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Zacks News
Pfizer's (PFE) COVID-19 Oral Treatment Gets FDA Nod in Adults
by Zacks Equity Research
Per the FDA, Pfizer's (PFE) Paxlovid is the first oral antiviral pill approved in the United States to treat COVID-19 in adults. The drug was granted emergency use authorization by the FDA in 2021.
Regeneron (REGN) Posts Upbeat Data From Multiple Myeloma Study
by Zacks Equity Research
A mid-stage study data shows that treatment with Regeneron's (REGN) experimental antibody achieved a 71% objective response rate in heavily pre-treated multiple myeloma patients.
Apellis' (APLS) Study on Pegcetacoplan to Treat ALS Fails
by Zacks Equity Research
Apellis' (APLS) phase II MERIDIAN study on pegcetacoplan for the treatment of amyotrophic lateral sclerosis fails to meet primary and key secondary endpoints.
Gilead's (GILD) Veklury Gets Positive CHMP View for Extended Use
by Zacks Equity Research
Gilead (GILD) obtains positive opinion for the use of Veklury in COVID-19 patients with severe renal impairment, including those on dialysis, from the European Medicines Agency's CHMP.
Wall Street Analysts See a 210.24% Upside in Allogene Therapeutics (ALLO): Can the Stock Really Move This High?
by Zacks Equity Research
The mean of analysts' price targets for Allogene Therapeutics (ALLO) points to a 210.2% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
PDS Biotech (PDSB) Up 32% on Interim Data From HPV Cancer Study
by Zacks Equity Research
PDS Biotech's (PDSB) shares gain as it announces encouraging interim data from the VERSATILE-002 study for treating HPV16-positive cancer patients.
Immutep (IMMP) Up on Initial Data From Lung Cancer Study
by Zacks Equity Research
Immutep (IMMP) shares surge on encouraging initial data from a triple combination therapy study, INSIGHT-003, for non-small cell lung cancer.
Mirati's (MRTX) Sitravatinib Fails Lung Cancer Study, Stock Down 8%
by Zacks Equity Research
Mirati Therapeutics' (MRTX) phase III study evaluating sitravatinib as a combination therapy in certain NSCLC patients fails to meet its primary endpoint.
Sarepta (SRPT) Down 11% on FDA Extending DMD Gene Therapy Review
by Zacks Equity Research
The FDA extends the review period for Sarepta's (SRPT) BLA for DMD gene therapy by almost four weeks to Jun 22. The agency may limit the use of the therapy in children aged between four and five.
PTC Therapeutics' (PTCT) Rare Disease Drug Fails in Study
by Zacks Equity Research
PTC Therapeutics' (PTCT) vatiquinone did not achieve its primary endpoint in a late-stage study in treating Friedreich Ataxia patients. Shares decline 21% post the news.
Icosavax (ICVX) Up on Positive VLP Vaccine Candidate Data
by Zacks Equity Research
Icosavax (ICVX) surges on positive data from the clinical study of IVX-A12, targeting respiratory syncytial virus and human metapneumovirus in older adults.
INOVIA's (INO) Rare Disease Drug Gets EC's Orphan Tag, Stock Up
by Zacks Equity Research
INOVIA (INO) shares surge 12% in the after-market hours, when its drug for treating a rare respiratory tract disease, INO-3107, receives orphan drug designation from the European Commission.
Immunovant (IMVT) Q4 Earnings Top Estimates, Pipeline in Focus
by Zacks Equity Research
Immunovant (IMVT) reports narrower-than-expected results in fourth-quarter fiscal 2023. Pipeline development is on track. Stock surges 12% on Monday.
Alnylam (ALNY) Reports Positive Results From APOLLO-B Study
by Zacks Equity Research
Alnylam (ALNY) announces positive interim analysis results from the phase III APOLLO-B study of patisiran to treat transthyretin-mediated amyloidosis with cardiomyopathy at the end of 18 months.
Moderna (MRNA) Posts Upbeat Data on Protein Replacement Therapy
by Zacks Equity Research
Interim data from a study shows that Moderna's (MRNA) investigational therapy for propionic acidemia (PA) exhibited early signs of dose-dependent pharmacology and potential clinical benefits.
Reasons to Add Puma (PBYI) Stock to Your Portfolio Right Now
by Zacks Equity Research
Puma Biotechnology (PBYI), a top-ranked stock, has a promising development candidate, alisertib. Its only marketed product, Nerlynx (neratinib), is witnessing improving demand trends in the United States.
Krystal's (KRYS) Dermatology Drug Gets FDA Nod, Stock Up 10%
by Zacks Equity Research
Krystal's (KRYS) stock soars 10% on Friday after the company announces the FDA approval of Vyjuvek for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa.
PDS Biotech (PDSB) Completes Enrollment for HPV Cancer Study
by Zacks Equity Research
PDS Biotech (PDSB) shares gain as it completes patient enrollment in the second arm of the VERSATILE-002 study for treating HPV16-positive cancer patients.
AbbVie's (ABBV) Rinvoq Gets FDA Nod to Treat Crohn's Disease
by Zacks Equity Research
AbbVie (ABBV) announces the seventh FDA approval of its JAK inhibitor, Rinvoq, for the treatment of adults with moderately to severely active Crohn's disease.
PTC Therapeutics' (PTCT) PKU Drug Meets Study Goal, Up 7.6%
by Zacks Equity Research
Data from a late-stage study data shows that treatment with PTC Therapeutics' (PTCT) sepiapterin led to a significant reduction in Phe levels in PKU patients. Post the news, share price rises.
MindMed (MNMD) Up on 50% Enrollment in Anxiety Disorder Study
by Zacks Equity Research
MindMed's (MNMD) mid-stage study, evaluating MM-120 for treating general anxiety disorder, reaches over 50% enrollment mark. Its top-line data is expected in late 2023.
Immutep (IMMP) Surges 65% on Upbeat Lung Cancer Study Data
by Zacks Equity Research
A mid-stage study data shows that Immutep's (IMMP) lead candidate as a combination therapy in first-line NSCLC achieved better-than-expected overall survival results.
Ultragenyx's (RARE) GTX-102 Gets FDA Nod for Uniform Dosing
by Zacks Equity Research
Ultragenyx (RARE) stock climbs 5% after the FDA agrees to a protocol amendment to the phase I/II study of GTX-102 in pediatric patients with Angelman syndrome.
Intercept's (ICPT) Liver Drug Combo Gets FDA's Orphan Drug Tag
by Zacks Equity Research
Intercept's (ICPT) fixed-dose combination of obeticholic acid and bezafibrate for the potential treatment of primary biliary cholangitis gets the FDA's Orphan Drug Designation.
PHIO's Skin Cancer Candidate to Enter Clinical Study, Stock Up
by Zacks Equity Research
PHIO surges on the FDA clearance of investigational new drug application for its lead product, PH-762, for the treatment of skin carcinomas.