Pipeline

May 24, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Laurent Pharmaceuticals	LAU-7b	hospitalized patients with COVID-19	recruitment complete in phase 2 trial
Kintor Pharmaceutical	proxalutamide	hospitalized patients with COVID-19	approval received from the FDA to proceed with a phase 3 trial
LabCorp	Pixel COVID-19 PCR test home collection kit for ages two to 17	COVID-19 test	Emergency Use Authorization (EUA) granted by the FDA
Roche	Cobas SARS-CoV-2 test	asymptomatic COVID-19 testing	EUA granted by the FDA
Other Trials and Actions
GammaDelta Therapeutics	GDX012	hematological malignancies	IND approved by the FDA
ImmunityBio	m-ceNK platform combined with Anktiva (N-803)	locally advanced or metastatic solid tumors	IND approved by the FDA
DiaMedica	DM199 (recombinant human tissue kallikrein-1or KLK1)	acute ischemic stroke	IND approved by the FDA for a phase 2/3 trial
PharmaTher Holdings	ketamine	levodopa-induced dyskinesia in patients with Parkinson’s disease	IND approved by the FDA for a phase 2 trial
Propella Therapeutics	PRL-02 (abiraterone decanoate)	metastatic prostate cancer	IND approved by the FDA
InnoCare	oral ICP-332	autoimmune diseases	IND approved by China's National Medical Products Administration
Altasciences SiteOne Therapeutics	ST-2427	management of moderate-to-severe pain	initiation of phase 1 trial
Crescendo Biologics	CB307	patients with advanced and/or metastatic PSMA-positive solid tumors	first patient enrolled in phase 1 trial
GoldFinch Bio	GFB-024	severe insulin-resistant diabetic nephropathy	first patients dosed in phase 1 trial
Mustang Bio City of Hope	MB-101 (autologous IL13R?2-CAR T cells)	leptomeningeal brain tumors (e.g., glioblastoma, ependymoma or medulloblastoma)	first patients dosed in phase 1 trial
Pyramid Biosciences	PBI-100	mild-to-moderate psoriasis	first patients dosed in phase 1 trial
Catalyst Biosciences	marzeptacog alfa (activated); MarzAA	bleeding in FVII deficiency, Glanzmann thrombasthenia and hemophilia A with inhibitor patients receiving Hemlibra prophylaxis	first patient dosed in phase 1/2 trial
GeneTx Biotherapeutics Ultragenyx Pharmaceuticals	intrathecally administered GTX-102	Angelman syndrome	clearance from Health Canada to initiate phase 1/2 trial
Xalud Therapeutics	XT-150	patients with radicular neuropathic pain due to lumbar disc disease	first patient dosed in phase 1/2a trial
Galera Therapeutics	GC4711 in combination with stereotactic body radiation therapy (SBRT)	locally advanced pancreatic cancer	first patient dosed in phase 2b trial
Xalud Therapeutics	XT-150	moderate-to-severe pain due to osteoarthritis of the knee	recruitment complete in phase 2b trial
Endogena Therapeutics	EA-2353 ophthalmic suspension	retinitis pigmentosa	Orphan Drug designation granted by the FDA
GammaDelta Therapeutics	GDX012	acute myeloid leukemia	Orphan Drug designation granted by the FDA
Bridge BioPharma	BBP-631	congenital adrenal hyperplasia	Fast-Track designation granted by the FDA
Palisade Bio	LB1148	reduction of adhesions following abdominal or pelvic surgery	Fast-Track designation granted by the FDA
Apellis Pharmaceuticals	Empaveli (pegcetacoplan)	adults with paroxysmal nocturnal hemoglobinuria	approved by the FDA