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Pharmaceuticals
Regulatory Science

Nicox cuts net loss to €2.4m as NCX 470 NDA filing nears

The French ophthalmology biotech doubled revenue to €16.8m in 2025 and expects to file its glaucoma candidate NCX 470 with the FDA by summer
The French ophthalmology biotech doubled revenue to €16.8m in 2025 and expects to file its glaucoma candidate NCX 470 with the FDA by summer
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  · 
Cell & Gene Therapy
Regulatory Science

Orchard Therapeutics wins Innovation Passport for OTL-201 in MPS-IIIA

OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the
OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the
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
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
Regulatory Science

Santhera proposes Dr Srishti Gupta for board ahead of May AGM

The Swiss rare-disease pharma is putting the former Idorsia CEO forward as an independent director at its 26 May annual general meeting.
The Swiss rare-disease pharma is putting the former Idorsia CEO forward as an independent director at its 26 May annual general meeting.
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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