Biogen's IND Application Accepted by FDA for C4 Therapeutics' Treatment of Autoimmune Diseases

Thursday, Sep 4, 2025 8:18 am ET2min read

C4 Therapeutics announced that Biogen's IND application for treating autoimmune diseases has been accepted by the FDA. Biogen is a global leader in therapeutic products, with net sales primarily coming from medicine sales (74.6%), royalties (6.7%), and other revenue streams (18.7%).

C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC) has announced that its partner, Biogen, has received approval from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application for BIIB142. This degrader of IRAK4, developed in collaboration with C4T, is intended for therapeutic use in patients with autoimmune diseases.

The approval marks a significant milestone in the collaboration between C4T and Biogen, which began in 2018. Under the terms of the strategic partnership, C4T provided expertise and research services in targeted protein degradation, while Biogen contributed scientific and drug development capabilities. C4T has delivered two development candidates to Biogen, with BIIB142 being the first to progress towards clinical development.

Paige Mahaney, Ph.D., chief scientific officer of C4 Therapeutics, expressed enthusiasm about the achievement, stating, "We are thrilled to see Biogen quickly advance the IRAK4 degrader that resulted from our collaboration toward the clinic in the hopes this molecule may bring a new treatment option to patients with autoimmune disease." Jane Grogan, Ph.D., head of research at Biogen, also highlighted the partnership's success, noting that it has been both powerful and productive, combining C4T's expertise in targeted protein degradation with Biogen's scientific leadership and drug development capabilities.

Biogen is responsible for all future clinical development and commercialization of BIIB142, while C4T is entitled to receive a $2 million milestone payment upon Biogen dosing patients in the clinical trial. This collaboration underscores the potential of targeted protein degradation as a cutting-edge modality for treating diseases with high unmet needs.

C4 Therapeutics, a clinical-stage biopharmaceutical company, is dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines. The company is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases.

Forward-Looking Statements

This press release contains forward-looking statements of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may include, but are not limited to, express or implied statements regarding the design and potential efficacy of our therapeutic approaches, and the potential timing of clinical development activities or the receipt of related milestone payments. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, uncertainties related to the initiation, timing, advancement, and conduct of clinical studies by Biogen; the risk that this product candidate may not be successfully developed and commercialized; and the risk that C4T will receive future milestone or royalty payments related to the development of this product candidate. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in C4 Therapeutics’ most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4 Therapeutics undertakes no duty to update this information unless required by law.

References:

[1] https://www.marketscreener.com/news/c4-therapeutics-highlights-recent-achievement-in-biogen-collaboration-ce7d59d8d98fff2c
[2] https://ir.c4therapeutics.com/news-releases/news-release-details/c4-therapeutics-highlights-recent-achievement-biogen

Biogen's IND Application Accepted by FDA for C4 Therapeutics' Treatment of Autoimmune Diseases

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