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Reviva Pharmaceuticals Shares Plunge 38% as Brilaroxazine Advances Toward NDA

NASDAQ

RVPH

September 19, 2025 | 1:02pm
REVIVA PHARMACEUTICALS HOLDINGS INC
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As of September 19, 2025 1:02pm

Introduction

Reviva Pharmaceuticals Holdings Inc (NASDAQ: RVPH) is a clinical-stage pharmaceutical company headquartered in Cupertino, California. The firm applies a chemical genomics-driven platform and proprietary chemistry to develop therapies aimed at addressing unmet medical needs in central nervous system, respiratory, and metabolic diseases. As of September 19, 2025, RVPH shares traded on the NASDAQ at $0.2597, reflecting a 38.08% decline from the prior day’s close of $0.4043, on a volume of 2,937,504 shares.

Corporate Structure and Leadership

Founded and led by Laxminarayan Bhat, Ph.D., Reviva employs between 11 and 50 professionals with experience in clinical development, regulatory affairs, and biopharmaceutical research. The management team has guided multiple compounds through Phase 2 and Phase 3 programs. Reviva maintains operations in Santa Clara, California, and collaborates with external partners to advance its in-house pipeline.

Pharmaceutical Research

Pharmaceutical Research by National Cancer Institute

Recent Developments

  • On June 30, 2025, Reviva reported second-quarter financial results, noting the completion of two randomized double-blind trials (one Phase 2 and one Phase 3), a one-year open-label extension (OLE) study, and supporting pharmacology work for a New Drug Application (NDA).
  • On September 18, 2025, the company issued a press release highlighting the safety profile and sustained efficacy of brilaroxazine (RP5063) over one year across various symptom domains, including negative symptoms of schizophrenia.
  • A pre-NDA meeting with the U.S. Food and Drug Administration is scheduled for Q4 2025 to discuss the registration pathway for brilaroxazine in schizophrenia.
  • Reviva aims to submit its NDA for brilaroxazine in Q2 2026.

Financial and Strategic Analysis

Reviva’s market capitalization stood at approximately $29 million as of September 19, 2025, with an enterprise value of $18.75 million. Key financial metrics (trailing twelve months) include:

MetricValue
52-Week Range$0.30 – $4.28
Average Daily Volume2,712,909 shares
Price/Book (MRQ)47.17
Net Income Available to Common (TTM)–$27.11 million
Diluted EPS (TTM)–$0.64
Total Cash (MRQ)$10.36 million
Levered Free Cash Flow (TTM)–$16.07 million
Return on Assets (TTM)–173.70%

The significant cash burn reflects ongoing clinical development costs. As a late-stage company without approved products, Reviva’s strategy centers on advancing brilaroxazine through pivotal trials and securing regulatory approval while managing its cash runway through Q2 2026.

Market Position and Industry Context

Reviva operates within the biotechnology research sector, focusing on central nervous system disorders, including schizophrenia, bipolar disorder, major depressive disorder, and ADHD. Its pipeline also includes RP1208, a triple reuptake inhibitor, and preclinical assets in pulmonary arterial hypertension, idiopathic pulmonary fibrosis, psoriasis, and obesity. The 52-week price target consensus of $7.00 reflects investor expectations linked to successful NDA filing and potential commercialization.

TL;DR

  • Shares declined 38.08% on September 19, 2025, to $0.2597 amid broader market conditions.
  • Second-quarter results (June 30, 2025) confirmed completion of two randomized trials and a one-year OLE study for brilaroxazine.
  • Pre-NDA meeting with FDA scheduled for Q4 2025; NDA submission anticipated in Q2 2026.
  • Cash balance of $10.36 million supports operations through pivotal milestones.
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