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Zacks News
Immunome (IMNM) COVID-19 Cocktail Hold Lifted, Shares Gain
by Zacks Equity Research
Immunome (IMNM) gains as FDA lifts clinical hold on its Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01) for the treatment of COVID-19.
Novartis (NVS) Announces Data on Zolgensma, Acquires Coalesce
by Zacks Equity Research
Novartis (NVS) reports positive data on SMA treatment from a phase III study. It also acquires Coalesce Product Development Limited to strengthen its respiratory and complex generics business.
AbbVie (ABBV) Inks Deal for Neuropsychiatric Conditions
by Zacks Equity Research
AbbVie (ABBV) forges an alliance with Gedeon Richter to develop novel treatments for neuropsychiatric diseases. Both collaborated in the past too on the blockbuster schizophrenia drug Vraylar.
Emergent (EBS) Begins Dosing in Phase I Cyanide Poisoning Study
by Zacks Equity Research
Emergent (EBS) initiates dosing in a phase I study evaluating stabilized isoamyl nitrite, the company's investigational single-use intranasal spray for treating acute cyanide poisoning.
Why is Viatris (VTRS) Stock Down 25% in the Year So Far?
by Zacks Equity Research
Viatris (VTRS) stock drops 25% in the year so far as investors do not seem to be impressed by the impending sale of its biosimilar business.
Moderna (MRNA) Starts Omicron-Specific Bivalent Booster Study
by Zacks Equity Research
Moderna (MRNA) administers the first dose in the phase II study of its Omicron-specific bivalent booster candidate (mRNA-1273.214). It expects to enrol 375 subjects for the same in the United States.
Denali (DNLI) Begins Frontotemporal Dementia-Granulin Study
by Zacks Equity Research
Denali (DNLI) starts an early-stage study of DNL593 for treating frontotemporal dementia (FTD) due to mutations in the granulin gene (GRN) in collaboration with Takeda.
Acadia (ACAD) Stock Up on FDA's Action Date for Nuplazid sNDA
by Zacks Equity Research
Acadia (ACAD) gets an action date of Aug 4, 2022, from the FDA for its resubmitted sNDA for pimavanserin to treat hallucinations and delusions associated with Alzheimer's disease psychosis.
Catalyst (CPRX) Skyrockets 110% Over a Year: Here's Why
by Zacks Equity Research
Catalyst's (CPRX) stock price has more than doubled in the past year, driven by its sole marketed drug, Firdapse, approved for the treatment of Lambert-Eaton Myasthenic Syndrome in adults.
Pfizer (PFE) Begins Pediatric Study on COVID Pill Paxlovid
by Zacks Equity Research
Pfizer's (PFE) Paxlovid is the first oral antiviral pill to be studied in a pediatric clinical study.
Intellia's (NTLA) NTLA-5001 Gets FDA Orphan Drug Tag for AML
by Zacks Equity Research
Intellia's (NTLA) investigational gene-editing therapy, NTLA-5001, gets an Orphan Drug tag from the FDA for AML.
Voyager (VYGR) Gains on Deal With Novartis for Gene Therapies
by Zacks Equity Research
Voyager (VYGR) stock rises on the license option agreement with Novartis to get a target-specific access to next-generation TRACER AAV capsids for gene therapy programs.
BioNTech (BNTX), Regeneron Expand Agreement for Lung Cancer Study
by Zacks Equity Research
BioNTech (BNTX) expands its strategic collaboration deal with Regeneron to evaluate the combo of BNT116 plus Libtayo for treating advanced non-small cell lung cancer.
Gilead's (GILD) Trodelvy Late-Line Breast Cancer Study Meets Goal
by Zacks Equity Research
While Gilead's (GILD) phase III study evaluating Trodelvy in late-line HR+/HER- breast cancer did achieve its primary endpoint, the lack of numerical data puts ambiguity on the significance of results.
Horizon's (HZNP) sBLA for Krystexxa Gets FDA Priority Review
by Zacks Equity Research
The FDA grants priority review to Horizon's (HZNP) sBLA for Krystexxa plus methotrexate to treat people living with uncontrolled gout. A decision is due on Jul 7, 2022.
AbbVie (ABBV) Outperforms Industry This Year So Far: What Next?
by Zacks Equity Research
AbbVie (ABBV) has several new drugs with the potential to drive revenues once Humira loses U.S. exclusivity in 2023. Its early and mid-stage pipeline has several candidates with blockbuster potential.
bluebird (BLUE) Posts Q4 Loss, Hit by Regulatory Pipeline Woes
by Zacks Equity Research
bluebird (BLUE) reports in-line fourth-quarter 2021 earnings but misses on revenues. The FDA placing clinical holds on BLUE's pipeline candidates does not augur well for the stock.
FDA Nods to Bristol Myers' (BMY) Opdivo for Additional Indication
by Zacks Equity Research
Bristol Myers' (BMY) immuno-oncology Opdivo gets FDA nod for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting in combination with platinum-doublet chemotherapy.
5 Market-Beating Stocks Backed by Women Power
by Sweta Killa
Occidental Petroleum (OXY), Northrop (NOC), Hershey (HSY), Commercial Metals (CMC) and Vertex Pharma (VRTX) are among the stocks that are outperforming the market this year and are headed by female CEOs.
Merck (MRK) Outperforms Industry, What's in Store for 2022?
by Zacks Equity Research
Strong sales of key products like Keytruda and Gardasil, a significant contribution from molnupiravir and positive pipeline/regulatory developments can keep Merck's (MRK) stock afloat in 2022.
Puma Biotech (PBYI) Q4 Earnings Beat Mark, Revenues Rise Y/Y
by Zacks Equity Research
Puma Biotechnology (PBYI) beats on earnings and sales for the fourth quarter of 2021. PBYI???s shares increase in after-market trading session following the news.
Intercept (ICPT) Q4 Earnings & Sales Beat, Ocaliva in Focus
by Zacks Equity Research
Intercept (ICPT) posts a narrower loss in the fourth quarter and sales beat estimates.
Kodiak (KOD) Down More Than 80% in Past 3 Months: Here's Why
by Zacks Equity Research
Kodiak Sciences (KOD) is developing its lead candidate, KSI-301, for treating various retinal vascular diseases. The recent setback for KSI-301 has hurt the stock.
ChemoCentryx (CCXI) Q4 Earnings and Sales Miss Estimates
by Zacks Equity Research
ChemoCentryx (CCXI) posts a wider year-over-year loss in the fourth quarter and sales miss estimates. Lead drug Tavneos has been launched in the United States.
Horizon (HZNP) Q4 Earnings Beat Estimates, Revenues Rise Y/Y
by Zacks Equity Research
Horizon's (HZNP) revenues beat estimates in the fourth quarter of 2021. Shares rise following the results.