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Zacks News
Apellis Stock Down as Eye Drug Faces Third CHMP Rejection in the EU
by Zacks Equity Research
APLS stock falls as the CHMP confirms its June 2024 negative opinion on the regulatory filing for intravitreal pegcetacoplan to treat GA in the EU.
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.
VNDA Stock Down as FDA Rejects NDA for Tradipitant in Gastroparesis
by Zacks Equity Research
The FDA issues a complete response letter to Vanda's new drug application for tradipitant for treating symptoms in gastroparesis.
EWTX Stock Soars on Upbeat Efficacy Data From Cardiomyopathy Studies
by Zacks Equity Research
Edgewise stock soars on positive data from an early-stage study and Part A of a mid-stage study of EDG-7500 in obstructive hypertrophic cardiomyopathy patients.
APLT Stock Soars 69% on Positive Update on Galactosemia Drug NDA
by Zacks Equity Research
Applied Therapeutics stock surges 69% as the FDA says that no advisory committee meeting is required to discuss the govorestat NDA for classic galactosemia.
Merck's Keytruda Obtains its First FDA Approval for Mesothelioma
by Zacks Equity Research
The FDA approves MRK's Keytruda for first-line treatment of malignant pleural mesothelioma. This marks Keytruda's first approval for the given indication.
Zoetis Stock Rises 15% in 3 Months: Time to Add to Your Portfolio?
by Zacks Equity Research
ZTS' innovative pet care products, along with efforts to expand the business, are expected to fuel significant growth in the future.
RCKT Completes Enrollment in Rare Heart Disease Study, Stock Rises
by Zacks Equity Research
Rocket completes enrollment of patients in a pivotal phase II study evaluating RP-A501 for treating male patients with Danon disease.
Zentalis Stock Up as FDA Lifts Partial Hold on Cancer Drug Studies
by Zacks Equity Research
ZNTL stock gains as the FDA lifts clinical hold on studies of its lead candidate, azenosertib, which is being developed for different cancer indications.
Incyte Announces Promising New Data on Oncology Candidate at ESMO
by Zacks Equity Research
INCY's INCB123667 data show the candidate's potential as a differentiated treatment option for cancers with increased cyclin E1 activity, amplification and/or overexpression in cells predictive of CDK2 dependency.
Here's Why Investors Should Invest in Arcturus Stock Now
by Zacks Equity Research
Here, we are discussing some reasons why investing in ARCT stock now may turn out to be a prudent move.
Fulcrum Therapeutics (FULC) Loses -65.58% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
by Zacks Equity Research
The heavy selling pressure might have exhausted for Fulcrum Therapeutics (FULC) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.
IMRX Stock Soars on Upbeat Efficacy Data From Pancreatic Cancer Study
by Zacks Equity Research
Immuneering stock soars 41% as lead drug combo regimen shows superior initial efficacy in the first-line treatment of pancreatic cancer in a mid-stage study.
Gilead Stock Rises as HIV Prevention Injection Meets Study Goals
by Zacks Equity Research
GILD reports the success of its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, in a second late-stage study for the prevention of HIV.
FULC Stock Falls as Muscle Disorder Study Misses Primary Goal
by Zacks Equity Research
The phase III REACH study evaluating Fulcrum's losmapimod for treating facioscapulohumeral muscular dystrophy fails to meet the primary endpoint.
Aura Stock Up as Lead Drug Shows Superior Efficacy in Eye Cancer Study
by Zacks Equity Research
AURA stock up as lead candidate shows tumor control and visual acuity preservation abilities in eye cancer patients over 12 months of treatment.
GSK's HSV Vaccine Study Fails to Meet Primary Efficacy Goal
by Zacks Equity Research
The phase I/II proof-of-concept study evaluating GSK's herpes simplex virus vaccine candidate, GSK3943104, fails to meet the primary efficacy objective.
FDA Grants Orphan Drug Tag to AGIO's Tebapivat for Rare Cancer
by Zacks Equity Research
The FDA bestows an orphan drug designation to Agios' PK activator, tebapivat, for treating myelodysplastic syndromes.
ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down
by Zacks Equity Research
Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.
VRDN Stock Soars as Eye Disorder Study Meets Primary Endpoints
by Zacks Equity Research
The phase III THRIVE study evaluating Viridian's veligrotug for treating active thyroid eye disease meets all primary and secondary endpoints.
Corvus Stock Up on Initiation of Phase III Lymphoma Study on Lead Drug
by Zacks Equity Research
CRVS stock gains 14% on initiating a registrational study on its lead candidate, soquelitinib, to treat relapsed/refractory peripheral T-cell lymphoma.
Xencor Stock Gains 23% on Encouraging Pipeline Advancements
by Zacks Equity Research
XNCR moves four new XmAb drug development programs for autoimmune diseases. It also provided favorable updates for two of its oncology drug candidates.
Summit Hits Record High on Lung Cancer Drug Topping Merck's Keytruda
by Zacks Equity Research
Data from a late-stage study shows that SMMT's experimental antibody beat Keytruda in a head-to-head setting in treating certain patients with NSCLC.
RZLT Stock Up as FDA Lifts Clinical Holds on Rare Disease Study
by Zacks Equity Research
The FDA removes the partial clinical holds on Rezolute's phase III study evaluating RZ358 for treating congenital hyperinsulinism.
Rocket Stock Down More Than 30% in Past Six Months: Here's Why
by Zacks Equity Research
The recent regulatory setbacks related to RCKT's pipeline candidate, Kresladi (marnetegragene autotemcel) weigh heavily on the stock.