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Reviva Pharmaceuticals Shares Jump 32% Ahead of FDA Pre-NDA Meeting

NASDAQ

RVPH

October 2, 2025 | 4:48pm
REVIVA PHARMACEUTICALS HOLDINGS INC
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As of October 2, 2025 4:48pm

Reviva Pharmaceuticals Holdings Inc. (RVPH)

Reviva Pharmaceuticals Holdings Inc. (NASDAQ: RVPH) is a clinical-stage pharmaceutical company headquartered in Cupertino, California. As of October 2, 2025, RVPH shares closed at $0.4783, reflecting an increase of 32.49% on a trading volume of 13,852,015 shares. The company focuses on developing therapeutics for central nervous system, respiratory, and metabolic diseases where there are significant unmet medical needs.

Corporate Structure and Leadership

Founded and led by President and CEO Laxminarayan Bhat, Ph.D., Reviva operates with a team of 11 to 50 employees. The management team includes professionals with experience in guiding drug candidates through development and market approval. Reviva utilizes a chemical genomics-driven platform and proprietary chemistry to advance two internally discovered new chemical entities: RP5063 (brilaroxazine) and RP1208.

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Recent Developments and News

On June 30, 2025, Reviva reported its second-quarter financial results. The company noted a well-tolerated safety profile and sustained efficacy for brilaroxazine during a one-year open-label extension trial. Reviva completed two randomized double-blind clinical trials—one Phase 2 and one Phase 3—as well as pharmacology studies to support a New Drug Application (NDA).

On September 23, 2025, a Globe Newswire release highlighted Reviva’s focus on addressing unmet needs in the central nervous system therapeutic area. An additional update on October 2, 2025, provided information on upcoming clinical milestones.

Key investor events include:

  • September 30, 2025: CEO presentation at the Lytham Partners Fall 2025 Investor Conference (virtual).
  • October 9, 2025: CEO panel discussion and one-on-one meetings at the 4th Annual Roth Healthcare Opportunities Conference in New York.

A pre-NDA meeting with the U.S. Food and Drug Administration is scheduled for Q4 2025, which is a step in the regulatory process for brilaroxazine in treating acute and maintenance-phase schizophrenia.

Financial and Strategic Analysis

According to Yahoo Finance (as of October 1, 2025):

MetricValue
Previous Close$0.3686
52-Week Range$0.25 – $4.28
Market Capitalization$35.51 M
Enterprise Value$25.26 M
Net Income (TTM)–$27.11 M
Diluted EPS (TTM)–$0.80
Total Cash (mrq)$10.36 M
Levered Free Cash Flow (TTM)–$16.07 M
1-Year Target Estimate$6.25

The company’s balance sheet indicates $10.36 million in cash with no reported debt, supporting ongoing clinical programs. A net loss of $27.11 million and negative free cash flow of $16.07 million may reflect ongoing investments in research and development. The analysts' consensus target of $6.25 per share suggests potential for appreciation depending on the outcome of the NDA filing and Phase 3 trial results.

SEC filings from late September 2025 revealed changes in beneficial ownership. A Schedule 13G filed on September 29, 2025, indicates that 683 Capital Management and affiliated entities hold approximately 5.36% of outstanding shares. A Schedule 13D/A amendment filed on September 24, 2025, reports Dr. Bhat’s ownership stake at approximately 3.8%, which includes sole voting power over approximately 3.35 million shares.

Market Position and Industry Context

Reviva is positioned within the competitive central nervous system therapeutic segment, where both large biopharmaceutical companies and emerging biotech firms are engaged in developing novel mechanisms of action. The company’s chemical genomics-based approach aims to distinguish brilaroxazine by targeting multiple serotonin and dopamine pathways. The scrutiny over existing schizophrenia medications regarding their efficacy and safety creates a potential market opportunity for Reviva’s lead candidate.

Trading volumes exceeding the average of 3.94 million shares in October 2025 reflect increased investor interest in advance of regulatory milestones. With a market capitalization of approximately $35.5 million, Reviva is classified among micro-cap clinical-stage companies, where clinical data releases and interactions with the FDA are significant drivers of value.

tl;dr

  • On October 2, 2025, RVPH shares increased by 32.49% to $0.4783 on a volume of 13.85 million shares.
  • A pre-NDA meeting with the FDA is planned for Q4 2025, following the completion of Phase 2, Phase 3, and one-year extension trials for brilaroxazine.
  • CEO Laxminarayan Bhat, Ph.D., is scheduled to present at Lytham Partners (September 30) and Roth Healthcare (October 9) investor conferences.
  • As of October 1, 2025: market cap is $35.5 million, cash is $10.36 million, net loss is $27.11 million, and the 1-year target is $6.25.
  • SEC filings from September 2025 indicate 683 Capital owns 5.36% of shares, and Dr. Bhat holds a 3.8% ownership stake.
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