Company Product Description Indication Status
Ana Therapeutics, of Foster City, Calif. ANA-001 (niclosamide) Antiviral COVID-19 FDA cleared the IND for a study of at least 400 patients
Biophytis SA, of Paris Sarconeos (BIO-101) Activates the MAS receptor COVID-19 with respiratory failure Brazilian regulatory agency, Agencia Nacional de Vigilancia Sanitaria, approved the start of the 310-patient Cova study
Biosight Ltd., of Airport City, Israel BST-236 (aspacytarabine) Antimetabolite Acute myeloid leukemia  FDA granted fast track designation for use in adults 75 or older or with co-morbidities that preclude use of intensive induction chemotherapy
Cerecor Inc., of Rockville, Md. CERC-006 Inhibitor of mTOR complexes 1 and 2 Lymphatic malformations FDA granted rare pediatric disease designation
DBV Technologies SA, of Montrouge, France Viaskin Peanut (DBV-712) Allergy immunotherapy Peanut allergies FDA issued a complete response letter for the BLA due to potential impact of patch-site adhesion on efficacy
Deciphera Pharmaceuticals Inc., of Waltham, Mass. Ripretinib  Switch-control tyrosine kinase inhibitor that inhibits KIT and PDGFR-alpha Advanced gastrointestinal stromal tumors China's NMPA granted priority review status to the NDA for the treatment of adults who have received prior treatment with 3 or more kinase inhibitors, including imatinib
Eloxx Pharmaceuticals Inc., of Waltham, Mass. ELX-02 CFTR gene modulator; ribosomal protein modulator Cystic fibrosis FDA granted orphan drug designation
I-Mab Biopharma Co. Ltd., of Shanghai Eftansomatropin  Long-acting recombinant human growth hormone Growth hormone deficiency in pediatric patients  China's NMPA accepted its pivotal trial application 
Leo Pharma A/S, of Ballerup, Denmark Delgocitinib cream JAK inhibitor Moderate to severe chronic hand eczema FDA granted fast track designation for the treatment of adults 
Myr Pharmaceuticals GmbH, of Bad Homburg, Germany Hepcludex (bulevirtide) Entry inhibitor Chronic hepatitis delta virus infection Received conditional marketing authorization from the European Commission
Reviral Ltd., of London Sisunatovir  RSV fusion inhibitor Serious respiratory syncytial virus infection FDA granted fast track designation
Vivoryon Therapeutics AG, of Halle, Germany Varoglutamstat (PQ-912) Targets glutaminyl cyclase Alzheimer's disease FDA cleared the company's IND application, enabling it to initiate its U.S. phase II trial program 

Notes

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

No Comments