Cleveland Diagnostics' IsoPSA Receives FDA Approval, Enhancing Prostate Biopsy Decision-Making
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 01 2025
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Source: Businesswire
- FDA Approval Milestone: Cleveland Diagnostics' IsoPSA® in vitro diagnostic kit has received FDA approval through the Premarket Approval process, marking a significant advancement in early cancer detection and is expected to greatly enhance physician confidence in prostate biopsy decision-making.
- Clinical Research Support: The FDA approval of IsoPSA is based on robust clinical evidence from a large-scale prospective study conducted at 14 sites across the U.S., addressing the diagnostic gap where over 1 million men undergo prostate biopsies annually, yet only 25% yield positive results for high-grade disease.
- Cost Reduction in Healthcare: By providing more accurate risk assessments, IsoPSA helps reduce unnecessary invasive procedures and associated healthcare costs, which is anticipated to alleviate physical risks and emotional stress for patients, thereby improving the overall healthcare experience.
- Market Access Expansion: Since its introduction as a Laboratory-Developed Test (LDT) in 2020, IsoPSA has gained coverage from Medicare and an increasing number of commercial payors, further driving its application in clinical practice and enhancing patient accessibility.
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Analyst Views on CLDX
Wall Street analysts forecast CLDX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CLDX is 55.00 USD with a low forecast of 24.00 USD and a high forecast of 90.00 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.
10 Analyst Rating
9 Buy
0 Hold
1 Sell
Strong Buy
Current: 24.770
Low
24.00
Averages
55.00
High
90.00
Current: 24.770
Low
24.00
Averages
55.00
High
90.00
About CLDX
Celldex Therapeutics, Inc. is a clinical-stage biotechnology company. The Company is focused on exploring the science of mast cell biology and the development of transformative therapeutics for patients. Its pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Its drug candidates include monoclonal and bispecific antibodies designed to address mast cell mediated diseases. Its Barzolvolimab (CDX-0159) is a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, which is being studied across multiple mast cell driven diseases, including Chronic Urticarias, Prurigo Nodularis, Atopic Dermatitis and Eosinophilic Esophagitis. The Company’s bispecific platform includes CDX- 622. The CDX- 622 is a bispecific candidate for inflammatory diseases.
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.
Celldex Therapeutics' Jimenez Sells 4,166 Shares for $121,210
- Executive Trading Activity: Freddy A. Jimenez, Senior VP & General Counsel of Celldex, sold 4,166 shares on December 4, 2025, for $121,210 at a price of $29.09, reducing his direct ownership by 11.92%, indicating a cautious outlook on the company's future.
- Historical Comparison: This sale of 4,166 shares is significantly larger than Jimenez's previous sale of 771 shares on August 13, 2025, and exceeds the recent median sell size of 2,468 shares, suggesting a heightened sensitivity to market conditions.
- Company Financials: With a market capitalization of $1.82 billion, Celldex has faced deteriorating financials, reporting zero revenue in Q3 2025 and a net loss of $67 million, highlighting the severe challenges the company is currently facing.
- Other Executive Transactions: In early 2026, other executives also engaged in stock transactions, with CBO Pepin Ronald exercising options worth $105,744, reflecting differing perspectives among executives regarding the company's future despite the overall poor market performance.
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Celldex Offers $25 Put Option, Attracting Investor Interest
- Put Option Appeal: The current bid for the $25.00 put option is $3.90, and if an investor sells this option, they commit to buying the stock at $25.00, effectively lowering their cost basis to $21.10, which represents a 6% discount to the current price of $26.53, making it attractive for those looking to enter at a lower price.
- Return Potential Analysis: Should the put option expire worthless, it would yield a 15.60% return on cash commitment, or 23.53% annualized, positioning this option as an appealing investment choice, especially in a volatile market environment.
- Call Option Opportunity: The $34.00 call option has a current bid of $2.00, and if an investor buys shares at $26.53 and sells this call, they could achieve a total return of 35.70% if the stock is called away at the August 2026 expiration, providing an additional revenue opportunity for investors.
- Market Volatility Consideration: The implied volatility for the put option is 76%, while for the call option it is 68%, compared to an actual trailing twelve-month volatility of 58%, indicating significant uncertainty in market expectations for Celldex's stock performance.
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