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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.
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.
The results of the catalysts highlighted in our Q4 2020 Outlook Report can be found on Page 6. At the end of this report, we have included a list of Large Impact catalysts through early 2021.
Contents
Summary …………………………………………………………………………………………………………………………………….2
About the Author…………………………………………………………………………………………………………………………2
Disclaimer……………………………………………………………………………………………………………………………………3
Outcomes of Biomedtracker’s Large Impact Drug Catalysts from the Q4 2020 Outlook Report……………..6
Drugs………………………………………………………………………………………………………………………………………….8
SUL-DUR for Acinetobacter-Specific Agents (Antibacterial) (ETTX)………………………………………………….8
Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Independent (AZN) …………………………..9
KP415 for Attention Deficit Hyperactivity Disorder (ADHD) (Corium)…………………………………………….10
Keytruda for Breast Cancer (MRK)…………………………………………………………………………………………….11
Udenafil for Cardiovascular Disease (AGN) ………………………………………………………………………………..12
BIIB111 for Choroideremia (BIIB)………………………………………………………………………………………………13
Tirzepatide for Diabetes Mellitus, Type II (LLY) …………………………………………………………………………..14
Casimersen for Duchenne Muscular Dystrophy (DMD) (SRPT) ……………………………………………………..15
MS1819 for Exocrine Pancreatic Insufficiency (AZRX)………………………………………………………………….16
Sparsentan for Focal Segmental Glomerulosclerosis (FSGS) (TVTX)……………………………………………….17
Umbralisib for Marginal Zone Lymphoma – NHL (TGTX)………………………………………………………………18
Tilsotolimod for Melanoma (IDRA)……………………………………………………………………………………………19
BBP-870 for Molybdenum Cofactor Deficiency (MoCD) (BBIO) …………………………………………………….20
ide-cel for Multiple Myeloma (MM) (BMY) ………………………………………………………………………………..21
Ponesimod for Multiple Sclerosis (MS) (JNJ) ………………………………………………………………………………22
Tepotinib for Non-Small Cell Lung Cancer (NSCLC) (MKKGY) ………………………………………………………..23
Nyxol for Other Ophthalmological Indications (Ophthalmology) (OCUP)……………………………………….24
Ropeginterferon alfa-2b for Polycythemia Vera (PV) (PharmaEssentia)…………………………………………25
AT-GAA for Pompe Disease (FOLD)……………………………………………………………………………………………26
Bimekizumab for Psoriasis (UCB)………………………………………………………………………………………………27
Imsidolimab for Psoriasis (ANAB) ……………………………………………………………………………………………..28
Trilaciclib for Small Cell Lung Cancer (SCLC) (GTHX)…………………………………………………………………….29
Devices……………………………………………………………………………………………………………………………………..31
MiniMed 770G for Diabetes Mellitus, Type I (MDT)…………………………………………………………………….31
Omnipod 5 for Diabetes Mellitus, Type I (PODD)………………………………………………………………………..32
LungFit for Drug Delivery Technology (XAIR)………………………………………………………………………………33
BEAR Scaffold for Soft Tissue Repair (Miach) ……………………………………………………………………………..34
Deals…………………………………………………………………………………………………………………………………………35
Almirall Option Decision to Acquire Bioniz…………………………………………………………………………………35
Viatris to Acquire Aspen’s Thrombosis Business…………………………………………………………………………35
Early 2021 Large Impact Catalysts……………………………….…………………………………………………………………………37
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