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Zacks News
Compugen (CGEN) Upgraded to Strong Buy: What Does It Mean for the Stock?
by Zacks Equity Research
Compugen (CGEN) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).
Can Compugen (CGEN) Run Higher on Rising Earnings Estimates?
by Zacks Equity Research
Compugen (CGEN) shares have started gaining and might continue moving higher in the near term, as indicated by solid earnings estimate revisions.
Compugen (CGEN) Reports Q2 Loss, Tops Revenue Estimates
by Zacks Equity Research
Compugen (CGEN) delivered earnings and revenue surprises of 75% and 150.54%, respectively, for the quarter ended June 2024. Do the numbers hold clues to what lies ahead for the stock?
Alterity (ATHE) Up on Interim Data From Advance MSA Study
by Zacks Equity Research
Alterity (ATHE) posts positive interim data from the phase II ATH434-202 study evaluating its lead candidate ATH434 for treating patients with multiple system atrophy. Stock rises.
Lexeo (LXEO) Down Despite Upbeat Rare Disease Gene Therapy Data
by Zacks Equity Research
Interim data from an early-stage study shows that treatment with Lexeo's (LXEO) experimental gene therapy reduced signs of heart complications in patients with Friedreich's ataxia.
Kazia Therapeutics (KZIA) Soars 490% in a Week: Here's Why
by Zacks Equity Research
Kazia (KZIA) surges after positive data from a phase II/III study on its lead pipeline drug in patients with glioblastoma. Based on this data, it plans to seek an accelerated nod from the FDA.
Verona (VRNA) Stock Surges 36% in the Past Month: Here's Why
by Zacks Equity Research
Verona Pharma (VRNA) surges on the recent FDA approval for its lead drug, which is the first inhaled COPD product with a novel mechanism of action in more than 20 years.
Pacira (PCRX) Rises on Proposed Exparel Reimbursement Plan
by Zacks Equity Research
Pacira (PCRX) gains upon the inclusion of Exparel as one of only six qualifying non-opioid drugs to treat postsurgical pain in the proposed reimbursement rule, if adopted.
Inovio (INO) Up as Lead Drug Gets Innovative Medicine Tag in UK
by Zacks Equity Research
Inovio (INO) soars 19% as its lead candidate, INO-3107, receives the innovative medicine tag under the U.K.'s Innovative Licensing and Access Pathway to treat recurrent respiratory papillomatosis.
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.