Praxis Precision Medicine’s Leading Essential Tremor-Only Program Underestimates Value: Analyst – Praxis Precision Medicine (NASDAQ:PRAX)

Needham began reporting on Practice Precision Medicine Inc. PRACTICEa clinical-stage biopharmaceutical company developing therapies for diseases of the central nervous system.

The company’s lead product, ulixacaltamide for essential tremor (ET), is currently progressing through the Essential3 Phase 3 program, with top-line results expected in the second half of 2024 to support the planned New Drug Application (NDA) submission in 2025.

• The analyst writes that if Ulixa is successful in Phase 3, its sales for the treatment of essential tremor (ET) could peak at over $1 billion in 2030 (probability of success 60%).
• Needham writes: “The value of ulixacaltamide alone in essential tremor is currently underestimated.”

The analyst starts with a buy recommendation and a price target of $145.

The company’s second program is PRAX-628 for partial-onset seizures.

• Practice plans to initiate two efficacy trials in partial-onset seizures. The first trial is scheduled to begin in the second half of 2024, with topline results expected in 2025, and the second trial is scheduled to begin in the first half of 2025, with topline results expected in the first half of 2026.

Praxis expects top-line results from the Phase 2 EMBOLD study of PRAX-562 for developmental and epileptic encephalopathies (DEEs) of types SCN2A and SCN8A in the third quarter of 2024.

Praxis is completing several global regulatory interactions in the first half of 2024, in advance of initiating the pivotal phase of the elsunersen (PRAX-222) program for SCN2A gain-of-function DEEs later in 2024.

PRAX-628 in focal epilepsy and elsunersen in SCN2A GoF could generate peak sales of over $1.5 billion, with upside potential from label expansion.

Praxis’s cash runway to 2027 and an early pipeline across the Cerebrum and Solidus platforms have the potential to generate significant long-term value.

Needham adds that positive Phase 3 data from Ulixa and POC for PRAX-562 in the third quarter should further drive momentum in Praxis stock.

Price promotion: PRAX shares fell 3.44% to $40.27 at last check on Monday.

Photo by PublicDomainPictures from Pixabay