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Zacks News
IGM Biosciences, Inc. (IGMS) Reports Q4 Loss, Lags Revenue Estimates
by Zacks Equity Research
IGM Biosciences, Inc. (IGMS) delivered earnings and revenue surprises of 4.72% and 31.47%, respectively, for the quarter ended December 2023. Do the numbers hold clues to what lies ahead for the stock?
Milestone Pharma (MIST) Down on Regulatory Update for Etripamil
by Zacks Equity Research
Milestone Pharma (MIST) plunges 31% following an RTF letter from the FDA due to insufficient data to begin a substantive review of the regulatory filing for etripamil nasal spray to treat PSVT.
Merck (MRK) & Daiichi Sankyo's Lung Cancer ADC Gets Priority Tag
by Zacks Equity Research
Merck (MRK) and Daiichi Sankyo's regulatory filing for HER3-DXd gets the FDA's priority review grant for the treatment of adult patients with lung cancer. A final decision is expected on Jun 26, 2024.
GSK, Hansoh Ink Deal to Develop Lung Cancer ADC Candidate
by Zacks Equity Research
GSK enters into an exclusive licensing agreement with China-based Hansoh to develop and commercialize the latter's lung cancer candidate, HS-20093.
Immunovant (IMVT) Up on Upbeat Initial Batoclimab GD Study Data
by Zacks Equity Research
Immunovant (IMVT) announces positive initial data from the mid-stage study of batoclimab in patients with Graves' disease. The stock gains 12% in the after-market hours, following the news.
CARA's Late-Stage Skin Disease Study Fails, Stock Plummets 49%
by Zacks Equity Research
CARA discontinues the clinical program of oral difelikefalin for pruritus associated with atopic dermatitis following the failure of dose-finding Part A of the late-stage study. Stock plunges 49%.
Reneo (RPHM) Plummets 83% on Failure of Metabolic Disorder Study
by Zacks Equity Research
Reneo (RPHM) loses 83% following the failure of the mid-stage pivotal study of its only pipeline candidate, mavodelpar, to treat primary mitochondrial myopathies in adults. It cuts the workforce by 70%.
Acadia (ACAD) Rises 35% on Positive Patent Ruling for Nuplazid
by Zacks Equity Research
Acadia (ACAD) announces a ruling from the U.S. District Court in Delaware, strongly in favor of the company for its patent for Nuplazid. The stock surges 35% in response.
Blueprint (BPMC) Gets EC Nod for Ayvakit Expanded Use, Stock Up
by Zacks Equity Research
Blueprint (BPMC) announces EC approval expanding Ayvakit's indication to include the treatment of adult patients with indolent systemic mastocytosis. The stock gained 5%.
Biomea Fusion (BMEA) Stock Surges 41% in a Month: Here's Why
by Zacks Equity Research
Biomea Fusion (BMEA) rises 41% in a month on the back of positive investor expectations regarding the clinical development of its lead candidate, BMF-219, for the type II diabetes indication.
Century (IPSC) Up 36% on FDA Nod to Begin Phase I Lupus Study
by Zacks Equity Research
Century (IPSC) set to begin early-stage study on lead product candidate, CNTY-101, for treatment of systemic lupus erythematosus following IND clearance by FDA. The stock rises 36%.
Dr. Reddy's (RDY), COYA Ink Deal to Develop COYA 302 for ALS
by Zacks Equity Research
Dr. Reddy's (RDY) enters into a licensing agreement with Coya Therapeutics to develop and commercialize the latter's ALS investigational combination therapy, COYA 302.
Bristol Myers' (BMY) Opdivo sBLA Gets FDA's Priority Review
by Zacks Equity Research
Bristol Myers (BMY) announces that the FDA has accepted its sBLA for Opdivo to treat first-line adult patients with unresectable or metastatic bladder cancer under priority review.
Acadia (ACAD) Begins Study on ACP-101 for Hyperphagia in PWS
by Zacks Equity Research
Acadia (ACAD) begins late-stage development of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome.
BioVie (BIVI) Falls 61% Despite Upbeat Alzheimer's Study Data
by Zacks Equity Research
BioVie (BIVI) stock plunges 61% in spite of positive phase III Alzheimer's Disease study results due to significant study conduct violations and protocol deviations reported by the company.
Acadia (ACAD) Begins Alzheimer's Disease Psychosis Study (Revised)
by Zacks Equity Research
Acadia (ACAD) initiates a phase II study on ACP-204 in the treatment of Alzheimer's disease psychosis, the first among the three studies planned in the phase II/III clinical program of the candidate.
Acadia (ACAD) Begins Alzheimer's Disease Psychosis Study
by Zacks Equity Research
Acadia (ACAD) initiates a phase II study on ACP-204 in the treatment of Alzheimer's disease psychosis, the first among the three studies planned in the phase II/III clinical program of the candidate.
Avita (RCEL) Falls 19% on Lowered 2023 Revenue Guidance
by Zacks Equity Research
Avita's (RCEL) stock declines 19% after the company lowered its total revenue guidance for 2023.
Can-Fite (CANF) Up on Liver Cancer Study Update of Namodenoson
by Zacks Equity Research
Can-Fite (CANF) stock up 7% as the liver cancer patient achieves a complete response and overall survival of 6.9 years upon continued treatment with namodenoson in a phase II study.
Anavex (AVXL) Up 12% on Regulatory Update for Alzheimer's Drug
by Zacks Equity Research
Anavex (AVXL) announces an encouraging regulatory update for its investigational candidate, blarcamesine, in the treatment of Alzheimer's disease. The stock rises 12%.
Repare Therapeutics (RPTX) Rises 34% in a Week: Here's Why
by Zacks Equity Research
Repare Therapeutics (RPTX) rises 34% in a week after announcing plans to begin clinal-stage development of two additional candidates, RP-1664 and RP-3467, in 2024 in several solid tumor indications.
Agenus (AGEN) to Focus on BOT/BAL Candidate, Stock Falls 7%
by Zacks Equity Research
Agenus (AGEN) to halt all other developmental programs to focus on its BOT/BAL program. The company plans to cut its workforce by 25%.
Compared to Estimates, Agenus (AGEN) Q2 Earnings: A Look at Key Metrics
by Zacks Equity Research
While the top- and bottom-line numbers for Agenus (AGEN) give a sense of how the business performed in the quarter ended June 2023, it could be worth looking at how some of its key metrics compare to Wall Street estimates and year-ago values.
Travere Therapeutics (TVTX) Reports Q2 Loss, Tops Revenue Estimates
by Zacks Equity Research
Travere (TVTX) delivered earnings and revenue surprises of 2.59% and 10.70%, respectively, for the quarter ended June 2023. Do the numbers hold clues to what lies ahead for the stock?
Agenus (AGEN) Reports Q1 Loss, Lags Revenue Estimates
by Zacks Equity Research
Agenus (AGEN) delivered earnings and revenue surprises of -4.76% and 2.68%, respectively, for the quarter ended March 2023. Do the numbers hold clues to what lies ahead for the stock?