Company Product Description Indication Status
Aeglea Biotherapeutics Inc., of Austin, Texas ACN-00177 Engineered human enzyme therapy designed to lower total level of homocysteine in plasma Homocystinuria FDA granted orphan designation
Bayer AG, of Leverkusen, Germany Foundationone CDx Companion diagnostic Cancer Approved by FDA to help identify NTRK gene fusion-positive patients for whom treatment with Vitrakvi (larotrectinib) may be appropriate 
Bioinvent International AB, of Lund, Sweden BI-1808 Type II TNF receptor modulator Solid tumors and cutaneous T-cell lymphoma Received regulatory authority approval of CTA in Denmark for a phase I/IIa study testing monotherapy and combination with Keytruda (pembrolizumab, Merck & Co. Inc.)
Bioxcel Therapeutics Inc., of New Haven, Conn. BXCL-501 Orally dissolving sublingual thin film formulation of dexmedetomidine Agitation associated with delirium FDA cleared IND; phase II study set to start within next several months
Forte Biosciences Inc., of Torrance, Calif. FB-401 Topically applied live biotherapeutic consisting of strains of commensal Roseomonas mucosa Atopic dermatitis FDA granted fast track designation
Janssen Pharmaceutical Cos., of Raritan, N.J., part of Johnson & Johnson Xarelto (rivaroxaban) Factor Xa antagonist Peripheral artery disease Submitted supplemental NDA to FDA to expand use in patients with PAD
Nicox SA, of Sophia Antipolis, France, and Ocumension Therapeutics Ltd., of Shanghai NCX-470 Second-generation nitric oxide-donating bimatoprost analogue Open-angle glaucoma or ocular hypertension Received approval from China’s Center for Drug Evaluation of the NMPA to carry out the Chinese part of the ongoing Mont Blanc trial, the first phase III trial testing the drug in lowering of intraocular pressure in open-angle glaucoma or ocular hypertension
Nitric Oxide Innovations LLC, of Austin, Texas Noviricid  Sodium nitrite dosing in oral lozenge COVID-19 FDA cleared IND for phase IIb/IIIa outpatient study in African Americans diagnosed with COVID-19
Passage Bio Inc., of Philadelphia PBGM-01 AAV-based gene therapy GM1 gangliosidosis European Commission granted orphan designation
Santen Inc., of Emeryville, Calif. Cyclosporine topical ophthalmic emulsion 0.1% Cyclosporine topical ophthalmic emulsion 0.1% Severe vernal keratoconjunctivitis FDA accepted NDA and set PDUFA date of June 26, 2021
Sesen Bio Inc., of Cambridge, Mass. Vicineum Locally administered fusion protein BCG-unresponsive non-muscle invasive bladder cancer Completed pre-submission meeting with EMA, addressing product-specific, legal, regulatory and scientific topics; agency also provided guidance on various administrative topics to clarify regulatory path forward; company intends to complete all necessary pre-submission activities for MAA by end of 2020
Spectrum Pharmaceuticals Inc., of Henderson, Nev. Rolontis (eflapegrastim) G-CSF analogue Neutropenia in patients on myelosuppressive cancer drugs FDA informed company it was unable to conduct inspection of manufacturing plan during the current BLA review cycle due to COVID-19-related travel restrictions; agency is deferring action until an inspection can be completed 
Tracon Pharmaceuticals Inc., of San Diego TRC-102 (methoxyamine)  Small-molecule inhibitor of DNA base excision repair pathway Malignant glioma FDA granted orphan designation for malignant glioma, including glioblastoma
Y-mabs Therapeutics Inc., of New York 177Lu-omburtamab-DTPA Omburtamab antibody radiolabeled with lutetium-177 B7-H3+ CNS and leptomeningeal metastasis from tumors FDA cleared the IND for testing in adults; phase I/II study expected to open for screening during fourth quarter of 2020

Notes

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