MarketPulse

accelerated approval

15 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Replimune Group, Inc.

Replimune's Melanoma Drug Rejected by FDA Despite Promising Trial Data

Replimune receives FDA rejection for RP1 immunotherapy despite 34% response rate in trials. Company plans layoffs, blames regulatory process.
REPLFDA rejectionComplete Response Letter
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Nurix Therapeutics Posts $87.2M Loss While Advancing Bexobrutideg Clinical Pipeline

Nurix Therapeutics reported Q1 2026 revenue of $6.3M (down 66% YoY) and $87.2M net loss, maintaining $540.7M cash while advancing bexobrutideg clinical program.
SNYGILDNRIXclinical trialsimmunology
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Inovio Faces Securities Fraud Class Action Over Misleading FDA Claims

Pomerantz LLP files class action against Inovio Pharmaceuticals for securities fraud over false FDA claims; stock fell 24.45% in December 2025.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Inovio Faces Class Action Over Misleading Device Claims and Regulatory Setback

Class action lawsuit filed against Inovio Pharmaceuticals for allegedly making false statements about manufacturing deficiencies and overstating regulatory prospects, triggering 24.45% stock decline.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Agios Pharmaceuticals Eyes Accelerated FDA Approval Path for Mitapivat in Sickle Cell

Agios Pharmaceuticals to report Q1 2026 results April 29 amid FDA accelerated approval pursuit for sickle cell mitapivat and UAE thalassemia approval.
AGIOrare diseasesFDA
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Beam Therapeutics' BEAM-302 Shows Promise in Alpha-1 Deficiency, Eyes Pivotal Trial

Beam Therapeutics reports positive Phase 1/2 data for BEAM-302 base editing therapy in alpha-1 antitrypsin deficiency, advancing toward pivotal development in late 2026.
BEAMclinical trialgene therapy
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Pomerantz Files Securities Fraud Suit Against $INO Over FDA Approval Misstatements

Pomerantz LLP sues Inovio Pharmaceuticals for alleged securities fraud over FDA approval misstatements. Stock fell 3.1% and 24.45% following manufacturing delays and accelerated approval rejection.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Faruqi & Faruqi, Llp

Inovio Faces Securities Class Action Over Failed FDA Approval Strategy

Inovio Pharmaceuticals faces a securities class action over allegedly false statements regarding manufacturing capabilities and regulatory prospects for INO-3107, following FDA's December 29 accelerated approval rejection.
INOstock declinesecurities class action
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Inovio Faces Securities Fraud Class Action Over Manufacturing Claims and FDA Setbacks

Pomerantz Law Firm files class action against $INO for alleged securities fraud involving false manufacturing capability and FDA approval claims for INO-3107.
INOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Inovio Faces Securities Class Action Over Undisclosed Manufacturing Delays, FDA Review Setbacks

Law firm Levi & Korsinsky seeks investors in Inovio Pharmaceuticals securities class action alleging failure to disclose manufacturing delays and FDA's standard review decision.
INOsecurities class actionFDA approval
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

Pomerantz Files Securities Fraud Class Action Against Inovio Pharmaceuticals

Pomerantz files class action against Inovio Pharmaceuticals for alleged securities fraud related to false FDA approval statements and concealed manufacturing deficiencies.
PLUGENPHINOsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Ascendis Pharma A/S

Ascendis Pharma Wins FDA Clearance for First Weekly Achondroplasia Treatment in Children

Ascendis Pharma wins FDA approval for YUVIWEL, the first once-weekly treatment for pediatric achondroplasia. The therapy offers improved dosing convenience over existing options.
ASNDFDA approvalaccelerated approval
GlobeNewswire Inc.GlobeNewswire Inc.··Bragar Eagel & Squire, P.C.

Inovio Pharmaceuticals Faces Class Action Over FDA Rejection and Device Claims

Inovio Pharmaceuticals faces class action lawsuit over alleged false statements regarding manufacturing defects and regulatory prospects after FDA rejected accelerated approval, causing 24% stock decline.
INOclass action lawsuitstock decline
GlobeNewswire Inc.GlobeNewswire Inc.··Faruqi & Faruqi, Llp

Inovio Pharmaceuticals Faces Securities Class Action; Investor Deadline Set for April 2026

Inovio Pharmaceuticals faces securities lawsuit over false statements about manufacturing and regulatory prospects. FDA rejected accelerated approval for lead drug candidate, causing 24% stock drop.
INOsecurities class actionFDA rejection
BenzingaBenzinga··Vandana Singh

Novartis Kidney Drug Demonstrates Sustained Efficacy in Long-Term Study Data

Novartis's kidney drug Vanrafia shows sustained efficacy in slowing kidney function decline, supporting its path to full regulatory approval in 2026 for IgA nephropathy treatment.
NVSkidney diseaseEGFR