Clinical Trials

Biologics
Pharmaceuticals

Regeneron's ubamatamab hits 73% response rate in LGSOC trial

Phase 1/2 data from 11 heavily pre-treated patients showed a 73% objective response rate and 11-month median progression-free survival.
Phase 1/2 data from 11 heavily pre-treated patients showed a 73% objective response rate and 11-month median progression-free survival.
Pharmaceuticals
Biologics

Survodutide hits 13.1% weight loss in Phase III obesity-T2D trial

Boehringer Ingelheim's glucagon/GLP-1 dual agonist met both co-primary endpoints in SYNCHRONIZE-2, with full results published simultaneously in the New England
Boehringer Ingelheim's glucagon/GLP-1 dual agonist met both co-primary endpoints in SYNCHRONIZE-2, with full results published simultaneously in the New England
Cell & Gene Therapy
Biologics
Genomics

Atsena's ATSN-201 shows durable XLRS benefit at 18 months

Atsena Therapeutics reported sustained structural and functional gains in seven of nine treated eyes, with a BLA filing now targeted for late 2028.
Atsena Therapeutics reported sustained structural and functional gains in seven of nine treated eyes, with a BLA filing now targeted for late 2028.
Biologics
Cell & Gene Therapy

Candel reports durable immune remodelling data for aglatimagene

AI-enabled digital pathology shows aglatimagene drove sustained lymphocyte-tumour engagement more than two years after treatment in a phase 3 prostate cancer trial.
AI-enabled digital pathology shows aglatimagene drove sustained lymphocyte-tumour engagement more than two years after treatment in a phase 3 prostate cancer trial.
Medical Devices
Digital Health
Diagnostics

Ceribell wins FDA clearance for qEEG trending on its AI platform

Ceribell's 510(k)-cleared software adds three quantitative EEG tools to its point-of-care platform, covering patients from premature neonates to adult ICU
Ceribell's 510(k)-cleared software adds three quantitative EEG tools to its point-of-care platform, covering patients from premature neonates to adult ICU
Biologics
Pharmaceuticals

Connect Biopharma: rademikibart cuts COPD failure rate 81% in Ph2

Connect Biopharma's IL-4Rα antibody rademikibart met its primary endpoint in a Phase 2 COPD trial, eliminating hospital return visits versus placebo.
Connect Biopharma's IL-4Rα antibody rademikibart met its primary endpoint in a Phase 2 COPD trial, eliminating hospital return visits versus placebo.
Biologics
Pharmaceuticals

Egle Therapeutics: EGL-003 Phase 1 shows clean safety, Treg lift

Egle's IL-2 agonist EGL-003 was well tolerated across four dose cohorts and produced selective Treg expansion, supporting a Q4 2026 atopic dermatitis
Egle's IL-2 agonist EGL-003 was well tolerated across four dose cohorts and produced selective Treg expansion, supporting a Q4 2026 atopic dermatitis
Pharmaceuticals
Biologics

Highlight Therapeutics: BO-112 meets Phase 2b BCC endpoint

Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.
Highlight Therapeutics' intralesional BO-112 met its primary visual and pathological response endpoint in 61% of basal cell carcinoma patients.
Pharmaceuticals
Biologics

Novo Nordisk CagriSema data shows brain, organ and bone effects

New EASD 2026 data show CagriSema modifies brain food-cue responses and reduces ectopic fat, with bone health maintained during weight loss.
New EASD 2026 data show CagriSema modifies brain food-cue responses and reduces ectopic fat, with bone health maintained during weight loss.
Diagnostics
Digital Health

Hub71 and Unilabs partner to bring diagnostics to Abu Dhabi startups

Unilabs joins Hub71+ Life Sciences as an anchor partner, with live collaborations already under way with mental health and biological-age testing startups.
Unilabs joins Hub71+ Life Sciences as an anchor partner, with live collaborations already under way with mental health and biological-age testing startups.
Digital Health
Diagnostics

DarDoc launches truesight beta AI layer inside Lifestyle Rx platform

Dubai-based DarDoc has launched a machine learning intelligence layer that proactively surfaces patient context between appointments, available to Lifestyle Rx members.
Dubai-based DarDoc has launched a machine learning intelligence layer that proactively surfaces patient context between appointments, available to Lifestyle Rx members.
Pharmaceuticals
Biologics

Novo Nordisk licenses Hengrui's oral GLP-1/GIP agonist for $2.6bn

Novo Nordisk will pay $300m upfront for global rights to HRS-1596, a once-weekly oral dual GLP-1/GIP agonist nearing Phase 1 trials.
Novo Nordisk will pay $300m upfront for global rights to HRS-1596, a once-weekly oral dual GLP-1/GIP agonist nearing Phase 1 trials.
Biologics
Regulatory Science

PolarityBio Phase 3 DFU data wins First-to-Podium slot at SAWC 2026

PolarityBio's pivotal COVER DFUS II trial results will be presented on 16 October, ahead of the FDA's March 2027 PDUFA date for SkinTE.
PolarityBio's pivotal COVER DFUS II trial results will be presented on 16 October, ahead of the FDA's March 2027 PDUFA date for SkinTE.
Pharmaceuticals
Biologics

Roche fenebrutinib NDA accepted by FDA for RMS and PPMS

Roche's oral BTK inhibitor fenebrutinib has received priority review acceptance for both relapsing and primary progressive MS, a first for the class.
Roche's oral BTK inhibitor fenebrutinib has received priority review acceptance for both relapsing and primary progressive MS, a first for the class.
Biologics
Pharmaceuticals

Tectonic Therapeutic reports clean Phase 1a data for HHT drug

TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for
TX2100 cleared all six dose cohorts without serious adverse events; FDA Fast Track status and a Phase 1b trial in HHT patients are set for
Cell & Gene Therapy
Genomics

uniQure AMT-130 shows 80% disease slowing at 36 months in HD trial

Updated Phase I/II data on ifezuntirgene inilparvovec show an 80% slowing of Huntington's disease progression at 36 months across 15 high-dose patients.
Updated Phase I/II data on ifezuntirgene inilparvovec show an 80% slowing of Huntington's disease progression at 36 months across 15 high-dose patients.
Pharmaceuticals
Biologics

Zealand Pharma petrelintide hits 10.7% weight loss in Phase 2

ZUPREME-1 Phase 2 results, published in The Lancet, show petrelintide cut body weight by up to 10.7% with placebo-comparable GI tolerability.
ZUPREME-1 Phase 2 results, published in The Lancet, show petrelintide cut body weight by up to 10.7% with placebo-comparable GI tolerability.
Cell & Gene Therapy
Biologics

4DMT enrols first patients in 4SIGHT Phase 3 DME gene therapy trial

4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
4D Molecular Therapeutics has opened its 514-patient Phase 3 4SIGHT trial of 4D-150 in diabetic macular edema, backed by two-year SPECTRA data.
Biologics
Pharmaceuticals

ALX Oncology's evorpacept hits 63.6% ORR in HER2+ gastric subgroup

Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Pharmaceuticals
Genomics

Belite Bio to present DRAGON Phase 3 tinlarebant data at Euretina

Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
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