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Zacks News
Wall Street Analysts Think ANI (ANIP) Is a Good Investment: Is It?
by Zacks Equity Research
According to the average brokerage recommendation (ABR), one should invest in ANI (ANIP). It is debatable whether this highly sought-after metric is effective because Wall Street analysts' recommendations tend to be overly optimistic. Would it be worth investing in the stock?
Gritstone (GRTS) Plummets 58% in a Week: Here's Why
by Zacks Equity Research
Gritstone (GRTS) plunges after a mid-stage study evaluating its personalized cancer vaccine in certain patients with colorectal cancer failed to achieve its primary endpoint.
Amylyx (AMLX) Withdraws ALS Drug, Cuts Workforce by 70%
by Zacks Equity Research
Amylyx (AMLX) makes a formal decision to remove its amyotrophic lateral sclerosis drug from the U.S. and Canadian markets. The company is expected to reduce its workforce by 70%. Its shares are trading up on the news.
Amarin (AMRN) Up 7% on Intellectual Property Wins in Europe
by Zacks Equity Research
Amarin (AMRN) secures a new patent for Vazkepa in Europe, which extends its exclusivity for eight more years. It achieves success in defending another patent on the drug against third parties.
Kintara (KTRA) Stock Soars on Merger Agreement With TuHURA
by Zacks Equity Research
Kintara (KTRA) inks a definitive merger agreement with TuHURA for an all-stock transaction. It is expected to close in the third quarter of 2024. The stock surges 63.4%.
Verve (VERV) Pauses Enrollment in Cholesterol Study, Stock Falls
by Zacks Equity Research
Verve (VERV) stops enrollment in the phase Ib study of gene therapy candidate VERVE-10 to reduce disease-driving low-density lipoprotein cholesterol due to safety issues. Stock plunges on the news.
Vanda (VNDA) Up on FDA Nod for Fanapt in Bipolar I Disorder
by Zacks Equity Research
Vanda (VNDA) announces the FDA's approval of Fanapt for the acute treatment of bipolar I disorder in adults. The stock rises 30.4%.
EMA Accepts Rocket (RCKT) Gene Therapy Filing for Fanconi Anemia
by Zacks Equity Research
The EMA accepts Rocket's (RCKT) regulatory submission seeking approval for RP-L102, a gene therapy for a rare genetic disorder called fanconi anemia that affects the bone marrow.
Bristol Myers (BMY) Wins EC Nod for Reblozyl Label Expansion
by Zacks Equity Research
Bristol Myers (BMY) receives European Commission's approval for a label expansion of Reblozyl (luspatercept) for another indication.
ANI Pharmaceuticals (ANIP) Dips More Than Broader Market: What You Should Know
by Zacks Equity Research
ANI Pharmaceuticals (ANIP) closed at $66.72 in the latest trading session, marking a -1.69% move from the prior day.
Disc Medicine (IRON) Down on Mixed Results From AURORA Study
by Zacks Equity Research
Disc Medicine's (IRON) shares lose after a phase II study of bitopertin in patients with erythropoietic protoporphyria does not achieve the key secondary endpoint.
Avalo Therapeutics (AVTX) Surges 270% in a Week: Here's Why
by Zacks Equity Research
Avalo (AVTX) surges on adding a new pipeline drug, which has its origins at Eli Lilly. Alongside the acquisition, it also secured funding to continue operations beyond 2027.
Vertex (VRTX) Moves Kidney Disease Drug to Phase 3 Development
by Zacks Equity Research
Vertex (VRTX) advances inaxaplin to late-stage development. It will evaluate the drug in lower age groups and will enroll patients aged 10 years and older with APOL1-mediated kidney disease.
Solid Biosciences (SLDB) Falls Despite FDA Rare Tag for DMD Drug
by Zacks Equity Research
Solid Biosciences' (SLDB) novel gene-therapy candidate, SGT-003, gets FDA's Rare Pediatric Disease Designation for the treatment of Duchenne muscular dystrophy.
Axsome (AXSM) Begins Solriamfetol Binge Eating Phase III Study
by Zacks Equity Research
Axsome's (AXSM) phase III ENGAGE study is set to evaluate the efficacy and safety of solriamfetol for the treatment of binge eating disorder in adults.
Kodiak (KOD) Stock Falls on Q4 Earnings Miss, Pipeline in Focus
by Zacks Equity Research
Kodiak (KOD) reports a wider-than-expected loss for fourth-quarter 2023. The company provides updates regarding its pipeline development plans.
Moderna (MRNA) Posts Pipeline Progress, Secures Blackstone Funding
by Zacks Equity Research
Moderna (MRNA) posts data on three experimental vaccines and intends to advance them to late-stage studies. It also secures $750 million in funding from Blackstone to advance its influenza program.
ANI Pharmaceuticals (ANIP) Rises Yet Lags Behind Market: Some Facts Worth Knowing
by Zacks Equity Research
ANI Pharmaceuticals (ANIP) concluded the recent trading session at $69.69, signifying a +0.2% move from its prior day's close.
Praxis (PRAX) Surges on Positive Epilepsy Study Results
by Zacks Equity Research
Praxis (PRAX) reports strong response rates across both study arms in a phase IIa proof of concept study for epilepsy patients with PPR.
Axsome's (AXSM) Narcolepsy Drug Study Meets Primary Goal
by Zacks Equity Research
Data from a late-stage study shows that a five-week treatment with Axsome's (AXSM) experimental narcolepsy drug reduced weekly cataplexy attacks by 83%, compared to 66% for placebo.
CHMP to Delay Nod on Biogen (BIIB), Eisai's Alzheimer's Drug
by Zacks Equity Research
Per Biogen (BIIB)/Eisai, the delay in CHMP recommendation for lecanemab is entirely related to procedural reasons at the EMA and is not related to the companies' regulatory filing.
Regeneron's (REGN) Lymphoma Candidate Rejected by the FDA
by Zacks Equity Research
Regeneron's (REGN) efforts to expand its oncology portfolio get a hit as the FDA refuses to approve the lymphoma drug odronextamab.
ANI Pharmaceuticals, Inc. (ANIP) Hits Fresh High: Is There Still Room to Run?
by Zacks Equity Research
ANI (ANIP) is at a 52-week high, but can investors hope for more gains in the future? We take a look at the company's fundamentals for clues.
Lisata's (LSTA) LSTA1 Gets FDA's RPDD Tag for Osteosarcoma
by Zacks Equity Research
Lisata's (LSTA) lead investigational product candidate, LSTA1, gets Rare Pediatric Disease Designation for treating osteosarcoma. Stock rises.
Novo Nordisk (NVO) Gets Positive CHMP Opinion for Insulin Icodec
by Zacks Equity Research
Novo Nordisk (NVO) receives a positive opinion from the CHMP for once-weekly basal insulin icodec for the treatment of diabetes in adults.