Drug & Device Pipeline News

April 4, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
HLT Medical	HLT Meridian TAVR Valve System	Aortic disease	Approval for two clinical studies granted by the FDA
Pipeline Therapeutics	PIPE-307	Relapsing-remitting multiple sclerosis	IND approved by the FDA
ReAlta Life Sciences	RLS-0071	Infants with hypoxic-ischemic encephalopathy	IND approved by the FDA
Sorrento Therapeutics	Abivertinib	Hospitalized patients with severe pneumonia due to COVID-19	Approval for a phase 3 trial granted by the FDA
Antengene	ATG-016	High-risk myelodysplastic syndromes	IND approved by China’s regulatory authorities
InnoCare Pharma	ICP-488	Autoimmune diseases	IND approved by China’s regulatory authorities
JW Therapeutics	Carteyva (relmacabtagene autoleucel injection)	Large B-cell lymphoma	IND approved by China’s regulatory authorities
Trials Initiated
Accutar Biotechnology	AC0176	Metastatic castration-resistant prostate cancer	Initiation of phase 1 trial
Anixa Biosciences	CER-T therapy	Ovarian cancer	Initiation of phase 1 trial
CStone Pharmaceuticals	CS5001	B-cell lymphomas and solid tumors	Initiation of phase 1 trial
CureVac GlaxoSmithKline	CV2CoV COVID-19 vaccine	COVID-19	Initiation of phase 1 trial
HDT Bio	HDT-301 COVID-19 vaccine	COVID-19	Initiation of phase 1 trial
Innovent Biologics	IBI389	Advanced solid tumors	Initiation of phase 1a/1b trial
Prothena	PRX012	Alzheimer’s disease	Initiation of phase 1 trial
Airway Therapeutics	AT-100	Preterm infants at risk for bronchopulmonary dysplasia	Initiation of phase 1b trial
Tiziana Life Sciences	Foralumab oral capsules	Crohn's disease	Initiation of phase 1b trial
Clarity Pharmaceuticals	64Cu SAR-bisPSMA	Prostate cancer	Initiation of phase 1/2 trial
Genprex	Reqorsa Immunogene Therapy plus Keytruda	Nonsmall-cell lung cancer	Initiation of phase 1/2 trial
Ribon Therapeutics	RBN-2397 plus Keytruda	Squamous-cell carcinoma of the lung	Initiation of phase 1b/2 trial
Sangamo Therapeutics	TX200	Kidney transplant	Initiation of phase 1/2 trial
Sumitomo Dainippon Pharma Oncology	DSP-5336	Relapsed or refractory acute myeloid leukemia or acute lymphocytic leukemia	Initiation of phase 1/2 trial
Acer Therapeutics	ACER-801	Vasomotor symptoms associated with menopause	Initiation of phase 2a trial
Morphic Therapeutic	MORF-057	Moderate-to-severe ulcerative colitis	Initiation of phase 2a trial
PTC Therapeutics	PTC518	Huntington's disease	Initiation of phase 2 trial
Prometheus Bioscience	PRA023	Systemic sclerosis-associated interstitial lung disease	Initiation of phase 2 trial
Taysha Gene Therapies	TSHA-102	Rett syndrome	Initiation of phase 1/2 trial in Canada
Aristea Therapeutics	RIST4721	Palmoplantar pustulosis	Initiation of phase 2b trial
Angiocrine Bioscience	AB-205	Lymphoma patients undergoing autologous hematopoietic cell transplantation	Initiation of phase 3 trial
GE Healthcare	PET radiopharmaceutical	Parkinsonian syndromes	Initiation of phase 3 trial
MaaT Pharma	MaaT013	Acute graft-vs.-host disease with gastrointestinal involvement	Initiation of phase 3 trial
Vaxxinity	UB-612 COVID-19 booster	COVID-19	Initiation of phase 3 trial
Approvals
Antares Pharma	Tlando (testosterone undecanoate)	Hypogonadism in adult males	Approved by the FDA
Janssen	Cabenuva (cabotegravir and rilpivirine)	HIV-1	Approved by the FDA for expanded indication
Moderna	mRNA-1273 COVID-19 vaccine	COVID-19	Emergency Use Authorization granted by the FDA for a second booster
Novo Nordisk	Ozempic (semaglutide)	Type 2 diabetes	Approved by the FDA for new dose formulation
UCB	Fintepla (fenfluramine)	Lennox-Gastaut syndrome	Approved by the FDA for new indication
STAAR Surgical	EVO/EVO+ Visian Implantable Collamer Lens	Myopia and myopia with astigmatism	Approved by the FDA
Gilead	Jyseleca (filgotinib)	Ulcerative colitis	Approved in Japan
Neurocrine Biosciences Mitsubishi Tanabe Pharma	Dysval (valbenazine)	Tardive dyskinesia	Approved in Japan
Sanofi	Xenpozyme (olipudase alfa)	Acid sphingomyelinase deficiency	Approved in Japan