Regulatory Science

Taysha reaffirms FDA BLA pathway for TSHA-102 Rett syndrome gene therapy

Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.
Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Tempest Therapeutics reports 100% CR rate in dual-targeting CAR-T trials

TPST-2003 achieved complete responses in all 15 CAR-T-naïve evaluable patients across two Phase 1 trials, with Tempest now targeting FDA talks on
TPST-2003 achieved complete responses in all 15 CAR-T-naïve evaluable patients across two Phase 1 trials, with Tempest now targeting FDA talks on
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Tonix Pharmaceuticals gains GPO coverage for TONMYA across 35m lives

The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
The payer agreement covers roughly 20% of US commercial lives for TONMYA, the first new fibromyalgia treatment approved in more than 15 years.
The Biotech Times Editorial Team  · 
Digital Health
Biotech

Transplants.org launches as transplant patient navigation platform

The US nonprofit has launched a centralised education and care navigation platform for organ and stem cell transplant patients, backed by 25 leading transplant centres.
The US nonprofit has launched a centralised education and care navigation platform for organ and stem cell transplant patients, backed by 25 leading transplant centres.
The Biotech Times Editorial Team  · 
Regulatory Science

Trethera to present TRE-515 optic neuritis data at LABEST 2026

The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.
The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

TScan Therapeutics eyes Phase 3 TCR-T launch in Q2 with $128m cash

TScan Therapeutics plans to initiate its pivotal ALLOHA-2 study of TSC-101 in haematological malignancies this quarter, backed by $128m in cash.
TScan Therapeutics plans to initiate its pivotal ALLOHA-2 study of TSC-101 in haematological malignancies this quarter, backed by $128m in cash.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science

UroGen's ZUSDURI more than doubles revenue in Q1 2026

UroGen posted $29.2m in ZUSDURI sales in Q1 2026, up 109% quarter-on-quarter, as a permanent J Code unlocked broader reimbursement access.
UroGen posted $29.2m in ZUSDURI sales in Q1 2026, up 109% quarter-on-quarter, as a permanent J Code unlocked broader reimbursement access.
The Biotech Times Editorial Team  · 
Diagnostics

Verrica Pharmaceuticals to present VP-315 abscopal BCC data at SID 2026

Phase 2 data show VP-315 reduced untreated basal cell carcinoma lesions by 67%, suggesting a systemic immune response beyond the injection site.
Phase 2 data show VP-315 reduced untreated basal cell carcinoma lesions by 67%, suggesting a systemic immune response beyond the injection site.
The Biotech Times Editorial Team  · 
Diagnostics

VVT Med publishes ScleroSafe peer-reviewed trial data

A 30-patient Mumbai study reported 92% vein occlusion at 90 days and no serious adverse events for VVT Med's catheter-directed sclerotherapy system.
A 30-patient Mumbai study reported 92% vein occlusion at 90 days and no serious adverse events for VVT Med's catheter-directed sclerotherapy system.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science

Zentalis doses first patient in Phase 3 ASPENOVA ovarian cancer trial

Zentalis Pharmaceuticals has opened enrolment in its confirmatory ASPENOVA Phase 3 trial of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer.
Zentalis Pharmaceuticals has opened enrolment in its confirmatory ASPENOVA Phase 3 trial of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Addex Therapeutics posts CHF 6.7m net loss as cash falls to CHF 1.6m

The Geneva-based allosteric modulator specialist ended 2025 with thinning cash reserves but two Phase 2 assets in hand after regaining rights to ADX71149.
The Geneva-based allosteric modulator specialist ended 2025 with thinning cash reserves but two Phase 2 assets in hand after regaining rights to ADX71149.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Annovis Bio publishes Phase 2/3 buntanetap Alzheimer's data in Nature

Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
The Biotech Times Editorial Team  · 
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