Reviva is a research and development pharmaceutical company with two portfolio compounds targeting nine indications. The candidates address multiple related mental disorders, rare diseases & other categories of un met need. Reviva's lead indication in schizophrenia with brilaroxazine (RP5063) completed its 1st Phase III trial & began its 2nd in 2Q:24. Phase II work with RP5063 in ADHD and PAH may also begin. Brilaroxazine is a novel, multimodal sero tonin, dopamine & nicotinic receptors modulator with an improved effi cacy & side effect profile compared with other antipsychotics. The drug class is established with over $10 billion in revenues. Unmet need persists in the category, related to efficacy, side effects & drug regimen compliance. Brilaroxazine's improved profile is ex pected to carve material share from the existing market and expand into untreated patients. Secondary can didate, RP1208, is in preclinical studies for depression and obesity. After agency review in the US and other jurisdictions, we anticipate NDA submission to the FDA in 2025 followed by regulatory submission in other territories. Our valuation as sumes commercializa tion in the US and rest of world in 2026 and 2027 respec tively.

22 May 2024
RVPH: Enrollment Right Around the Corner

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RVPH: Enrollment Right Around the Corner
- Published:
22 May 2024 -
Author:
John Vandermosten -
Pages:
10 -
Reviva is a research and development pharmaceutical company with two portfolio compounds targeting nine indications. The candidates address multiple related mental disorders, rare diseases & other categories of un met need. Reviva's lead indication in schizophrenia with brilaroxazine (RP5063) completed its 1st Phase III trial & began its 2nd in 2Q:24. Phase II work with RP5063 in ADHD and PAH may also begin. Brilaroxazine is a novel, multimodal sero tonin, dopamine & nicotinic receptors modulator with an improved effi cacy & side effect profile compared with other antipsychotics. The drug class is established with over $10 billion in revenues. Unmet need persists in the category, related to efficacy, side effects & drug regimen compliance. Brilaroxazine's improved profile is ex pected to carve material share from the existing market and expand into untreated patients. Secondary can didate, RP1208, is in preclinical studies for depression and obesity. After agency review in the US and other jurisdictions, we anticipate NDA submission to the FDA in 2025 followed by regulatory submission in other territories. Our valuation as sumes commercializa tion in the US and rest of world in 2026 and 2027 respec tively.