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Zacks News
PRME Stock Rises 11.8% on Collaboration With Bristol Myers
by Zacks Equity Research
Prime Medicine collaborates with Bristol Myers Squibb for the development of T-cell therapies. Shares gain.
AstraZeneca's Enhertu sBLA Gets FDA Priority Tag for Expanded Use
by Zacks Equity Research
The FDA grants priority review to AZN's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer. A decision is due in first-quarter 2025.
MRNA Begins Dosing in Pivotal Study on Norovirus Vaccine
by Zacks Equity Research
Moderna doses the first participant in a phase III study evaluating its mRNA norovirus vaccine candidate, mRNA-1403, in the United States.
AbbVie Seeks Approval for Lung Cancer Candidate Teliso-V
by Zacks Equity Research
ABBV submits a BLA for Teliso-V to the FDA for treating previously treated non-small cell lung cancer patients with c-Met overexpression.
SAVA Stock Down on Settling Misleading Alzheimer's Study Data Claims
by Zacks Equity Research
Casava stock falls as the company agrees to pay a cumulative fine exceeding $40 million to settle misleading claims charges brought against it by the SEC.
ABBV's Newly Added Parkinson's Disease Drug Meets Second Study Goal
by Zacks Equity Research
Data from a late-stage study shows that AbbVie's tavapadon reduced the burden of Parkinson's disease. The drug previously demonstrated efficacy as adjunctive therapy.
SAGE, BIIB End Collaboration for Neurology Candidate SAGE-324
by Zacks Equity Research
Sage Therapeutics announces discontinuation of the collaboration agreement with Biogen related to SAGE-324 for essential tremor.
Bristol Myers Stock Up on FDA Nod for Schizophrenia Treatment
by Zacks Equity Research
The FDA approves BMY's differentiated schizophrenia treatment for adults and broadens its diverse portfolio. Shares gain.
BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies
by Zacks Equity Research
Biomea stock rises 9% after the FDA lifts clinical hold on two phase I/II studies evaluating the company's lead candidate, BMF-219, for diabetes.
AZN's Tagrisso Gets FDA Nod for Expanded Use in NSCLC
by Zacks Equity Research
The FDA approves AstraZeneca's Tagrisso for treating unresectable, stage III EGFR-mutated non-small cell lung cancer.
Pfizer Withdraws Sickle Cell Disease Therapy Oxbryta From Market
by Zacks Equity Research
PFE's decision is based on clinical data, which suggests that the overall benefit of the drug no longer outweighs the risk in the approved patient population.
CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study
by Zacks Equity Research
Celldex stock falls due to safety concerns related to the treatment of urticaria patients with barzolvolimab in a phase II study, despite robust efficacy data.
Roche's Lupus Study for Gazyva Meets Primary & Key Secondary Goals
by Zacks Equity Research
RHHBY announces meeting primary and key secondary goals in the late-stage study of its lymphoma drug, Gazyva/Gazyvaro, for treating active lupus nephritis.
WVE Stock Soars on Upbeat Efficacy Data From Muscle Disease Study
by Zacks Equity Research
Wave Life Sciences stock soars 53% on positive interim data from a mid-stage study showing superior efficacy of investigational DMD drug, WVE-N531.
CHMP Endorses AstraZeneca's Fasenra in Rare Autoimmune Disease
by Zacks Equity Research
If approved, AZN's Fasenra will be the second biologic approved in the European Union to treat eosinophilic granulomatosis with polyangiitis.
BHVN Stock Up as Rare Neurological Disease Study Meets Primary Goal
by Zacks Equity Research
The pivotal BHV4157-206-RWE study evaluating Biohaven's pipeline candidate, troriluzole, for treating spinocerebellar ataxia meets its primary endpoint.
Here's Why Bausch Health Stock Gained 14.7% in a Week
by Zacks Equity Research
BHC stock rises 14.7% in a week after a report surfaced that the company is in talks with Jefferies Financial Group to push out maturities on some of its debt.
Apellis Stock Down as Eye Drug Faces Third CHMP Rejection in the EU
by Zacks Equity Research
APLS stock falls as the CHMP confirms its June 2024 negative opinion on the regulatory filing for intravitreal pegcetacoplan to treat GA in the EU.
MRK Gets Positive CHMP Nod for Keytruda in Two Gynecologic Cancers
by Zacks Equity Research
The Committee for Medicinal Products for Human Use recommends marketing approval for Merck's Keytruda for treating two types of gynecologic cancers.
Longboard Stock Soars on FDA Designations for Epilepsy Drug
by Zacks Equity Research
The FDA grants orphan drug and rare pediatric disease designations to LBPH's lead pipeline drug for the treatment of Dravet Syndrome.
J&J's Rybrevant Receives FDA Nod for Expanded Use in NSCLC
by Zacks Equity Research
With this approval, JNJ's Rybrevant is now approved for a total of four indications in the United States.
VNDA Stock Down as FDA Rejects NDA for Tradipitant in Gastroparesis
by Zacks Equity Research
The FDA issues a complete response letter to Vanda's new drug application for tradipitant for treating symptoms in gastroparesis.
GSK Meets Study Goal for Co-Administered RSV-Shingles Vaccines
by Zacks Equity Research
Data from a late-stage study shows that co-administering GSK's RSV and Shingles vaccines together was as effective as giving each separately.
EWTX Stock Soars on Upbeat Efficacy Data From Cardiomyopathy Studies
by Zacks Equity Research
Edgewise stock soars on positive data from an early-stage study and Part A of a mid-stage study of EDG-7500 in obstructive hypertrophic cardiomyopathy patients.
APLT Stock Soars 69% on Positive Update on Galactosemia Drug NDA
by Zacks Equity Research
Applied Therapeutics stock surges 69% as the FDA says that no advisory committee meeting is required to discuss the govorestat NDA for classic galactosemia.