Clinical Trials

Pharmaceuticals
Biologics

Actimed Therapeutics completes PROACT Phase 2a recruitment

The London biotech has enrolled over 100 patients in a trial testing S-pindolol benzoate to preserve lean mass during and after semaglutide therapy.
The London biotech has enrolled over 100 patients in a trial testing S-pindolol benzoate to preserve lean mass during and after semaglutide therapy.
Pharmaceuticals
Diagnostics

Actinogen XanaMIA Alzheimer's trial completes visits; data due November

Actinogen Medical's phase 2b/3 XanaMIA trial has completed all 247 patient visits, with topline results for its oral cortisol inhibitor expected in November.
Actinogen Medical's phase 2b/3 XanaMIA trial has completed all 247 patient visits, with topline results for its oral cortisol inhibitor expected in November.
Diagnostics
Medical Devices
Digital Health

Adaptyx wins FDA Breakthrough Device tag for cortisol monitor

Adaptyx Biosciences has secured FDA Breakthrough Device Designation and TAP entry for its continuous cortisol wearable, targeting Cushing syndrome and adrenal
Adaptyx Biosciences has secured FDA Breakthrough Device Designation and TAP entry for its continuous cortisol wearable, targeting Cushing syndrome and adrenal
Medical Devices

Anaconda Biomed closes $56m round to fund stroke thrombectomy trial

The Barcelona-based medtech secured $56m led by Omega Funds to complete the ATHENA pivotal IDE study of its ANA Funnel Catheter in ischaemic stroke.
The Barcelona-based medtech secured $56m led by Omega Funds to complete the ATHENA pivotal IDE study of its ANA Funnel Catheter in ischaemic stroke.
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject and BARDA align ZEPIZURE paediatric plan with FDA

An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.
An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.
Pharmaceuticals

Elevar Therapeutics wins FDA approval for Lyrfigtu in bile duct cancer

Lirafugratinib becomes a second-line option for FGFR2-rearranged cholangiocarcinoma after posting a 46% confirmed response rate in the ReFocus trial.
Lirafugratinib becomes a second-line option for FGFR2-rearranged cholangiocarcinoma after posting a 46% confirmed response rate in the ReFocus trial.
Pharmaceuticals
Biologics

HUTCHMED takes savolitinib-osimertinib combo to ESMO 2026

Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
Pharmaceuticals
Biologics

Roche sefaxersen hits Phase III primary endpoint in IgA nephropathy

Interim IMAgINATION trial data show sefaxersen significantly reduced proteinuria versus placebo at 37 weeks in 459 adults with IgAN.
Interim IMAgINATION trial data show sefaxersen significantly reduced proteinuria versus placebo at 37 weeks in 459 adults with IgAN.
Biologics
Pharmaceuticals

SOTIO wins dual FDA designations for ADC SOT106 in sarcoma

SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in
SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in
Biologics
Cell & Gene Therapy

Adagene wins NMPA IND clearance for masked HER2xCD3 bispecific ADG138

Adagene's double-masked T-cell engager ADG138 cleared China's NMPA for a Phase 1 solid tumour trial due to start in Q4 2026.
Adagene's double-masked T-cell engager ADG138 cleared China's NMPA for a Phase 1 solid tumour trial due to start in Q4 2026.
Biologics
Pharmaceuticals

Celldex barzolvolimab Phase 3 trials meet all endpoints in CSU

Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for
Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for
Medical Devices
Biologics

Dialybrid raises €15m Series A and achieves first-in-human implant

The Italian medtech closed a €15m Series A and implanted its Silkothane® hybrid arteriovenous graft in its first patient in an ongoing Italian pilot trial.
The Italian medtech closed a €15m Series A and implanted its Silkothane® hybrid arteriovenous graft in its first patient in an ongoing Italian pilot trial.
Biologics
Pharmaceuticals

Eledon tegoprubart shows 13 mL/min eGFR edge over tacrolimus

Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six
Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six
Pharmaceuticals
Regulatory Science

Filana Therapeutics clears FDA hold on simufilam for TSC epilepsy

The NASDAQ-listed biotech can now progress its Phase 2a proof-of-concept study after the FDA lifted a clinical hold on its simufilam IND.
The NASDAQ-listed biotech can now progress its Phase 2a proof-of-concept study after the FDA lifted a clinical hold on its simufilam IND.
Pharmaceuticals
Regulatory Science

Ophirex BRAVIO trial misses endpoints but signals krait benefit

Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.
Phase 2 data published in PLOS NTD show varespladib cut krait patients' ventilation time by half, despite missing both primary endpoints.
Biologics
Pharmaceuticals

PDS Biotech's PDS0101 combo shows 39-month survival in HNSCC trial

VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
Pharmaceuticals
Regulatory Science

Quoin Pharma wins FDA Fast Track for QRX003 in Peeling Skin Syndrome

Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by
Medical Devices

Traferox X°Port Heart wins FDA 510(k) clearance for transplant use

Traferox Technologies has secured FDA 510(k) clearance for its X°Port Heart Preservation System, targeting improved donor heart outcomes via 10°C static cold
Traferox Technologies has secured FDA 510(k) clearance for its X°Port Heart Preservation System, targeting improved donor heart outcomes via 10°C static cold
Pharmaceuticals
Biologics

Zealand Pharma starts Phase 3 ZUPREME programme for petrelintide

The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
The Copenhagen biotech and Roche partner have initiated three placebo-controlled trials enrolling around 7,000 participants across obesity sub-populations.
Pharmaceuticals
Biologics

Roche enicepatide hits both Phase II endpoints in T2D and obesity

Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
Roche's once-weekly dual GLP-1/GIP agonist enicepatide achieved 2.65% HbA1c reduction and 15.5% weight loss at 48 weeks, with Phase
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