Clinical Trials

Pharmaceuticals
Biologics

Alumis files NDA plan for envudeucitinib after Phase 3 psoriasis data

Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
Pharmaceuticals
Medical Devices

MannKind presents Furoscix ReadyFlow PK/PD data at HFSA 2026

New analyses support IV-equivalent diuresis from MannKind's autoinjector, cleared by the FDA in July 2026 for outpatient fluid management in heart failure and
New analyses support IV-equivalent diuresis from MannKind's autoinjector, cleared by the FDA in July 2026 for outpatient fluid management in heart failure and
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.
Medical Devices
Biologics

Vascudyne lab-grown bypass vessel sustains flow at two-year mark

The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.
The Minnesota biotech presented two-year clinical patency data for its acellular bioengineered coronary graft at the EACTS Annual Meeting in Barcelona.
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
Biologics
Pharmaceuticals
Diagnostics

FDA approves Roche's Tecentriq for adjuvant stage III dMMR colon cancer

Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC
Roche's PD-L1 inhibitor becomes the first approved adjuvant immunotherapy for dMMR stage III colon cancer, cutting recurrence risk by 50% in the ATOMIC
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
Medical Devices

Iantrek reports 37% IOP reduction in bio-reinforced canaloplasty study

Six-month first-in-human data showed a 37% drop in intraocular pressure and no serious adverse events across 52 treated eyes.
Six-month first-in-human data showed a 37% drop in intraocular pressure and no serious adverse events across 52 treated eyes.
Medical Devices

MMI raises $125m Series D to scale Symani robotic microsurgery

Medical Microinstruments secured the oversubscribed round to expand its Symani Surgical System globally, with around 50 systems installed and 3,500 procedures completed.
Medical Microinstruments secured the oversubscribed round to expand its Symani Surgical System globally, with around 50 systems installed and 3,500 procedures completed.
Diagnostics
Genomics
Biologics

Myriad Genetics and SOPHiA GENETICS team up on prostate HRD biomarker

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
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
Medical Devices

Spirair publishes six-month Vayu Study data for SeptAlign implant

Peer-reviewed results show a 63% reduction in nasal obstruction scores at six months, with no serious adverse events recorded across 75 patients.
Peer-reviewed results show a 63% reduction in nasal obstruction scores at six months, with no serious adverse events recorded across 75 patients.
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
Subscribe to Clinical Trials