Disease

Pharmaceuticals
Biologics

Mineralys lorundrostat hits BP target in 46% of resistant HTN patients

New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.
New analyses from Launch-HTN and Explore-OSA trials presented at AHA 2026 add to the evidence base supporting lorundrostat's NDA under FDA review.
Pharmaceuticals
Biologics

Idorsia daridorexant Phase 2 paediatric data to headline Sleep Europe

Idorsia will present the first clinical data for a dual orexin receptor antagonist in children with insomnia at Sleep Europe 2026 in Maastricht.
Idorsia will present the first clinical data for a dual orexin receptor antagonist in children with insomnia at Sleep Europe 2026 in Maastricht.
Pharmaceuticals
Biologics

Retension Pharmaceuticals raises $45m in Nasdaq IPO for RTN-001

The Virginia-based cardiovascular biotech priced 3.75 million shares at $12 each to fund its Phase 2b and planned Phase 3 trials of RTN
The Virginia-based cardiovascular biotech priced 3.75 million shares at $12 each to fund its Phase 2b and planned Phase 3 trials of RTN
Pharmaceuticals
Diagnostics

Sagimet's denifanstat shows sustained acne efficacy at 52 weeks

Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening
Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening
Pharmaceuticals
Biologics

Teva wins FDA approval for WELTRUZA once-monthly olanzapine

Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.
Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.
Pharmaceuticals
Regulatory Science

Agomab to present STENOVA OLE data at UEG Week 2026

Agomab's ontunisertib Phase 2a extension data in fibrostenosing Crohn's disease will be presented orally at UEG Week as the company readies its Phase
Agomab's ontunisertib Phase 2a extension data in fibrostenosing Crohn's disease will be presented orally at UEG Week as the company readies its Phase
Biologics
Pharmaceuticals
Cell & Gene Therapy

Cullinan Therapeutics doses first patient in pivotal CLN-049 AML study

The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.
The Cambridge biotech has initiated a potentially registrational Phase 2 study of its FLT3xCD3 T cell engager in relapsed/refractory acute myeloid leukaemia.
Cell & Gene Therapy
Genomics
Pharmaceuticals
Biologics

Editas Medicine clears first hurdle for EDIT-401 hyperlipidaemia trial

Editas has received ethics and regulatory approval in Australia to begin its Phase 1/2 Strive trial of in vivo gene editor EDIT-401 in
Editas has received ethics and regulatory approval in Australia to begin its Phase 1/2 Strive trial of in vivo gene editor EDIT-401 in
Biotech
Diagnostics
Bioinformatics

Holobiome and Radicle Science launch 6,000-person gut-brain trial

The ARPA-H-backed GUT-FEELINGS study will test 19 prebiotic formulas against anxiety outcomes across 6,000 participants, with initial results expected in late
The ARPA-H-backed GUT-FEELINGS study will test 19 prebiotic formulas against anxiety outcomes across 6,000 participants, with initial results expected in late
Pharmaceuticals
Regulatory Science

Pharvaris HAE pill data published in The Lancet ahead of FDA review

Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due
Phase 3 RAPIDe-3 results for oral deucrictibant met all 12 endpoints, with symptom onset relief in 1.28 hours; an FDA decision is due
Pharmaceuticals
Regulatory Science

Rua Bioscience and PharmAla partner to supply MDMA in New Zealand

Rua Bioscience will distribute PharmAla's GMP-grade LaNeo MDMA to authorised New Zealand psychiatrists following Medsafe's September approval for PTSD treatment.
Rua Bioscience will distribute PharmAla's GMP-grade LaNeo MDMA to authorised New Zealand psychiatrists following Medsafe's September approval for PTSD treatment.
Pharmaceuticals
Biologics

X4 Pharmaceuticals secures $150m debt facility with K2 HealthVentures

The Boston rare-haematology biotech refinanced its existing loan and gains fresh capital to support mavorixafor's Phase 3 trial and potential commercial launch.
The Boston rare-haematology biotech refinanced its existing loan and gains fresh capital to support mavorixafor's Phase 3 trial and potential commercial launch.
Biologics
Pharmaceuticals

argenx Phase 2 data back FB102 as first drug for celiac disease

argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now
argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now
Biologics
Pharmaceuticals

argenx halts Phase 3 UNITY trial of efgartigimod in Sjögren's disease

An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
Medical Devices
Diagnostics
Regulatory Science

SeaStar Medical wins seventh Breakthrough Device tag for SCD in sepsis

The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
The FDA designation covers hyperinflammation in adult sepsis patients, a population with no currently approved immunomodulatory therapy.
Pharmaceuticals
Biologics

Novartis wins FDA approval for Rhapsido in symptomatic dermographism

Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
Cell & Gene Therapy
Biologics
Medical Devices

GenSight optogenetic therapy safe and restores object detection

A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
A first clinical cohort of ten blind retinitis pigmentosa patients showed meaningful light sensitivity gains with GenSight's gene therapy and goggle system.
Pharmaceuticals
Biologics

Rezera: ruvonoflast cuts inflammation added to semaglutide

Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
Biologics
Pharmaceuticals

Vaxcyte raises ~$1bn via equity and convertible notes to fund VAX-31

Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.
Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.
Pharmaceuticals
Biologics

vTv Therapeutics wins FDA Orphan Drug tag for HPPD in sickle cell

The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin
The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin
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