Biomedtracker / Meddevicetracker Q2 2021 Outlook Report
Biomedtracker / Meddevicetracker Q2 2021 Outlook Report
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In this report, we cover catalysts from 28 drugs, devices, diagnostics, and deals expected to occur in early 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.
Publisher: Biomedtracker / Meddevicetracker
- Description
- Contents
Summary
In this report, we cover catalysts from 26 drugs, devices, diagnostics, and deals expected to occur in the second 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. The results of the catalysts highlighted in our Early 2021 Outlook Report can be found on Page 6. At the end of this report, we have included a list of Large Impact catalysts through Q2 2021.
Contents
Summary …………………………………………………………………………………………………………………………………….2
About the Author…………………………………………………………………………………………………………………………2
Disclaimer……………………………………………………………………………………………………………………………………3
Outcomes of Biomedtracker’s Large Impact Drug Catalysts from the Early 2021 Outlook Report ………….6
Drugs………………………………………………………………………………………………………………………………………….8
Reproxalap for Allergic Conjunctivitis (Ophthalmology) (ALDX)………………………………………………………8
Aducanumab for Alzheimer’s Disease (AD) (BIIB)………………………………………………………………………….9
SB206 for Antiviral – Other Treatments (NOVN)………………………………………………………………………….10
SPN-812 for Attention Deficit Hyperactivity Disorder (ADHD) (SUPN)……………………………………………11
SYD985 for Breast Cancer (Byondis)………………………………………………………………………………………….12
mRNA-1273 for COVID-19 Prevention (MRNA) …………………………………………………………………………..13
NVX-CoV2373 for COVID-19 Prevention (NVAX) …………………………………………………………………………14
Finerenone for Diabetic Nephropathy (BAYN) ……………………………………………………………………………15
ADCT-402 for Diffuse Large B-Cell Lymphoma (DLBCL) – NHL (ADCT) ……………………………………………16
Pegunigalsidase Alfa for Fabry’s Disease (Chiesi) ………………………………………………………………………..17
Ryplazim for Hypoplasminogenemia (LMNL)………………………………………………………………………………18
SLS-002 for Major Depressive Disorder (MDD) (SEEL)………………………………………………………………….19
Miplyffa for Niemann-Pick Disease (ORPHA)………………………………………………………………………………21
Pegcetacoplan for Paroxysmal Nocturnal Hemoglobinuria (PNH) (APLS) ……………………………………….22
ET-104 for Partial Seizures (Epilepsy) (Azurity)……………………………………………………………………………23
Avalglucosidase Alfa for Pompe Disease (SNY)……………………………………………………………………………24
Lybalvi for Schizophrenia (ALKS)……………………………………………………………………………………………….25
TransCon Growth Hormone for Short Stature / Growth Hormone Deficiency (ASND)……………………..26
Orgovyx for Uterine Fibroids (MYOV)………………………………………………………………………………………..27
WTX101 for Wilson’s Disease (ALXN)…………………………………………………………………………………………28
Devices……………………………………………………………………………………………………………………………………..29
PortIO for Drug Delivery Technology (PAVM)……………………………………………………………………………..29
Biotres for Hemodynamic/Vital Sign Monitoring (BTCY)………………………………………………………………30
April 2021 / 5
ALFApump System for Malignant Ascites (SEQUA) ……………………………………………………………………..31
EVO Visian ICL Toric Lens for Refractive Errors (Ophthalmology) (STAA)………………………………………..31
Deals…………………………………………………………………………………………………………………………………………33
Merck to Acquire Pandion Therapeutics ……………………………………………………………………………………33
Servier to Acquire Agios’ Oncology Portfolio………………………………………………………………………………33
Q2 2021 Large Impact Catalysts…………………………………………………………………………………………………………….35
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