Pharmaceuticals

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  · 
Pharmaceuticals
Genomics

Annovis Bio publishes Phase 2/3 buntanetap Alzheimer's data in Nature

Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Addex Therapeutics posts CHF 6.7m net loss as cash falls to CHF 1.6m

The Geneva-based allosteric modulator specialist ended 2025 with thinning cash reserves but two Phase 2 assets in hand after regaining rights to ADX71149.
The Geneva-based allosteric modulator specialist ended 2025 with thinning cash reserves but two Phase 2 assets in hand after regaining rights to ADX71149.
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
Regulatory Science

Quoin Pharma maps multi-indication clinical push for QRX009 rapamycin

Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.
Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Crescent Biopharma posts Q1 2026 results with $189m cash runway

The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
The Waltham-based oncology biotech reported a $23.3m net loss and outlined data readouts from its CR-001 bispecific and two ADC programmes beginning
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Cristcot to present CESSA corticosteroid data at DDW 2026

Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.
Cristcot will present Phase 3 ulcerative colitis trial data on covert steroid use at Digestive Disease Week in Chicago on 5 May.
The Biotech Times Editorial Team  · 
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

Avalyn Pharma raises $300m in Nasdaq IPO for fibrosis drugs

The Boston-based clinical-stage biotech priced 16.7 million shares at $18 each to fund inhaled antifibrotic programmes targeting pulmonary fibrosis.
The Boston-based clinical-stage biotech priced 16.7 million shares at $18 each to fund inhaled antifibrotic programmes targeting pulmonary fibrosis.
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  · 
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