Fortress Biotech Pref A's 15min chart shows Bollinger Bands Narrowing, Bearish Marubozu.

According to the 15-minute chart for Fortress Biotech Pref A, a narrowing of Bollinger Bands and the appearance of a bearish Marubozu candlestick pattern at 10:15 on October 3, 2025, indicate a decrease in the magnitude of stock price fluctuations, a market dominated by sellers, and a likely continuation of bearish momentum.

Fortress Biotech (NASDAQ: FBIO) experienced a regulatory setback on October 3, 2025, as the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its Menkes disease treatment, CUTX-101 Fortress Biotech stock faces setback as FDA issues CRL for CUTX-101^[1]. The CRL cited manufacturing facility deficiencies identified during FDA inspections, which require resolution. Despite this, Fortress Biotech's stock price continued to fluctuate, with the 15-minute chart indicating a narrowing of Bollinger Bands and the appearance of a bearish Marubozu candlestick pattern at 10:15 on October 3, 2025, suggesting a decrease in price volatility and a market dominated by sellers .

The FDA's rejection was due to deficiencies in Good Manufacturing Practices (GMP) at the manufacturing facility, impacting the drug’s potential treatment for pediatric patients with Menkes disease, a rare genetic disorder. Fortress Biotech plans to meet with the FDA within approximately 30 days to address these manufacturing concerns. Sentynl Therapeutics, part of Zydus Group and Fortress’s partner for CUTX-101, had previously addressed similar deficiencies and recently responded to additional observations from September 2025 re-inspections.

Analysts remain optimistic about Fortress Biotech's prospects. H.C. Wainwright maintained its Buy rating and lowered its price target from $26 to $17, attributing the adjustment to changes in factors such as the base year, fully diluted share count, and net present value calculations based on the development stages of Fortress’ assets Fortress Biotech stock faces setback as FDA issues CRL for CUTX-101^[1]. The broader analyst consensus remains bullish, with an average rating of 1.5 (Strong Buy).

In a separate development, Fortress Biotech's Urica/Crystalys program secured a $205 million Series A financing round from leading investors. The funding is expected to support completion of two ongoing Phase 3 trials and regulatory filing for dotinurad, a treatment for gout.

The regulatory setback for Fortress Biotech underscores the challenges faced by biotech companies in navigating the complex regulatory landscape. However, the company's strategic partnerships and financial backing indicate a commitment to overcoming these hurdles and pursuing growth opportunities.