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Zacks News
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.
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.
Amgen's (AMGN) Tarlatamab BLA Gets FDA Priority Tag for SCLC
by Zacks Equity Research
Amgen's (AMGN) BLA for tarlatamab to treat advanced small cell lung cancer gets FDA's priority review. A decision is expected on Jun 12, 2024.
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%.
C4 Therapeutics (CCCC) Soars on Oncology Deal With Merck
by Zacks Equity Research
C4 Therapeutics (CCCC) inks an agreement with Merck to discover and develop degrader-antibody conjugates with a focus on one oncology target. Shares rise on the same.
Candel (CADL) Rises on FDA's Fast Track Status for CAN-2409
by Zacks Equity Research
The FDA gives Fast Track designation to Candel's (CADL) lead candidate, CAN-2409 plus prodrug (valacyclovir), for the treatment of patients with pancreatic cancer.
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.
Sanofi (SNY) Terminates Pompe Disease Deal as FTC Objects
by Zacks Equity Research
Sanofi (SNY) decides to end the licensing deal with Maze Therapeutics for MZE001, a phase II ready oral tablet for Pompe disease, due to the FTC's decision to block the deal.
GSK's Jemperli Gets EU Nod for Endometrial Cancer Expanded Use
by Zacks Equity Research
GSK's Jemperli combo receives the European Commission's marketing authorization as a frontline treatment for certain types of primary advanced/recurrent endometrial cancer.
Pfizer's (PFE) Multiple Myeloma Drug Elrexfio Gets Nod in EU
by Zacks Equity Research
Pfizer's (PFE) targeted immunotherapy, Elrexfio, for treating heavily pretreated adults with relapsed/refractory multiple myeloma gets EC's conditional marketing authorization.
Merck's (MRK) Keytruda, Lenvima Endometrial Cancer Study Fails
by Zacks Equity Research
The combination of Merck's (MRK) Keytruda and Eisai's Lenvima for the first-line treatment of advanced/recurrent endometrial carcinoma fails to meet dual primary endpoints in late-stage study.
CRISPR (CRSP), Vertex Fall Despite FDA Nod to SCD Drug Casgevy
by Zacks Equity Research
CRISPR (CRSP) and Vertex announce the FDA approval of the first-ever CRISPR-based gene-editing therapy, Casgevy, for the treatment of sickle cell disease.
Snap These 4 Top-Performing Liquid Stocks for Strong Returns
by Vaishali Doshi
Here are four top-ranked liquid stocks, Puma Biotechnology (PBYI), Amphastar Pharmaceuticals (AMPH), DropBox (DBX) and GigaCloud Technology Inc. (GCT), which investors can add to their portfolio for solid gains.
Kymera (KYMR) Rises as Dosing Begins in AD Study on KT-474
by Zacks Equity Research
Kymera (KYMR) receives a $15 million milestone payment from Sanofi as dosing begins in a phase II study evaluating KT-474 for treating atopic dermatitis. Shares rise on the same.
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%.
Syros (SYRS) Rises on Upbeat Initial Study Data on Tamibarotene
by Zacks Equity Research
Syros (SYRS) posts encouraging initial data from the phase II SELECT-AML-1 study evaluating tamibarotene in combination with venetoclax and azacitidine to treat acute myeloid leukemia.
Journey Medical (DERM) Up on Update for Skin Disease Candidate
by Zacks Equity Research
Journey Medical (DERM) plans to submit a new drug application (NDA) to the FDA for DFD-29 to treat rosacea in adults by 2023-end. Stock rises.
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.
Travere (TVTX) Up on Latest Portfolio Updates & Reorganization
by Zacks Equity Research
Travere (TVTX) to submit an sNDA to the FDA to convert the accelerated approval for Filspari to full approval for IgAN in first-quarter 2024. The company is implementing a strategic reorganization to cut costs. Stock rises.
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?
J&J (JNJ) Announces 2024 and Long-Term Financial Outlook
by Zacks Equity Research
J&J (JNJ) expects operational sales growth in the range of 5-6% in 2024, driven by both its Innovative Medicine and MedTech divisions.
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.