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Zacks News
Reata (RETA) Announces FDA's Acceptance of Skyclarys PAS
by Zacks Equity Research
Reata (RETA) gets FDA acceptance for the filing of new drug application supplement approval for Skyclarys' release.
GSK Announces Extension of FDA Review for Rare Blood Therapy
by Zacks Equity Research
GSK announces the FDA's extension of the review period of its new drug application for momelotinib to treat myelofibrosis by three months. A decision is now expected on Sep 16, 2023.
Aldeyra (ALDX) Up On Positive Data From Conjunctivitis Study
by Zacks Equity Research
Aldeyra (ALDX) soars on meeting primary and secondary endpoints in the late-stage study of reproxalap for patients with allergic conjunctivitis.
Iovance (IOVA) Updates on Combo Drug in Advanced Melanoma Study
by Zacks Equity Research
Iovance (IOVA) announces randomizing the first patient in the TILVANCE-301 study evaluating the safety and efficacy of its lifileucel/Keytruda combo therapy in frontline advanced melanoma patients.
Lava (LVTX) Discontinues Hematological Tumor Study, Shares Fall
by Zacks Equity Research
Lava (LVTX) falls 10% due to its decision to discontinue the study on LAVA-051, which is being evaluated for multiple hematological tumors. The company shifts focus to LAVA-1207 in the prostate cancer study.
Blue Water (BWV) Up on Acquisition of 6 FDA-Approved Drugs
by Zacks Equity Research
Blue Water (BWV) soars 62% after declaring its deal to purchase six FDA-approved products for $8.5 million. The agreement will help expand the company's portfolio into cardiology and pain management.
IO Biotech (IOBT) Down Despite Positive Update on Melanoma Study
by Zacks Equity Research
IO Biotech (IOBT) falls 25% despite achieving the clinical milestone of enrolling 225 patients in the advanced melanoma study evaluating the IO102-IO103/Keytruda combo.
Can-Fite (CANF) Up on Namodenoson Progress in Pancreatic Cancer
by Zacks Equity Research
Can-Fite's (CANF) shares rise 11.4% as it reveals its plans of submitting an investigational new drug application. The idea is to initiate expansion studies for namodenoson to treat pancreatic carcinoma.
Recursion (RXRX) Up on Completing REC-994 Study Enrollment
by Zacks Equity Research
Recursion's (RXRX) shares rise as it completes patient enrollment for a mid-stage study of REC-994 to treat cerebral cavernous malformations.
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.