Disease

Regulatory Science

Agomab aligns with FDA on Phase 2b NOV-ERA design for FSCD

Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
The Biotech Times Editorial Team  · 
Pharmaceuticals

Orion Pharma's ODM-212 wins EU Orphan Designation for mesothelioma

The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
The Biotech Times Editorial Team  · 
Biologics

Sanofi's Wayrilz wins Japan approval for immune thrombocytopenia

Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero
Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero
The Biotech Times Editorial Team  · 
Regulatory Science

BridgeBio to present Phase 3 infigratinib achondroplasia data at ICCBH

BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.
BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.
The Biotech Times Editorial Team  · 
Biologics

Sanofi wins EU approval for tolebrutinib in progressive MS

The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.
The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

ENA Respiratory secures two US patents for TLR2 agonist COPD programme

USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
The Biotech Times Editorial Team  · 
Biologics

Essential Pharma names Becki Morison as CEO from July 2026

The Egham-based rare disease pharma company has appointed the former LEO Pharma and Eli Lilly executive to lead its next phase of commercial growth.
The Egham-based rare disease pharma company has appointed the former LEO Pharma and Eli Lilly executive to lead its next phase of commercial growth.
The Biotech Times Editorial Team  · 
Biologics

MoonLake's sonelokimab hits 67% HiSCR75 at one year in HS

Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
The Biotech Times Editorial Team  · 
Biologics

CTD-ILD pipeline heats up as physicians seek disease modification

A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
The Biotech Times Editorial Team  · 
Biologics

Kither Biotech completes Phase 1 of inhaled peptide KIT2014 in COPD

The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
The Biotech Times Editorial Team  · 
Regulatory Science

Nerandomilast modelling predicts multi-year survival gain in IPF

Boehringer Ingelheim survival models predict nerandomilast could more than double median IPF survival, based on Phase III FIBRONEER trial data.
Boehringer Ingelheim survival models predict nerandomilast could more than double median IPF survival, based on Phase III FIBRONEER trial data.
The Biotech Times Editorial Team  · 
Diagnostics
Biotech

Trinity Biotech wins 2m TrinScreen HIV order; Q1 revenue up 43%

Trinity Biotech secured orders for over 2 million TrinScreen HIV rapid tests, supporting 2026 targets as Q1 revenue rose 43% to $10.8m.
Trinity Biotech secured orders for over 2 million TrinScreen HIV rapid tests, supporting 2026 targets as Q1 revenue rose 43% to $10.8m.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Denali Therapeutics sells rare paediatric PRV for $195m

Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
Denali will use the proceeds to accelerate its TransportVehicle pipeline across lysosomal storage disorders and neurodegenerative diseases.
The Biotech Times Editorial Team  · 
Regulatory Science

Grace Therapeutics plans NDA resubmission after FDA CRL for GTx-104

Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
Grace Therapeutics has scheduled a Type A FDA meeting to clarify its path to resubmitting the NDA for IV nimodipine candidate GTx-104 in aSAH.
The Biotech Times Editorial Team  · 
Biologics

Memento Medicines raises $93m Series A for retinal bispecific

The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The newly launched Boston biotech licensed MMT-205, a Tie2-agonist and VEGF-inhibitor bispecific antibody, from MabTics and Curacle, with clinical trials targeted for
The Biotech Times Editorial Team  · 
Biologics

Memo Therapeutics presents full Phase II potravitug data at ATC 2026

Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
Complete SAFE KIDNEY II results show potravitug cut BKPyV viral loads and nephropathy rates in kidney transplant recipients with no treatment-related serious adverse
The Biotech Times Editorial Team  · 
Regulatory Science

Nicox NCX 470 clears China pre-submission review ahead of dual NDA push

Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.
Ocumension will file for Chinese marketing approval of NCX 470 shortly after Kowa submits a US NDA, expected summer 2026.
The Biotech Times Editorial Team  · 
Biologics
Genomics

Prime Medicine clears NZ hurdle for first in vivo Prime Editing trial

Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
Medsafe has cleared PM577a for a Phase 1/2 study in Wilson Disease, marking Prime Medicine's first clinical authorisation for an in vivo Prime
The Biotech Times Editorial Team  · 
Regulatory Science

Teva files NDA for ecopipam in paediatric Tourette syndrome

Teva has submitted an NDA for ecopipam, a selective D1 receptor antagonist backed by Phase 3 data published in JAMA Neurology.
Teva has submitted an NDA for ecopipam, a selective D1 receptor antagonist backed by Phase 3 data published in JAMA Neurology.
The Biotech Times Editorial Team  · 
Diagnostics

Avalyn completes Phase 2b MIST enrollment for inhaled pirfenidone

Avalyn Pharma has enrolled 375 patients in its MIST trial of AP01, with topline data on lung function expected in the second half of 2027.
Avalyn Pharma has enrolled 375 patients in its MIST trial of AP01, with topline data on lung function expected in the second half of 2027.
The Biotech Times Editorial Team  · 
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