$4,750.00
In this report, we cover catalysts from 35 drugs, devices, diagnostics, and deals expected to occur in Q4 2020. 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 35 drugs, devices, diagnostics, and deals expected to occur in Q4 2020. 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.
Summary …………………………………………………………………………………………………………………………………….2
About the Author…………………………………………………………………………………………………………………………2
Disclaimer……………………………………………………………………………………………………………………………………3
Outcomes of Biomedtracker’s Large Impact Drug Catalysts from the Q3 2020 Outlook Report……………..6
Drugs………………………………………………………………………………………………………………………………………….8
SPN-812 for Attention Deficit Hyperactivity Disorder (ADHD) (SUPN)……………………………………………..8
BIVV009 for Autoimmune Hemolytic Anemia (AIHA) (SNY) ……………………………………………………………9
Margetuximab for Breast Cancer (MGNX)………………………………………………………………………………….10
VGX-3100 for Cervical Dysplasia (INO)……………………………………………………………………………………….11
Omecamtiv Mecarbil (Oral) for Congestive Heart Failure (CHF) and Cardiomyopathies (AMGN)………12
Actemra for COVID-19 (RHHBY)………………………………………………………………………………………………..13
AZD1222 for COVID-19 (AZN) …………………………………………………………………………………………………..14
BNT162 for COVID-19 (BNTX) …………………………………………………………………………………………………..15
mRNA-1273 for COVID-19 (MRNA)……………………………………………………………………………………………16
Bronchitol for Cystic Fibrosis (CF) (PXS)……………………………………………………………………………………..17
PTI-NC-733 for Cystic Fibrosis (CF) (PTI) …………………………………………………………………………………….18
SAR341402 for Diabetes Mellitus, Type I (SNY)…………………………………………………………………………..19
Breyanzi for Diffuse Large B-Cell Lymphoma (DLBCL) – NHL (BMY)……………………………………………….21
EYSUVIS for Dry Eye (Ophthalmology) (KALA) …………………………………………………………………………….22
RGN-259 for Dry Eye (Ophthalmology) (RGRX) …………………………………………………………………………..23
REGN-EB3 for Ebola (REGN)……………………………………………………………………………………………………..24
CPP-1X/Sulindac for Familial Adenomatous Polyposis (FAP) (MNK) ………………………………………………25
VT-1161 for Fungal Infections – Non-Systemic (Mycovia)……………………………………………………………..27
Zokinvy for Hutchinson-Gilford Progeria Syndrome (EIGR)…………………………………………………………..28
Lumasiran for Hyperoxaluria (ALNY)………………………………………………………………………………………….29
SAGE-217 for Major Depressive Disorder (MDD) (SAGE) ……………………………………………………………..30
SGX942 for Mucositis (SNGX)……………………………………………………………………………………………………31
Danyelza for Neuroendocrine Tumors (NET) (YMAB)…………………………………………………………………..32
September 2020 / 5
Rolontis for Neutropenia / Leukopenia (SPPI)…………………………………………………………………………….33
Tanezumab for Osteoarthritis and Osteoarthritis Pain (PFE) ………………………………………………………..34
Vibegron for Overactive Bladder (OAB) (UROV)………………………………………………………………………….36
ERY-ASP for Pancreatic Cancer (ERYP)……………………………………………………………………………………….37
Telaglenastat for Renal Cell Cancer (RCC) (CALA)………………………………………………………………………..38
ALKS 3831 for Schizophrenia (ALKS) ………………………………………………………………………………………….40
Devices……………………………………………………………………………………………………………………………………..42
BuMA Biodegradeable Drug Coating Coronary Stent System for Coronary Artery Disease (Sino
Medical) ………………………………………………………………………………………………………………………………..42
Optune for Non-Small Cell Lung Cancer (NSCLC) (NVCR) ……………………………………………………………..43
Elipse Gastric Balloon for Obesity (Allurion)……………………………………………………………………………….43
Deals…………………………………………………………………………………………………………………………………………45
Acquisition of Akcea by Ionis……………………………………………………………………………………………………45
Acquisition of Aspen’s European Thrombosis Business by Mylan………………………………………………….45
Merger of Yumanity and Proteostasis……………………………………………………………………………………….46
Q4 2020 Large Impact Catalysts……………………………….……………………………………………………………………………48
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