|AI Therapeutics Inc., of Guilford, Conn.||LAM-002||PIKfyve kinase inhibitor that activates transcription factor EB||Follicular lymphoma||Conducted type C meeting with FDA and reached concurrence on design of a pivotal trial that could support accelerated approval|
|Arena Pharmaceuticals Inc., of San Diego||APD-418||β3-adrenergic receptor antagonist and cardiac myotrope||Decompensated heart failure||FDA granted fast track status|
|Cyprium Therapeutics Inc., of New York, a Fortress Biotech Inc. company||CUTX-101||Copper histidinate||Menkes disease||FDA granted rare pediatric disease designation|
|Genetex Biotherapeutics LLC, of Sarasota, Fla., and Ultragenyx Pharmaceutical Inc., of Novato, Calif.||GTX-102||Antisense oligonucleotide||Angelman syndrome||IND filed with FDA is active; enrollment in phase I/II study expected to start in first half of 2020|
|Intellipharmaceutics International Inc., of Toronto||Aximris XR (oxycodone extended-release tablets)||Long-acting, abuse-deterrent formulation of opioid drug||Pain||FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted to not support approval for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate|
|Nicox SA, of Sophia Antipolis, France, and Bausch + Lomb, of Rochester, N.Y.||Vyzulta (latanoprostene bunod ophthalmic solution) 0.024%||Prostaglandin F2 alpha analogue||Reduction of intraocular pressure in open-angle glaucoma or ocular hypertension||Bausch + Lomb received approval in Hong Kong and Argentina|
|TG Therapeutics Inc., of New York||Umbralisib||Oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon||Previously treated marginal zone lymphoma and follicular lymphoma||Initiated rolling NDA submission to FDA; expects to complete submission in first half of 2020|
For more information about individual companies and/or products, see Cortellis.