Pharmaceuticals

Moleculin Biotech completes Part A enrolment in AML MIRACLE trial

Moleculin has closed enrolment of 89 subjects in Part A of its pivotal MIRACLE trial, targeting a comprehensive data readout in Q1 2027.
Moleculin has closed enrolment of 89 subjects in Part A of its pivotal MIRACLE trial, targeting a comprehensive data readout in Q1 2027.
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.
Biologics
Pharmaceuticals

Knight Therapeutics signs Latin America deal for Kyowa Kirin's Poteligeo

Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.
Knight Therapeutics will seek regulatory approval and commercialise mogamulizumab across Brazil, Mexico, Colombia and Argentina under an exclusive distribution pact.
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.
Pharmaceuticals
Biologics

Cellectar to present Phase 2 WM subset data at IWWM 2026

Iopofosine I 131 showed an 87.5% overall response rate in BTK inhibitor-refractory Waldenström Macroglobulinemia, with a duration of response exceeding 16 months.
Iopofosine I 131 showed an 87.5% overall response rate in BTK inhibitor-refractory Waldenström Macroglobulinemia, with a duration of response exceeding 16 months.
Cell & Gene Therapy
Biologics

Immix Biopharma NXC-201 hits 89% CR rate in AL amyloidosis trial

An interim read of 45 NEXICART-2 patients shows NXC-201 achieving an 89% complete response rate, with MRD-negativity pointing to a potential 98
An interim read of 45 NEXICART-2 patients shows NXC-201 achieving an 89% complete response rate, with MRD-negativity pointing to a potential 98
Biologics
Pharmaceuticals

Invivyd's VYD2311 beats mRNA vaccine on safety in Phase 3 LIBERTY study

Invivyd said VYD2311 met all primary and secondary endpoints in LIBERTY, with superior tolerability to Pfizer's COMIRNATY and a BLA filing now planned.
Invivyd said VYD2311 met all primary and secondary endpoints in LIBERTY, with superior tolerability to Pfizer's COMIRNATY and a BLA filing now planned.
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
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.
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