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Zacks News
Magenta (MGTA) Down on Pipeline Update for Leukemia Drug
by Zacks Equity Research
Magenta Therapeutics (MGTA) stops dosing participants in a phase I/II study cohort, evaluating its blood cancer pipeline candidate due to dose-limiting toxicities.
LianBio (LIAN) Up After Pfizer Opts in Rights to RSV Drug in China
by Zacks Equity Research
As a result of Pfizer's (PFE) opt-in for LianBio's (LIAN) rights to develop RSV therapeutic candidate sisunatovir in Greater China, the latter is eligible to receive potential royalties and milestone payments.
AstraZeneca (AZN) Gets EU Nod & CHMP Opinions for Some Drugs
by Zacks Equity Research
The CHMP recommends approvals for expanded use of AstraZeneca's (AZN) Enhertu in breast cancer, Imfinzi plus Imjudo in lung and liver cancers and Forxiga in heart failure.
Moderna's (MRNA) BA.1 Omicron Booster Gets CHMP Nod for Kids
by Zacks Equity Research
The CHMP recommends authorizing Moderna's (MRNA) bivalent COVID-19 booster vaccine, targeting the Omicron BA.1 subvariant, for young children aged between six and 11 years.
Wave Life Sciences (WVE) Up 26% on Collaboration With GSK
by Zacks Equity Research
Wave Lifesciences (WVE) signs a four-year research collaboration with GSK to advance discovery and development of oligonucleotide therapeutics focusing on novel genetic targets
Eli Lilly (LLY) 2023 Guidance Falls Short, Stock Declines
by Zacks Equity Research
Eli Lilly's (LLY) 2023 EPS guidance falls short of the Zacks Consensus Estimates and our model estimates. The company plans to launch four new drugs next year.
Moderna (MRNA) Up 20% on Upbeat Data From Cancer Jab Study
by Zacks Equity Research
Data from a mid-stage study showed that Moderna's (MRNA) personalized cancer vaccine candidate combined with Merck's Keytruda reduces the risk of recurrence/death by 44% in melanoma patients.
Vertex (VRTX) to Start Clinical Study on mRNA-based CF Therapy
by Zacks Equity Research
Following clearance of the IND application by the FDA, Vertex (VRTX) intends to start a clinical study evaluating a single ascending dose of VX-522 in cystic fibrosis patients in the coming weeks.
Alnylam (ALNY) Seeks to Expand Onpattro Label in Cardiomyopathy
by Zacks Equity Research
Alnylam (ALNY) initiates label expansion filing with FDA for Onpattro to treat cardiomyopathy in patients suffering from ATTR-amyloidosis. The drug is already approved to treat polyneuropathy in such patients.
Emergent (EBS) OTC Narcan Filing Gets FDA Priority Review Tag
by Zacks Equity Research
The FDA grants priority review to Emergent's regulatory filing seeking approval for an OTC version of its Narcan nasal spray. A final decision is expected by March 2023-end.
Oncolytics (ONCY) Up on Lead Drug Securing 2nd FDA Fast Track Tag
by Zacks Equity Research
Oncolytics Biotech (ONCY) receives a fast-track designation from the FDA for pelareorep combined with Roche's Tecentriq in advanced/metastatic pancreatic cancer indication.
Valneva (VALN) Up on 6-Month Lyme Disease Jab Persistence Data
by Zacks Equity Research
Persistence data from a mid-stage study showed that Valneva's (VALN) Lyme disease vaccine elicited antibody levels which remained above baseline six months after completing dose administration in children and adults.
New Strong Buy Stocks for November 28th
by Zacks Equity Research
KMDA, SLCA and FTNT have been added to the Zacks Rank #1 (Strong Buy) List on November 28, 2022.
Kamada (KMDA) Q3 Earnings and Revenues Top Estimates
by Zacks Equity Research
Kamada (KMDA) delivered earnings and revenue surprises of 433.33% and 8.26%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
Aridis Pharmaceuticals (ARDS) Reports Q3 Loss, Misses Revenue Estimates
by Zacks Equity Research
Aridis Pharmaceuticals (ARDS) delivered earnings and revenue surprises of -4,100% and 96.44%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
Syros Pharmaceuticals, Inc. (SYRS) Reports Q3 Loss, Misses Revenue Estimates
by Zacks Equity Research
Syros Pharmaceuticals, Inc. (SYRS) delivered earnings and revenue surprises of 38.36% and 21.65%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
Science 37 Holdings, Inc. (SNCE) Reports Q3 Loss, Misses Revenue Estimates
by Zacks Equity Research
Science 37 Holdings, Inc. (SNCE) delivered earnings and revenue surprises of 5.88% and 21.12%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
IDEAYA Biosciences, Inc. (IDYA) Q3 Earnings and Revenues Beat Estimates
by Zacks Equity Research
IDEAYA Biosciences, Inc. (IDYA) delivered earnings and revenue surprises of 106.15% and 271.24%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
J&J (JNJ) Beats on Q3 Earnings, Cuts 2022 Sales View on Fx Woes
by Zacks Equity Research
J&J (JNJ) beats estimates for third-quarter earnings as well as sales. It lowers the full-year sales guidance. Stock up
Vertex Pharmaceuticals' (VRTX) New AAT Corrector Enters Clinic
by Zacks Equity Research
The FDA clears Vertex's (VRTX) Investigational New Drug application for VX-634, a small molecule AAT corrector, thereby allowing the company to initiate a first-in-human clinical study in healthy volunteers.
Eli Lilly (LLY) Gets FDA Nod for RET Inhibitor in Solid Tumors
by Zacks Equity Research
The FDA grants approval to Lilly's (LLY) Retevmo in advanced or metastatic solid tumors with a RET gene fusion. It converts the drug's accelerated approval in NSCLC indication to full approval.
AbbVie (ABBV) Gets CHMP Nod for Skyrizi in a Third Indication
by Zacks Equity Research
The CHMP recommends authorizing AbbVie's (SNY) Skyrizi as a treatment for Crohn's disease. The drug is approved for treating plaque psoriasis and psoriatic arthritis indications.
Sanofi (SNY) Gets CHMP Nod for Enjaymo in Hemolytic Anemia
by Zacks Equity Research
The CHMP recommends authorizing Sanofi's (SNY) Enjaymo as a treatment for hemolytic anemia in patients with cold agglutinin disease (CAD). The CHMP endorses SNY's RSV vaccine for use in infants.
Merck's (MRK) Pneumococcal Jab Gets CHMP Endorsement for Kids
by Zacks Equity Research
The EMA's CHMP recommends approving Merck's (MRK) pneumococcal 15-valent conjugate vaccine for expanded use in infants and children. The vaccine received similar approval from the FDA in June 2022.
Pfizer's (PFE) Late-Stage Meningococcal Jab Study Meets Goal
by Zacks Equity Research
Based on positive top-line data from phase III on its pentavalent meningococcal vaccine, Pfizer (PFE) intends to submit a regulatory application to the FDA seeking approval by year-end.