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Zacks News
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.
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.
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.
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.
bluebird (BLUE) Down Despite FDA Nod to Gene Therapy for SCD
by Zacks Equity Research
bluebird (BLUE) receives FDA approval for its third gene therapy. However, the label carries a black box warning, on which its shares have slumped.
Will Bristol Myers' (BMY) Efforts to Boost Portfolio be Enough?
by Zacks Equity Research
Shares of Bristol Myers (BMY) have been impacted by pipeline bottlenecks and its key drugs face generic competition. We take a look at the company's efforts to counter these.
Regeneron (REGN) Posts Positive Data on Blood Cancer Candidate
by Zacks Equity Research
Regeneron's (REGN) multiple myeloma candidate demonstrates strong rates and depth of response in pre-treated patients.
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.
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.
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.
Novartis (NVS) Gets FDA Nod for Rare Blood Disorder Drug
by Zacks Equity Research
Novartis (NVS) obtains FDA approval for Fabhalta, the first oral monotherapy for treating adults with PNH.
Roche (RHHBY) Breast Cancer Drug Meets Primary Goal in Phase III
by Zacks Equity Research
Roche's (RHHBY) phase III study evaluating inavolisib in combination with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation achieves its primary goal.
Vanda (VNDA) Rises as FDA Accepts NDA for Gastroparesis Drug
by Zacks Equity Research
The FDA accepts Vanda's (VNDA) new drug application ("NDA") for tradipitant for treating the symptoms of gastroparesis. The company's shares rise in after-hours trading.
AstraZeneca (AZN) to Discontinue Two Studies on Lokelma
by Zacks Equity Research
Owing to increased enrollment timelines and low event rates, AstraZeneca (AZN) plans to stop the STABILIZE-CKD and DIALIZE-Outcomes phase III evidence studies for the hyperkalemia drug Lokelma.
bluebird bio (BLUE) Stock Gains 25.6% in a Month: Here's How
by Zacks Equity Research
bluebird bio (BLUE) rises 25.6% in past thirty days on upbeat earnings results and promising progress with its approved therapies.
Immunovant (IMVT) Up on Positive Initial IMVT-1402 MAD Study Data
by Zacks Equity Research
Immunovant (IMVT) posts encouraging initial results from the 600 mg MAD cohort of its early-stage study on IMVT-1402. Stock rises.
SpringWorks (SWTX) Rises on FDA Nod for Desmoid Tumor Drug
by Zacks Equity Research
The FDA approves SpringWorks' (SWTX) Ogsiveo (nirogacestat) for the treatment of adult patients with desmoid tumors. Shares rise.
Xenon (XENE) Up on Top-Line Data From MDD Drug Phase II Study
by Zacks Equity Research
Xenon (XENE) posts top-line data from a phase II proof-of-concept study evaluating its pipeline candidate, XEN1101, for treating moderate-to-severe major depressive disorder. Stock rises.
TC BioPharm (TCBP) Falls Despite FDA Clearing IND for AML Drug
by Zacks Equity Research
The FDA clears TC BioPharm's (TCBP) investigational new drug application seeking approval to begin a clinical study on its pipeline candidate, TCB008, for treating acute myeloid leukemia. Stock declines.
Entrada (TRDA) Down on FDA Maintaining Clinical Hold on DMD Drug
by Zacks Equity Research
Despite providing additional information, the FDA declines to lift the clinical hold on Entrada's (TRDA) regulatory filing seeking approval to start studies on its DMD drug in the United States.
Biotech Stock Roundup: BMY, TSVT Down on Setback, TRDA, MOR Offer Updates
by Zacks Equity Research
Regulatory setback for Bristol Myers (BMY) and other updates are in focus in the biotech sector.
Entrada Therapeutics, Inc. (TRDA) Surpasses Q3 Earnings and Revenue Estimates
by Zacks Equity Research
Entrada Therapeutics, Inc. (TRDA) delivered earnings and revenue surprises of 285.45% and 168.23%, respectively, for the quarter ended September 2023. Do the numbers hold clues to what lies ahead for the stock?