BioLineRx gains on update for pre-NDA meeting with FDA for Motixafortide
Jan. 18, 2022 8:44 AM ETBioLineRx Ltd. (BLRX)
By: Dulan Lokuwithana, SA News
BioLineRX (NASDAQ:BLRX) ADRs have added ~6.5% in the pre-market after the company announced the successful conclusion of a pre-New Drug Application (NDA) meeting with the FDA for Motixafortide, its therapeutic candidate for multiple myeloma patients.
Motixafortide is undergoing late-stage studies as a stem-cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients.
At the meeting, the federal agency has confirmed that a proposed data package from a single Phase 3 pivotal study will be adequate for its NDA submission, which the company anticipates in H1 2022.
"We are highly encouraged by the collaborative pre-NDA meeting that we held with the FDA, and having confirmed alignment with the agency, our NDA submission remains on track for the first half of this year," CEO Philip Serlin noted.
In May 2021, BioLineRX (BLRX) disclosed topline data from its GENESIS Phase 3 trial for Motixafortide.
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