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Pharvaris Stock Surges After HAE Drug Meets All Endpoints in Pivotal Phase 3 Trial

ENTHMSVIIDZHZH-TWJAKOHI
Sep 8, 20262 min read
Pharvaris Stock Surges After HAE Drug Meets All Endpoints in Pivotal Phase 3 Trial
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Background

Shares of Pharvaris NV (PHVS) surged in morning trading after the company announced statistically significant positive results from its pivotal Phase 3 study of deucrictibant XR, an investigational treatment for preventing hereditary angioedema (HAE) attacks.

Pivotal Trial Success

The CHAPTER-3 trial, a global, double-blind, placebo-controlled study, met its primary endpoint, according to a company announcement. The treatment reduced the mean monthly HAE attack rate by 83% compared to placebo, a result with high statistical significance (p < 0.0001).

Pharvaris also reported that all secondary efficacy endpoints were met and that deucrictibant XR demonstrated a well-tolerated safety profile. The company noted this is the first and only Phase 3 prophylaxis study to have evaluated all three types of HAE, a rare genetic disorder characterized by severe swelling.

  • The trial enrolled 85 adolescent and adult patients across 21 countries.
  • Patients with HAE Type 1 or Type 2 experienced an even stronger 87% reduction in attack rates versus placebo.

Market Reaction

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Investors responded favorably to the news, sending Pharvaris shares up by 12.4% in morning trading. The stock reached a new 52-week high of $43.25 during the session before paring some gains.

The rally was driven entirely by the clinical data, standing in contrast to the broader market. According to Investing.com, both the S&P 500 and Nasdaq Composite were down approximately 0.4%, underscoring the company-specific nature of the move. The strong results validated a pre-existing bullish consensus among analysts covering the stock.

Path to Market

Following the successful trial readout, Pharvaris confirmed its plans to use the CHAPTER-3 data as the basis for regulatory filings. The company is targeting the submission of a New Drug Application (NDA) to U.S. regulators in the first half of 2027.

A successful late-stage trial is a critical de-risking event for a clinical-stage biopharmaceutical company, often leading to a significant repricing of its equity as a product moves closer to potential commercialization.

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