Clinical Trials

Biologics

Cellectis lasme-cel wins FDA RMAT tag ahead of Phase 2 interim read

Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.
Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.
Biologics

IN8bio GBM data shows mOS above 19.5 months in repeat-dose patients

IN8bio reported updated Phase 1 glioblastoma data and advanced its CD19-targeting gamma-delta T cell engager toward IND-enabling studies.
IN8bio reported updated Phase 1 glioblastoma data and advanced its CD19-targeting gamma-delta T cell engager toward IND-enabling studies.
Regulatory Science

Priovant enrolls first patients in Phase 3 brepocitinib CS trial

Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.
Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.
Diagnostics

Tarsus Pharmaceuticals raises XDEMVY guidance after 69% sales surge

The Irvine-based eye care company reported record Q2 sales of $173.9m for XDEMVY and announced a deal to acquire Alkeus Pharmaceuticals for its
The Irvine-based eye care company reported record Q2 sales of $173.9m for XDEMVY and announced a deal to acquire Alkeus Pharmaceuticals for its
Diagnostics
Digital Health

Sigrid Therapeutics lists SiPore® portfolio on Fullscript platform

Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Diagnostics
Digital Health
Biotech

Sigrid Therapeutics lists SiPore® range on Fullscript platform

The Stockholm-based company's gut-local metabolic health products are now accessible to more than 125,000 US practitioners via Fullscript.
The Stockholm-based company's gut-local metabolic health products are now accessible to more than 125,000 US practitioners via Fullscript.
Biologics

Adneuris licenses cebranopadol to Maruishi for Japan and South Korea

Adneuris Therapeutics receives $35m upfront as it grants Maruishi Pharmaceutical exclusive rights to develop its dual-receptor pain candidate in two Asian markets.
Adneuris Therapeutics receives $35m upfront as it grants Maruishi Pharmaceutical exclusive rights to develop its dual-receptor pain candidate in two Asian markets.
Biologics

Arcutis raises 2026 guidance after ZORYVE revenue jumps 59%

Arcutis posted Q2 net product revenue of $129.9m, up 59% year-on-year, and lifted its full-year sales guidance to $525m–$540m.
Arcutis posted Q2 net product revenue of $129.9m, up 59% year-on-year, and lifted its full-year sales guidance to $525m–$540m.
Diagnostics

Black Diamond reports 86% CNS response rate for silevertinib in NSCLC

Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases
Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases
Biologics

BriaCell wins FDA clearance for Bria-PROS+ prostate cancer study

BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.
BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.
Diagnostics

Eton Pharmaceuticals licenses ASN-001 to broaden hemangioma portfolio

Eton has acquired US rights to topical timolol gel ASN-001, targeting moderate infantile hemangiomas with an NDA filing planned for late 2027.
Eton has acquired US rights to topical timolol gel ASN-001, targeting moderate infantile hemangiomas with an NDA filing planned for late 2027.
Biologics
Regulatory Science

IQVIA and Medera partner to advance cardiac gene therapy trials

IQVIA will provide clinical and regulatory infrastructure to Medera's AAV gene therapy and human cardiac tissue modelling platforms.
IQVIA will provide clinical and regulatory infrastructure to Medera's AAV gene therapy and human cardiac tissue modelling platforms.
Biologics

NewAmsterdam wins CHMP backing for obicetrapib ahead of PREVAIL

NewAmsterdam Pharma secured a positive CHMP opinion for obicetrapib in Europe as its 9,500-patient PREVAIL outcomes trial heads toward an interim readout.
NewAmsterdam Pharma secured a positive CHMP opinion for obicetrapib in Europe as its 9,500-patient PREVAIL outcomes trial heads toward an interim readout.
Biologics

Nurix earns $10m milestone as Sanofi starts STAT6 degrader Phase 1

Sanofi's first-in-human trial of oral STAT6 degrader SAR448272 triggers a milestone payment, bringing Nurix's total collaboration receipts to roughly $139m.
Sanofi's first-in-human trial of oral STAT6 degrader SAR448272 triggers a milestone payment, bringing Nurix's total collaboration receipts to roughly $139m.
Biologics

NeuroThera Labs opens Yale site for Phase IIb Tourette trial

SCI-110, a cannabinoid combination candidate, is now being tested across three global sites after Phase IIa data showed a 21% average tic reduction.
SCI-110, a cannabinoid combination candidate, is now being tested across three global sites after Phase IIa data showed a 21% average tic reduction.
Biologics

Altimmune begins Phase 3 PERFORMA trial of pemvidutide in MASH

Altimmune has started enrolling patients in its global registrational PERFORMA study, with a 52-week data readout anticipated in 2029.
Altimmune has started enrolling patients in its global registrational PERFORMA study, with a 52-week data readout anticipated in 2029.
Biologics

Dianthus Therapeutics reports 75% CIDP response rate and $1.2bn cash

Dianthus posted positive interim Phase 3 data for claseprubart in CIDP and unveiled a third pipeline asset, DNTH312, alongside Q2 2026 financials.
Dianthus posted positive interim Phase 3 data for claseprubart in CIDP and unveiled a third pipeline asset, DNTH312, alongside Q2 2026 financials.
Biologics
Regulatory Science

Oblenio Bio doses first patients in LBL-051 autoimmune Phase 1a trial

The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
Diagnostics

Molecure KITE trial clears interim review with no protocol changes

An IDMC review of 30 patients found sufficient probability of hitting the primary endpoint, letting the Phase II sarcoidosis study proceed unchanged.
An IDMC review of 30 patients found sufficient probability of hitting the primary endpoint, letting the Phase II sarcoidosis study proceed unchanged.
Biologics

Novo Nordisk raises 2026 guidance as Wegovy pill tops 5m prescriptions

Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
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