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
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.
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
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
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
Biologics
Bioprocessing
Regulatory Science

ATCC wins $99m DOW contract to manage military medical countermeasures

ATCC will lead lifecycle management of vaccines, biologics and drugs for the US military's RAPID programme under a 10-year, $99 million contract.
ATCC will lead lifecycle management of vaccines, biologics and drugs for the US military's RAPID programme under a 10-year, $99 million contract.
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

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
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
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.
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