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Zacks News
United Therapeutics (UTHR) Completes Enrolment in IPF Study
by Zacks Equity Research
United Therapeutics' (UTHR) late-stage study is evaluating Tyvaso inhalation solution in IPF patients living outside the United States and Canada.
Indivior (INDV) Down on Dropping Schizophrenia Drug, Cuts '24 View
by Zacks Equity Research
Indivior (INDV) slashes financial guidance for 2024, primarily to reflect adverse sales conditions of its top-selling opioid drug. It will discontinue the sales of its schizophrenia drug.
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.
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.
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.
FDA Rejects Rocket's (RCKT) Gene Therapy BLA for Rare Disease
by Zacks Equity Research
Per the FDA, Rocket (RCKT) needs to submit additional manufacturing information on Kresladi gene therapy to secure approval for severe leukocyte adhesion deficiency-I (LAD-I), a rare genetic disorder.
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.
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.
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.
Alnylam (ALNY) Soars as Heart Disease Drug Study Meets Goals
by Zacks Equity Research
Alnylam (ALNY) soars as its phase III study, seeking to expand Anvuttra's label to include the treatment of ATTR amyloidosis with cardiomyopathy, achieves primary and all secondary endpoints.
Should You Hold Kodiak Sciences (KOD) Stock in Your Portfolio?
by Zacks Equity Research
Kodiak Sciences (KOD) is evaluating its lead candidate, tarcocimab, in a late-stage study for diabetic retinopathy, which is expected to support a regulatory filing for three eye disease indications.
Day One (DAWN) In-Licenses MabCare Cancer Candidate, Stock Up
by Zacks Equity Research
Day One (DAWN) gains 11% on in-licensing exclusive worldwide rights to MabCare???s MTX-13, which is set to begin clinical studies for adult and pediatric solid tumor indications.
Intra-Cellular (ITCI) Up as Second Depression Study Meets Goals
by Zacks Equity Research
Intra-Cellular (ITCI) gains 10% after achieving key goals in the second late-stage study evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD.
Aerovate (AVTE) Down as Lead Drug Fails to Meet PAH Study Goals
by Zacks Equity Research
Aerovate's (AVTE) shares plunge 93% as its lead candidate, AV-101, fails to meet the primary and secondary endpoints in the phase IIb/III study to treat pulmonary arterial hypertension patients.