Clovis (CLVS) Up 19.4% on Upbeat Data From Solid Tumor Study

08:20pm, Thursday, 16'th Jun 2022 Zacks Investment Research
Clovis Oncology (CLVS) reports favorable data from a study, which supports the potential clinical utility of FAP-2286, its targeted radiotherapy candidate, as a treatment for advanced solid tumors.

FDA Committee Endorses bluebird's (BLUE) Thalassemia Therapy

05:27pm, Monday, 13'th Jun 2022 Zacks Investment Research
An FDA advisory committee favors approval for bluebird bio's (BLUE) beti-cel to treat transfusion-dependent thalassemia. A final decision by the regulatory body is expected on Aug 19, 2022.

FDA Committee Recommends bluebird's (BLUE) CALD Therapy

07:30pm, Friday, 10'th Jun 2022 Zacks Investment Research
An FDA advisory committee supports approving bluebird bio's (BLUE) eli-cel for treating cerebral adrenoleukodystrophy. NASDAQ halts trading BLUE's common stock on Jun 9 and 10.

bluebird (BLUE) Up as FDA Nod Likely for Thalassemia Therapy

05:21pm, Wednesday, 08'th Jun 2022 Zacks Investment Research
Based on briefing documents issued by the FDA, a positive regulatory approval is expected on bluebird bio's (BLUE) gene-therapy for treating thalassemia.

AstraZeneca (AZN) Breast Cancer Drug Cuts Risk of Death to Half

06:04pm, Monday, 06'th Jun 2022 Zacks Investment Research
Data from a late-stage study shows that AstraZeneca's (AZN) Enhertu meets superior and clinically meaningful progression-free survival and overall survival in HER2-low metastatic breast cancer patient
NEW YORK and CLEVELAND, June 06, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that company management is schedu

BioMarin (BMRN) Delays FDA Re-Submission for Hemophilia Drug

06:25pm, Wednesday, 01'st Jun 2022 Zacks Investment Research
BioMarin (BMRN) posts follow-up data from a phase I/II study on its gene-therapy candidate for hemophilia A. However, the stock falls 7% as management plans to defer the candidate's BLA filing.

Amicus' (FOLD) Galafold Aids Growth, Overdependence a Woe

06:27pm, Tuesday, 31'st May 2022 Zacks Investment Research
Currently, Amicus Therapeutics (FOLD) has only one marketed product in its portfolio, the Fabry disease drug Galafold. The FDA is reviewing FOLD's filings that seek approval for Pompe disease.

Verrica (VRCA) Down 64% as Molluscum Drug Gets CRL From FDA

07:37pm, Thursday, 26'th May 2022 Zacks Investment Research
Verrica Pharmaceuticals' (VRCA) new drug application for VP-102 to treat molluscum contagiosum faces rejection from the FDA for a second time.

Aerie (AERI) Starts Late-Stage Study to Treat Dry Eye Disease

06:29pm, Wednesday, 25'th May 2022 Zacks Investment Research
Aerie Pharmaceutials (AERI) doses the first patient in a phase III study on its investigational TRMP8 agonist drug for the treatment of dry eye disease.

Athersys (ATHX) Down as Ischemic Stroke Study Fails to Meet Goal

07:32pm, Monday, 23'rd May 2022 Zacks Investment Research
While a mid-stage/late-stage study evaluating Athersys' (ATHX) stem cell treatment for ischemic stroke misses out on its primary endpoint, top-line data shows evidence of therapeutic impact.

Enanta's (ENTA) RSV Drug Fails to Meet Study Goal, Stock Drops

07:02pm, Thursday, 19'th May 2022 Zacks Investment Research
While a mid-stage study evaluating Enanta's (ENTA) RSV candidate misses out on its primary endpoint, a statistically huge number of subjects achieved undetectable RSV RNA at the end of treatment.
NEW YORK and CLEVELAND, May 19, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that the Company has been grante

AVROBIO (AVRO) Stock Up on Upbeat Data From Cystinosis Study

07:12pm, Wednesday, 18'th May 2022 Zacks Investment Research
Results from AVROBIO's (AVRO) phase I/II study, which is evaluating its gene-therapy candidate for cystinosis, show the latter's potential to stabilize or reduce the impact of cystinosis on different

Ultragenyx (RARE) Acquires Rights of AAV Gene Therapy Candidate

03:47pm, Wednesday, 18'th May 2022 Zacks Investment Research
Ultragenyx (RARE) signs an exclusive license agreement with Abeona Therapeutics to acquire the latter's gene therapy candidate, ABO-102 (now UX111), for treating Sanfilippo syndrome type A.
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