New Pipeline Updates from Aravive Biologics, Biohaven Pharma and Sun Pharmaceutical

August 27, 2018

Company Drug/Device Medical Condition Status
Aravive Biologics, Inc. AVB-S6-500 Platinum-resistant ovarian cancer Granted Fast Track Designation by the FDA
Biohaven Pharma BHV-0223 Social anxiety and public speaking anxiety disorders Positive data from a proof-of-concept Phase III clinical trial
Sun Pharmaceutical Industries Ltd. Cequa (cyclosporine ophthalmic solution) 0.09 percent Keratoconjunctivitis sicca (dry eye) Approval granted by FDA
Lion TCR Pte. Ltd. LioCyx™ Relapsed liver cancer post-liver transplantation Approval granted by Health Sciences Authority (HSA), Singapore, for multicenter Phase I/II clinical trial
Taiwan Liposome Company, Ltd. TLC590, a proprietary BioSeizer™ liposomal formulation of ropivacaine Postsurgical pain Dosing of first patients in a Phase I/II trial
Teva Pharmaceuticals Generic version of EpiPen Auto-Injector Severe allergic reactions Approval granted by the FDA
BeiGene Ltd. Tislelizumab, an investigational anti-PD-1antibody, combined with chemotherapy as a potential first-line treatment Stage IIIB or IV squamous non-small cell lung cancer (NSCLC) Phase III clinical trial initiated
Eiger BioPharmaceuticals, Inc. Avexitide (formerly exendin 9-39) Post-bariatric surgical patients who experience post-bariatric hypoglycemia (PBH) Completion of enrollment in Phase II clinical trial
Escalier Biosciences, BV ESR-114 topical gel Mild-to-moderate psoriasis Phase I/IIa clinical trial initiated
Sangamo Therapeutics, Inc. SB-525, a cDNA gene therapy candidate Hemophilia A Positive preliminary data from the Phase I/II clinical trial
ADC Therapeutics ADCT-402 (loncastuximab tesirine) Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Phase II clinical trial initiated
Alexion Pharmaceuticals, Inc. ALXN1210, investigational long-acting C5 complement inhibitor Paroxysmal nocturnal hemoglobinuria (PNH) FDA accepted Biologics License Application (BLA) for approval
Merck & Co. Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy as first-line treatment Metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations Granted approval by the FDA
SPR Therapeutics SPRING endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems Pain Cleared by the FDA
Univision 360 Luminelle DTx Hysteroscopy System Hysteroscopy and cystoscopy Received 510(k) clearance from the FDA
Tolero Pharmaceuticals, Inc. Combination therapy with AbbVie’s venetoclax and Tolero’s investigational agent Relapsed/refractory acute myeloid leukemia (AML) Tolero Pharmaceuticals and AbbVie partner for trial