Fortress Biotech (FBIO) stock took a beating on Wednesday after the company updated investors on a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) concerning its New Drug Application (NDA) for CUTX-101. CUTX-101 is a treatment in development for Menkes disease in pediatric patients. Menkes disease is a rare genetic disorder that affects the body’s copper distribution. Its symptoms include intellectual disability, seizures, poor muscle tone, and kinky, steel-colored hair.
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The CRL from the FDA noted Current Good Manufacturing Practice deficiencies at a facility where CUTX-101 is manufactured. This location responded to the FDA’s inspection in September, and Fortress Biotech subsidiary Cyprium will work with partner Sentynl to address the agency’s concerns.
In other Fortress Biotech news, the company announced that Crystalys Therapeutics has closed a $205 million Series A financing agreement to fund its Phase 3 clinical trial for dotinurad for the treatment of gout. Urica Therapeutics, a subsidiary of Fortress Biotech, holds an equity position in Crystalys Therapeutics.
Fortress Biotech Stock Movement Today
Fortress Biotech stock was down 29.91% in pre-market trading on Wednesday, following a 5.26% drop yesterday. Even so, the shares have rallied 82.92% year-to-date and 135.35% over the past 12 months. Today’s news came with strong trading of FBIO stock, with some 1.17 million shares traded, compared to a three-month daily average of about 1.2 million units.
Is Fortress Biotech Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for Fortress Biotech is Moderate Buy, based on two Buy ratings over the past three months. With that comes an average FBIO stock price target of $14.50, representing a potential 292.42% upside for the shares.
