Drug & Device Pipeline News - June 24, 2024

June 24, 2024

This week’s Pipeline features a phase 1 trial approval for type 2 diabetes, a phase 3 trial start for NRAS-mutant melanoma and an FDA drug approval for infantile spasms in pediatric patients.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Vivani Medical	NPM-119	Type 2 diabetes	IND for a phase 1 trial approved by the FDA
Zymeworks	ZW171	Mesothelin-expressing cancers	IND for a phase 1 trial approved by the FDA
NMD Pharma	NMD670	Charcot-Marie tooth disease type 1 and type 2	IND for a phase 2 trial approved by the FDA
NovelMed Therapeutics	Ruxoprubart	ANCA-associated vasculitis	IND for a phase 2 trial approved by the FDA
Trials Initiated
Aprea Therapeutics	APR-1051	Advanced solid tumors	Initiation of a phase 1 trial
Cytokinetics	Aficamten	Hypertrophic cardiomyopathy	Initiation of a phase 1 trial
LG Chem	LB-LR1109	Unresectable metastatic solid tumors	Initiation of a phase 1 trial
Spyre Therapeutics	SPY001	Inflammatory bowel disease	Initiation of a phase 1 trial
VYNE Therapeutics	VYN202	Immunoinflammatory diseases	Initiation of a phase 1a trial
Mozart Therapeutics	MTX-101	Autoimmune diseases	Initiation of a phase 1a/1b trial
Assembly Biosciences	ABI-4334	Chronic hepatitis B virus	Initiation of a phase 1b trial
Erasca	Naporafenib	NRAS-mutant melanoma	Initiation of a phase 3 trial
Immunocore	Brenetafusp	First-line advanced or metastatic cutaneous melanoma	Initiation of a phase 3 trial
Approvals
Biotest	Yimmugo (immune globulin intravenous, human-dira)	Primary immunodeficiency in patients age two years and over	Approved by the FDA
Pyros Pharmaceutical	Vigafyde (vigabatrin oral solution)	Infantile spasms in patients aged one month to two years	Approved by the FDA
AbbVie	Skyrizi (risankizumab-rzaa)	Moderate-to- severe ulcerative colitis	Approved by the FDA for a new indication
Amgen	Blincyto (blinatumomab)	CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase in patients age one month and older	Approved by the FDA for expanded indication
Merck	Keytruda (pembrolizumab)	Primary advanced or recurrent endometrial carcinoma	Approved by the FDA for expanded indication
SOBI	Altuvoct (efanesoctocog alfa)	Bleeds and perioperative prophylaxis in hemophilia A	Approved by the European Commission