Drug & Device Pipeline News

September 26, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Alterity Therapeutics	ATH434	Multiple system atrophy	IND approved by the FDA
Artiva Biotherapeutics	AB-201	HER2-expressing cancer	IND approved by the FDA
Immunitas Therapeutics	IMT-009	Solid tumors and hematological malignancies	IND approved by the FDA
Verismo Therapeutics	SynKIR-110	Mesothelin-expressing ovarian cancer, cholangiocarcinoma and mesothelioma	IND approved by the FDA
Xpira Pharmaceuticals	Psilocybin	Anorexia nervosa	IND approved by the FDA
Belite Bio	LBS-008	Stargardt disease	Approval for a phase 3 trial granted by China’s regulatory authority
Psyence	Psilocybin	Adjustment disorder due to an incurable cancer diagnosis	Approval for a phase 2a trial granted by the UK regulatory authority
Trials Initiated
Mind Medicine	MDMA-like substances	Mood disorders	Initiation of phase 1 trial
RVAC Medicines	RVM-V001 vaccine	COVID-19	Initiation of phase 1 trial
Revolution Medicines	RMC-6291	Cancers driven by the KRASG12C mutation	Initiation of phase 1 trial
Amydis Diagnostics	AMDXP-2011P	Parkinson’s disease and amyotrophic lateral sclerosis	Initiation of phase 1/2 trial
Immunis Biomedical	IMM01-STEM	Muscle atrophy	Initiation of phase 1/2 trial
Glyscend Therapeutics	GLY-200	Type 2 diabetes	Initiation of phase 2 trial
Vir Biotechnology	VIR-2218 and VIR-3434	Chronic hepatitis D virus	Initiation of phase 2 trial
Genelux	Olvimulogene nanivacirepvec	Platinum-resistant/refractory ovarian cancer	Initiation of phase 3 trial
POP Biotechnologies	EuCorVac-19 vaccine	COVID-19	Initiation of phase 3 trial
Approvals
Bluebird Bio	Skysona (elivaldogene autotemcel)	Cerebral adrenoleukodystrophy	Approved by the FDA
Biocodex	Diacomit (stiripentol)	Seizures associated with Dravet syndrome	Approved by the FDA for expanded age indication
Eli Lilly	Retevmo (selpercatinib)	Advanced or metastatic solid tumors with an RET gene fusion	Approved by the FDA
Heron Therapeutics	Aponvie (aprepitant)	Postoperative nausea and vomiting	Approved by the FDA
Marius Pharmaceuticals	Kyzatrex (testosterone undecanoate)	Hypogonadism	Approved by the FDA
Edwards Lifesciences	PASCAL Precision transcatheter valve repair system	Degenerative mitral regurgitation	Approved by the FDA
AstraZeneca Merck	Lynparza (olaparib)	HRD-positive ovarian cancer	Approved in China