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Zacks News
uniQure (QURE) Soars on New Huntington's Disease Study Data
by Zacks Equity Research
uniQure (QURE) surges 77% on updated positive interim data from 29 treated patients in the ongoing phase I/II studies of investigational gene therapy, AMT-130, for Huntington's disease.
IDEAYA (IDYA) Up on Upbeat Phase II Bladder & Lung Cancer Data
by Zacks Equity Research
IDEAYA (IDYA) gains 15% on positive clinical data from its phase II study evaluating the 30 mg monotherapy expansion dose of IDE397 to treat MTAP-deletion urothelial and NSCLC patients.
Adicet (ACET) Up as Kidney Cancer Drug Gets FDA's Fast Track Tag
by Zacks Equity Research
Adicet (ACET) gains as the FDA grants the Fast Track designation to ADI-270 for the potential treatment of a form of kidney cancer. A phase I study for this indication is set to begin in 2024.
Dianthus (DNTH) Gains 18% in the Past Month: Here's Why
by Zacks Equity Research
Dianthus (DNTH) shares have rallied 18% in the past month on FDA clearance to initiate a phase II study on its lead candidate, DNTH103, to treat an autoimmune indication. Top-line data is expected in 2026.
Roche (RHHBY) Receives FDA Nod for Vabysmo Prefilled Syringe
by Zacks Equity Research
The FDA approves Roche's (RHHBY) Vabysmo prefilled syringe for treating three retinal conditions that can cause blindness.
Apellis' (APLS) Syfovre Boost Sales, Regulatory Setbacks a Woe
by Zacks Equity Research
Apellis' (APLS) revenues rise on the back of the robust uptake of Syfovre for the GA indication. However, the recent regulatory setback in the EU for pegcetacoplan to treat GA is a woe.
Roche's (RHHBY) Combo Therapy Misses Lung Cancer Study Goals
by Zacks Equity Research
Roche (RHHBY) announces that its mid to late-stage lung cancer study evaluating the tiragolumab combination therapy compared with Keytruda fails to meet primary endpoints.
Cartesian (RNAC) MG Study Meets Goals, Stock Down on Other Updates
by Zacks Equity Research
Cartesian (RNAC) announced that the phase IIb study in MG patients has achieved its primary endpoints. However, the stock nosedives following an equity financing announcement.
Annovis (ANVS) Up as Its Lead Candidate Meets Goals in PD Study
by Zacks Equity Research
Annovis (ANVS) surges 76% on Jul 2 after meeting the primary and secondary goals with statistical significance in the late-stage PD study of its lead candidate, buntanetap.
Regeneron (REGN), SNY Win EC Approval for Dupixent for COPD
by Zacks Equity Research
Regeneron (REGN) and partner Sanofi get approval for their blockbuster drug Dupixent for the chronic obstructive pulmonary disease indication in the EU.
Longboard (LBPH) Up 14% as Epilepsy Drug Gets Breakthrough Tag
by Zacks Equity Research
Longboard (LBPH) gains 14% as the FDA grants the Breakthrough Therapy designation to its investigational epilepsy treatment candidate, bexicaserin, for patients aged two years or older.
Mesoblast (MESO) Soars 208% YTD on Positive Regulatory Updates
by Zacks Equity Research
Mesoblast (MESO) skyrockets 208.2% year to date on encouraging progress with its pipeline candidates.
Roche (RHHBY) Gets Positive CHMP Recommendation for Its Drugs
by Zacks Equity Research
Roche (RHHBY) gets CHMP recommendation for a label expansion of ophthalmology drug Vabysmo (faricimab) and PiaSky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria.
Apellis (APLS) Falls on Second Negative CHMP Opinion for GA Drug
by Zacks Equity Research
Apellis (APLS) declines as CHMP issues a second negative opinion for the approval of intravitreal pegcetacoplan to treat GA in the EU. The company plans to seek re-examination of the same.
PTC Therapeutics (PTCT) Down on Negative CHMP Opinion on DMD Drug
by Zacks Equity Research
PTC Therapeutics (PTCT) falls as the EC's advisory committee adopts a negative opinion regarding the renewal of the conditional marketing approval of Translarna to treat nmDMD in the EU.
Cogent (COGT) Up on SUMMIT Study Update Post Positive FDA Meeting
by Zacks Equity Research
Cogent (COGT) announces a positive FDA meeting and alignment on MS2D2, a novel patient-reported outcome measure for the SUMMIT study. The company's shares rise on the news.
Denali (DNLI) Outperforms Industry in 3 Months: Here's Why
by Zacks Equity Research
Denali (DNLI) gains 11.9% in three months on positive updates on its candidates.
Merck's (MRK) New Pneumococcal Jab Capvaxive Gets CDC Panel Vote
by Zacks Equity Research
Merck's (MRK) vaccine, Capvaxive, gets unanimous recommendation by a CDC committee for adults aged 65 years and older for pneumococcal vaccination and those with certain other underlying conditions.
Dr. Reddy's (RDY) to Acquire Haleon's Nicotine Addiction Drug
by Zacks Equity Research
Dr. Reddy's (RDY) is set to acquire Haleon's leading global NRT brand, Nicotinell, and its related portfolio across all formats of the drug for GBP 500 million to boost its OTC presence worldwide.
Novo Nordisk's (NVO) Hypertension Drug Study Fails to Meet Goal
by Zacks Equity Research
Novo Nordisk (NVO) declines as a late-stage study of its uncontrolled hypertension and advanced chronic kidney disease candidate, ocedurenone, fails to achieve the primary goal.
CASI Pharmaceuticals (CASI) Up on Buyout Offer for China Business
by Zacks Equity Research
CASI Pharmaceuticals (CASI) gets a proposal letter from its chairman for acquiring its business operations in China. Its shares rise on the news.
Bayer's (BAYRY) AskBio Advances Parkinson Disease Study
by Zacks Equity Research
Bayer's (BAYRY) wholly owned and independently operating subsidiary AskBio started recruitment in the phase II study for Parkinson's disease.
ImmunityBio (IBRX) Gains 17% in the Past Week: Here's Why
by Zacks Equity Research
ImmunityBio (IBRX) rises 17% in the past week as it announces insurance coverage as well as the treatment of the first patients with its newly approved bladder cancer immunotherapy, Anktiva.
AbbVie (ABBV) Parkinson's Candidate Faces 2nd FDA Rejection
by Zacks Equity Research
AbbVie (ABBV) issues the second CRL for Parkinson's disease medicine, ABBV-951, based on some observations on inspection of one of its third-party manufacturing facilities.
Roche's (RHHBY) Ocrevus Subcutaneous Gets European Commission Nod
by Zacks Equity Research
Roche (RHHBY) obtains approval for the subcutaneous formulation of relapsing multiple sclerosis drug Ocrevus in Europe. In addition, a review of the company's MAA for gene therapy, Elevidys, is also underway.