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Zacks News
GSK's NDA for UTI Drug Gepotidacin Gets FDA's Priority Review
by Zacks Equity Research
The FDA accepts and grants priority review to GSK's NDA for gepotidacin for treating uncomplicated urinary tract infections. A decision is due on March 26, 2025.
SNY Inks Deal With Orano Med for Next-Generation Radioligand Therapies
by Zacks Equity Research
Sanofi inks an agreement with Orano Med to develop next-generation radioligand medicines to treat rare cancers.
Are Medical Stocks Lagging Alnylam Pharmaceuticals (ALNY) This Year?
by Zacks Equity Research
Here is how Alnylam Pharmaceuticals (ALNY) and ANI Pharmaceuticals (ANIP) have performed compared to their sector so far this year.
Alnylam Stock Up on Cardiomyopathy Drug Regulatory Filing in the EU
by Zacks Equity Research
ALNY stock gains after submitting a regulatory application in the EU, seeking the approval of vutrisiran to treat ATTR amyloidosis with cardiomyopathy.
Why Investors Need to Take Advantage of These 2 Medical Stocks Now
by Zacks Equity Research
Finding stocks expected to beat quarterly earnings estimates becomes an easier task with our Zacks Earnings ESP.
IMRX Stock Up on FDA's Orphan Drug Tag for Pancreatic Cancer Drug
by Zacks Equity Research
The FDA bestows an orphan drug designation to Immuneering's lead candidate, IMM-1-104, for the treatment of pancreatic cancer. Shares rise.
MGTX Stock Up on Upbeat Efficacy Data From Parkinson's Disease Study
by Zacks Equity Research
MeiraGTx stock rises 15% as gene therapy candidate betters sham treatment in Parkinson's disease patients.
JAZZ Stock Soars After Combo Therapy Meets Goal in Lung Cancer Study
by Zacks Equity Research
Data from a late-stage study showed that Jazz's Zepzelca, combined with Roche's Tecentriq, improved survival rates in certain patients with small-cell lung cancer.
These 2 Medical Stocks Could Beat Earnings: Why They Should Be on Your Radar
by Zacks Equity Research
Why investors should use the Zacks Earnings ESP tool to help find stocks that are poised to top quarterly earnings estimates.
Will ANI (ANIP) Beat Estimates Again in Its Next Earnings Report?
by Zacks Equity Research
ANI (ANIP) has an impressive earnings surprise history and currently possesses the right combination of the two key ingredients for a likely beat in its next quarterly report.
VNDA Rejects Second Takeover Bid by Cycle Group, Stock Rises
by Zacks Equity Research
Vanda's board of directors unanimously rejects the second takeover proposal from Cycle Group Holdings. Shares rise on the news.
Longboard Set to be Acquired by Lundbeck for $2.6B, Stock Soars 52%
by Zacks Equity Research
LBPH stock soars 52% on announcing that it is set to be acquired by Lundbeck for a total consideration of $2.6 billion to bolster the latter's neuro pipeline.
RPTX Stock Up as Dosing Begins in Solid Tumor Study for Combo Drug
by Zacks Equity Research
Repare stock gains 8% as the company initiates dosing patients in its phase I study of the RP-3467 combo regimen for advanced solid tumor indications.
PTCT Stock Rises on Positive Updates on Friedreich Ataxia Program
by Zacks Equity Research
PTC Therapeutics announces positive results from long-term treatment studies on vatiquinone for the treatment of Friedreich ataxia.
SAGE's Dalzanemdor Fails to Meet Goal in Alzheimer's Disease Study
by Zacks Equity Research
The phase II LIGHTWAVE study evaluating Sage Therapeutics' dalzanemdor for treating cognitive issues due to Alzheimer's disease fails to meet the primary goal.
Wall Street Analysts Predict a 42.98% Upside in ANI (ANIP): Here's What You Should Know
by Zacks Equity Research
The consensus price target hints at a 43% upside potential for ANI (ANIP). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
SLNO Stock Rises on Upbeat Regulatory Update on PWS Drug NDA
by Zacks Equity Research
Soleno stock gains as the FDA says no advisory committee meeting is required for the DCCR NDA at present to treat hyperphagia associated with PWS.
NTLA Begins Phase III Study on Hereditary Angioedema Candidate
by Zacks Equity Research
Intellia starts the pivotal phase III HAELO study on NTLA-2002 for the treatment of hereditary angioedema (HAE).
AstraZeneca Inks Agreement to Boost Cardiovascular Pipeline
by Zacks Equity Research
AZN inks an agreement with CSPC Pharmaceutical to develop a novel lipid-lowering therapy targeting various cardiovascular diseases.
RARE's Bone Disorder Drug Gets FDA's Breakthrough Therapy Tag
by Zacks Equity Research
Ultragenyx announces that the FDA grants Breakthrough Therapy designation to its investigational osteogenesis imperfecta treatment candidate, setrusumab.
SRRK Stock Soars as Muscle Disease Drug Meets Phase III Study Goal
by Zacks Equity Research
Scholar Rock stock skyrockets as the late-stage study of the investigational therapy, apitegromab, to treat spinal muscular atrophy meets the primary goal.
Johnson & Johnson Scraps Phase II Study on Antiviral for Dengue Virus
by Zacks Equity Research
As part of the strategic re-prioritization, JNJ terminates the phase II field study on mosnodenvir for the prevention of the dengue virus.
Sage Therapeutics Stock Down Almost 40% in 3 Months: Here's Why
by Zacks Equity Research
The pipeline setbacks related to SAGE's neurology candidate, SAGE-324, being developed for essential tremor, weigh heavily on the stock.
ONCY Stock Up on Regulatory Update From Breast Cancer Program
by Zacks Equity Research
Oncolytics stock soars as the company seeks an accelerated approval pathway for its lead candidate, pelareorep, to treat a breast cancer indication.
Pacira's Exparel Receives Permanent New Product-Specific J-Code
by Zacks Equity Research
PCRX reports that the CMS has assigned a permanent product-specific J-code for Exparel, which is set to facilitate better insurance coverage for the drug.