Drug & Device Pipeline News

May 2, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Gamida Cell	GDA-201	B-cell lymphomas	IND approved by the FDA
Moleculin Biotech	WP1066	Recurrent malignant glioma	IND approved by the FDA
Quoin Pharmaceuticals	QRX003	Netherton syndrome	IND approved by the FDA
Sorrento Therapeutics	STI-9167 (Intravenous COVISHIELD)	COVID-19	IND approved by the FDA
Renovion	ARINA-1	Noncystic fibrosis bronchiectasis	Study may proceed letter issued by the FDA for phase 2 trial
Direct Biologics	ExoFlo	Acute respiratory distress syndrome due to COVID-19	Phase 3 trial approved by the FDA
Alterity Therapeutics	ATH434	Multiple system atrophy	Phase 2 trial authorized by the UK regulatory authority
Lemonex	LEM-S401	Hypertrophic scars	IND approved by South Korea’s regulatory authority
Trials Initiated
Starton Therapeutics	24-hour continuous subcutaneous infusion of lenalidomide	Multiple myeloma	Initiation of phase 1 trial in the Netherlands
Phio Pharmaceuticals	PH-762	Advanced melanoma	Initiation of phase 1b trial
Biomind Labs	BMND01 (inhaled formulation of N,N-dimethyltryptamine)	Treatment-resistant depression	Initiation of phase 1/2a trial
SOTIO Biotech	SOT102	Gastric and pancreatic cancer	Initiation of phase 1/2 trial
VITRAC Therapeutics	VIC-1911	Graft-vs.-host disease prophylaxis	Initiation of phase 1/2 trial
Arrowhead Pharmaceuticals	ARO-ANG3	Homozygous familial hypercholesterolemia	Initiation of phase 2 trial
Fervent Pharmaceuticals	FP-101	Symptoms of menopause	Initiation of phase 2 trial
HiberCell	Odetiglucan plus Keytruda (pembrolizumab)	Metastatic, hormone-refractory breast cancer	Initiation of phase 2 trial
Lyra Therapeutics	LYR-220	Postsurgical chronic rhinosinusitis	Initiation of phase 2 trial
Tryp Therapeutics	TRP-8802 in combination with psychotherapy	Binge eating disorder	Initiation of phase 2 trial
HighTide Therapeutics	HTD1801	Type 2 diabetes	Initiation of phase 2 trial in China
Citius Pharmaceuticals	Halo-Lido	Hemorrhoids	Initiation of phase 2b trial
Harmony Biosciences	Pitolisant	Idiopathic hypersomnia	Initiation of phase 3 trial
Novavax	NVX-CoV2373, COVID-19 vaccine	COVID-19	Initiation of phase 3 booster expansion trial in adolescents
Sedana Medical	Inhaled isoflurane	Sedation of adult mechanically ventilated ICU patients	Initiation of two phase 3 trials
Approvals
Gilead	Veklury (remdesivir)	COVID-19 in pediatric patients older than 28 days	Approved by the FDA for expanded indication
Mycovia Pharmaceuticals	Vivjoa (oteseconazole capsules)	Recurrent vulvovaginal candidiasis (chronic yeast infection)	Approved by the FDA
Biohaven Pharmaceuticals Pfizer	Vydura (rimegepant)	Acute treatment of migraine and prophylaxis of episodic migraine	Approved by the European Commission
Vifor Fresenius Medical Care Renal Pharma Cara Therapeutics	Kapruvia (difelikefalin)	Moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients	Approved by the European Commission