drug approval

15 articles
BenzingaBenzinga··Vandana Singh

Biogen Rallies on Pipeline Progress Despite Leqembi Review Delay

Biogen shares rise 1.06% to $193.40 despite FDA extending Leqembi review to August 2026, offset by $5.6B Apellis acquisition and Spinraza approval momentum.
APLSBIIBbiotechApellis Pharmaceuticals
The Motley FoolThe Motley Fool··Prosper Junior Bakiny

Vertex Pharma's Turnaround Play: Gene Therapy Bets Could Reignite Growth

Vertex Pharmaceuticals faces cystic fibrosis revenue slowdown but eyes major growth catalysts with Casgevy gene-editing and povetacicept kidney disease therapies.
VRTXCRSPbiotechrevenue growth
The Motley FoolThe Motley Fool··Prosper Junior Bakiny

Iovance Stock Could Soar 165% on Cancer Drug Success, Despite Manufacturing Risks

Iovance Biotherapeutics surged 34% in 2026 on strong melanoma drug sales, with analysts projecting 165% upside. Manufacturing challenges present significant execution risks.
IOVAregulatory riskstock valuation
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Disc Medicine Stock Crashes 22% After FDA Rejects Bitopertin; Class Action Looms

FDA rejected Disc Medicine's bitopertin drug application on February 13, 2026, triggering a 22% stock plunge. The Rosen Law Firm investigates potential securities claims for affected shareholders.
IRONstock declineinvestor losses
The Motley FoolThe Motley Fool··James Brumley

Pfizer's Monthly GLP-1 Shot Could Crack Novo and Lilly's Weight-Loss Monopoly

Pfizer's experimental monthly GLP-1 injection threatens to disrupt the weight-loss market dominated by Novo Nordisk and Eli Lilly, potentially triggering price competition.
PFELLYNVOGLP-1 drugspharmaceutical competition
GlobeNewswire Inc.GlobeNewswire Inc.··Researchandmarkets.Com

BsADC Market Set to Reach $2B by 2030 as First Drug Approval Looms

Bispecific antibody drug conjugates market projected at $2B+ by 2030, with first approval expected by 2028 amid 150+ global clinical trials.
AMGNAZNGMABclinical trialsmarket opportunity
The Motley FoolThe Motley Fool··Adria Cimino

Lilly's Retatrutide Could Cement Dominance in Surging Weight Loss Drug Market

Eli Lilly controls 60% of U.S. weight loss market with $11B+ quarterly revenue. Pipeline drug retatrutide showing 28% weight reduction could extend lead over Novo Nordisk.
LLYNVOclinical trialsweight loss drugs
GlobeNewswire Inc.GlobeNewswire Inc.··Pomerantz Llp

ALDX Stock Crashes 71% After FDA Rejects Lead Drug; Class Action Lawsuit Filed

Aldeyra Therapeutics stock plummets 71% following FDA rejection of reproxalap for dry eye disease. Class action lawsuit filed; investor deadline May 29, 2026.
ALDXsecurities fraudclass action lawsuit
The Motley FoolThe Motley Fool··James Brumley

Agios Pharma Soars 21% on FDA Fast-Track Win for Sickle Cell Drug

Agios Pharmaceuticals surges on FDA accelerated approval for mitapivat sickle cell treatment, enabling faster path to full approval despite company's ongoing losses.
AGIObiotechpharmaceutical
GlobeNewswire Inc.GlobeNewswire Inc.··Glancy Prongay Wolke & Rotter Llp

CORT Stock Plunges 50% on FDA Rejection; Securities Fraud Lawsuit Filed

Corcept Therapeutics shares crashed 50% after FDA rejected relacorilant application. Class action lawsuit alleges company concealed prior FDA warnings about clinical development concerns.
CORTsecurities fraudclass action lawsuit
The Motley FoolThe Motley Fool··Adria Cimino

Vertex Pharma's $600 Target Hinges on Diversification Beyond Cystic Fibrosis

Vertex Pharmaceuticals eyes 25% stock upside to $600 as it expands beyond cystic fibrosis with new drug approvals and kidney disease candidate povetacicept.
VRTXbiotechrevenue growth
The Motley FoolThe Motley Fool··Jonathan Ponciano

Biotech Darling $PRAX Soars 685% as $80.5M Investment Bets on Dual FDA Filings

$PRAX surges 685% annually, securing $80.5M from Driehaus Capital. Two FDA applications pending for neurological therapies with potential $20B+ revenue.
TSMPRAXGHbiotechinstitutional investment
The Motley FoolThe Motley Fool··Prosper Junior Bakiny

Eli Lilly's Oral GLP-1 Drug Could Reshape Weight Loss Market as Novo Nordisk Faces Competition

Eli Lilly's orforglipron oral GLP-1 drug offers no food restrictions and dual obesity-diabetes approval potential, threatening Novo Nordisk's oral Wegovy dominance.
LLYNVOpharmaceutical competitionweight-loss drug
GlobeNewswire Inc.GlobeNewswire Inc.··Glancy Prongay Wolke & Rotter Llp

CORT Plunges 50% After FDA Rejection; Securities Fraud Lawsuit Filed

Corcept Therapeutics faces class action lawsuit after FDA rejected relacorilant drug application, triggering 50% stock collapse and disclosure allegations.
CORTsecurities fraudclass action lawsuit
The Motley FoolThe Motley Fool··Prosper Junior Bakiny

Vertex Pharmaceuticals: Evaluating Path to Million-Dollar Returns

Vertex Pharmaceuticals needs 26% annual growth to turn $100K into $1M by 2036, but its maturing cystic fibrosis franchise and competitive pressures make this ambitious target unlikely despite solid fundamentals.
LLYVRTXbiotechcystic fibrosis