Company Product Description Indication Status
Acadia Pharmaceuticals Inc., of San Diego Nuplazid (pimavanserin) Selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors Dementia-related psychosis FDA accepted for filing supplemental NDA seeking approval to treat hallucinations and delusions associated with DRP
Arcturus Therapeutics Holdings Inc., of San Diego, and Duke-NUS Medical School in Singapore Lunar-COV19 Vaccine COVID-19 Clinical trial application approved by Singapore Health Sciences Authority; dosing to begin shortly in up to 108 adults, including older adults, to evaluate several dose levels
Chemomab Ltd., of Tel Aviv, Israel CM-101 Humanized monoclonal antibody targeting CCL24 Primary sclerosing cholangitis Received approvals in the U.K. and Israel for a phase IIa trial 
Genor Biopharma Co. Inc., of Hong Kong Geptanolimab PD-1 monoclonal antibody Peripheral T-cell lymphoma China’s NMPA accepted NDA
Grunenthal GmbH, of Aachen, Germany, and subsidiary Averitas Pharma Inc. Qutenza (capsaicin) 8% patch TRPV1 agonist Neuropathic pain associated with diabetic peripheral neuropathy of the feet Approved by FDA
Janone Inc., of Las Vegas TV-1001SR Sodium nitrate tablets Peripheral artery disease Received confirmation from FDA of the transfer of the IND previously held by Soin Neuroscience 
Mesoblast Ltd., of Melbourne, Australia Ryoncil (remestemcel-L) Therapy comprising culture-expanded mesenchymal stem cells derived from bone marrow of unrelated donor Steroid-refractory acute graft-vs.-host disease  U.S. FDA’s Oncology Drugs and Advisory Committee scheduled a meeting Aug. 13, 2020, to review data supporting the BLA, seeking approval for use in children; BLA has action date of Sept. 30, 2020
Pieris Pharmaceuticals Inc., of Boston PRS-343 4-1BB/HER2 fusion protein HER2-positive solid tumors FDA placed partial clinical hold on phase I studies, while company conducts additional in-use and compatibility study requested by agency; currently enrolled patients may continue to receive treatment but no additional patients are to be enrolled until resolution of partial hold
Seelos Therapeutics Inc., of New York SLS-005 Transcription factor EB stimulator Sanfilippo syndrome EMA’s Committee for Orphan Medicinal Products issued positive opinion on orphan designation 

Notes

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

No Comments