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Biotech

SynCardia's Emperor TAH completes next-gen preclinical implant series

Picard Medical said three acute animal implant procedures demonstrated stable full circulatory support for its fully implantable artificial heart platform.
Picard Medical said three acute animal implant procedures demonstrated stable full circulatory support for its fully implantable artificial heart platform.
The Biotech Times Editorial Team  · 
Diagnostics
Biotech

ACTG launches Phase 2 trial of dasatinib to shrink HIV reservoir

The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Alpha Tau and Tolmar partner to commercialise Alpha DaRT in U.S.

Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
The Biotech Times Editorial Team  · 
Regulatory Science

Attralus wins FDA orphan drug status for AL amyloidosis candidate AT-02

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
The Biotech Times Editorial Team  · 
Genomics

Biogen's salanersen wins FDA Breakthrough Therapy tag for SMA

The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

GH Research publishes Phase 2a PPD data for inhaled GH001

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
The Biotech Times Editorial Team  · 
Regulatory Science

Gilead and Lakefront close Ouro Medicines deal for $1.675bn

The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The Biotech Times Editorial Team  · 
Diagnostics

Spectral Medical PMX shows sustained mortality benefit at 12 months

Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
The Biotech Times Editorial Team  · 
Regulatory Science

Candel prostate therapy shows 30% DFS gain in Lancet Oncology

Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.
Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

Cardiff Oncology: onvansertib hits 72% ORR in RAS-mutated mCRC

Phase 2 CRDF-004 data presented at ASCO 2026 support a registrational Phase 3 trial after FDA End-of-Phase 2 alignment.
Phase 2 CRDF-004 data presented at ASCO 2026 support a registrational Phase 3 trial after FDA End-of-Phase 2 alignment.
The Biotech Times Editorial Team  · 
Diagnostics

CG Oncology: cretostimogene combo shows high CR in NMIBC

Phase 2 Cohort CX data show 92.3% complete response and no Grade 3 adverse events for cretostimogene plus gemcitabine in high-risk bladder cancer.
Phase 2 Cohort CX data show 92.3% complete response and no Grade 3 adverse events for cretostimogene plus gemcitabine in high-risk bladder cancer.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science

Disc Medicine RALLY-MF data show broad anemia responses in MF

Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year
Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year
The Biotech Times Editorial Team  · 
Genomics

Ziftomenib triplet shows 87% ORR in venetoclax-naive R/R AML

Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health
Regulatory Science

ESO EMS Index: one in five patients accounts for 44% of 911 calls

ESO's 2026 EMS Index, drawing on 17.3 million records, reveals repeat callers and persistent obstetric care gaps as key system pressures.
ESO's 2026 EMS Index, drawing on 17.3 million records, reveals repeat callers and persistent obstetric care gaps as key system pressures.
The Biotech Times Editorial Team  · 
Biotech

Actuate Therapeutics names Martin Huber to board of directors

The NASDAQ-listed oncology biotech has appointed the former Mersana Therapeutics CEO as an independent director to support elraglusib's path to registration studies.
The NASDAQ-listed oncology biotech has appointed the former Mersana Therapeutics CEO as an independent director to support elraglusib's path to registration studies.
The Biotech Times Editorial Team  · 
Regulatory Science

Alpha Tau to present Alpha DaRT plus pembrolizumab data at AHNS 2026

Alpha Tau Medical's combination therapy abstract has been selected for podium presentation at the AHNS International Conference on Head and Neck Cancer in July.
Alpha Tau Medical's combination therapy abstract has been selected for podium presentation at the AHNS International Conference on Head and Neck Cancer in July.
The Biotech Times Editorial Team  · 
Bioinformatics
Diagnostics
Digital Health

Alzai Health files IPO prospectus on TSXV to raise up to C$4m

The Toronto-based AI Alzheimer's screening company plans to list on the TSX Venture Exchange in May, raising up to C$4 million at
The Toronto-based AI Alzheimer's screening company plans to list on the TSX Venture Exchange in May, raising up to C$4 million at
The Biotech Times Editorial Team  · 
Digital Health

Amazon One Medical GLP-1 programme launch reshapes weight-loss market

Amazon's integrated GLP-1 programme combines One Medical clinical care, Amazon Pharmacy, and same-day delivery, but cash-pay and new patients face notable
Amazon's integrated GLP-1 programme combines One Medical clinical care, Amazon Pharmacy, and same-day delivery, but cash-pay and new patients face notable
The Biotech Times Editorial Team  · 
Medical Devices

Anika Therapeutics posts 13% revenue rise as margins recover sharply

The Bedford-based orthopaedic biotech grew Q1 2026 revenue to $29.6m and lifted gross margin eight points to 64%, driven by its Integrity regenerative
The Bedford-based orthopaedic biotech grew Q1 2026 revenue to $29.6m and lifted gross margin eight points to 64%, driven by its Integrity regenerative
The Biotech Times Editorial Team  · 
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