Company Product Description Indication Status
Akouos Inc., of Boston AK-OTOF Gene therapy Otoferlin gene-mediated hearing loss FDA granted orphan drug and rare pediatric disease designations
Avenue Therapeutics Inc., of New York Tramadol (intravenous) Opioid receptor mu agonist Acute pain FDA is still reviewing its NDA and has not provided a decision; an acknowledgement letter from FDA in February 2021 stated that the resubmission of its NDA was a complete, class 1 response to the CRL dated October 9, 2020, and the resubmission had been assigned a PDUFA goal date of April 12, 2021
Axcella Health Inc., of Cambridge, Mass. AXA-1125 Endogenous metabolic modulator Nonalcoholic steatohepatitis FDA cleared the IND application, enabling the company to initiate a phase IIb trial
Celularity Inc., of Florham Park, N.J. CYNK-001 Cryopreserved human placental hematopoietic stem cell-derived NK cell therapy Malignant gliomas FDA granted orphan drug designation
Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson Janssen COVID-19 vaccine candidate Single-dose vaccine developed using the Advac platform COVID-19 prophylaxis CDC and FDA issued a joint statement, which stated they are reviewing data involving 6 reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine; CDC will convene a meeting on April 14, 2021, to further review these cases and assess their potential significance, and FDA will review that analysis as it also investigates these cases; until that process is complete, the agencies are recommending a pause in the use of this vaccine
Kibow Biotech Inc., of Newtown Square, Pa. US-APR-2020 Natural probiotics formulation that metabolizes nitrogenous waste Chronic kidney disease stage IV FDA approved the IND to initiate phase II trials
Lintonpharm Co. Ltd., of Guangzhou, China Catumaxomab T-cell engaging bispecific antibody Non-muscle invasive bladder cancer China's NMPA authorized the company to proceed with a phase I/II trial evaluating the safety and efficacy
Neuraptive Therapeutics Inc., of Philadelphia NTX-001 Drug-device combination Prevention of postoperative facial paralysis requiring surgical repair FDA cleared the IND application and the company plans to initiate a phase II study later in 2021
Novartis AG, of Basel, Switzerland Xolair (omalizumab) Antibody designed to target and block immunoglobulin E Moderate to severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps FDA approved the sBLA for the prefilled syringe for self-injection in appropriate patients across all indications approved the U.S., where it is partnered with Genentech, a unit of Roche Holding AG
Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Received emergency use authorization in India
Vtv Therapeutics Inc., of High Point, N.C. TTP-399 Glucokinase activator Type 1 diabetes Received FDA breakthrough therapy designation

Notes

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