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Zacks News
Alnylam Wins EC Nod for Label Expansion of Amvuttra for ATTR-CM
by Zacks Equity Research
ALNY gains approval to expand Amvuttra's label in the EU, boosting its position as the only RNAi therapy for ATTR-CM.
KURA Stock Rises More Than 15% This Past Week: Here's Why
by Zacks Equity Research
Kura Oncology shares rise this week after the FDA accepts its NDA for ziftomenib, a potential first-in-class treatment for NPM1-mutant AML.
TPST Stock Up on EMA's Orphan Drug Tag for Liver Cancer Therapy
by Zacks Equity Research
Tempest jumps after EMA grants orphan drug status to its liver cancer candidate, amezalpat, based on positive study data.
Zoetis Stock Rises 13% in a Month: Time to Add to Your Portfolio?
by Zacks Equity Research
ZTS jumps 13% in a month as strong new product sales, strategic deals, and rising earnings estimates boost investor confidence.
Lyra Stock Soars 356% in a Week on Strong Rhinosinusitis Study Success
by Zacks Equity Research
LYRA skyrockets 356% after its lead nasal implant, LYR-210, meets key goals in a pivotal phase III chronic rhinosinusitis study.
JNJ's Combo Therapy Shows Strong Phase III Efficacy in Prostate Cancer
by Zacks Equity Research
Johnson & Johnson's niraparib combo significantly delays prostate cancer progression in HRR-altered patients with strong phase III data.
SNY's Rilzabrutinib Wins 4th Orphan Drug Tag for Sickle Cell Disease
by Zacks Equity Research
Sanofi's rilzabrutinib earns its fourth orphan drug status from the FDA, this time targeting sickle cell disease.
Kymera Stock Gains on Positive Data on Investigational Dermatitis Drug
by Zacks Equity Research
KYMR jumps after KT-621 phase I data beats expectations, matching or topping Dupixent on key biomarkers in Th2 diseases.
Amgen's Imdelltra Cuts Lung Cancer Death Risk by 40% in Phase III
by Zacks Equity Research
AMGN's Imdelltra slashes lung cancer death risk by 40% in Phase III, extending survival by over five months compared to chemotherapy.
MRK's ADC Drug Combo Shows Antitumor Activity in Lymphoma Study
by Zacks Equity Research
Merck reports promising response rates for its ADC zilovertamab vedotin in relapsed DLBCL and KRAS inhibitor MK-1084 in solid tumors.
NTLA Stock Down as Patient Faces Adverse Event in Gene Therapy Study
by Zacks Equity Research
Intellia stock tanks after a patient in its phase III study evaluating gene therapy candidate nex-z in ATTR-CM experiences serious liver enzyme elevation.
IMVT Q4 Loss Narrower Than Expected, Stock Up, Pipeline in Focus
by Zacks Equity Research
Immunovant stock rises on encouraging fourth-quarter fiscal 2025 results. It is on track to initiate 10 studies on IMVT-1402 across various autoimmune indications.
BMY's Opdivo SC Gets EU Nod for Multiple Solid Tumor Indications
by Zacks Equity Research
Bristol Myers' Opdivo SC wins EU approval as the first PD-1 inhibitor for subcutaneous use across multiple solid tumor indications.
CADL Up as FDA Grants RMAT Status to CAN-2409 in Prostate Cancer
by Zacks Equity Research
Candel stock rises as FDA grants RMAT tag to CAN-2409 after phase III success in prostate cancer. BLA submission is planned at the end of 2026.
RCKT Stock Tanks on Patient Death in Danon Disease Study
by Zacks Equity Research
Rocket Pharmaceuticals plunges after a patient death in its Danon disease study, prompting a voluntary dosing pause. The FDA puts a clinical hold on the study.
TEVA Begins IND-Enabling Studies on Inflammatory Disease Candidate
by Zacks Equity Research
TEVA starts IND-enabling studies for BD9, a dual-targeting multibody for asthma and eczema. Shares rise on the news.
VSTM Stock Soars 22% in a Month on Ovarian Cancer Combo Drug Approval
by Zacks Equity Research
Verastem Oncology jumps 22% on FDA nod for Avmapki Fakzynja, the first approved KRAS-mutant LGSOC therapy, with strong early data in a pancreatic cancer study.
AZN Gets CHMP Nod for Imfinzi in Muscle-Invasive Bladder Cancer
by Zacks Equity Research
AstraZeneca wins CHMP nod for Imfinzi combo in muscle-invasive bladder cancer, based on data from the phase III NIAGARA study.
GSK Gets CHMP Nod for Blenrep Combos in Multiple Myeloma
by Zacks Equity Research
GSK wins CHMP nod for Blenrep combos in relapsed or refractory multiple myeloma. A decision in the EU is expected in the third quarter of 2025.
SpringWorks Gets CHMP Nod for Mirdametinib in Rare Disease
by Zacks Equity Research
SWTX wins CHMP backing for mirdametinib in NF1-PN. EU nod is expected in the third quarter of 2025.
ETFs to Capitalize on the Novo Nordisk-Septerna Deal
by Sweta Killa
Novo Nordisk announces a $2.2 billion deal with Septerna to tap the growing obesity treatment market.
Lexicon Pharmaceuticals (LXRX) Reports Q1 Loss, Lags Revenue Estimates
by Zacks Equity Research
Lexicon (LXRX) delivered earnings and revenue surprises of 30% and 23.52%, respectively, for the quarter ended March 2025. Do the numbers hold clues to what lies ahead for the stock?
Agenus (AGEN) Reports Q1 Loss, Tops Revenue Estimates
by Zacks Equity Research
Agenus (AGEN) delivered earnings and revenue surprises of 36.02% and 14.73%, respectively, for the quarter ended March 2025. Do the numbers hold clues to what lies ahead for the stock?
Femasys Inc. (FEMY) Reports Q1 Loss, Misses Revenue Estimates
by Zacks Equity Research
Femasys (FEMY) delivered earnings and revenue surprises of -35.29% and 77.27%, respectively, for the quarter ended March 2025. Do the numbers hold clues to what lies ahead for the stock?
LXRX Stock Moves Up 30% in a Week: What is Driving This Rally?
by Zacks Equity Research
The upside comes after Lexicon lands a deal worth $1 billion for its experimental obesity drug with Novo Nordisk.