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

Telix OPTIMAL-PSMA dosimetry data back TLX597-Tx dose push

Phase 2 data presented at IPCS 2026 show low off-target radiation, supporting dose intensification and a new mHSPC trial for Telix's next-generation
Phase 2 data presented at IPCS 2026 show low off-target radiation, supporting dose intensification and a new mHSPC trial for Telix's next-generation
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

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  · 
Pharmaceuticals

OSE Immunotherapeutics posts €37.7m net loss as runway nears Q4 2026

The Nantes-based biotech reported a sharp swing to loss in 2025 and warned auditors may issue a going concern qualification absent new financing.
The Nantes-based biotech reported a sharp swing to loss in 2025 and warned auditors may issue a going concern qualification absent new financing.
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
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
Medical Devices

Syncromune presents SYNC-T Phase 1 data at ECIO 2026

The Fort Lauderdale biotech reported an 87% overall response rate in a 15-patient Phase 1 study and is advancing to Phase 2 in metastatic
The Fort Lauderdale biotech reported an 87% overall response rate in a 15-patient Phase 1 study and is advancing to Phase 2 in metastatic
The Biotech Times Editorial Team  · 
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