Clinical Trials

Biologics
Pharmaceuticals
Regulatory Science

Ethris secures €30M EIB loan to advance mRNA antiviral ETH47

The Munich biotech will use the HERA Invest-backed funds to progress its interferon-lambda mRNA candidate into Phase 2b trials in asthma and COPD.
The Munich biotech will use the HERA Invest-backed funds to progress its interferon-lambda mRNA candidate into Phase 2b trials in asthma and COPD.
Cell & Gene Therapy
Biologics
Pharmaceuticals

IMUNON signs NCI CRADA to expand IMNN-001 into new solid tumours

IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
IMUNON has partnered with the NCI's CTEP to trial its IL-12 DNA immunotherapy in additional solid tumour indications and combinations beyond ovarian cancer.
Digital Health
Diagnostics

Instinct Science launches Attending, an AI clinical assistant for vets

Instinct Science says its Attending tool answers clinical questions using peer-reviewed veterinary content, with safety-critical dosing drawn directly from Plumb's.
Instinct Science says its Attending tool answers clinical questions using peer-reviewed veterinary content, with safety-critical dosing drawn directly from Plumb's.
Cell & Gene Therapy
Biologics
Pharmaceuticals

Legend Biotech to present five-year CARVYKTI data at IMS 2026

Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
Pharmaceuticals
Biologics
Medical Devices

MannKind and Rose Pharma partner on inhaled GLP-1 for weight loss

MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
MannKind will supply its Technosphere platform and manufacturing support to develop ROSE-010, an inhaled rapid-acting GLP-1, through Phase 1b.
Pharmaceuticals
Diagnostics

Medicus Pharma selects 200 µg SkinJect dose after Phase 2 BCC readout

Medicus Pharma published its Phase 2 CSR for SkinJect, selecting the 200 µg patch dose and pivoting development toward rare Gorlin syndrome.
Medicus Pharma published its Phase 2 CSR for SkinJect, selecting the 200 µg patch dose and pivoting development toward rare Gorlin syndrome.
Medical Devices
Digital Health

ONWARD Medical doubles revenue as ARC-EX unit sales surge 430%

The Eindhoven neurotechnology company reported EUR 4.2M in H1 2026 revenue and enrolled 22 participants in its pivotal ARC-IM blood pressure study.
The Eindhoven neurotechnology company reported EUR 4.2M in H1 2026 revenue and enrolled 22 participants in its pivotal ARC-IM blood pressure study.
Pharmaceuticals
Bioprocessing

Optimi Health to launch Phase 2 psilocybin trial for depression

The Vancouver-based manufacturer will run a 200-participant, Health Canada-authorised study of naturally derived psilocybin in major depressive disorder.
The Vancouver-based manufacturer will run a 200-participant, Health Canada-authorised study of naturally derived psilocybin in major depressive disorder.
Pharmaceuticals
Biologics

Beeline Medicines' afimetoran meets Phase 2 primary endpoint in SLE

The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
Biologics
Pharmaceuticals

Disc Medicine RESTORE-PV data show DISC-3405 cut phlebotomy in PV

Phase 2 results show the anti-TMPRSS6 antibody reduced mean phlebotomy events from 4.0 to 0.6 over 26 weeks, with 61.5% of
Phase 2 results show the anti-TMPRSS6 antibody reduced mean phlebotomy events from 4.0 to 0.6 over 26 weeks, with 61.5% of
Pharmaceuticals
Biologics

Ascendis Pharma reports 52-week infant data for TransCon CNP at ESPE

Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Biologics
Medical Devices
Regulatory Science

Humacyte wins FDA nod to extend Symvess shelf life to 36 months

The FDA has authorised doubling Symvess's expiry dating, easing hospital inventory management for the bioengineered vascular conduit approved in 2024.
The FDA has authorised doubling Symvess's expiry dating, easing hospital inventory management for the bioengineered vascular conduit approved in 2024.
Pharmaceuticals
Diagnostics

ImPact Biotech completes ENLIGHTED Phase 3 for padeliporfin VTP

ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
Pharmaceuticals
Biologics

Caspian Therapeutics launches with $50m to target diabetes

Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Kura Oncology's newly spun-out subsidiary will use menin inhibition to try to restore pancreatic beta-cell function in Type 1 and Type 2
Cell & Gene Therapy
Genomics
Pharmaceuticals

Opus Genetics reports positive Phase 1/2 OPGx-BEST1 data

All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
Pharmaceuticals
Regulatory Science

BridgeBio PROPEL 3 data show infigratinib cuts ear infections

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Pharmaceuticals
Biologics

Sobi wins FDA Fast Track for pacritinib in VEXAS syndrome

The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
Biologics
Pharmaceuticals

Solstice Oncology launches with $225m Series A for CTLA-4 antibody

The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
Biologics
Pharmaceuticals

SOTIO doses first patient in CDH17-targeting ADC trial for CRC

SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
Biologics
Regulatory Science

Roche wins FDA Priority Review for Enspryng in MOGAD

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
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