Pharmaceuticals

InnoCare doses first patient in Phase III orelabrutinib SLE trial

InnoCare has initiated a registrational Phase III study of its BTK inhibitor orelabrutinib in SLE, backed by promising Phase IIb data showing a 57% SRI

The Phase III study is a randomised, double-blind, placebo-controlled, multicentre design. The primary endpoint is the SLE Response Index-4 (SRI-4) response rate at Week 52 — the same validated composite measure used in the preceding Phase IIb programme.

InnoCare's confidence in advancing to Phase III rests on a Phase IIb readout in which orelabrutinib 75 mg once daily produced a statistically significant improvement in SRI-4 response versus placebo at Week 48, recording rates of 57.1% against 34.4% (p < 0.05). The results were achieved under stringent steroid-tapering requirements, which the company argues makes the signal more clinically meaningful than comparisons in which corticosteroid use was unrestricted.

The Biotech Times Editorial Team  · 
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  · 
Cell & Gene Therapy
Regulatory Science

Mesoblast completes enrolment in Phase 3 chronic back pain trial

Mesoblast has hit its 300-patient recruitment target for MSB-DR004, with topline data expected mid-2027 ahead of a planned FDA BLA filing.
Mesoblast has hit its 300-patient recruitment target for MSB-DR004, with topline data expected mid-2027 ahead of a planned FDA BLA filing.
The Biotech Times Editorial Team  · 
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  · 
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  · 
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