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Zacks News
RARE's Wilson Disease Candidate Betters Standard Therapy in Study
by Zacks Equity Research
Ultragenyx reports superior efficacy of UX701 for Wilson disease compared with standard therapy from the Stage 1 cohorts of its pivotal phase I/II/III study.
Zevra Stock Surges Close to 70% in 3 Months: Here's Why
by Zacks Equity Research
The FDA approval for ZVRA's Miplyffa (arimoclomol) capsules in September for treating Niemann-Pick disease type C drives the stock.
GILD Grants Right for HIV PrEP Candidate to Six Generic Companies
by Zacks Equity Research
Gilead signs non-exclusive, royalty-free voluntary licensing agreements with six generic companies to market its investigational medicine, lenacapavir, for HIV Prevention.
AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded Use
by Zacks Equity Research
The FDA grants priority review to AZN's sNDA for Calquence for untreated mantle cell lymphoma. A decision is expected in first-quarter 2025.
STTK Discontinues Cancer Program, Plans Workforce Cut, Stock Falls
by Zacks Equity Research
Shattuck stock plunges as it discontinues the clinical development of SL-172154 for two blood cancer indications and plans to reduce the workforce by 40%.
IONS' Rare Neurology Disorder Candidate Gets FDA's Fast Track Tag
by Zacks Equity Research
The FDA bestows a Fast Track designation to Ionis' investigational candidate, zilganersen, for treating a rare neurological disorder called Alexander disease.
Here's Why Investors Should Consider Buying Corcept Stock Now
by Zacks Equity Research
Here, we are discussing some reasons why investing in CORT stock now may turn out to be a prudent move.
AstraZeneca's Enhertu sBLA Gets FDA Priority Tag for Expanded Use
by Zacks Equity Research
The FDA grants priority review to AZN's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer. A decision is due in first-quarter 2025.
MRNA Begins Dosing in Pivotal Study on Norovirus Vaccine
by Zacks Equity Research
Moderna doses the first participant in a phase III study evaluating its mRNA norovirus vaccine candidate, mRNA-1403, in the United States.
AbbVie Seeks Approval for Lung Cancer Candidate Teliso-V
by Zacks Equity Research
ABBV submits a BLA for Teliso-V to the FDA for treating previously treated non-small cell lung cancer patients with c-Met overexpression.
SAVA Stock Down on Settling Misleading Alzheimer's Study Data Claims
by Zacks Equity Research
Casava stock falls as the company agrees to pay a cumulative fine exceeding $40 million to settle misleading claims charges brought against it by the SEC.
Are Investors Undervaluing ANI Pharmaceuticals (ANIP) Right Now?
by Zacks Equity Research
Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.
BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies
by Zacks Equity Research
Biomea stock rises 9% after the FDA lifts clinical hold on two phase I/II studies evaluating the company's lead candidate, BMF-219, for diabetes.
MRK's Keytruda Combo Fails in Phase III Colorectal Cancer Study
by Zacks Equity Research
The phase III KEYFORM-007 study, evaluating Merck's Keytruda plus favezelimab for treating metastatic colorectal cancer, fails to meet the primary endpoint.
AZN's Tagrisso Gets FDA Nod for Expanded Use in NSCLC
by Zacks Equity Research
The FDA approves AstraZeneca's Tagrisso for treating unresectable, stage III EGFR-mutated non-small cell lung cancer.
CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study
by Zacks Equity Research
Celldex stock falls due to safety concerns related to the treatment of urticaria patients with barzolvolimab in a phase II study, despite robust efficacy data.
Roche's Lupus Study for Gazyva Meets Primary & Key Secondary Goals
by Zacks Equity Research
RHHBY announces meeting primary and key secondary goals in the late-stage study of its lymphoma drug, Gazyva/Gazyvaro, for treating active lupus nephritis.
Biogen's Lupus Candidate Meets Key Goals in Phase III Study
by Zacks Equity Research
The phase III PHOENYCS GO study evaluating BIIB and UCB's drug candidate, dapirolizumab pegol, for treating systemic lupus erythematosus meets the primary endpoint.
WVE Stock Soars on Upbeat Efficacy Data From Muscle Disease Study
by Zacks Equity Research
Wave Life Sciences stock soars 53% on positive interim data from a mid-stage study showing superior efficacy of investigational DMD drug, WVE-N531.
BHVN Stock Up as Rare Neurological Disease Study Meets Primary Goal
by Zacks Equity Research
The pivotal BHV4157-206-RWE study evaluating Biohaven's pipeline candidate, troriluzole, for treating spinocerebellar ataxia meets its primary endpoint.
MRK Gets Positive CHMP Nod for Keytruda in Two Gynecologic Cancers
by Zacks Equity Research
The Committee for Medicinal Products for Human Use recommends marketing approval for Merck's Keytruda for treating two types of gynecologic cancers.
Are Medical Stocks Lagging Argenx (ARGX) This Year?
by Zacks Equity Research
Here is how argenex SE (ARGX) and ANI Pharmaceuticals (ANIP) have performed compared to their sector so far this year.
Should Value Investors Buy ANI Pharmaceuticals (ANIP) Stock?
by Zacks Equity Research
Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.
Compared to Estimates, ANI (ANIP) Q2 Earnings: A Look at Key Metrics
by Zacks Equity Research
The headline numbers for ANI (ANIP) give insight into how the company performed in the quarter ended June 2024, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.
ANI Pharmaceuticals (ANIP) Tops Q2 Earnings and Revenue Estimates
by Zacks Equity Research
ANI (ANIP) delivered earnings and revenue surprises of 9.68% and 8.16%, respectively, for the quarter ended June 2024. Do the numbers hold clues to what lies ahead for the stock?