Company Product Description Indication Status
Alume Biosciences Inc., of La Jolla, Calif. ALM-488 Peptide-dye conjugate targeting nerves Head and neck surgery FDA issued a study-may-proceed letter for the phase I/II study of up to 36 patients to determine the safety and pharmacokinetics of the drug; study expected to start in the second quarter of 2020
Ascentage Pharma Group International, of Suzhou, China HQP-1351 BCR-ABL inhibitor Chronic myeloid leukemia FDA granted orphan drug designation
Aspargo Laboratories Inc., of Englewood Cliffs, N.J. Sildenafil oral spray Phosphodiesterase type 5 inhibitor Erectile dysfunction During a pre-IND meeting, the FDA was supportive of a single-dose bioequivalent study comparing the drug to Viagra (sildenafil, Pfizer Inc.) with approval through the 505(b)(2) regulatory pathway; plans to file the IND in the third quarter of 2020
Combioxin SA, of Geneva CAL-02 Liposomes that bind bacterial virulence effectors COVID-19 at high risk of secondary bacterial infections FDA reviewed the pre-IND
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist COVID-19 Submitted a request to the FDA to grant compassionate use for patients not eligible for 2 ongoing studies
Freeline Therapeutics Ltd., of London FLT-190 Liver-directed adeno-associated viral gene therapy expressing alpha-galactosidase A Fabry  disease FDA granted orphan drug designation
Genetx Biotherapeutics LLC, of Sarasota, Fla., and Ultragenyx Pharmaceutical Inc., of Novato, Calif. GTX-102 Antisense oligonucleotide targeting UBE3A-AS Angelman syndrome FDA granted fast track designation
Kala Pharmaceuticals Inc., of Watertown, Mass. Eysuvis (loteprednol etabonate) Corticosteroid Dry eye disease Resubmitted NDA to FDA; company believes the application will be considered a class 2 resubmission
Kempharm Inc., of Celebration, Fla. KP-415 Serdexmethylphenidate, a prodrug of d-methylphenidate Attention deficit hyperactivity disorder FDA accepted the NDA; PDUFA date in March 2021
Marinus Pharmaceuticals Inc., of Radnor, Pa. Ganaxolone   Positive allosteric modulator of GABAA receptors Status epilepticus Based on feedback from an end-of-phase-II meeting with the FDA, company has designed a 125-patient phase III study with co-primary endpoints that focus on status cessation within 30-minutes and suppression of status for at least 24 hours; study scheduled to start in the third quarter of 2020 and generate data in the first half of 2022
Stallergenes Greer plc, of London STAGR-320  Sublingual house dust mite immunotherapy HDM-induced allergic rhinitis Submitted MAA via a European decentralized procedure
Tolmar Pharmaceuticals Inc., of Buffalo Grove, Ill. Fensolvi (leuprolide acetate) Gonadotropin-releasing hormone receptor agonist Central precocious puberty FDA approved the NDA


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

No Comments