Drug & Device Pipeline News

April 17, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Aviceda Therapeutics	AVD-104	Geographic atrophy secondary to age-related macular degeneration	IND for a phase 2 trial approved by the FDA
Trials Initiated
QurAlis	QRL-201	Amyotrophic lateral sclerosis	Initiation of a phase 1 trial
Sirnaomics	STP122G	Anticoagulation disorders	Initiation of a phase 1 trial
Vega Therapeutics	VGA039	Von Willebrand disease	Initiation of a phase 1 trial
SciNeuro Pharmaceuticals	SNP318	Neurodegenerative and inflammatory diseases	Initiation of a phase 1 trial in Australia
Nuvectis Pharma	NXP800	Platinum-resistant, ARID1a-mutated ovarian carcinoma	Initiation of a phase 1b trial
HotSpot Therapeutics	HST-1011	Treatment of patients with advanced solid tumors who are relapsed/ refractory to anti-PD-L1 therapy	Initiation of a phase 1/2 trial
Kineta	KVA12123	Advanced solid tumors	Initiation of a phase 1/2 trial
ONL Therapeutics	ONL1204	Macula-off rhegmatogenous retinal detachment	Initiation of a phase 2 trial
Panbela Therapeutics	CPP-1X-T (eflornithine tablets)	Recent onset type 1 diabetes	Initiation of a phase 2 trial
Quadriga BioSciences	QBS72S	Brain metastases of breast cancers	Initiation of a phase 2 trial
Bridge Biotherapeutics	BBT-877	Idiopathic pulmonary fibrosis	Initiation of a phase 2a trial
Nuance Pharma	Ensifentrine	Maintenance treatment of chronic obstructive pulmonary disease	Initiation of a phase 3 trial in China
Approvals
Takeda	Hyqvia (immune globulin infusion 10% (human) with recombinant human hyaluronidase)	Primary immunodeficiency in children age two to 16 years	Approved by the FDA for expanded age indication