Company Product Description Indication Status
Alterity Therapeutics Ltd., of Melbourne, Australia ATH-434  Inhibitor of alpha-synuclein aggregation Multiple system atrophy Reached agreement with the FDA on the nonclinical studies required for the phase II study; FDA agreed to key aspects of the study design, including the patient population, safety monitoring plan and strategy for evaluating drug exposure during the study
Ardelyx Inc., of Fremont, Calif. Tenapanor Inhibits sodium hydrogen exchanger 3 Control of serum phosphorus in adult patients with chronic kidney disease on dialysis Submitted NDA to the FDA
Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Selumetinib  Mitogen-activated protein kinase kinases 1 and 2 inhibitor Neurofibromatosis type 1 Japanese Ministry of Health, Labour and Welfare granted orphan drug designation
Bioinvent International AB, of Lund, Sweden BI-1808 Monoclonal antibody targeting tumor necrosis factor receptor 2 Ovarian cancer, non-small-cell lung cancer and cutaneous T-cell lymphoma Submitted a CTA to the EMA to test the drug as a monotherapy and in combination with Keytruda (pembrolizumab, Merck & Co. Inc.)
Mediwound Ltd., of Yavne, Israel, and Vericel Corp., of Cambridge, Mass. Nexobrid Proteolytic enzymes Eschar removal in deep partial-thickness and/or full-thickness thermal burns Submitted BLA to the FDA
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Monoclonal antibody targeting PD-1 Unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer FDA approved the supplemental BLA for use in first-line treatment
Nuvox Pharma LLC of Tucson, Ariz. NanO2  Emulsion for oxygen delivery COVID-19 with acute hypoxic respiratory failure Health Canada issued a no objection letter for the phase IIa study
Oncopeptides AB, of Stockholm Melflufen  Aminopeptidase-targeting peptide-drug conjugate Multiple myeloma  Submitted NDA to the FDA seeking approval for use in patients refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent and 1 anti-CD38 monoclonal antibody
Oncternal Therapeutics Inc., of San Diego Cirmtuzumab Monoclonal antibody targeting ROR1 Mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma FDA granted orphan designations
Osmotica Pharmaceuticals plc, of Bridgewater, N.J. Arbaclofen Active R-enantiomer of baclofen Spasticity in multiple sclerosis Resubmitted NDA to FDA
Prestige Biopharma Ltd., of Singapore PBP-1510 Monoclonal antibody targeting pancreatic adenocarcinoma up-regulated factor Pancreatic cancer FDA granted orphan designation
Sparingvision SAS, of Paris SPVN-06 NXNL1 gene stimulator; AAV-based gene therapy Inherited retinal dystrophies European Commission granted orphan designation
Synthetic Biologics Inc., of Rockville, Md. SYN-020 Purified recombinant bovine intestinal alkaline phosphatase formulated for oral delivery to intestines Radiation enteropathy secondary to pelvic cancer therapy Submitted IND to FDA for phase I single ascending-dose study in healthy volunteers
Verrica Pharmaceuticals Inc., of West Chester, Pa. VP-102 (cantharidin 0.7% topical solution) Protein phosphatase 2A inhibitor Molluscum contagiosum Received letter from FDA stating there are deficiencies in NDA that preclude discussion of labeling and postmarketing requirements/commitments at this time, though that does not reflect a final decision on the information under review; FDA previously assigned a PDUFA date of July 13, 2020, for completion of NDA review

Notes

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

No Comments