Company Product Description Indication Status
Bayer AG, of Leverkusen, Germany Xarelto (rivaroxaban) Oral factor Xa inhibitor Venous thromboembolism  Approved by the EMA to treat VTE and prevent VTE recurrence in children from birth to under 18 after at least 5 days of initial parenteral anticoagulation treatment, including catheter-related thrombosis, cerebral vein and sinus thrombosis
Bristol Myers Squibb Co., of New York Zeposia (ozanimod) Oral S1P receptor modulator Moderately to severely active ulcerative colitis FDA accepted the supplemental NDA for use in adults; following redemption of a priority review voucher, FDA assigned a PDUFA date of May 30, 2021
Cerecor Inc., of Rockville, Md. CERC-803 (L-fucose) Substrate replacement therapy Leukocyte adhesion deficiency type II FDA granted fast track designation
Chinook Therapeutics Inc., of Vancouver, British Columbia CHK-336 Oral small-molecule inhibitor of lactate dehydrogenase A Primary hyperoxaluria  FDA granted rare pediatric disease designation
Durect Corp., of Cupertino, Calif. Posimir (bupivacaine extended-release solution) Binds to intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells Postoperative pain FDA approved it for postsurgical pain reduction for up to 72 hours following arthroscopic subacromial decompression
Kintor Pharmaceutical Ltd., of Suzhou, China GT-20029 Topical androgen receptor  Androgenetic alopecia and acne vulgaris China's NMPA accepted the IND application
Mustang Bio Inc., of Worcester, Mass. MB-107 Lentiviral gene therapy X-linked severe combined immunodeficiency FDA removed the clinical hold for the pivotal phase II trial
Neurmedix, LLC, of San Diego NE-3107 Orally administered, anti-inflammatory, insulin-sensitizing agent  Alzheimer’s disease Received FDA authorization to initiate a pivotal phase III trial 
Paxmedica Inc., of Woodcliff Lake, N.J. PAX-101 I.V. suramin Human African trypanosomiasis  FDA granted orphan drug designation 
Russian Direct Investment Fund, of Moscow Sputnik V Adenoviral vector-based vaccine COVID-19 prophylaxis Approved by the Ministry of Health of Tunisia
Sesen Bio Inc., of Cambridge, Mass. Vicineum (oportuzumab monatox) EpCAM modulator BCG-unresponsive non-muscle invasive bladder cancer Completed a successful application orientation meeting with the FDA regarding its BLA
SQZ Biotechnologies Inc., of Watertown, Mass. SQZ-AAC-HPV SQZ activating antigen carrier, a cell therapy candidate generated from red blood cells engineered with tumor-specific antigen HPV+ tumors The FDA cleared the IND application 
VBI Vaccines Inc., of Cambridge Mass. 3-antigen hepatitis B virus vaccine S, pre-S1 and pre-S2 surface antigens of the hepatitis B virus HBV infection prophylaxis FDA accepted the BLA filing

Notes

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