clinical trial

149 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Muscular Dystrophy Association

FDA Expands VYVGART Approval to All Generalized Myasthenia Gravis Patients

FDA expands VYVGART approval to include seronegative myasthenia gravis patients, broadening treatment access and increasing commercial opportunity for Ultragenyx.
ARGXFDA approvalclinical trial
Investing.comInvesting.com··Tim Baker

Moderna Surges on Hantavirus Vaccine Success, Signaling mRNA Platform Diversification

Moderna stock rises after positive Phase 1 hantavirus vaccine data, with analysts raising price targets amid signs of mRNA platform diversification beyond COVID.
MRNAclinical trialpipeline expansion
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Glucotrack Advances Implantable Glucose Monitor With FDA Clinical Study Approval

Glucotrack submits IDE application for FDA clinical trial of implantable continuous glucose monitoring technology, marking major regulatory milestone for diabetes care innovation.
GCTKFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Arcutis Reports 65% YoY Growth in ZORYVE Revenue Despite Seasonal Decline

Arcutis reports Q1 2026 ZORYVE revenue of $105.4 million, up 65% year-over-year, with expanded pediatric development and reaffirmed full-year guidance of $480-495 million.
ARQTFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Annexon to Present Pivotal Data Catalyst at Major Healthcare Conference

$ANNX set to showcase ARCHER II Phase 3 results targeting $1B+ geographic atrophy market at BofA Securities conference May 2026.
ANNXclinical trialbiopharmaceutical
GlobeNewswire Inc.GlobeNewswire Inc.··Biocryst Pharmaceuticals, Inc.

BioCryst Lands $70M Deal, Reports ORLADEYO Growth Ahead of Navenibart Catalyst

BioCryst posts 11% ORLADEYO revenue growth to $148.3M in Q1 2026, inks $70M European licensing deal for navenibart with up to $275M in milestones.
BCRXrevenue growthclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

Kymera Therapeutics Advances IBD Pipeline With Promising KT-579 Preclinical Data

Kymera Therapeutics showcases KT-579 preclinical data matching approved IBD therapies ahead of Phase 1 trials in late 2026.
KYMRclinical trialinflammatory bowel disease
BenzingaBenzinga··Vandana Singh

Eli Lilly's Omvoh Shows Durable Long-Term IBD Benefits, Bolstering Pipeline Confidence

Eli Lilly reports durable four-year efficacy data for Omvoh in IBD, with 63.5% ulcerative colitis remission and 92.4% Crohn's response rates, bolstering pipeline confidence.
LLYFDA approvalclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Portnoy Law Firm

Soleno Therapeutics Faces Class Action Over Safety Risks in Lead Drug DCCR

Portnoy Law Firm launches class action lawsuit against $SLNO alleging concealment of safety issues in lead drug DCCR, following 27% stock plunge.
SLNOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Nektar Therapeutics Faces Securities Fraud Suit Over Clinical Trial Protocol Violations

Nektar Therapeutics faces securities class action lawsuit alleging REZOLVE-AA trial enrolled four ineligible patients, masking disappointing efficacy results.
NKTRsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Nektar Therapeutics Faces Class Action Over REZOLVE-AA Trial Disclosure Failures

Class action lawsuit filed against $NKTR for allegedly concealing REZOLVE-AA trial protocol violations and ineligible patient enrollment. Stock fell 7.77% on trial failure announcement.
NKTRsecurities fraudclass action lawsuit
BenzingaBenzinga··Vandana Singh

AstraZeneca's Prostate Drug Wins FDA Panel Backing While Breast Cancer Candidate Falters

AstraZeneca's prostate drug Truqap wins FDA panel backing (7-1 vote) for PTEN-deficient tumors, but breast cancer candidate camizestrant rejected despite superior efficacy data.
AZNFDA approvalbreast cancer
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Rein Therapeutics Raises $50M via IPO to Fund Pulmonary Fibrosis Trial

Rein Therapeutics prices $50M stock offering at $1.00 per share to fund LTI-03 Phase 2 trial for idiopathic pulmonary fibrosis, with cash runway extended through 2028.
RNTXclinical trialpublic offering
GlobeNewswire Inc.GlobeNewswire Inc.··Bronstein, Gewirtz & Grossman Llc

Soleno Therapeutics Hit With Class Action Over Undisclosed DCCR Safety Data

Class action lawsuit filed against $SLNO alleging failure to disclose fluid retention safety concerns in DCCR drug trials, harming investors who bought shares March-November 2025.
SLNOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Mesoblast Limited

Mesoblast Hits $30.3M Ryoncil Revenue as Cash Burn Slows to $4.1M

Mesoblast reports Q3 FY2026 Ryoncil revenues of $30.3M, approaching $100M cumulative sales, while reducing operating cash spend and strengthening balance sheet.
MESOFDA approvalrevenue growth
GlobeNewswire Inc.GlobeNewswire Inc.··Telix Pharmaceuticals Limited

Telix's Next-Gen Prostate Cancer Drug Shows Promise With Lower Toxicity Profile

Telix's next-gen prostate cancer therapy shows reduced organ toxicity in Phase 2 trial, expanding into earlier-stage disease applications with expanded clinical potential.
TLXclinical trialprostate cancer
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Tempest's Dual-Targeting CAR-T Shows Promise as Clinical Data Update Looms

Tempest Therapeutics will present updated TPST-2003 CAR-T trial data at ISCT 2026, building on earlier 100% complete response rates in multiple myeloma patients.
TPSTclinical trialmultiple myeloma
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Soleno Faces Securities Class Action Over Undisclosed Drug Safety Concerns

Investors in $SLNO have until May 5, 2026 to join securities lawsuit alleging undisclosed safety issues with DCCR drug candidate.
SLNOsecurities class actionlead plaintiff deadline
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Anteris Lands Medicare Reimbursement for PARADIGM Heart Valve Trial

Anteris Technologies secures CMS reimbursement eligibility for its PARADIGM Trial evaluating DurAVR transcatheter heart valve in 1,000 patients, accelerating U.S. site activation.
AVRclinical trialPARADIGM Trial
GlobeNewswire Inc.GlobeNewswire Inc.··Telix Pharmaceuticals Limited

Telix Pharmaceuticals to Showcase Next-Gen PSMA Cancer Therapy Portfolio

Telix Pharmaceuticals hosts webinar April 30 discussing next-gen PSMA cancer therapy pipeline, featuring OPTIMAL-PSMA2 trial data on TLX597-Tx candidate.
TLXclinical trialprostate cancer