Drug & Device Pipeline News

July 18, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
SCG Cell Therapy	SCG101	Hepatitis B virus-related liver cancer	IND approved by the FDA for phase 1/2 trials
Annovis Bio	Buntanetap	Early Parkinson’s disease	Study May Proceed letter issued by the FDA for phase 3 trial
Nyxoah	Genio system	Moderate-to-severe obstructive sleep apnea and complete concentric collapse of the soft palate	IDE approved by the FDA
Dyne Therapeutics	DYNE-101	Myotonic dystrophy type 1	Phase 1/2 trial approved by New Zealand’s regulatory authority
Rznomics	RZ001	Liver cancer	IND approved by South Korea’s regulatory authority for phase 1/2a trial
Trials Initiated
Biomica	BMC128 plus Opdivo	Non-small cell lung cancer, melanoma or renal cell carcinoma	Initiation of phase 1 trial
Bio-Thera Solutions	BAT8006	Advanced solid tumors	Initiation of phase 1 trial
Endevica Bio	TCMCB07	Cachexia	Initiation of phase 1 trial
Moderna Therapeutics	mRNA-1215 Nipah virus vaccine	Nipah virus	Initiation of phase 1 trial
Propanc Biopharma	PRP (trypsinogen and chymotrypsinogen)	Advanced cancer	Initiation of phase 1 trial
Pulmatrix	PUR3100	Acute migraine	Initiation of phase 1 trial
Verve Therapeutics	VERVE-101	Heterozygous familial hypercholesterolemia	Initiation of phase 1 trial
Clinilabs Drug Development	CYB003	Major depressive disorder	Initiation of phase 1/2a trial
SunHo BioPharmaceutical	IAP0971	Locally advanced or metastatic malignant tumors	Initiation of phase 1/2 trial
SunHo BioPharmaceutical	IAE0972	Locally advanced or metastatic malignant tumors	Initiation of phase 1/2 trial
Edgewise Therapeutics	EDG-5506	Becker muscular dystrophy	Initiation of phase 2 trial
Tetra Therapeutics	BPN14770 (zatolmilast)	Fragile X syndrome	Initiation of phase 2b/3 trial
Overland ADCT BioPharma	Zynlonta plus rituximab	Diffuse large B-cell lymphoma	Initiation of phase 3 trial in China
Biohaven Pharmaceuticals	Taldefgrobep alfa	Spinal muscle atrophy	Initiation of phase 3 trial
Radius Health	RAD011	Prader-Willi syndrome	Initiation of phase 2/3 trial
Approvals
Horizon Therapeutics	Krystexxa (pegloticase) injection co-administered with methotrexate	Uncontrolled gout	Approved by the FDA for expanded indication
Novavax	COVID-19 Vaccine	COVID-19	Emergency Use Authorization granted by the FDA
Aurora Spine	ZIP MIS implants	Lumbar spinal stenosis	Approved by the FDA for new indication
Renovia	Leva Pelvic Health System	Chronic fecal incontinence in women	Approved by the FDA