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In this report, we cover catalysts from 27 drugs, devices, diagnostics, and deals expected to occur in the third quarter of 2021. For each drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided. These data points were provided using a combination of Pharmapremia, Informa’s drug development benchmarking product utilizing Biomedtracker’s LOA data to assist in informed decisions about drug pipeline prioritization, partnerships, and acquisitions, and drug approval data from Biomedtracker.
In this report, we cover catalysts from 27 drugs, devices, diagnostics, and deals expected to occur in the third quarter of 2021. For each drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided. These data points were provided using a combination of Pharmapremia, Informa’s drug developmentbenchmarking product utilizing Biomedtracker’s LOA data to assist in i nformed decisions about drug pipeline prioritization, partnerships, and acquisitions, and drug approval data from Biomedtracker.
Contents
Summary …………………………………………………………………………………………………………………………………….2
About the Author…………………………………………………………………………………………………………………………2
Disclaimer……………………………………………………………………………………………………………………………………3
Outcomes of Biomedtracker’s Large Impact Drug Catalysts from the Q2 2021 Outlook Report……………..6
Drugs………………………………………………………………………………………………………………………………………….8
Maralixibat for Alagille Syndrome (MIRM)…………………………………………………………………………………..8
Ritlecitinib for Alopecia Areata (PFE)…………………………………………………………………………………………..9
Avacopan for Antineutrophil Cytoplasmic Antibodies (ANCA) Associated Vasculitis (CCXI)………………10
Abrocitinib for Atopic Dermatitis (PFE)………………………………………………………………………………………12
Vicineum for Bladder Cancer (SESN)………………………………………………………………………………………….13
Empaveli for Dry Age-Related Macular Degeneration (Dry AMD) (APLS) ……………………………………….14
Teplizumab for Diabetes Mellitus, Type I (PRVB) ………………………………………………………………………..15
Tonmya for Fibromyalgia (TNXP)………………………………………………………………………………………………16
Margenza for Gastric Cancer (MGNX) ……………………………………………………………………………………….17
Nefecon for Immunoglobulin A (IgA) Nephropathy (Berger’s Disease) (CALT) ………………………………..18
Sparsentan for Immunoglobulin A (IgA) Nephropathy (Berger’s Disease) (TVTX)…………………………….20
Trudhesa for Migraine and Other Headaches (IMPL)…………………………………………………………………..21
Rolontis for Neutropenia / Leukopenia (SPPI)…………………………………………………………………………….22
CPI-613 for Pancreatic Cancer (Rafael)………………………………………………………………………………………23
Bylvay for Progressive Familial Intrahepatic Cholestasis (PFIC) (ALBO) ………………………………………….24
Belzutifan for Renal Cell Cancer (RCC) (MRK)……………………………………………………………………………..25
Doria for Schizophrenia (ROVI)…………………………………………………………………………………………………26
Reltecimod for Skin and Skin-Structure Infections (Antibacterial) (Atox) ……………………………………….27
Anifrolumab for Systemic Lupus Erythematosus (SLE) (AZN)………………………………………………………..28
Sulopenem for Urinary Tract and Reproductive Tract Infections (Antibacterial) (ITRM)…………………..29
Devices……………………………………………………………………………………………………………………………………..31
Contour Neurovascular System for Aneurysm (Cerus)…………………………………………………………………31
CarpX for Orthopedic Disorder (PAVM)……………………………………………………………………………………..32
Optune for Ovarian Cancer (NVCR)……………………………………………………………………………………………33
VenoValve for Vascular Disease (HJLI)……………………………………………………………………………………….34
Deals…………………………………………………………………………………………………………………………………………35
AstraZeneca to Acquire Alexion………………………………………………………………………………………………..35
Chiasma to be Acquired by Amryt …………………………………………………………………………………………….36
MorphoSys to Acquire Constellation …………………………………………………………………………………………36
Q3 2021 Large Impact Catalysts…………….………………………………………………………………………………………………38
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