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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 |
| 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 |
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