Biologics
Regulatory Science

uniQure to file AMT-130 BLA for Huntington's disease in Q3 2026

The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
The FDA has confirmed that three-year Phase I/II data can support an accelerated approval BLA for AMT-130, with uniQure targeting a Q3
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sernova wins FDA Orphan Drug tag for autologous islet transplant

The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
The Canadian biotech's Cell Pouch device could shield total-pancreatectomy patients from type 3c diabetes, with seven years of US exclusivity now on the
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  · 
Biologics

Connect Biopharma fills Phase 2 asthma study of rademikibart

The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The San Diego biotech completed enrolment of 160 participants in its Seabreeze STAT asthma trial, with topline data expected in early September 2026.
The Biotech Times Editorial Team  · 
Biologics

Roche files sBLA for Lunsumio-Polivy combo in relapsed LBCL

The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The Biotech Times Editorial Team  · 

Nyxoah draws $15m EIB tranche to fund US Genio launch

The Belgian sleep-apnea medtech has completed a $110m capital raise in June, combining equity proceeds with non-dilutive EIB debt financing.
The Belgian sleep-apnea medtech has completed a $110m capital raise in June, combining equity proceeds with non-dilutive EIB debt financing.
The Biotech Times Editorial Team  · 
Biologics

Lexeo Therapeutics publishes LX2006 Phase I/II data in JAMA Cardiology

Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
Peer-reviewed findings show LX2006 gene therapy improved cardiac measures in Friedreich ataxia patients, with a pivotal study now initiating.
The Biotech Times Editorial Team  · 
Regulatory Science

F2G and Shionogi's olorofim meets Phase 3 non-inferiority endpoint

Olorofim matched liposomal amphotericin B on 42-day mortality in azole-refractory invasive aspergillosis, with a markedly lower adverse-event burden.
Olorofim matched liposomal amphotericin B on 42-day mortality in azole-refractory invasive aspergillosis, with a markedly lower adverse-event burden.
The Biotech Times Editorial Team  · 
Biologics

Biogen to acquire RayThera for up to $1bn to bolster immunology pipeline

Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
Biogen has agreed to buy San Diego-based small-molecule immunology company RayThera, with the lead candidate expected to enter Phase 1 in Q3 2026.
The Biotech Times Editorial Team  · 
Biologics

Odyssey Therapeutics IPO raises $315m as OD-001 hits UC proof-of-concept

The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Boston biotech floated on Nasdaq in May 2026, reporting Phase 2a remission data for its oral RIPK2 inhibitor in ulcerative colitis alongside a $464m
The Biotech Times Editorial Team  · 
Biologics

Zelluna ASA raises NOK 58m ahead of first TCR-NK clinical data

The Oslo-listed cell therapy company closed a private placement and retail offering to fund its MAGE-A4-targeting TCR-NK candidate as initial trial
The Oslo-listed cell therapy company closed a private placement and retail offering to fund its MAGE-A4-targeting TCR-NK candidate as initial trial
The Biotech Times Editorial Team  · 
Biologics

Utebzi approved as first oral carbapenem for cUTIs in the US

The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
The FDA has approved GSK and Spero Therapeutics' tebipenem pivoxil, the first oral carbapenem antibiotic for complicated urinary tract infections in US adults.
The Biotech Times Editorial Team  · 
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