Category: Clinical Data
PharmaSignal — Clinical Data
Moderna, after losing US funding, rebounds to start mRNA bird flu vaccine trial
BioPharma Dive
A program that got caught up in HHS decision to abandon mRNA research was revived by a public-private coalition and is now beginning a large, late-stage test that could support a future approval.
Ionis’ antisense drug stabilizes ultra-rare disease ahead of FDA decision
BioSpace
The pivotal study of zilganersen in Alexander disease missed a secondary endpoint, but analysts expect the FDA to approve the asset given the unmet need and overall data.
New data build case for Roche’s oral BTK drug for MS
Pharmaphorum
Roche remains confident in the prospects for its soon-to-be-filed oral BTK drug fenebrutinib for multiple sclerosis, despite safety concerns.
Pivotal trial of Moderna’s H5N1 bird flu jab gets underway
Pharmaphorum
The first volunteers in a large-scale trial of Moderna’s mRNA-based vaccine against bird flu have received shots in the UK and US.
Merck’s fast-ascending kidney cancer drug hits a setback
BioPharma Dive
Welireg s failure in first-line kidney cancer removes a blockbuster opportunity and could leave an opening for a rival drug from Arcus Biosciences, analysts said.
BioAge says early data suggest ‘best-in-class’ potential for inflammation drug
BioPharma Dive
The company has rallied from an earlier setback in obesity thanks to early progress for a drug targeting NLRP3, an inflammasome linked to a variety of health conditions.
Merck, Eisai’s Keytruda triplet fails to improve survival in kidney cancer
BioSpace
A triplet regimen comprising Merck’s Welireg and PD-1 blockbuster Keytruda and Eisai’s Lenvima flopped in a Phase 3 renal cell carcinoma trial.
AACR 2026: Moderna, Revolution, Zymeworks and BeOne showcase new data
BioSpace
Moderna, Revolution Medicines and Zymeworks record wins in melanoma, lung and breast cancers, while BeOne swings and misses at head and neck cancer.
MSD, Eisai report setback in first-line kidney cancer trial
Pharmaphorum
The LITESPARK-012 trial saw no benefit when Welireg was added to treatment with Keytruda plus Lenvima for renal cell carcinoma.
Gilead, Arcus tumble again in TIGIT, triggering 2 trial culls
BioSpace
The Phase 3 failure has prompted Gilead Sciences and Arcus Biosciences to terminate a mid-stage study of their TIGIT asset in lung cancer.
Nektar surges again as alopecia drug shows new promise in extension study
BioPharma Dive
Patients who’d seen substantial hair regrowth in the first part of Nektar s trial had a deepening treatment response, extending a comeback bid that s caused shares to skyrocket over the last year.
Novo’s late-stage sickle cell win piles pressure on competitors
BioSpace
Novo Nordisk’s etavopivat elicited a 27% drop in vaso-occlusive crises and 48.7% hemoglobin response after 24 weeks, creating “separation amongst PK class candidates,” Truist analysts said on Monday.
AZ is three for three with COPD hope tozorakimab
Pharmaphorum
AstraZeneca’s IL-33-targeting antibody tozorakimab has hit the target in the third of three phase 3 trials in COPD, setting up filings.
Novo may have muscle advantage over Lilly in weight-loss race: preprint
BioSpace
More patients on Eli Lilly’s tirzepatide lost over 5% of their lean mass versus those on Novo Nordisk’s semaglutide, according to a study that has yet to be peer reviewed.
Lilly’s new obesity pill passes heart safety test in diabetes
BioPharma Dive
The findings, which come amid FDA scrutiny of Foundayo s safety, will enable Lilly to seek a new clearance in diabetes.
Lilly debuts more Foundayo data as FDA requests post-marketing trials
Pharmaceutical Technology
The FDA requires Eli Lilly to evaluate “unexpected serious” risks associated with Foundayo – some of which have been addressed by the ACHIEVE-4 trial.
Roche to start new Elevidys study following setback in Europe
BioPharma Dive
The Swiss drugmaker, which owns rights to the Duchenne gene therapy outside the U.S., hopes the trial will yield additional approvals in Europe and elsewhere.
Lilly’s Foundayo posts ‘outstanding’ diabetes data, possibly easing FDA safety concerns
BioSpace
Right after the FDA flagged safety concerns for Eli Lilly’s newly approved obesity pill, the pharma posted diabetes data demonstrating a clean safety profile and revealed plans to seek approval in the
Lilly says Foundayo safety confirmed in ACHIEVE-4 trial
Pharmaphorum
Eli Lilly’s ACHIEVE-4 trial results for oral GLP-1 Foundayo set up a filing in diabetes, and provide safety data sought by the FDA.
Boehringer Ingelheim and Zai Lab team up for dual DLL3 therapy study
Pharmaceutical Business Review
This Phase Ib/II study will measure the tolerability, safety, and early clinical activity by combining Boehringer Ingelheim’s DLL3 / cluster of differentiation 3 (CD3) T-cell engager, obrixtamig, with