Clinical Trials

Pharmaceuticals
Biologics

AirNexis AN01 meets primary endpoint in Phase 2b COPD study

Dual PDE3/4 inhibitor AN01 improved lung function versus placebo in COPD patients already on bronchodilator therapy, with data presented at ERS 2026.
Dual PDE3/4 inhibitor AN01 improved lung function versus placebo in COPD patients already on bronchodilator therapy, with data presented at ERS 2026.
Pharmaceuticals
Regulatory Science

Apnimed files NDA for OSA drug Oxnimbi ahead of $221m Nasdaq IPO

The Cambridge, Massachusetts biotech secured FDA acceptance of its Oxnimbi NDA with a PDUFA date of 28 February 2027, as it raised $221m in a
The Cambridge, Massachusetts biotech secured FDA acceptance of its Oxnimbi NDA with a PDUFA date of 28 February 2027, as it raised $221m in a
Pharmaceuticals
Biologics

Assembly Bio exercises Gilead profit-share option for HSV drug programme

Assembly Biosciences will take a 40% share of US costs and profits for the GS-1179 helicase-primase inhibitor as a Phase 2 trial approaches.
Assembly Biosciences will take a 40% share of US costs and profits for the GS-1179 helicase-primase inhibitor as a Phase 2 trial approaches.
Pharmaceuticals
Diagnostics

BBOT reports 75% ORR for BBO-8520 plus pembrolizumab in 2L+ NSCLC

BridgeBio Oncology Therapeutics posted new Phase 1 data showing its KRAS G12C inhibitor combo achieved a 75% response rate in inhibitor-experienced lung cancer patients.
BridgeBio Oncology Therapeutics posted new Phase 1 data showing its KRAS G12C inhibitor combo achieved a 75% response rate in inhibitor-experienced lung cancer patients.
Cell & Gene Therapy
Biologics

BrainChild Bio closes $116m Series A to fund pivotal DIPG CAR-T trial

The Seattle-based biotech will use proceeds to run its ILLUMINATE Phase 2 study of BCB-276 in diffuse intrinsic pontine glioma, a universally fatal
The Seattle-based biotech will use proceeds to run its ILLUMINATE Phase 2 study of BCB-276 in diffuse intrinsic pontine glioma, a universally fatal
Pharmaceuticals
Biologics

Dyne Therapeutics to share one-year ACHIEVE DM1 data at WMS and AANEM

Dyne will present pooled Phase 1/2 data for z-basivarsen against a matched natural history cohort, with registrational topline results due Q1 2027.
Dyne will present pooled Phase 1/2 data for z-basivarsen against a matched natural history cohort, with registrational topline results due Q1 2027.
Biologics
Pharmaceuticals

Korsana Biosciences lists on Nasdaq after $380m raise

The Waltham-based neurodegenerative disease biotech completed its merger with Cyclerion and a $380m private placement, beginning Nasdaq trading under "KRSA" on 9
The Waltham-based neurodegenerative disease biotech completed its merger with Cyclerion and a $380m private placement, beginning Nasdaq trading under "KRSA" on 9
Pharmaceuticals
Biologics
Regulatory Science

Monte Rosa pockets $50m milestone as Novartis starts MRT-6160 Phase 2

Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Pharmaceuticals
Regulatory Science
Biologics

Pharvaris HAE prophylaxis trial hits 83% attack rate reduction

Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
Pharvaris's CHAPTER-3 Phase 3 study of once-daily deucrictibant XR met all endpoints, with NDA submissions planned for the first half of 2027.
Pharmaceuticals
Biologics

Roivant's mosliciguat hits Phase 2 primary endpoint in PH-ILD

Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.
Phase 2 PHocus trial showed a 56.3% placebo-adjusted PVR reduction; Roivant has now initiated the Phase 3 PHrontier study in the same indication.
Biologics
Pharmaceuticals

Spyre Therapeutics completes IBD proof-of-concept with SPY003 data

SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
Biologics
Pharmaceuticals

Vor Bio completes UPSTREAM MG enrolment and launches oMG trial

Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Pharmaceuticals
Regulatory Science

Aprea Therapeutics expands patent estate for WEE1 and ATR programmes

The Nasdaq-listed oncology company has detailed patents covering APR-1051 and ATRN-119, with WEE1 protection potentially running to 2047.
The Nasdaq-listed oncology company has detailed patents covering APR-1051 and ATRN-119, with WEE1 protection potentially running to 2047.
Pharmaceuticals
Biologics

Ascendis to present infant achondroplasia data at ESPE 2026

Ascendis Pharma will share sentinel cohort data from its reACHin pivotal trial of navepegritide in infants under two at ESPE 2026.
Ascendis Pharma will share sentinel cohort data from its reACHin pivotal trial of navepegritide in infants under two at ESPE 2026.
Medical Devices
Diagnostics

BTT Medical opens first-in-human trial of fever-induction device

BTT Medical Institute has launched a safety trial of its brain-guided hyperthermia system, citing a single ALS case report as the basis for development.
BTT Medical Institute has launched a safety trial of its brain-guided hyperthermia system, citing a single ALS case report as the basis for development.
Biologics
Pharmaceuticals

Novartis HARBOR Phase III trial misses primary endpoint in DM1

Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.
Del-desiran failed to improve hand myotonia in a 150-patient Phase III study, though secondary endpoints showed signs of clinical activity.
Pharmaceuticals
Biologics

Novo Nordisk: semaglutide clears obesity threshold in 40% of children

Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Phase 3 STEP Young data show 40.4% of children aged 6 to 11 treated with semaglutide dropped below the obesity BMI threshold after 68
Medical Devices

Nyxoah enrols first patient in BREATHE post-approval OSA study

The Belgian medtech has begun a 229-patient, five-year US real-world study of its Genio bilateral hypoglossal nerve stimulator, approved by the FDA
The Belgian medtech has begun a 229-patient, five-year US real-world study of its Genio bilateral hypoglossal nerve stimulator, approved by the FDA
Pharmaceuticals
Diagnostics

Zentalis Pharmaceuticals launches share offering for azenosertib

Zentalis is raising fresh capital via an underwritten public offering to fund trials and pre-commercial activities for its WEE1 inhibitor azenosertib in ovarian cancer.
Zentalis is raising fresh capital via an underwritten public offering to fund trials and pre-commercial activities for its WEE1 inhibitor azenosertib in ovarian cancer.
Medical Devices
Bioprocessing

Biomimetic Innovations' OsStic bone filler used in first human case

An injectable synthetic bone void filler from Biomimetic Innovations was used in a tibial plateau fracture repair at the University of Leeds, marking the start
An injectable synthetic bone void filler from Biomimetic Innovations was used in a tibial plateau fracture repair at the University of Leeds, marking the start
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