The biotech space represents a gold mine of opportunity for investors to multiply their investment returns, courtesy of the volatility generated by market-moving catalysts.
In a note this week, Canaccord Genuity analyst Sumant Kulkarni presented a list of key catalysts for companies in his coverage universe, with those involving neurological disorder drugs dominating the list.
Biogen Inc (NASDAQ: BIIB) and partner Eisai will make an oral presentation of Phase 2 results from their Alzheimer’s disease candidate BAN2401 at the upcoming Alzheimer’s Association International Conference in Chicago on July 25.
The company reported positive top-line results from the Phase 2 study July 5.
Kulkarni expects the data presentation at the AAIC and its potential read-through to remain a focal point over the next several quarters ahead of more Alzheimer’s-related events. (See the analyst’s track record here.)
Biogen is also expected to complete enrollment midyear for the Phase 3 study of aducanumab, a human monoclonal antibody for Alzheimer’s.
BioXcel Therapeutics Inc (NASDAQ: BTAI) is set to present Phase 1b pharmacokinetic/pharmacodynamic data on its intravenous dex for treating Alzheimer’s as well as schizophrenia in the second half of this year. The readouts of the company’s Phase 2 open-label proof-of-concept studies for both programs, which are due to start in the second half, are likely to arrive late this year.
The company will start bridging bioavailability/bioequivalence studies for its sublingual film in the second half of 2018, Kulkarni said.
Intra-Cellular Therapies Inc (NASDAQ: ITCI) is likely to complete a new drug application for its schizophrenia treatment lumateperone in mid-2018.
Voyager Therapeutics Inc (NASDAQ: VYGR) expects updates from a Type C meeting with the FDA for VY-AADC, its gene therapy for Parkinson’s disease, as well as first-patient dosing in the pivotal trial.
SAGE Therapeutics Inc (NASDAQ: SAGE) has an upcoming FDA adcom meeting for its brexanolone IV for treating postpartum depression in Q3 or early Q4. The PDUFA action date is set for Dec. 19.
Rival Marinus Pharmaceuticals Inc (NASDAQ: MRNS) is likely to report data for its ganaxolone IV for women with severe/moderate postpartum depression in Q3/Q4 of 2018.
Spinal Muscular Atrophy
Canaccord expects Biogen’s spinal muscular atrophy gene therapy candidate to enter clinical trials in mid-2018.
SMA, caused by a mutation in the survival motor gene 1, affects the motor nerve cells in the spinal cord, which impairs the ability to walk, eat or breathe.
Novartis AG (ADR) (NYSE: NVS)’s Avexis unit is also expected to reveal details on FDA-related developments on its AVSX-101 gene therapy for SMA.
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