Clinical Trials

TScan Therapeutics doses first patient in Phase 3 ALLOHA-2 trial

TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
The Biotech Times Editorial Team  · 
Biologics

Allogene wins FDA RMAT and Fast Track tags for cema-cel in LBCL

Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
The Biotech Times Editorial Team  · 
Biologics

Claris Bio raises $118m Series B to fund pivotal LSCD eye-drop study

The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The Biotech Times Editorial Team  · 
Biologics

Dyne Therapeutics gains FDA Priority Review for DMD drug z-rostudirsen

Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
The Biotech Times Editorial Team  · 
Biologics

Ipsen raises FY 2026 guidance after 23.5% CER sales growth in H1

Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
The Biotech Times Editorial Team  · 
Diagnostics

MannKind's nintedanib DPI clears Phase 1b safety bar in IPF

INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
The Biotech Times Editorial Team  · 
Biologics
Digital Health
Diagnostics

Clue data study links follicular-phase vaccination to more side effects

Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
The Biotech Times Editorial Team  · 
Regulatory Science

PharmAla grants Jupiter Neurosciences exclusive U.S. rights to ALA-002

PharmAla Biotech has out-licensed its lead MDMA-derived candidate to Jupiter Neurosciences for up to US$100 million, retaining all rights outside the United
PharmAla Biotech has out-licensed its lead MDMA-derived candidate to Jupiter Neurosciences for up to US$100 million, retaining all rights outside the United
The Biotech Times Editorial Team  · 
Regulatory Science

PolyPid secures FDA Priority Review for D-PLEX100 NDA

The Israeli biotech's surgical site infection candidate has a PDUFA date of 28 November 2026, a quarter ahead of prior guidance.
The Israeli biotech's surgical site infection candidate has a PDUFA date of 28 November 2026, a quarter ahead of prior guidance.
The Biotech Times Editorial Team  · 
Regulatory Science

Idorsia QUVIVIQ sales jump 62% as daridorexant pipeline broadens

Idorsia reported CHF 91 million in QUVIVIQ sales for H1 2026 and reaffirmed full-year guidance of CHF 200 million as it prepares to expand
Idorsia reported CHF 91 million in QUVIVIQ sales for H1 2026 and reaffirmed full-year guidance of CHF 200 million as it prepares to expand
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor DMD cell therapy data in The Lancet before FDA ruling

Deramiocel slowed upper limb decline by 54% versus placebo in a Phase 3 trial, with an FDA decision due 22 August 2026.
Deramiocel slowed upper limb decline by 54% versus placebo in a Phase 3 trial, with an FDA decision due 22 August 2026.
The Biotech Times Editorial Team  · 
Biologics

Crystalys raises $130m Series B for gout drug dotinurad

The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.
The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.
The Biotech Times Editorial Team  · 
Biologics

Humacyte wins FDA IND clearance for CTEV coronary bypass study

Humacyte's bioengineered coronary vessel cleared for a first-in-human Phase 2a trial in CABG patients, with study start targeted this quarter.
Humacyte's bioengineered coronary vessel cleared for a first-in-human Phase 2a trial in CABG patients, with study start targeted this quarter.
The Biotech Times Editorial Team  · 
Diagnostics

Sonablate highlights 10-year HIFU focal therapy data from 3,477 patients

A European Urology study of UK registry data found 0.1% prostate cancer-specific mortality and 3% metastatic progression at 10 years for focal HIFU.
A European Urology study of UK registry data found 0.1% prostate cancer-specific mortality and 3% metastatic progression at 10 years for focal HIFU.
The Biotech Times Editorial Team  · 
Diagnostics

Medicus Pharma clears FDA review for SkinJect Gorlin Syndrome trial

The NASDAQ-listed biotech received a "Study May Proceed" letter for its Phase 2b NDA-enabling study of SkinJect in patients with Gorlin Syndrome.
The NASDAQ-listed biotech received a "Study May Proceed" letter for its Phase 2b NDA-enabling study of SkinJect in patients with Gorlin Syndrome.
The Biotech Times Editorial Team  · 

Mission Therapeutics divests AKI asset MTX652 to Dimerix for up to $292m

The Cambridge biotech sheds its renal USP30 programme to fund its Phase 1 Parkinson's candidate MTX325, receiving milestones and tiered royalties.
The Cambridge biotech sheds its renal USP30 programme to fund its Phase 1 Parkinson's candidate MTX325, receiving milestones and tiered royalties.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science
Biologics

OraSure wins FDA EUA for second-generation OraQuick Ebola 2.0 test

OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
The Biotech Times Editorial Team  · 
Biologics

Adlai Nortye doses first patient in weekly arm of AN9025 Phase 1

The NASDAQ-listed biotech has opened a weekly dosing cohort in its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025, with both arms
The NASDAQ-listed biotech has opened a weekly dosing cohort in its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025, with both arms
The Biotech Times Editorial Team  · 
Biologics

BriaCell adds Sunnybrook to Phase 3 breast cancer trial

Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
The Biotech Times Editorial Team  · 
Biologics

Compass Therapeutics tovecimig data wins oral slot at ESMO 2026

Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
The Biotech Times Editorial Team  · 
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