Clinical Trials

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.

Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.

The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.

Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.

Real-world study in 73 patients found clinically meaningful skin symptom improvements from week 4, sustained through 48 weeks of follow-up.

The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.

Week 104 data from the ApproaCH trial show tibial-femoral angle continued improving in children with achondroplasia, with greater gains in those with preexisting leg

Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.

Interim MIRACLE trial data showed Annamycin complete remission rates up to 43% versus 12% for control in relapsed or refractory AML patients.

The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.

Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.

4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of

Interim 12-month data from the ABATE trial show ACI-24 is well tolerated with antibody responses at all dose levels in prodromal Alzheimer's

The oversubscribed round, co-led by Janus Henderson and Balyasny, funds two autoimmune degrader candidates toward Phase 1 proof-of-concept.

Taysha will share Phase 1/2 REVEAL trial results and natural history data supporting its pivotal study design for TSHA-102 in Rett syndrome.

The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.

Atea has fully enrolled its 880-patient global HCV trial, with topline data from the head-to-head DAA study expected around year-end 2026.

The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.

The pan-European research network intends to test whether brensocatib can modify bronchiectasis disease course over three years in six countries.

The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.