Pipeline

June 21, 2021

Company	Drug/Device	Medical Condition	Status
Asieris Pharmaceuticals	APL-1202 in combination with BeiGene's tislelizumab	neoadjuvant therapy in patients with muscle-invasive bladder cancer	IND approved by the FDA
ImmunityBio	Anktiva in combination with standard chemotherapy and Trodelvy (sacituzumab govitecan-hziy)	advanced triple-negative breast cancer	IND approved by the FDA
Oryzon Therapeutics	vafidemstat	borderline personality disorder	IND approved by the FDA for phase 2b trial
Xilio Therapeutics	XTX101	solid tumors	IND approved by the FDA
Siranomics	STP705	skin squamous-cell carcinoma in situ	IND approved by China’s National Medical Product Administration
LivaNova	aura6000 System, implantable hypoglossal neurostimulator	moderate-to-severe obstructive sleep apnea in adults	Investigational Device Exemption approved by the FDA
Quidel	Sofia Q	rapid antigen test device	Emergency Use Authorization granted by the FDA
Blueprint Medicines	Ayvakit (avapritinib)	advanced systemic mastocytosis (SM), including aggressive SM and SM with an associated hematological neoplasmand mast-cell leukemia	approved by the FDA
Eton Pharmaceuticals	Rezipres (ephedrine hydrochloride injection)	hypotension occurring in the setting of anesthesia	approved by the FDA
Gilead Sciences	Epclusa (sofosbuvir/velpatasvir)	chronic hepatitis C in children as young as three years regardless of HCV genotype or liver disease severity	approved by the FDA for new formulation
AVITA Medical	Recell System in combination with meshed autografting	treatment of all sizes of acute full-thickness thermal burn wounds for both pediatrics and adults	approved by the FDA for expanded use
Neo Medical Osartis	Neo Pedicle Screw System in combination with BonOs Inject cement	compromised bone quality in late-stage tumors	approved by the FDA
Stratatech	StrataGraft	deep partial-thickness burns	approved by the FDA