Pharmaceuticals

Pharmaceuticals

Greenwich LifeSciences delays 10-K amid FLAMINGO-01 data update

Greenwich LifeSciences has pushed its 2025 annual filing to May while reporting a 70–80% recurrence reduction in preliminary Phase III open-label data.
Greenwich LifeSciences has pushed its 2025 annual filing to May while reporting a 70–80% recurrence reduction in preliminary Phase III open-label data.
The Biotech Times Editorial Team  · 
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  · 
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  · 
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  · 
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  · 
Cell & Gene Therapy
Pharmaceuticals

Tempest Therapeutics to present TPST-2003 CAR-T data at ISCT 2026

Tempest will share updated REDEEM-1 Phase 1/2a results for its CD19/BCMA dual-targeting CAR-T in relapsed/refractory myeloma at Dublin's
Tempest will share updated REDEEM-1 Phase 1/2a results for its CD19/BCMA dual-targeting CAR-T in relapsed/refractory myeloma at Dublin's
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  · 
Pharmaceuticals

Valneva closes €84m reserved offering to fund Lyme vaccine push

The Lyon-based vaccine specialist raised €37m at closing, with up to €47m more if warrants tied to FDA Lyme approval are exercised.
The Lyon-based vaccine specialist raised €37m at closing, with up to €47m more if warrants tied to FDA Lyme approval are exercised.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Zealand Pharma and Roche to start petrelintide Phase 3 in H2 2026

The Copenhagen biotech and its Roche partner will advance their once-weekly amylin analog into Phase 3 obesity trials after Phase 2 showed double-digit
The Copenhagen biotech and its Roche partner will advance their once-weekly amylin analog into Phase 3 obesity trials after Phase 2 showed double-digit
The Biotech Times Editorial Team  · 
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