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Zacks News
Pfizer (PFE) Posts Positive Data on Bivalent BA.4/5 COVID Jab
by Zacks Equity Research
Pfizer (PFE) and partner BioNTech's Omicron BA.4/BA.5-adapted bivalent COVID vaccine exhibits substantial antibody response above pre-booster levels in adults after seven days of dose administration.
BioMarin (BMRN) Starts Restructuring Moves to Increase Efficiency
by Zacks Equity Research
BioMarin (BMRN) intends to reduce the existing workforce by nearly 4%. The company plans to use the savings in costs and redirect them toward its operating expenses.
BioMarin (BMRN) Refiles BLA With FDA for Hemophilia Gene Therapy
by Zacks Equity Research
If approved, BioMarin's (BMRN) valoctocogene roxaparvovec will be the first gene therapy for hemophilia A in the United States. The FDA filing also incorporates BMRN's responses to the CRL issued to the BLA in 2020.
Sarepta (SRPT) Seeks FDA Nod for DMD Gene Therapy Candidate
by Zacks Equity Research
If approved, Sarepta's (SRPT) SRP-9001 will be the first gene therapy for DMD indication in the United States. The company seeks approval for gene therapy under the accelerated pathway.
EMA Accepts Moderna's (MRNA) Filing for Omicron BA.4, BA.5 Booster
by Zacks Equity Research
The EMA accepts Moderna's (MRNA) regulatory filing seeking authorization for bivalent COVID-19 booster vaccine, mRNA-1273.222, designed to target the Omicron BA.4 and BA.5 subvariants.
Pfizer (PFE), BNTX Seek EU Nod for Omicron Booster in Kids
by Zacks Equity Research
Pfizer (PFE) and BioNTech seek to expand the EU label of their Omicron BA.4/BA.5-adapting bivalent COVID vaccine for children. It is already authorized for use in adolescents and adults.
Morphic Holding, Inc. (MORF) Moves 7.3% Higher: Will This Strength Last?
by Zacks Equity Research
Morphic Holding, Inc. (MORF) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
Vertex (VRTX), CRISPR to Seek FDA Nod for Hemoglobinopathy Therapy
by Zacks Equity Research
Vertex (VRTX) and partner CRISPR intend to start a rolling BLA submission with the FDA for their gene therapy in thalassemia and sickle cell disease indications by November 2022.
Pfizer (PFE) Seeks FDA Approval for Omicron Booster in Kids
by Zacks Equity Research
Pfizer (PFE) and partner BioNTech seek authorization from the FDA for using their bivalent COVID-19 booster vaccine in kids. The vaccine is already authorized for use in adolescents and adults.
Valneva (VALN) Stock Down 66% in the Past 6 Months: Here's Why
by Zacks Equity Research
Valneva's (VALN) COVID-19 vaccine looks promising, but the European Commission's revised advance purchase agreement jeopardizes its COVID-19 vaccine program.
AstraZeneca's (AZN) Ultomiris Gets EC Nod for New Indication
by Zacks Equity Research
AstraZeneca's (AZN) Ultomiris becomes the first and only long-acting C5 inhibitor to be approved for gMG in Europe.
Merck's (MRK) Stock Up on Januvia Patent Win Against Viatris
by Zacks Equity Research
Merck (MRK) gets a favorable ruling from a district court of West Virginia in two patents related to Januvia/Janumet against Viatris, which is looking to market its generic versions of the medicines in the United States
Spero (SPRO) Skyrockets 168% on Licensing Deal With GSK
by Zacks Equity Research
The exclusive licensing agreement with GSK will fund Spero's (SPRO) existing operations and extend its current cash runway beyond 2024.
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.
AstraZeneca (AZN) Gets EU Nod for Evusheld to Treat COVID
by Zacks Equity Research
Following the label expansion approval in the European Union, Evusheld is currently the only long-acting antibody combination available for both prevention and treatment of COVID-19.
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.
AstraZeneca (AZN) Gets CHMP Nod for Evusheld to Treat COVID
by Zacks Equity Research
CHMP recommends authorizing AstraZeneca's (AZN) Evusheld as a COVID-19 treatment and its RSV vaccine, nirsevimab in Europe.
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.
Eloxx (ELOX) Down After Cystic Fibrosis Study Fails to Meet Goal
by Zacks Equity Research
Eloxx Pharmaceuticals' (ELOX) phase II combination study evaluating pipeline candidate ELX-02 in cystic fibrosis fails to achieve statistical significance in efficacy endpoints.
J&J (JNJ) Announces $5B Stock Repurchase Program, Stock Up
by Zacks Equity Research
J&J (JNJ) to buy back $5 billion worth of shares. It also reaffirms its financial guidance for 2022.
Pfizer (PFE) Starts Late-Stage Study on Influenza Vaccine
by Zacks Equity Research
Pfizer (PFE) doses the first participants in the phase III study of its investigational mRNA-based influenza vaccine. The study will enroll nearly 25,000 participants.
Key Factors Driving Merck's (MRK) Outperformance This Year
by Zacks Equity Research
Strong sales of key products like Keytruda and Gardasil, a significant contribution from Lagevrio and positive pipeline/regulatory developments have been keeping Merck's (MRK) stock afloat in 2022.
Clovis (CLVS) Seeks Nod for Rubraca in First Line Ovarian Cancer
by Zacks Equity Research
Clovis (CLVS) files regulatory applications in the United States and Europe seeking label expansion for its sole marketed drug as a first-line maintenance treatment in advanced ovarian cancer.