Company Product Description Indication Status
Allogene Therapeutics Inc., of South San Francisco ALLO-316 CD70 antigen modulator Renal cell carcinoma FDA cleared IND; phase I study set to start in 2021
Alzecure Pharma AB, of Stockholm ACD-440 Vanilloid VR1 antagonist Neuropathic pain German regulators cleared start of phase Ib study testing topical drug; results expected in first half of 2021
Antengene Corp. Ltd., of Shanghai and Hong Kong ATG-010 (selinexor) Nuclear export protein exportin 1 inhibitor Relapsed/refractory diffuse large B-cell lymphoma China’s NMPA accepted IND for a phase II/III trial testing combination with R-GDP
Artiva Biotherapeutics Inc., of San Diego AB-101 Optimized and cryopreserved off-the-shelf NK cell therapy Relapsed/refractory B-cell non-Hodgkin lymphoma FDA cleared IND for a phase I/II study testing drug alone and in combination with rituximab in patients who have progressed beyond 2 or more prior lines of therapy
Bellicum Pharmaceuticals Inc., of Houston BPX-601 GoCAR-T candidate Metastatic pancreatic or prostate cancers FDA placed clinical hold on patient enrollment and dosing in ongoing phase I/II trial in previously treated patients, following a death of pancreatic cancer patient; clinical investigator and Bellicum classified death as unrelated to BPX-601 and rimiducid
Chimerix Inc., of Durham, N.C. Brincidofovir Nucleotide analogue lipid-conjugate Smallpox FDA accepted the filing of NDA seeking approval as a medical countermeasure; agency granted priority review and set PDUFA date of April 7, 2021
Immunicum AB, of Stockholm Ilixadencel Cell-based, off-the-shelf immune primer Gastrointestinal stromal tumors FDA granted fast track designation
Kronos Bio Inc., of San Mateo, Calif. KB-0742 Selective, oral inhibitor of CDK9 Advanced solid tumors FDA cleared IND for phase I/II study, set to start in first quarter of 2021
Lipocine Inc., of Salt Lake City Tlando  Testosterone replacement therapy Hypogonadism FDA informed company it is continuing to work toward taking action on the NDA during week of Dec. 7, 2020; however, company cannot assure that FDA will act in that time frame
Neuren Pharmaceuticals Ltd., of Melbourne, Australia NNZ-2591 Synthetic analogue of molecule derived from IGF-1 Phelan-McDermid syndrome EMA issued positive opinion for orphan designation
Neuren Pharmaceuticals Ltd., of Melbourne, Australia NNZ-2591 Synthetic analogue of molecule derived from IGF-1 Angelman syndrome EMA issued positive opinion for orphan designation
Neuren Pharmaceuticals Ltd., of Melbourne, Australia NNZ-2591 Synthetic analogue of molecule derived from IGF-1 Pitt Hopkins syndrome EMA issued positive opinion for orphan designation
Novo Nordisk A/S, of Bagsvaerd, Denmark Saxenda (liraglutide) GLP-1 receptor agonist Obesity FDA approved updated label for use in treating adolescents, ages 12-17, with body weight above 60 kg and initial body mass index corresponding to 30 kg/m2 or greater for adults, as an adjunct to reduced-calorie meals and increased physical activity
Scpharmaceuticals Inc., of Burlington, Mass. Furoscix  Furosemide solution formulated to a neutral pH Worsening heart failure due to congestion Received complete response letter from FDA; agency cited its need to conduct pre-approval inspections at 2 third-party manufacturing facilities that could not be conducted due to travel restrictions; FDA also raised questions related to testing, labeling and features of the combination product unrelated to the drug constituent
Scynexis Inc., of Jersey City, N.J. Ibrexafungerp Antifungal Vulvovaginal candidiasis FDA accepted for filing the NDA; agency granted priority review and set PDUFA date of June 1, 2021
Sol-Gel Technologies Ltd., of Ness Ziona, Israel Twyneo (benzoyl peroxide and tretinoin) Retinoic acid receptor agonist Acne vulgaris FDA accepted for filing the NDA; PDUFA date of Aug. 1, 2021
Viracta Therapeutics Inc., of San Diego Nanatinostat and valganciclovir HDAC 1/2/3 inhibitor Relapsed/refractory Epstein-Barr virus-positive lymphomas Based on outcome of end-of-phase II meeting with FDA, company intends to initiate global registration study in first half of 2021, designed to support multiple potential marketing approvals across various subtypes of EBV+ lymphoma
Yiling Pharmaceutical Co. Ltd., of Shijiazhuang City, China Lianhua qingwen capsules Traditional Chinese medicine COVID-19 Approved by China’s NMPA to treat lightly and ordinarily infected patients

Notes

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