million in financing
Quince Therapeutics said it completed its acquisition of Orphai Therapeutics and arranged a concurrent private placement that could raise up to $187 million in gross proceeds, adding Orphai’s pulmonary program to its pipeline.
Avalo Therapeutics reports positive Phase 2 LOTUS data in hidradenitis suppurativa
Avalo Therapeutics said its Phase 2 LOTUS trial of abdakibart met the primary endpoint in hidradenitis suppurativa.
NIH-funded breakthrough shrinks CRISPR for precision delivery in the body
Researchers say a compact CRISPR system and an engineered variant could make gene editing easier to deliver inside the body.
Avacta announces 2026 Science Day event
Avacta has announced a May 6 Science Day in London focused on its pre|CISION platform and recent scientific progress.