Company Product Description Indication Status
Alphamab Oncology Co. Ltd., of Suzhou, China KN-046 PD-L1/CTLA4 bispecific antibody Anti-PD-(L)1-refractory or relapsed non-small-cell lung cancer FDA issued a safe to proceed letter for the phase II study
Ascendis Pharma A/S, of Copenhagen, Denmark Transcon hGH (lonapegsomatropin) Long-acting prodrug of somatropin Growth hormone deficiency FDA granted orphan drug designation
Autolus Therapeutics plc, of London AUTO-1 CD19-targeting CAR T-cell therapy Acute lymphoblastic leukemia FDA accepted the IND for the pivotal phase Ib/II AUTO1-AL1 study
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J. Ryanodex Dantrolene sodium COVID-19 Submitted IND to FDA for a phase II trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with SARS-CoV-2
Emmaus Life Sciences Inc., of Torrance, Calif. Endari L-glutamine oral powder Sickle cell disease Saudi Food & Drug Authority accepted request for priority review
Index Pharmaceuticals Holding AB, of Stockholm Cobitolimod TLR9 agonist Moderate to severe ulcerative colitis Following discussions with the FDA and EMA, company plans to advance drug to phase III development with sequential studies that may include a higher dose than was tested in the phase IIb study
Mayne Pharma Group Ltd., of Adelaide, Australia, and Mithra Pharmaceuticals SA, of Liege, Belgium E4/DRSP Estetrol and drospirenone  Prevention of pregnancy Submitted NDA to FDA
Provention Bio Inc., of Oldwick, N.J. Teplizumab Anti-CD3 monoclonal antibody Delay or prevention of clinical type 1 diabetes Started rolling submission of a BLA; nonclinical module submitted; clinical module submission planned for third quarter of 2020; chemistry, manufacturing and controls module submission planned for fourth quarter of 2020
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. REGN-EB3 Triple antibody cocktail Ebola virus infection FDA accepted BLA for priority review with a PDUFA date of Oct. 25, 2020
Tetra Bio-Pharma Inc., of Ottawa PPP-004 Delta-9 tetrahydrocannabinol and cannabidiol Epidermolysis bullosa FDA granted orphan drug designation
Tissuetech Inc., of Miami TTAX-02 Cryopreserved human umbilical cord investigational biologic product Spina bifida FDA granted regenerative medicine advanced therapy designation for treatment of spina bifida in-utero
Zai Lab Ltd., of Shanghai Zejula (niraparib) PARP inhibitor Epithelial ovarian, fallopian tube or primary peritoneal cancer China’s National Medical Products Administration accepted the supplemental NDA seeking use as maintenance treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer after complete or partial response to first-line platinum-based chemotherapy

Notes

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

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