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Pipeline

New Pipeline Updates from ACell, PellePharm and Merck

April 8, 2019

Company Drug/Device Medical Condition Status
Tizona Therapeutics, Inc. TTX-030 cancer Phase I/Ib trial initiated
Amylyx Pharmaceuticals, Inc. AMX0035 Alzheimer’s Disease Phase II trial initiated enrolling 100 subjects
Odonate Therapeutics, Inc. tesetaxel locally advanced or metastatic breast cancer (MBC) Phase II trial initiated
Poxel SA PXL770 non-alcoholic steatohepatitis (NASH) Phase IIa trial initiated enrolling 100 subjects with nonalcoholic fatty liver disease (NAFLD) who likely have NASH at sites in the U.S.
Biohaven Pharmaceutical Holding Company, Ltd. BHV-3500 migraine Phase II/III trial initiated
Hutchison China MediTech Limited surufatinib (HMPL-012 or sulfatinib) with capecitabine advanced biliary tract cancer (BTC) Phase IIb/III trial initiated
PellePharm, Inc. Patidegib Topical Gel, 2% Gorlin Syndrome Phase III trial initiated enrolling 150 subjects
Aldeyra Therapeutics, Inc. topical ocular reproxalap dry eye disease Phase III trial initiated enrolling 400 subjects with moderate-to-severe dry eye disease
ACell, Inc. Gentrix Surgical Matrix gastroenterological or plastic and reconstructive surgery 510(k) clearance granted by the FDA
ACell, Inc. Gentrix Surgical Matrix Thin urological, gastroenterological or plastic and reconstructive surgery 510(k) clearance granted by the FDA
ACell, Inc. Gentrix Surgical Matrix Plus gastroenterological or plastic and reconstructive surgery 510(k) clearance granted by the FDA
AstraZeneca and Merck selumetinib NF1 plexiform neurofibromas Breakthrough Therapy designation granted by the FDA
CSA Medical, Inc. RejuvenAir System moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB) Breakthrough Device designation granted by the FDA
Fera Pharmaceuticals Avaclyr (acyclovir ophthalmic ointment) herpetic keratitis NDA approval granted by the FDA
Intellirod Spine LOADPRO kyphotic correction surgery De Novo approval granted by the FDA
Immunocore Limited tebentafusp (IMCgp100) metastatic uveal melanoma (mUM) Fast Track approval granted
by the FDA
Clarus Therapeutics Jatenzo (testosterone undecanoate) hypogonadism Approval granted by the FDA
EMD Serono Mavenclad (cladribine) relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS) Approval granted by the FDA