Drug & Device Pipeline News

June 20, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Jazz Pharmaceuticals Redx	JZP815	Solid tumors and hematologic malignancies that contain MAPK mutations	IND approved by the FDA
Phanes Therapeutics	PT886	Gastric, gastroesophageal junction and pancreatic cancers	IND approved by the FDA
Tremeau Pharmaceuticals	TRM-201 (rofecoxib)	Acute migraine	Study May Proceed letter issued by the FDA
Trials Initiated
Clover Biopharmaceuticals	SCB-219M	Chemotherapy-induced thrombocytopenia	Initiation of phase 1 trial
Halia Therapeutics	HT-6184	Chronic inflammatory diseases	Initiation of phase 1 trial
KeyMed Biosciences	CM350	Solid tumors	Initiation of phase 1 trial
Kymera Therapeutics	KT-333	Relapsed/refractory liquid and solid tumors	Initiation of phase 1 trial
Kymera Therapeutics	KT-413	Relapsed/refractory B cell lymphomas	Initiation of phase 1 trial
Regulus Therapeutics	RGLS8429	Autosomal dominant polycystic kidney disease	Initiation of phase 1 trial
Surrozen	SZN-043	Severe alcoholic hepatitis	Initiation of phase 1 trial
Ortho Regenerative Technologies	ORTHO-R	Rotator cuff tear repair	Initiation of phase 1/2 trial
Treadwell Therapeutics	CFI-402257	Advanced solid tumors and ER+/Her2- breast cancer	Initiation of phase 1b/2 trial
Galecto	GB1211 plus Tecentriq	Non-small cell lung cancer	Initiation of phase 2a trial
Inhibikase Therapeutics	IkT-148009	Parkinson's disease and related disorders	Initiation of phase 2a trial
Kangpu Biopharmaceuticals	KPG-818	Systemic lupus erythematosus	Initiation of phase 2a trial
Amytrx Therapeutics	AMTX-100 CF3	Atopic dermatitis	Initiation of phase 2 trial
HUYA Bioscience	HBI-3000	Cardioversion of atrial fibrillation	Initiation of phase 2 trial
Cend Therapeutics	CEND-1	First-line metastatic pancreatic ductal adenocarcinoma	Initiation of phase 2b trial
Clover Biopharmaceuticals	SCB-2019 COVID-19 booster	COVID-19	Initiation of phase 3 trial
Daiichi Sankyo AstraZeneca	Datopotamab deruxtecan (Dato-DXd)	Previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer	Initiation of phase 3 trial
Swing Therapeutics	Digital ACT device	Fibromyalgia	Initiation of phase 3 trial
Approvals
Alnylam Pharmaceuticals	Amvuttra (vutrisiran)	Polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults	Approved by the FDA
Eli Lilly	Olumiant (baricitinib) oral tablets	Severe alopecia areata in adults	Approved by the FDA for new indication
Medicalgorithmics	Qpatch (ECG wearable unit)	Cardiac arrhythmia diagnosis	Approved by the FDA
Amylyx Pharmaceuticals	Albrioza (AMX0035)	Amyotrophic lateral sclerosis	Approved in Canada
Everest Medicines	Trodelvy (sacituzumab govitecan)	Second-line metastatic triple-negative breast cancer in adults	Approved in China