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Zacks News
Gracell Biotechnologies (GRCL) Surges 62% in a Week: Here's Why
by Zacks Equity Research
Shares of Gracell (GRCL) increase after it reported positive data from two clinical studies, which evaluated its experimental CAR T cell therapy drug in patients with B-cell non-hodgkin's lymphoma and multiple myeloma.
First Wave (FWBI) Surges 33% on Finishing Enrolment in CF Study
by Zacks Equity Research
First Wave (FWBI) completes enrolment in a mid-stage study evaluating its investigational oral capsule in patients with cystic fibrosis. Topline data from the study is expected next month.
Acadia (ACAD) to Begin Study on ACP-101 for Hyperphagia in PWS
by Zacks Equity Research
Acadia (ACAD) is set to begin a pivotal study evaluating a new developmental candidate, ACP-101, in the treatment of hyperphagia associated with Prader-Willi syndrome.
AstraZeneca (AZN) Breast Cancer Combo Drug Gets Priority Review
by Zacks Equity Research
The FDA grants priority review status to AstraZeneca's (AZN) capivasertib/Faslodex combination for the treatment of adult patients with HR-positive, HER2-negative locally advanced breast cancer.
Is Akero Therapeutics (AKRO) Outperforming Other Medical Stocks This Year?
by Zacks Equity Research
Here is how Akero Therapeutics, Inc. (AKRO) and Accelerate Diagnostics (AXDX) have performed compared to their sector so far this year.
Ironwood (IRWD), AbbVie Get FDA Nod for Linzess Label Expansion
by Zacks Equity Research
Ironwood (IRWD) lead drug Linzess gets FDA approval for pediatric functional constipation The label expansion of the drug is expected to boost the company's sales.
Intellia (NTLA) Up on Positive Data Updates From HAE Study
by Zacks Equity Research
Intellia's (NTLA) promising interim data on the early-stage study of NTLA-2002 shows potential as a single-dose treatment for hereditary angioedema.
Editas (EDIT) Posts Upbeat Initial Data From SCD & TDT Studies
by Zacks Equity Research
Editas (EDIT) announces positive preliminary safety and efficacy data from patients treated with its lead drug, EDIT-301, in the RUBY and EdiTHAL studies to treat SCD and TDT, respectively.
AstraZeneca (AZN) & Quell to Co-Develop Autoimmune Cell Therapies
by Zacks Equity Research
AstraZeneca (AZN) enters into a collaboration agreement with Quell Therapeutics to co-develop novel cell therapy options in major autoimmune indications for an upfront payment of $85 million.
Rocket (RCKT) Heart Disease Drug Gets Fast Track & Orphan Drug Tag
by Zacks Equity Research
The FDA grants fast track tag and orphan drug designation to Rocket's (RCKT) investigational gene therapy candidate, RP-A601, for cardiac indication. The stock gains 2.3% following the news.
Timber (TMBR) Surges on Carcinogenicity Waiver for TMB-001
by Zacks Equity Research
Timber (TMBR) receives a dermal carcinogenicity waiver from the FDA for TMB-001, which is being developed to treat moderate-to-severe subtypes of congenital ichthyosis.
AVITA (RCEL) Gets FDA Nod for Expanded Use of RECELL System
by Zacks Equity Research
AVITA (RCEL) surges on FDA approval for expanded use of its RECELL System to treat full-thickness skin defects.
Alkermes (ALKS) Gets Final Award in Janssen Arbitration, Ups View
by Zacks Equity Research
Alkermes (ALKS) receives final award in arbitration proceedings with partner Janssen. It also raises its financial outlook for 2023.
Akero Therapeutics, Inc. (AKRO) Is a Great Choice for 'Trend' Investors, Here's Why
by Zacks Equity Research
Akero Therapeutics, Inc. (AKRO) could be a solid choice for shorter-term investors looking to capitalize on the recent price trend in fundamentally sound stocks. It is one of the many stocks that passed through our shorter-term trading strategy-based screen.
Bellerophon (BLPH) Down 87% as Lung Disease Candidate Fails
by Zacks Equity Research
Bellerophon's (BLPH) shares fall as a late-stage study of INOpulse to treat fibrotic interstitial lung disease fails to meet its primary endpoint.
Ultragenyx (RARE) Posts Data From Osteogenesis Imperfecta Study
by Zacks Equity Research
Ultragenyx (RARE), along with partner Mereo BioPharma, announces encouraging data on mid-stage study evaluating setrusumab for patients with osteogenesis imperfecta.
BioNTech (BNTX) Up on Initial Data From Lung Cancer Antibody
by Zacks Equity Research
BioNTech (BNTX) announces positive initial data evaluating BNT316/ONC-392 to treat metastatic non-small cell lung cancer.
Novo Nordisk (NVO) Gears Up to Acquire BIOCORP for 154M Euros
by Zacks Equity Research
Novo Nordisk (NVO) enters into negotiations to acquire a majority stake in BIOCORP, followed by a tender offer to acquire all remaining shares in BIOCORP for a total equity value of 154 million Euros.
Bristol Myers (BMY) Announces Upbeat Data From NSCLC Study
by Zacks Equity Research
Bristol Myers (BMY) reports encouraging four-year clinical efficacy results from its lung cancer study upon treatment with the combination immunotherapy of Opdivo plus Yervoy.
Bayer (BAYRY) & Cedilla to Co-Develop Novel Cancer Therapies
by Zacks Equity Research
Bayer (BAYRY) announces licensing agreement with Cedilla Therapeutics to jointly develop and commercialize the latter's selective protein complex inhibitors as novel cancer therapies.
Aridis (ARDS) Up After FDA Nod for Pneumonia Drug Study Design
by Zacks Equity Research
Aridis (ARDS) stock jumps 115% after the company reports reaching an agreement with the FDA on its proposed study on AR-301 as an adjunctive treatment for hospital-acquired pneumonia.
AstraZeneca (AZN) Discontinues Brazikumab Development
by Zacks Equity Research
AstraZeneca (AZN) announces its decision to discontinue the development of brazikumab for all indications under its inflammatory bowel disease program.
PepGen (PEPG) Down on Clinical Hold for DM1 Candidate
by Zacks Equity Research
PepGen (PEPG) shares fall after FDA places clinical hold on a study evaluating potential treatment for myotonic dystrophy.
J&J (JNJ) Submits NDA for Single Tablet Combo to Treat PAH
by Zacks Equity Research
J&J (JNJ) submits a new drug application for a single tablet combination therapy of macitentan and tadalafil for the long-term treatment of pulmonary arterial hypertension.
Lexicon's (LXRX) Heart Failure Drug Inpefa Gets FDA Approval
by Zacks Equity Research
Lexicon's (LXRX) shares rise as it receives FDA approval for Inpefa, a once-daily oral tablet to treat a broad population of heart failure patients.