Hemogenyx Pharma Stock Price, News & Analysis

Hemogenyx Pharmaceuticals has announced that the FDA has deferred its pre-Investigational New Drug meeting for its lead product candidate, HEMO-CAR-T, until May 2022. This change is due to the FDA prioritizing COVID-19 related work, but the company emphasizes that this will not delay HEMO-CAR-T's development or its IND filing. Additionally, progress continues positively on the CDX bispecific antibody for acute myeloid leukaemia and the CBR platform technology for viral diseases. The CEO reassures that the IND application remains on track despite the changes.

Hemogenyx Pharmaceuticals has formed a partnership with Selexis SA to enhance the development of its CDX bispecific antibody targeting acute myeloid leukemia (AML). This collaboration allows Hemogenyx to utilize Selexis' SUREtechnology Platform, streamlining the process of creating high-performance mammalian cell lines for clinical trials. The CDX bispecific antibody is aimed at offering an innovative therapy for AML patients, potentially increasing treatment efficacy and survival rates. The agreement marks a significant step towards advancing Hemogenyx's clinical initiatives.

Hemogenyx Pharmaceuticals announces its participation in the H.C. Wainwright Bioconnect Conference from January 10-13, 2022. CEO Dr. Vladislav Sandler will present the company's progress and product candidates via a virtual platform. The conference aims to enhance the company's visibility and inform investors about its advancements in developing therapies for blood diseases. Hemogenyx focuses on innovative treatments, particularly bone marrow transplantation, to address life-threatening conditions such as leukemia and autoimmune diseases.

Hemogenyx Pharmaceuticals has announced a strategic partnership with WuXi Advanced Therapies to manufacture lentiviral vectors for its HEMO-CAR-T program targeting acute myeloid leukemia (AML). This collaboration aims to accelerate the product development towards phase I clinical trials. The partnership enhances Hemogenyx's ability to produce clinical materials necessary for regulatory submissions. The company anticipates filing an Investigational New Drug (IND) application in 2022. This program is expected to provide a more effective treatment for AML patients.

Hemogenyx Pharmaceuticals has announced progress on its lead product candidate, HEMO-CAR-T, for treating acute myeloid leukemia (AML). The company has requested a pre-Investigational New Drug (PIND) meeting with the FDA, aimed at refining its clinical trial plans and facilitating the IND application process. CEO Dr. Vladislav Sandler emphasized the importance of this step in enhancing the therapy's potential effectiveness, given AML's low survival rates. Successful development could greatly improve treatment outcomes for AML patients. Hemogenyx focuses on innovative therapies for blood diseases.

Hemogenyx Pharmaceuticals has successfully repaid convertible loans totaling $2,110,761 to Orgenesis, Inc., a step originally announced in October 2018. Both subsidiaries, Hemogenyx-Cell and Immugenyx, fulfilled the loan repayment terms. The company is poised for continued progress in developing its product candidates, backed by a substantial cash reserve that supports ongoing product development.

Hemogenyx Pharmaceuticals has secured a lease for a new 10,000 sq. ft. laboratory in New York's Mink Building, aimed at advancing its HEMO-CAR-T cell therapy for acute myeloid leukemia. The facility will feature two clean rooms designed for in-house cell manufacturing. CEO Dr. Vladislav Sandler expressed enthusiasm for the strategic location, citing collaboration opportunities with nearby Columbia University and City College. The move supports the company's anticipated growth and operational flexibility over the coming three years.

Hemogenyx Pharmaceuticals has signed a licence agreement with Eli Lilly, granting it exclusive rights to develop a CDX bispecific antibody for treating acute myeloid leukemia and other blood cancers. The agreement includes an upfront payment of US$250,000 and potential milestone payments up to US$1 million through clinical trials. This collaboration marks a significant advancement for Hemogenyx as it initiates IND-enabling studies, confirming the wider applicability of CDX beyond initial expectations. Successful therapy development could greatly impact patient survival rates for AML.