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Pharmaceuticals

Kestrel Therapeutics doses first patient in FALCON pan-KRAS trial

Watertown biotech Kestrel has entered a warrant deal with AbbVie worth up to $1.45bn alongside dosing the first patient in its KST-6051 Phase
Watertown biotech Kestrel has entered a warrant deal with AbbVie worth up to $1.45bn alongside dosing the first patient in its KST-6051 Phase
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Ocular Therapeutix enrols first patient in SOL-X wet AMD extension trial

The Bedford-based biotech has opened a three-year extension study for AXPAXLI, its long-acting intravitreal hydrogel, aiming to demonstrate disease-modifying benefit in
The Bedford-based biotech has opened a three-year extension study for AXPAXLI, its long-acting intravitreal hydrogel, aiming to demonstrate disease-modifying benefit in
The Biotech Times Editorial Team  · 
Pharmaceuticals

Oruka Therapeutics launches $500m public offering on Nasdaq

The Menlo Park psoriasis biotech is seeking up to $575m including an overallotment option, with Leerink Partners and Goldman Sachs among the bookrunners.
The Menlo Park psoriasis biotech is seeking up to $575m including an overallotment option, with Leerink Partners and Goldman Sachs among the bookrunners.
The Biotech Times Editorial Team  · 
Medical Devices

Picard Medical and SynCardia featured in Mullings Group interview series

The NYSE-listed artificial heart maker used the two-part series to discuss its SynCardia device and next-generation Emperor platform.
The NYSE-listed artificial heart maker used the two-part series to discuss its SynCardia device and next-generation Emperor platform.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices

PRF Technologies wins FDA IND clearance for OcuRing-K cataract trial

PRF Technologies says FDA has cleared its IND for OcuRing-K, enabling a Phase II trial in cataract surgery patients expected to begin enrolling in
PRF Technologies says FDA has cleared its IND for OcuRing-K, enabling a Phase II trial in cataract surgery patients expected to begin enrolling in
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Quoin Pharma lines up four QRX009 rapamycin studies for 2026

Quoin Pharmaceuticals is launching investigator-led trials of its topical rapamycin in three rare skin diseases and plans a first IND filing by Q3 2026.
Quoin Pharmaceuticals is launching investigator-led trials of its topical rapamycin in three rare skin diseases and plans a first IND filing by Q3 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Cell & Gene Therapy

Regeneron Q1 2026 revenues rise 19% on Dupixent and new approvals

Regeneron posted $3.6bn in Q1 revenues and secured three FDA approvals, including the first gene therapy for genetic hearing loss.
Regeneron posted $3.6bn in Q1 revenues and secured three FDA approvals, including the first gene therapy for genetic hearing loss.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Rein Therapeutics enrolls first patients in Phase 2 IPF trial

Eight patients are now enrolled in the RENEW study of inhaled peptide LTI-03, with sites active in the US, Australia, and Poland.
Eight patients are now enrolled in the RENEW study of inhaled peptide LTI-03, with sites active in the US, Australia, and Poland.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Teva Q1 2026: AUSTEDO hits $578m as brands offset generics slide

Teva posted $4.0bn in Q1 revenues as AUSTEDO, AJOVY and UZEDY collectively grew 41%, cushioning a sharp fall in lenalidomide generics.
Teva posted $4.0bn in Q1 revenues as AUSTEDO, AJOVY and UZEDY collectively grew 41%, cushioning a sharp fall in lenalidomide generics.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Teva to acquire Emalex Biosciences for up to $900m in neuroscience bet

Teva will pay $700m upfront for Emalex and its NDA-ready D1 receptor antagonist ecopipam, targeting paediatric Tourette syndrome.
Teva will pay $700m upfront for Emalex and its NDA-ready D1 receptor antagonist ecopipam, targeting paediatric Tourette syndrome.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Tonix Pharmaceuticals presents Phase 1 data for Lyme mAb TNX-4800

Tonix plans an adaptive Phase 2 field study of its anti-OspA monoclonal antibody in 2027, targeting a prevention gap with no approved U.S
Tonix plans an adaptive Phase 2 field study of its anti-OspA monoclonal antibody in 2027, targeting a prevention gap with no approved U.S
The Biotech Times Editorial Team  · 
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