ALDX

B. Riley Financial Performance: B. Riley Financial Inc reported a significant turnaround with earnings of $4.50 per share for Q2, compared to a loss of $14.35 per share a year ago, and sales increased to $225.302 million from $94.885 million, leading to a 25% rise in share price during pre-market trading.

Pre-Market Stock Movements: Several stocks experienced notable pre-market trading movements, with Biodexa Pharmaceuticals gaining 51.4% and Venus Concept surging 31.1%, while Radiopharm Theranostics saw a sharp decline of 39.8%.

Other Notable Gainers: Other stocks that rose in pre-market trading included Uniqure NV (+14.1%), Adagio Medical Holdings (+11.7%), and Sunrise New Energy (+10.5%), reflecting a mix of recovery and growth in various sectors.

Significant Losers: Stocks that faced declines included iRobot Corp, which fell 23.2% after filing for Chapter 11 bankruptcy, and Saverone 2014 Ltd, which tumbled 37.8% following a previous gain, indicating volatility in the market.

FDA Review Delay: Aldeyra Therapeutics experienced a ~12% drop in premarket trading after announcing a delay in the FDA review of its resubmitted marketing application for reproxalap, with a new target action date set for March 16, 2026.

Clinical Study Report Submission: The delay follows the company's submission of a clinical study report for a dry eye disease trial, which the FDA deemed a major amendment to the new drug application (NDA).

Trial Results: The trial did not meet its primary goal of improving dry eye symptoms, and Aldeyra submitted the safety data to the FDA in August.

Prospective Labeling: Despite the delay, the FDA has provided a draft of the prospective label for reproxalap, indicating that if no major deficiencies are found, the company will receive proposed labeling requests and potential postmarketing requirements.