Aldeyra Therapeutics(ALDX) Soars 3.36% on FDA Agreement for PVRL Treatment

Aldeyra Therapeutics(ALDX)跌2.07%。，The share price rose to its highest level since April 2025 today, with an intraday gain of 3.36%.

The strategy of buying ALDX shares after they reached a recent high and holding for 1 week showed poor performance over the past 5 years. The annualized return was -22.4%, significantly underperforming the market. This indicates that this strategy failed to capitalize on potential gains, suggesting a need for a more robust approach or a different investment strategy.

Aldeyra Therapeutics, Inc. recently received a significant boost from the U.S. Food and Drug Administration (FDA). On June 26, 2025, the company announced that it had secured a Special Protocol Assessment Agreement Letter from the FDA for its investigational drug candidate ADX-2191. This drug is being developed to treat primary vitreoretinal lymphoma (PVRL), a rare and potentially fatal cancer that currently lacks FDA-approved therapy. The FDA's agreement supports a single clinical trial, which is expected to begin in the second half of 2025. The trial aims to compare cancer cell clearance in patients receiving different injection frequencies of ADX-2191. This development has been met with enthusiasm by investors, as it represents a significant step forward in the treatment of PVRL. If successful, ADX-2191 could become the first FDA-approved treatment for this condition, potentially revolutionizing the treatment landscape for patients suffering from this rare disease.

The FDA's backing of ADX-2191 is a testament to the potential of Aldeyra Therapeutics' research and development efforts. The company's focus on rare diseases and its commitment to innovation have positioned it as a leader in the biopharmaceutical industry. The upcoming clinical trial will be a critical milestone for Aldeyra, as it seeks to bring a much-needed treatment to patients with PVRL. The company's stock has seen a surge in response to this news, reflecting investor confidence in Aldeyra's ability to deliver on its promises. As the trial progresses, Aldeyra will continue to work closely with the FDA to ensure that ADX-2191 meets all regulatory requirements and can be brought to market as quickly as possible. The success of this trial could have far-reaching implications for the treatment of rare cancers, and Aldeyra Therapeutics is poised to play a leading role in this exciting field.