Coya Therapeutics Receives FDA IND Approval for COYA 302 to Treat Frontotemporal Dementia
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
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Source: Newsfilter
- FDA Approval: Coya Therapeutics announced that its IND for COYA 302 to treat frontotemporal dementia has been accepted by the FDA, marking a significant advancement in the treatment of neurodegenerative diseases and aiming to address the urgent medical needs of approximately 60,000 patients.
- Clinical Need: Frontotemporal dementia is the most common form of dementia in individuals under 65, with an average onset age of 58 and a survival time of only 7.5 years, making Coya's new therapy potentially transformative in improving patient quality of life and slowing disease progression.
- Scientific Rationale: COYA 302 employs a dual immunomodulatory mechanism designed to enhance the anti-inflammatory function of regulatory T cells, which Coya believes will provide a new treatment option for frontotemporal dementia patients, filling a significant gap in the current market with no effective therapies available.
- Clinical Trial Plans: Coya expects to announce topline results from an open-label study evaluating low-dose IL-2 and CTLA4-Ig in patients with mild-to-moderate frontotemporal dementia in the coming weeks, further validating its efficacy and safety profile.
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Analyst Views on COYA
Wall Street analysts forecast COYA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for COYA is 17.00 USD with a low forecast of 16.00 USD and a high forecast of 18.00 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.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.600
Low
16.00
Averages
17.00
High
18.00
Current: 4.600
Low
16.00
Averages
17.00
High
18.00
About COYA
Coya Therapeutics, Inc. is a clinical-stage biotechnology company, which is engaged in developing treatments focused on the biology and potential therapeutic advantages of regulatory T cells (Tregs) to target systemic inflammation and neuroinflammation. Its initial developmental programs are focused on neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases of high unmet medical need. Its diversified candidate pipeline includes both ex vivo and in vivo approaches. Its product candidate pipeline is based on its three therapeutic modalities. The product candidates utilizing its Treg-enhancing biologics are collectively referred to as the 300 Series. The product candidates utilizing its Treg-derived exosomes are collectively referred to as the 200 Series. The product candidates utilizing its autologous Treg cell therapy are collectively referred to as the 100 Series. The Company's 300 Series product candidates include COYA 301 and COYA 302.
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.
Coya Therapeutics Secures $11.1 Million in Private Placement
- Funding Size: Coya Therapeutics announced the sale of approximately 2.52 million shares at $4.40 per share, raising about $11.1 million, which will provide essential capital to accelerate the commercial readiness of its COYA 302 program.
- Investor Background: In this financing round, Dr. Reddy’s Laboratories invested $10 million through a subsidiary, while the company's largest institutional shareholder, Greenlight Capital, contributed $1.1 million, reflecting strong market confidence and support for Coya.
- Use of Proceeds: Coya plans to utilize the funds raised to expedite technology transfer and scale-up manufacturing for low-dose IL-2, thereby enhancing its competitive position in the market as it prepares for the commercialization of COYA 302.
- Transaction Timeline: The private placement is expected to close on or about January 30, 2026, subject to customary conditions, which ensures future liquidity and project advancement for the company.
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Coya Therapeutics Secures $11.1 Million in Private Placement
- Funding Amount: Coya Therapeutics has secured approximately $11.1 million through a private placement of 2,522,727 shares at $4.40 each, reflecting strong market confidence in its biologics development.
- Key Investors: The primary investors include Dr. Reddy’s Laboratories, contributing $10 million, and Greenlight Capital with $1.1 million, indicating a positive outlook from institutional investors regarding Coya's future prospects.
- Use of Proceeds: The company intends to utilize the proceeds to accelerate technology transfer and scale-up manufacturing for low-dose IL-2, supporting the commercial readiness of COYA 302, thereby enhancing its competitive position in the neurodegenerative disease market.
- Compliance Commitment: Coya has committed to filing a registration statement with the SEC within 45 days post-closing, ensuring the legal resale of the securities, which will bolster investor confidence and facilitate future capital operations.
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