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Zacks News
FDA Grants Three Fast Track Tags to Allogene's Autoimmune Disease Drug
by Zacks Equity Research
The FDA's fast track designations will facilitate rapid development and expedited review of ALLO's autoimmune disease candidate.
SRPT Stock Down After EMA Places Clinical Hold on DMD Gene Therapy
by Zacks Equity Research
The EMA pauses all clinical studies of Sarepta and Roche's Elevidys following the reported death of a treated patient
BMRN's PKU Drug Palynziq Meets Goal in Late-Stage Pediatric Study
by Zacks Equity Research
Based on the late-stage data, BioMarin plans to submit a regulatory filing for expanding the label of its PKU drug Palynziq in adolescents before this year's end.
CORT Shares Rise as Relacorilant Combo Meets Ovarian Cancer Study Goal
by Zacks Equity Research
The ROSELLA study evaluating Corcept's relacorilant plus nab-paclitaxel for treating patients with platinum-resistant ovarian cancer meets the primary endpoint.
FDA Accepts Merck's Filing for Subcutaneous Version of Keytruda
by Zacks Equity Research
The filing is based on late-stage data, which shows that treatment with the subcutaneous version of MRK's Keytruda is at least as effective as the IV version.
GSK Secures FDA Nod for Oral Antibiotic to Treat Urinary Tract Infection
by Zacks Equity Research
The FDA approval is based on late-stage data, which shows that GSK's Blujepa is at least as effective as a leading standard treatment for uncomplicated UTIs.
FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib (Revised)
by Zacks Equity Research
If approved, SNY's tolebrutinib will be the first therapy to target smoldering neuroinflammation, a key driver of disability accumulation in multiple sclerosis.
FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib
by Zacks Equity Research
If approved, SNY's tolebrutinib will be the first therapy to target smoldering neuroinflammation, a key driver of disability accumulation in multiple sclerosis.
Elevation Oncology Plunges 42% on Ending Development of Lead Drug
by Zacks Equity Research
ELEV decides to stop developing its lead drug after disappointing data from an early-stage study evaluating its sole clinical-stage drug in gastric cancers.
Akebia Stock Drops 28% on Pricing of $50M Common Stock Offering
by Zacks Equity Research
AKBA's shares fell after announcing the pricing of its secondary issue of shares, which were at a discount to the previous closing price.
SRPT Nosedives 27% on Patient Death Following DMD Therapy Infusion
by Zacks Equity Research
Despite the reported death, Sarepta maintains that its gene therapy has a favorable 'benefit-risk profile.'
Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority Review
by Zacks Equity Research
The FDA accepts and grants priority review to BAYRY's sNDA for Kerendia to treat patients with a common form of heart failure.
AMGN Posts Upbeat Data on Uplizna From Myasthenia Gravis Study
by Zacks Equity Research
New late-stage study data shows that treatment with Amgen's Uplizna for a year improves disease symptoms in patients with generalized myasthenia gravis.
Allogene's Q4 Loss Narrower Than Expected, Revenues Nil
by Zacks Equity Research
ALLO's fourth-quarter earnings beat estimates. Devoid of marketed products, the company records no sales in the quarter.
CytomX Therapeutics (CTMX) Upgraded to Strong Buy: Here's What You Should Know
by Zacks Equity Research
CytomX Therapeutics (CTMX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).
CytomX Therapeutics (CTMX) Tops Q4 Earnings and Revenue Estimates
by Zacks Equity Research
CytomX Therapeutics (CTMX) delivered earnings and revenue surprises of 210% and 89.28%, respectively, for the quarter ended December 2024. Do the numbers hold clues to what lies ahead for the stock?
Acadia Pharmaceuticals (ACAD) Q4 Earnings Lag Estimates (Revised)
by Zacks Equity Research
Acadia (ACAD) delivered earnings and revenue surprises of -10.53% and 1.79%, respectively, for the quarter ended December 2024. Do the numbers hold clues to what lies ahead for the stock?
CytomX Gears Up to Report Q4 Earnings: What Should Investors Expect?
by Zacks Equity Research
On CTMX's fourth-quarter 2024 earnings call, investors can expect updates regarding the developmental programs for its clinical-stage candidates.
Acadia Pharmaceuticals (ACAD) Q4 Earnings Lag Estimates
by Zacks Equity Research
Acadia (ACAD) delivered earnings and revenue surprises of -10.53% and 1.79%, respectively, for the quarter ended December 2024. Do the numbers hold clues to what lies ahead for the stock?
Ginkgo Bioworks Holdings, Inc. (DNA) Reports Q4 Loss, Misses Revenue Estimates
by Zacks Equity Research
Ginkgo Bioworks (DNA) delivered earnings and revenue surprises of -25.52% and 2.74%, respectively, for the quarter ended December 2024. Do the numbers hold clues to what lies ahead for the stock?
PFE Stock Rises on Reports of Averting Proxy Fight With Activist Investor
by Zacks Equity Research
A Bloomberg article suggests activist investor Starboard cut Pfizer some slack by not nominating any director on the company's board this year.
CYTK Stock Rises as Enrollment Begins in Phase II Heart Failure Study
by Zacks Equity Research
Cytokinetics stock up as the company initiates patient enrollment in its mid-stage study of pipeline candidate, CK-586, for treating heart failure patients.
Keros Therapeutics Stock Plunges 81% in 3 Months: Here's Why
by Zacks Equity Research
KROS stock crashes 81% in three months after dosing with cibotercept was halted in a phase II lung disease study due to adverse pericardial effusion events.
AstraZeneca Secures FDA Nod for New ADC Drug Datroway in Breast Cancer
by Zacks Equity Research
The FDA's nod is based on late-stage data, which show AZN's Datroway cuts the risk of disease progression/death by 37% vs chemotherapy in certain breast cancer patients.
Amgen's Lumakras Gets FDA Nod for Expanded Use in Colorectal Cancer
by Zacks Equity Research
The FDA approves Amgen's Lumakras in combination with Vectibix for treating previously treated adults with KRAS G12C-mutated metastatic colorectal cancer.