Summary
• Reviva Pharmaceuticals’ shares plummet 43% in pre-market trading to $0.3377 after regulatory feedback.
• The FDA recommends a second phase 3 trial for brilaroxazine, delaying NDA submission.
• Trading volume increases to 6.94 million, surpassing average levels amid investor reactions.
Reviva Pharmaceuticals Holdings, Inc. (RVPH) is experiencing a significant drop of 43% in pre-market trading, with shares changing hands at $0.3377 compared to the last close of $0.5900. This sharp decline is taking place without a clear catalyst beyond the backdrop of a recent regulatory update.
Regulatory Feedback Impact
The pre-market move comes after the company announced regulatory feedback regarding brilaroxazine, a drug in development for the treatment of schizophrenia. Following a pre-NDA meeting with the FDA, Reviva received a recommendation to conduct a second phase 3 trial to gather additional efficacy and safety data before proceeding with the NDA submission. This feedback may influence investor sentiment heavily, as it implies further delays in bringing the drug to market.
Market Performance Overview
Reviva’s stock has been volatile, with a 52-week low of approximately $0.27 and a high of $0.78. The current volatility levels are notable, with a 13% weekly volatility and around 10% monthly volatility. Despite the severe drop today, the company showed a quarterly performance increase of nearly 92%. However, the yearly performance remains bleak, down approximately 74%, reflecting broader challenges within the company.
Trading Data Insight
The action in RVPH this session aligns with a substantial increase in trading volume, reported at 6.94 million, which exceeds the average volume of 3 million over the past three months. This uptick in volume suggests heightened investor activity, likely driven by the regulatory announcement and the anticipated implications on brilaroxazine’s development timeline.
As the trading session unfolds, all eyes will be on how the market reacts to this significant regulatory feedback and whether Reviva can stabilize its position amid ongoing developmental hurdles. With no clear catalysts beyond the recent communication, traders will assess how the stock navigates the following sessions.