Company Product Description Indication Status
7 Hills Pharma, of Houston 7HP-349 Oral integrin activator  Solid tumors and infectious disease FDA cleared its IND and granted approval to proceed with a proposed phase I trial in healthy volunteers 
Alnylam Pharmaceuticals Inc., of Cambridge, Mass. Vutrisiran (ALN-TTRsc02) RNAi targeting TTR Polyneuropathy of hereditary transthyretin-mediated amyloidosis FDA granted fast track designation 
AVM Biotechnology Inc., of Seattle AVM-0703 Small molecule that supercharges and mobilizes immune cells Non-Hodgkin lymphoma, acute lymphocytic leukemia and chronic lymphocytic leukemia Received FDA approval to begin phase I/II trials
Epirium Bio Inc., of San Diego EB-002 ((+)-epicatechin) Synthetic flavanol Duchenne and Becker muscular dystrophy Received orphan drug designation from the FDA 
Grid Therapeutics LLC, of Durham, N.C. GT-103 Recombinant antibody Solid tumors FDA approved its IND application and the company plans to initiate a phase I trial 
Kadmon Holdings Inc., of New York KD-025 Oral inhibitor of ROCK2 Chronic graft-vs.-host disease Received the final meeting minutes from the FDA following its NDA pre-submission meeting, and the company said it believes the proposed data package will be sufficient to support a submission
The KD Pharma Group SA, of Bioggio, Switzerland, and SLA Pharma AG, of Liestal, Switzerland Epaspire Oral formulation of highly purified eicosapentaenoic acid free fatty acid COVID-19 U.K.'s MHRA approved the trial; the companies have submitted an application to the FDA for a trial
Lifemax Laboratories Inc., of Palo Alto, Calif. LM-030 Kallikrein-related peptidase inhibitor Netherton syndrome FDA granted fast track designation

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments