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Zacks News
Acadia's (ACAD) Nuplazid Sales Drive Growth Amid Competition
by Zacks Equity Research
Acadia (ACAD) is witnessing robust growth in revenues, driven by Nuplazid and Daybue sales. However, dependence on Nuplazid sales for revenues, along with stiff competition, remains a woe.
Amicus (FOLD) Banks on Galafold, Overdependence a Concern
by Zacks Equity Research
Amicus' (FOLD) lead drug, Galafold, is witnessing solid uptake since its launch. The drug holds blockbuster potential. However, overdependence on Galafold for revenues remains a concern.
4 Promising Liquid Stocks to Boost Your Portfolio in 2024
by Vaishali Doshi
Here are four top-ranked liquid stocks, Puma Biotechnology (PBYI), Amphastar Pharmaceuticals (AMPH), Vimeo (VMEO) and Fluor Corporation (FLR), which investors can add to their portfolio for solid gains
Iovance (IOVA) Falls After Clinical Update on Lung Cancer Drug
by Zacks Equity Research
Iovance (IOVA) is likely to pause enrollment in the phase II IOV-LUN-202 study evaluating its tumor infiltrating lymphocyte therapy, LN-145, for treating non-small cell lung cancer. Stock declines.
Coherus (CHRS) Stock Rallies on FDA Nod for Udenyca Onbody
by Zacks Equity Research
The FDA approves Coherus' (CHRS) Udenyca Onbody, an on-body injector presentation of Udenyca (pegfilgrastim-cbqv). Shares of the company rise on the news.
Cytokinetics (CYTK) Up 83% as Cardiomyopathy Drug Meets Goals
by Zacks Equity Research
Cytokinetics (CYTK) reports positive results from its pivotal late-stage study of aficamten in symptomatic obstructive hypertrophic cardiomyopathy patients. The stock rallies 83% in response.
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.
Senti Bio (SNTI) Rises as FDA Clears IND for Cancer Candidate
by Zacks Equity Research
The FDA clears Senti Bio's (SNTI) investigational new drug application for SENTI-202 for the treatment of relapsed/refractory hematologic malignancies, including acute myeloid leukemia. Stock rises.
Cidara (CDTX) Up on EC Nod for Rezzayo in Invasive Candidiasis
by Zacks Equity Research
Cidara's (CDTX) Rezzayo (rezafungin acetate) gets approval from the European Commission for the treatment of invasive candidiasis in adults. The stock rises 11.1%.
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.
PBYI or TECH: Which Is the Better Value Stock Right Now?
by Zacks Equity Research
PBYI vs. TECH: Which Stock Is the Better Value Option?
Bausch Health (BHC) Ulcerative Colitis Drug Meets Primary Goal
by Zacks Equity Research
Bausch's (BHC) amiselimod achieves the primary and key secondary endpoints, including clinical and endoscopic measures, in the double-blind period of a phase II study.
Sanofi (SNY) Discontinues Tusamitamab Ravtansine Cancer Program
by Zacks Equity Research
Sanofi (SNY) stops the development of tusamitamab ravtansine after a phase III study on the candidate for second-line metastatic non-small cell lung cancer fails to meet the primary endpoint.
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.
argenx (ARGX) Tanks on Top-Line Data From Pemphigus Study
by Zacks Equity Research
argenx's (ARGX) phase III ADDRESS study, evaluating efgartigimod subcutaneous for treating pemphigus, fails to meet primary and secondary endpoints. Stock falls.
Roche's (RHHBY) sBLA for Xolair Gets FDA Priority Review Tag
by Zacks Equity Research
The FDA accepts and grants priority review to Roche's (RHHBY) supplemental biologics license application for Xolair for the reduction of food allergic reactions. A decision is due in the first quarter of 2024.
Anavex (AVXL) Rises as CHMP Deems Blarcamesine Eligible for MAA
by Zacks Equity Research
The CHMP agrees that Anavex's (AVXL) blarcamesine for Alzheimer's disease is eligible for submission for a Union Marketing Authorisation in the EU. Shares rise.
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%.
Invivyd (IVVD) Surges on Positive Data From COVID-19 Study
by Zacks Equity Research
Invivyd (IVVD) reports positive initial data from the phase III CANOPY study on VYD222 for the prevention of symptomatic COVID-19. Stock shoots up on the news.
Arcutis (ARQT) Up on FDA Nod for Zoryve in Seborrheic Dermatitis
by Zacks Equity Research
The FDA approves Arcutis' (ARQT) NDA for Zoryve topical foam 0.3% for treating seborrheic dermatitis in individuals nine years of age and above.
Pfizer (PFE) Stock Rises on FDA Nod for Expanded Use of Padcev
by Zacks Equity Research
The FDA approves Pfizer's (PFE) Padcev in combination with Merck's (MRK) Keytruda for adult patients with advanced bladder cancer. Stock rises 1.6%.
Biogen's (BIIB) Rare Disease Drug Skyclarys Gets CHMP Nod in EU
by Zacks Equity Research
Biogen (BIIB) gets positive CHMP opinion recommending marketing authorization to Skyclarys in the EU for the treatment of Friedreich's ataxia in patients aged 16 years and older.
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%.
Apellis (APLS) Falls on Europe Update for Pegcetacoplan in GA
by Zacks Equity Research
The CHMP may adopt a negative opinion on Apellis' (APLS) intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration in the EU. Stock declines.