Pipeline

November 4, 2019

Company	Drug/Device	Medical Condition	Status
Mustang Bio, Inc.	MB-108 (oncolytic virus C134)	recurrent glioblastoma multiforme	Phase 1 trial initiated enrolling 24 subjects at the University of Alabama at Birmingham
Replimune Group Inc.	RP2 as a single agent and in combination with Opdivo (nivolumab)	advanced solid tumors	Phase 1 trial initiated
Linnaeus Therapeutics, Inc.	LNS8801	advanced solid and hematologic cancers	Phase 1/2 trial initiated
XBiotech Inc.	bermekimab	moderate to severe Hidradenitis Suppurativa (HS)	Phase 2 trial initiated enrolling 150 subjects at multiple international sites
Arena Pharmaceuticals, Inc.	etrasimod	moderate-to-severe atopic dermatitis (AD)	Phase 2 trial initiated enrolling 120 subjects at sites across the U.S., Canada and Australia
CytomX Therapeutics, Inc.	CX-072 in combination with the anti-CTLA-4 antibody YERVOY (ipilimumab)	relapsed or refractory melanoma	Phase 2 trial initiated enrolling subjects with unresectable or metastatic melanoma whose disease has progressed or relapsed following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
SpringWorks Therapeutics, Inc.	mirdametinib (formerly PD-0325901)	neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NF1-PN)	Phase 2b trial initiated enrolling subjects two years of age and older with an inoperable NF1-associated PN causing significant morbidity
Zosano Pharma Corporation	C213	cluster headache	Phase 2/3 trial initiated enrolling 120 subjects
BeyondSpring Inc.	Plinabulin	prevention of chemotherapy-induced neutropenia (CIN)	Phase 3 trial initiated enrolling subjects receiving TAC (taxotere, doxorubicin and cyclophosphamide) chemotherapy plus Neulasta vs. TAC plus Plinabulin and Neulasta
Talaris Therapeutics, Inc.	FCR001	living donor kidney transplant (LDKT)	Phase 3 trial initiated enrolling 120 adult LDKT recipients at multiple sites across the U.S.
Rafael Pharmaceuticals, Inc.	CPI-613 (devimistat)	metastatic pancreatic cancer	Phase 3 trial initiated enrolling subjects at four sites in South Korea
AVROBIO, Inc.	AVR-RD-02	Gaucher disease	Orphan Drug designation granted by the FDA
Mirum Pharmaceuticals, Inc.	maralixibat	pruritus associated with Alagille syndrome (ALGS) in subjects one year of age and older	Breakthrough Therapy designation granted by the FDA
SurModics, Inc.	Sundance sirolimus-coated balloon (SCB) catheter	below-the-knee (BTK) arterial lesions in subjects suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease	Breakthrough Device designation granted by the FDA
Allergan plc	BOTOX (onabotulinumtoxinA)	lower limb spasticity, excluding spasticity caused by cerebral palsy (CP) in pediatric subjects two to 17 years of age	sBLA approval granted by the FDA
SunGen Pharmaceuticals	Lidocaine Ointment USP, 5%, Package size: 1 ½ oz tube (35.44 g)	production of anesthesia of accessible mucous membranes of the oropharynx, an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin and insect bites	ANDA approval granted by the FDA
GlaxoSmithKline	Zejula (niraparib)	advanced ovarian, fallopian tube or primary peritoneal cancer	Approval granted by the FDA
Melinta Therapeutics	BAXDELA (delafloxacin)	adult subjects with community-acquired bacterial pneumonia (CABP)	Approval granted by the FDA
Biogen Inc. Alkermes plc	VUMERITY (diroximel fumarate)	relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease	Approval granted by the FDA