Company Product Description Indication Status
Agilent Technologies Inc., of Santa Clara, Calif. PD-L1 IHC 22C3 Pharmdx Companion diagnostic Triple-negative breast cancer Approved by FDA for use to identify patients for treatment with Keytruda (pembrolizumab, Merck & Co. Inc.)
Amylyx Pharmaceuticals Inc., of Cambridge, Mass. AMX-0035 Designed to reduce neuronal death and dysfunction Wolfram syndrome FDA granted orphan designation
Artelo Biosciences Inc., of La Jolla, Calif. ART-27.13 Synthetic cannabinoid Cancer anorexia and weight loss Received clinical trial authorization in the U.K. for Cares phase I/II study; enrollment expected to initiate before year-end
Aruvant Sciences Ltd., of New York, part of the Roivant Sciences group ARU-1801 Lentiviral gene therapy Sickle cell disease EMA granted orphan designation
Boehringer Ingelheim GmbH, of Ingelheim, Germany Pradaxa (dabigatran etexilate) Factor IIa antagonist; protease-activated receptor-1 antagonist Venous thromboembolic events EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for treating VTE and prevention of recurrent VTE in pediatric patients, from birth to less than 18 years
Cytodyn Inc., of Vancouver, Washington Leronlimab (PRO-140) CCR5 antagonist HIV Health Canada cleared firm to file BLA as combination therapy for multidrug-resistant HIV 
Dicerna Pharmaceuticals Inc., of Lexington, Mass., and Eli Lilly and Co., of Indianapolis LY-3561774 RNAi drug Cardiometabolic disease FDA accepted IND filed by Lilly to start phase I trial; study expected to begin by year-end
Eisai Co. Ltd., of Tokyo Fycompa (perampanel) Selective, noncompetitive AMPA receptor antagonist Partial-onset seizures Approved by European Commission for pediatric patients, extending use as adjunctive therapy for POS, with or without secondary generalization, by expanding approved age range from 12 and older to 4 and older
Exegi Pharma LLC, of Rockville, Md. EXE-346 Live biotherapeutic containing fixed-proportion of 8 strains of live probiotic bacteria Pouchitis FDA granted orphan designation for prevention of disease relapse in pouchitis
Innovation Pharmaceuticals Inc., of Wakefield, Mass. Brilacidin Defensin mimetic COVID-19 Overseas CTA submitted to governing health agency for phase II study, expected to begin in 2020
Insmed Inc., of Bridgewater, N.J. Brensocatib Oral, reversible inhibitor of DPP1 Non-cystic fibrosis bronchiectasis  EMA granted priority medicines (PRIME) designation
Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda Vixarelimab Monoclonal antibody targeting oncostatin M receptor beta Prurigo nodularis FDA granted breakthrough therapy designation
Jounce Therapeutics Inc., of Cambridge, Mass. JTX-8064 Anti-leukocyte immunoglobulin-like receptor B2 Solid tumors Received a study may proceed letter from FDA to begin phase I Innate study
Lupin Pharmaceuticals Inc., of Mumbai, India Solosec (secnidazole) Antibacterial Trichomoniasis FDA accepted supplemental NDA seeking approval for use in adults and adolescents; PDUFA date of June 30, 2021
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) PD-1-inhibiting antibody Triple-negative breast cancer Approved by FDA for use in patients with locally recurrent unresectable or metastatic disease whose tumors express PL-L1 as determined by an FDA-approved test
Mindmed Inc., of New York Microdoses of LSD Psychedelic Attention deficit hyperactivity disorder Received positive response on its protocol design for phase IIa trial in adults from Swiss and Dutch health authorities
Mindmed Inc., of New York Microdoses of LSD Psychedelic Anxiety disorders Submitted pre-IND briefing package to FDA for potential phase IIb trial 
Neoimmunetech Inc., of Rockville, Md. NT-17 (efineptakin alfa) Long-acting human interleukin-7  Non-small-cell lung cancer FDA cleared the IND for phase II study testing combination with Tecentriq (atezolizumab, Roche Holding AG) in patients with previously untreated, PD-L1-expressing, locally advanced or metastatic disease
Neuronasal Inc., of Wexford, Pa. NAC N-acetylcysteine Acute mild traumatic brain injury Granted IND clearance by FDA to continue plans for a phase I study testing nose-to-brain delivery of NAC in partnership with Atai Life Sciences
Sanofi SA, of Paris Sutimlimab Monoclonal antibody Hemolysis in adults with cold agglutinin disease FDA issued a complete response letter regarding BLA, referring to deficiencies identified during a pre-license inspection of a third-party facility responsible for manufacturing; no clinical or safety deficiencies noted
Tracon Pharmaceuticals Inc., of San Diego, Alphamab Oncology Co. Ltd., of Suzhou, China, and 3D Medicines Co. Ltd., of Chengdu, China Envafolimab (KN-035) Single-domain antibody against PD-L1 Microsatellite instability-high/deficient mismatch repair cancer Alphamab and 3D Medicines submitted NDA to China’s NMPA

Notes

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