The pre-commercial stage biopharmaceutical business BioLineRx Ltd. (NASD: BLRX) has increased 8.35% at $0.75 in after-hours trading hours on the latest check Friday after providing a corporate and portfolio update.
What kind of update has BLRX given?
When presenting its financial results this month, BioLineRx (BLRX) also gave business and portfolio updates. The conclusion of a $40 million non-dilutive debt financing deal with Kreos Capital and a $15 million registered direct offering to support the commercial launch of APHEXDA in the United States are recent corporate developments from BioLineRx. The U.S. commercialization strategy for APHEXDA was also disclosed by BLRX during the quarter, and Holly May was appointed president of BioLineRx USA.
BLRX stated that the FDA had approved the APHEXDA NDA for the mobilization of stem cells for autologous transplantation in patients with multiple myeloma. 9 September 2023 has been assigned as the PDUFA target action date. BLRX also disclosed that it would present a cost-effectiveness comparison of motixafortide and plerixafor in stem cell mobilization for autologous transplantation in patients with multiple myeloma at the American Society of Hematology (ASH) 64th Annual Meeting, which will take place in New Orleans, Louisiana, from December 10–13, 2022.
Pancreatic Ductal Adenocarcinoma (PDAC):
BLRX and partnership partner GenFleet started Phase 2b PDAC randomized clinical trial preparatory work. Expect the start of clinical trials in 2023. According to the partnership agreement, BioLineRx can continue to use motixafortide for all indications throughout the whole world. BLRX continues to work together on the Phase 2 research of motixafortide in conjunction with an anti-PD-1 and standard-of-care chemotherapy in first-line PDAC patients, which was investigator-initiated by Columbia University.
At the ASH Annual Meeting, which will be place December 10–13, 2022, in New Orleans, Louisiana, BLRX will present its clinical trial study design of new stem cell mobilization regimen with motixafortide to assist the development of gene therapy for sickle cell patients. Additionally, BLRX made progress with their biomarker analysis from the Phase 1/2a study of AGI-134 in solid tumors, and they plan to release the findings from Part 2 of the trial before the end of the year.
How will BLRX expand further?
The FDA’s approval of BLRX’s new drug application for APHEXDA significantly advances the company’s twin objectives of developing a significant new therapy for mobilizing stem cells in advance of autologous transplantation in patients with multiple myeloma and, concurrently, establishing itself as a commercial-stage company. According to BioLineRx (BLRX), the treatment has the potential to replace chemotherapy as the mobilizing agent of choice for those with multiple myeloma.