Fortress Biotech's shares rose 7.62% in pre-market trading as the stock crossed above the 5-day SMA, reflecting optimism ahead of a key FDA decision on CUTX-101 by January 14, 2025.
The catalyst for this price movement is the anticipation surrounding the FDA decision for CUTX-101, a therapy that, if approved, will be the only FDA-approved treatment for Menkes disease. Fortress Biotech's subsidiary, Cyprium Therapeutics, stands to gain up to $129 million in milestone payments from its partner Sentynl Therapeutics, significantly enhancing the company's financial outlook and potential future revenues.
The successful launch of CUTX-101 is crucial not only for the company but also for patients suffering from Menkes disease, which has a high mortality rate in untreated cases. This development could provide much-needed treatment options and holds significant implications for both the market and society.
Wall Street analysts forecast FBIO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for FBIO is 10.75 USD with a low forecast of 4.50 USD and a high forecast of 17.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
Wall Street analysts forecast FBIO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for FBIO is 10.75 USD with a low forecast of 4.50 USD and a high forecast of 17.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 3.380
Low
4.50
Averages
10.75
High
17.00
Current: 3.380
Low
4.50
Averages
10.75
High
17.00
Alliance Global
Scott Henry
Buy
maintain
$4
2025-11-19
Reason
Alliance Global
Scott Henry
Price Target
$4
AI Analysis
2025-11-19
maintain
Buy
Reason
Alliance Global analyst Scott Henry raised the firm's price target on Fortress Biotech to $4.50 from $4 and keeps a Buy rating on the shares following the Q3 report. The company's operating expenses are lower now in the absence of Checkpoint, the analyst tells investors in a research note.
H.C. Wainwright
Joseph Pantginis
Buy
downgrade
$26 -> $17
2025-08-21
Reason
H.C. Wainwright
Joseph Pantginis
Price Target
$26 -> $17
2025-08-21
downgrade
Buy
Reason
H.C. Wainwright analyst Joseph Pantginis lowered the firm's price target on Fortress Biotech to $17 from $26 and keeps a Buy rating on the shares. The firm updated the company's model.
Unlock Full Analyst Thesis， Get the complete breakdown of rating reason for FBIO
Unlock Now
Roth Capital
Buy
downgrade
$15 -> $12
2025-08-19
Reason
Roth Capital
Price Target
$15 -> $12
2025-08-19
downgrade
Buy
Reason
Roth Capital lowered the firm's price target on Fortress Biotech to $12 from $15 and keeps a Buy rating on the shares after its Q2 results. The firm notes that with Journey's Emrosi launched, the recently completed sale of Checkpoint and a September PDUFA for CUTX-101, Fortress is well positioned to become a self-funding entity, the analyst tells investors in a research note. Roth adds however that its lower price target reflects a higher share count, lower market capitalizations of the company's public company portfolio, and lower probability of previously anticipated approval timing for CAEL-101.
Roth MKM
Jason Wittes
Strong Buy
Reiterates
$15 → $16
2025-03-11
Reason
Roth MKM
Jason Wittes
Price Target
$15 → $16
2025-03-11
Reiterates
Strong Buy
Reason
About FBIO
Fortress Biotech, Inc. is a biopharmaceutical company focused on acquiring and advancing assets. The Company has eight marketed prescription pharmaceutical products and over 20 programs in development, with its majority-owned and majority-controlled partners and subsidiaries and partners and subsidiaries it founded and in which it holds significant minority ownership positions. Its portfolio is being commercialized and developed for various therapeutic areas, including oncology, dermatology, and rare diseases. Its dermatology products include Emrosi, Qbrexza, Amzeeq, Zilxi, Exelderm, Targadox, and Luxamend. Its late-stage product candidates include CUTX-101 (copper histidinate injection for Menkes disease), Triplex (cytomegalovirus (CMV) vaccine), and CAEL-101 (monoclonal antibody for AL amyloidosis). Its early and mid-stage product candidates include Dotinurad (urate transporter (URAT1) inhibitor for gout), MB-101 (IL13Rα2 CAR T Cell Program for Glioblastoma), and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
