Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K. Imfinzi (durvalumab)  PD-L1 inhibitor Small-cell lung cancer FDA accepted sBLA and granted priority review to treat previously untreated extensive-stage disease
Diurnal Group plc, of Cardiff, U.K. Alkindi (hydrocortisone oral granules) Glucocorticoid receptor agonist Adrenal gland hypofunction NDA submitted to FDA under 505(b)(2) pathway 
Epizyme Inc., of Cambridge, Mass. Tazemetostat EZH2 inhibitor Metastatic or locally advanced epithelioid sarcoma FDA’s Oncologic Drugs Advisory Committee is set to review data supporting the NDA requesting accelerated approval for patients not eligible for curative surgery at its Dec. 18 meeting at 1 p.m. ET
Faron Pharmaceuticals Ltd., of Turku, Finland Clevegen (FP-1305) Immunotherapy targeting Clever-1 positive tumor-associated macrophages Metastatic or inoperable solid tumors FDA cleared IND to expand ongoing phase I/II Matins study into the U.S.
Hutchison China Meditech Ltd. (Chi-Med), of Hong Kong Elunate (fruquintinib) VEGF-1/2/3 receptor antagonist Advanced colorectal cancer Drug included in updated National Reimbursement Drug List by China’s NHSA
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas Zynquista (sotagliflozin) Dual inhibitor of SGLT1/2 Type 1 diabetes FDA’s Office of New Drugs reiterated agency’s prior position and denied appeal of complete response letter; Lexicon intends to appeal decision to FDA’s Center for Drug Evaluation and Research
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) PD-1-inhibiting antibody Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer FDA accepted and granted priority review for supplemental BLA seeking approval as monotherapy in patients with carcinoma in-situ, with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy; PDUFA date anticipated in January 2020
Orchard Therapeutics Ltd., of London OTL-200 Ex vivo, autologous, hematopoietic stem cell-based gene therapy Metachromatic leukodystrophy EMA validated marketing application to begin formal review process
Valneva SE, of Saint Herblain, France Ixiaro Vaccine Prevention of Japanese encephalitis  EMA approved extension of shelf-life from 24 months to 36 months
Y-mabs Therapeutics Inc., of New York Naxitamab Anti-GD2 monoclonal antibody Relapsed/refractory high-risk neuroblastoma Submitted to FDA first portions of its rolling BLA

Notes

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

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