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FDA Snubs BMY And BLUE, Stocks That Moved On ASCO Abstracts (ARVN, CTMX, MGNX)

pharma 032417 13may20 lt

Today's Daily Dose brings you news about the status of Bristol Myers and bluebird bio's Idecabtagene vicleucel Biologics License Application and the companies that have released Abstracts for the ASCO 2020 Virtual Meeting and their stock movement.

Read on…

Bristol Myers Squibb (BMY) and bluebird bio Inc. (BLUE) have been issued a Refusal to File letter by the FDA for their Biologics License Application for Idecabtagene vicleucel, proposed for the treatment of patients with heavily pretreated relapsed and refractory multiple myeloma.

The FDA has sought further details related to the Chemistry, Manufacturing, and Control (CMC) module of the BLA. However, no additional clinical or non-clinical data have been requested or are required.

Bristol Myers Squibb is planning to resubmit the Idecabtagene vicleucel BLA no later than the end of July 2020.

BMY closed Wednesday's trading at $63.27, down 0.13%.

The following are some of the companies that have released Abstracts for the ASCO 2020 Virtual Meeting taking place from May 29 to May 31, 2020.

Arvinas Inc. (ARVN) announced updated data from a phase I study of ARV-110, an androgen receptor PROTAC degrader, in patients with metastatic castrate-resistant prostate cancer following enzalutamide and/or abiraterone.

ARVN closed Wednesday's trading at $51.00, down 8.52%. In after-hours, the stock fell 15.69% and was at $43.

Allogene Therapeutics Inc. (ALLO) announced initial data from its ongoing phase I dose-escalation study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma, dubbed ALPHA. This study utilizes ALLO-647 as a part of its differentiated lymphodepletion regimen.

ALLO closed Wednesday's trading at $30.98, down 4.7%. In after-hours, the stock gained 27.50% and was at $39.50.

CytomX Therapeutics Inc. (CTMX) announced data from a phase I/II first-in-human study of PDC CX-2029 in advanced solid tumors and phase I multi-part dose-escalation study of CX-2009 in patients with advanced solid tumors. The Company has also announced data from programs in its pipeline, including CX-072, a Probody checkpoint inhibitor, and BMS-986249, the anti-CTLA-4 Probody therapeutic being developed in collaboration with Bristol Myers. (BMY).

CTMX closed Wednesday's trading at $14.44, down 1.37%. In after-hours, the stock fell 25.76% and was at $10.72.

MacroGenics Inc. (MGNX) announced data covering safety and preliminary anti-tumor activity from its phase I dose-escalation and expansion clinical trial of MGD013 in patients with unresectable or metastatic neoplasms and phase I dose expansion results from a phase I/II trial of MGC018 in patients with advanced solid tumors.

MGNX closed Wednesday's trading at $26.50, down 2.39%. In after-hours, the stock slumped 20.42% to $21.09.

Iovance Biotherapeutics Inc. (IOVA) announced new interim data from Cohort 2 in its phase II clinical trial of Lifileucel in advanced melanoma, dubbed C-144-01.

IOVA closed Wednesday's trading at $34.04, down 5.15%. In after-hours, the stock was up 2.82% at $35.

Enochian Biosciences (ENOB) announced data from an in vivo study of a novel approach to potentially cure HIV and data of in vivo studies of an innovative potential cure for Hepatitis B virus (HBV) infection.

ENOB closed Wednesday's trading at $4.25, up 38.89%.

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