|Astellas Pharma Canada Inc., of Markham, Ontario, part of Astellas Pharma Inc.||Xospata (gilteritinib)||FLT3 inhibitor||Relapsed/refractory acute myeloid leukemia||Health Canada approved for use in adults whose disease had FLT3 mutation|
|Avrobio Inc., of Cambridge, Mass.||AVR-RD-02||Gene therapy||Gaucher disease||FDA cleared the IND to expand ongoing phase I/II study to U.S.|
|Biolinerx Ltd., of Tel Aviv, Israel||Motixafortide (BL-8040)||Functions as CXCR4 antagonist||Pancreatic cancer||European Commission granted orphan designation|
|Cynata Therapeutics Ltd., of Melbourne, Australia||CYP-002||Cymerus mesenchymal stem product||Critical limb ischemia||Received approval from the U.K.’s MHRA to proceed with phase II study|
|Denali Therapeutics Inc., of South San Francisco||DNL-301||Recombinant form of iduronate 2-sulfatase enzyme engineered using Enzyme Transport Vehicle technology||Hunter syndrome||Submitted an IND to the FDA|
|Denali Therapeutics Inc., of South San Francisco||DNL-343||EIF2B activator||Amyotrophic lateral sclerosis and other neurodegenerative disorders||CTA cleared for phase I trial in healthy volunteers|
|Innate Pharma SA, of Marseille, France||Lacutamab (IPH-4102)||Anti-KIR3DL2 humanized cytotoxicity-inducing antibody||Relapsed/refractory Sezary syndrome and mycosis fungoides||French regulators agreed the Tellomak phase II trial can resume recruitment of new patients who have received at least 2 prior lines of systemic therapy; no new peripheral T-cell lymphoma patients can enroll into the study until a new GMP-certified batch of drug is available though currently enrolled PTCL patients can continue treatment|
For more information about individual companies and/or products, see Cortellis.