Drug & Device Pipeline News

October 11, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
4D Molecular Therapeutics	4D-150	Wet age-related macular degeneration	IND approved by the FDA
4D Molecular Therapeutics	4D-710	Cystic fibrosis	IND approved by the FDA
Tenax Therapeutics	Delayed-release imatinib	Pulmonary arterial hypertension	IND approved by the FDA
Cocrystal Pharma	CC-42344	Pandemic and seasonal influenza A	Approval for a phase 1 trial granted by Australia’s regulatory authority
Revelation Biosciences	REVTx-99	Allergic rhinitis and chronic nasal congestion	Approval for a phase 1b trial granted by Australia’s regulatory authority
Intellia Therapeutics	NTLA-2002	Adults with hereditary angioedema	Approval for a phase 1/2 trial granted by New Zealand’s regulatory authority
Pharmaxis	PXS-5505	Bone marrow cancer myelofibrosis	Approval for the phase 2 portion of a phase 1c/2a trial approved by the FDA
Trials Initiated
AlzeCure Pharma	ACD856	Alzheimer’s disease	Initiation of phase 1 trial
Antares Pharma	ATRS-1902	Adrenal crisis rescue	Initiation of phase 1 trial
Appello Pharmaceuticals	AP-472	Parkinson’s disease	Initiation of phase 1 trial
Dialectic Therapeutics	DT2216	Relapsed or refractory solid tumor and hematologic malignancies	Initiation of phase 1 trial
Inhalon Biopharma	IN-006	Treatment of COVID-19	Initiation of phase 1 trial
Rafael Pharmaceuticals	CPI-613 (devimistat) in combination with hydroxychloroquine	Clear-cell sarcoma	Initiation of phase 1 trial
Altimmune	pemvidutide	Nonalcoholic fatty liver disease	Initiation of phase 1b trial
Elicio Therapeutics	ELI-002	mKRAS+ solid tumors	Initiation of phase 1/2 trial
Lutris Pharma	LUT014	Radiation-induced dermatitis in breast cancer patients	Initiation of part two of phase 1/2 trial
Precirix NV	CAM-H2	HER2-positive metastatic cancer	Initiation of phase 1/2 trial
Viracta Therapeutics	nanatinostat plus valganciclovir	EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors	Initiation of phase 1b/2 trial
Boston Pharmaceuticals	BOS-580	Nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis	Initiation of phase 2a trial
BioNTech	BNT122 (autogene cevumeran) personalized vaccine	Stage II/III colorectal cancer	Initiation of phase 2 trial
Covicept Therapeutics	PSJ-539	Mild-to-moderate COVID-19	Initiation of phase 2 trial
PharmaTher Holdings	ketamine	Levodopa-induced dyskinesia in patients with Parkinson’s disease	Initiation of phase 2 trial
Vaxart	COVID-19 oral tablet vaccine	Prevention of COVID-19	Initiation of phase 2 trial
Cassava Sciences	simufilam	Alzheimer’s disease	Initiation of phase 3 trial
VYNE Therapeutics	Amzeeq (minocycline) topical foam, 4%	Moderate-to-severe acne	Initiation of phase 3 trial in China
Approvals
PerkinElmer	PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay	RT-PCR test to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus	Emergency Use Authorization granted by the FDA
Kite Pharmaceuticals	Tecartus (brexucabtagene autoleucel)	Adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia	Approved by the FDA
ChoiceSpine	Triton sacroiliac joint fixation system	Degenerative sacroiliitis and sacroiliac joint disruption	Approved by the FDA