Company Product Description Indication Status
Adaptive Phage Therapeutics Inc., of Gaithersburg, Md. Phagebank  Phage therapy Diabetic foot osteomyelitis FDA accepted the IND
Amgen Inc., of Thousand Oaks, Calif. Avsola (infliximab) Biosimilar of anti-TNF-alpha drug Remicade Chronic inflammatory diseases Registration obtained by Brazil’s ANVISA for the same indications as Remicade, including psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis and plaque psoriasis
Circ Biosciences Inc., of Chicago Chemically induced photoreceptor-like cells Chemically induced photoreceptor-like cells Retinitis pigmentosa FDA granted orphan designation
Demerx IB Inc., of New York, an Atai Life Sciences platform company Ibogaine HCl (DMX-1002) Dopamine modulator Opioid use disorder Received approval from U.K.’s MHRA to start enrollment in phase I/IIa trial
Idorsia Ltd., of Allschwil, Switzerland Daridorexant Dual orexin receptor antagonist Insomnia FDA accepted the NDA seeking approval for use in adults; upon approval, the company anticipates U.S. launch in first half of 2022
Kiromic Biopharma Inc., of Houston chPD1 CAR T-cell therapy Solid tumors Plans to resubmit revised IND
Kiromic Biopharma Inc., of Houston Iso-Mesothelin CAR T-cell therapy Solid tumors Plans to resubmit revised IND
Lannett Co. Inc., of Philadelphia Biosimilar insulin glargine Insulin glargine Diabetes Received feedback from FDA related to pivotal trial protocol and statistical analysis plan; plans to submit IND to FDA in 2021 for a pivotal trial to start early in 2022
Linnaeus Therapeutics Inc., of Haddonfield, N.J. LNS-8801 Oral agonist of GPER Metastatic uveal melanoma FDA granted orphan designation
Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 Authorized for use in Morocco and Kenya
Tarus Therapeutics Inc., of New York TT-10 Oral, small molecule targeting adenosine A2A receptor Advanced solid tumors Submitted IND to FDA for a phase Ia/Ib study testing monotherapy and combination with other cancer agents
Vertex Pharmaceuticals Inc., of Boston VX-880 Allogeneic human stem cell-derived islet cell therapy Type 1 diabetes with severe hypoglycemia and impaired hypoglycemic awareness FDA granted fast track designation

Notes

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