This section highlights FDA-related milestones and regulatory updates for drugs developed by Chemomab Therapeutics (CMMB).
Over the past two years, Chemomab Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CCL24, CM-101, and nebokitug. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CCL24 - FDA Regulatory Timeline and Events
CCL24 is a drug developed by Chemomab Therapeutics for the following indication: Key driver of the fibrotic and inflammatory disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CCL24
- Announced Date:
- June 18, 2024
- Indication:
- Key driver of the fibrotic and inflammatory disease
Announcement
Chemomab Therapeutics announced a new scientific publication that further confirms the important role of the soluble protein CCL24 in the pathologies underlying the rare fibrotic liver disease primary sclerosing cholangitis (PSC). The new study reinforces the extensive evidence showing the potential of Chemomab's CCL24-neutralizing antibody, CM-101, to interrupt the biological processes driving PSC disease progression and severity.
AI Summary
Chemomab Therapeutics recently announced a new study confirming the key role of the soluble protein CCL24 in primary sclerosing cholangitis (PSC), a rare fibrotic liver disease. Using machine learning on patient samples, the study found that higher levels of CCL24 were linked to increased disease severity and cirrhosis. These results support the potential of Chemomab’s CCL24-neutralizing antibody, CM-101, to disrupt the biological processes that drive PSC progression. The findings add to extensive evidence that targeting CCL24 may help reduce both fibrosis and inflammation, which are major contributors to PSC. Chemomab is hopeful that upcoming Phase 2 data will deliver the first clinical proof-of-concept for CM-101, offering promise for a therapy in a disease area with a significant unmet medical need.
Read Announcement
CM-101 (PSC) - FDA Regulatory Timeline and Events
CM-101 (PSC) is a drug developed by Chemomab Therapeutics for the following indication: Primary Sclerosing Cholangitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CM-101 (PSC)
- Announced Date:
- June 11, 2025
- Indication:
- Primary Sclerosing Cholangitis
Announcement
Chemomab Therapeutics today reported that it has obtained confirmation from the FDA on two significant development milestones as the company continues to finalize the nebokitug Phase 3 program.
AI Summary
Chemomab Therapeutics announced that it has obtained FDA confirmation on two major development milestones as it finalizes its nebokitug Phase 3 program for primary sclerosing cholangitis (PSC). During the FDA End-of-Phase 2 review process, the agency agreed with the company’s proposed Chemistry, Manufacturing, and Controls (CMC) strategy. This agreement ensures that the quality and consistency of the drug supply will be maintained as the product advances toward commercialization.
The company also received a favorable decision from the FDA during a Type C meeting regarding non-clinical developmental toxicology studies. The FDA confirmed that these studies may be conducted in parallel with the Phase 3 clinical trial, with results to be included in the planned Biologics Licensing Application. These regulatory milestones mark significant progress for Chemomab as it continues preparation for the pivotal Phase 3 trial while engaging discussions with potential strategic partners.
Read Announcement- Drug:
- CM-101 (PSC)
- Announced Date:
- May 5, 2025
- Indication:
- Primary Sclerosing Cholangitis
Announcement
Chemomab Therapeutics, Ltd announced that data from the company's Phase 2 SPRING trial of nebokitug (CM-101) in primary sclerosing cholangitis (PSC)1 was presented in an oral Distinguished Abstract Plenary session at Digestive Disease Week® (DDW 2025) in San Diego, California.
AI Summary
Chemomab Therapeutics, Ltd recently presented promising data from its Phase 2 SPRING trial of nebokitug (CM-101) for primary sclerosing cholangitis (PSC) at Digestive Disease Week® 2025 in San Diego, California. The data, shared during an oral Distinguished Abstract Plenary session, showed that nebokitug was safe and well-tolerated during both a double-blind 15-week period and an extended treatment up to 48 weeks.
Investigators observed significant improvements in several biomarkers related to inflammation, fibrosis, and cholestasis, suggesting that nebokitug may slow disease progression. These encouraging results, especially in patients with moderate to severe PSC, support the clinical potential of nebokitug as a first-in-class therapy. The positive findings from the SPRING trial provide momentum as the company looks toward advancing nebokitug into a Phase 3 study for patients with PSC.
Read Announcement- Drug:
- CM-101 (PSC)
- Announced Date:
- April 21, 2025
- Indication:
- Primary Sclerosing Cholangitis
Announcement
Chemomab Therapeutics, announced that clinical data on nebokitug (CM-101) for the treatment of patients with primary sclerosing cholangitis (PSC) will be presented at major upcoming scientific conferences including DDW25, Digestive Disease Week 2025®; EASL 2025, the Annual Congress of the European Association for the Study of the Liver; and BSG LIVE'25, the British Society of Gastroenterology's annual meeting. Chemomab will report information on the content of the presentations after the meeting embargoes lift.
AI Summary
Chemomab Therapeutics announced that clinical data on nebokitug (CM-101), a novel monoclonal antibody for primary sclerosing cholangitis (PSC), will be presented at several key scientific meetings in 2025. The data will be shared at Digestive Disease Week 2025® (DDW25) in San Diego, the EASL 2025 Annual Congress in Amsterdam, and BSG LIVE'25 in Glasgow.
These meetings will feature both oral and poster presentations detailing nebokitug’s effects on biomarkers related to inflammation, fibrosis, and cholestasis in patients with PSC. Chemomab plans to disclose additional details of the presentation content once the respective meeting embargoes are lifted.
This announcement highlights the promising clinical potential of nebokitug in addressing the high unmet need in PSC treatment and supports continued investigations aimed at advancing therapeutic options for patients suffering from this fibro-inflammatory disease.
Read Announcement- Drug:
- CM-101 (PSC)
- Announced Date:
- February 19, 2025
- Indication:
- Primary Sclerosing Cholangitis
Announcement
Chemomab Therapeutics announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA)
AI Summary
Chemomab Therapeutics announced that it successfully completed its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) for nebokitug (CM-101), its lead drug candidate for treating primary sclerosing cholangitis (PSC). The FDA has agreed with Chemomab’s plan to use a single Phase 3 registration study, providing a clear, streamlined path toward full regulatory approval. This pivotal trial is notable for not requiring invasive liver biopsies and for using a primary endpoint based on well-characterized clinical events connected with PSC progression. The design also leverages encouraging biomarker improvements seen in previous trials, which are linked to reduced PSC-related events. Chemomab sees this as a significant step forward in addressing the unmet need in PSC treatment and is now preparing to launch the Phase 3 trial while discussing potential strategic partnerships to further support its program.
Read Announcement- Drug:
- CM-101 (PSC)
- Announced Date:
- February 19, 2025
- Indication:
- Primary Sclerosing Cholangitis
Announcement
Chemomab Therapeutics announced that alignment with FDA on the design of a single Phase 3 registration study for its lead product candidate nebokitug (CM-101) for the treatment of primary sclerosing cholangitis (PSC).
AI Summary
Chemomab Therapeutics has secured important FDA alignment on a single Phase 3 registration study for nebokitug (CM-101) in treating primary sclerosing cholangitis (PSC). This newly designed trial will be based on well-characterized clinical events, offering a streamlined path to full regulatory approval. By focusing on clinical outcomes, the trial eliminates the need for invasive liver biopsies and additional confirmatory studies, potentially accelerating the approval process.
This approach builds on promising biomarker improvements observed in the Phase 2 SPRING trial. The FDA’s acceptance of this design marks the first time a primary endpoint based on PSC clinical events has been agreed upon, setting a clear regulatory pathway. With plans to enroll approximately 350 PSC patients, Chemomab is also engaging with potential strategic partners as it moves forward with the pivotal Phase 3 study.
Read Announcement- Drug:
- CM-101 (PSC)
- Announced Date:
- November 19, 2024
- Indication:
- Primary Sclerosing Cholangitis
Announcement
Chemomab Therapeutics announced that data from its Phase 2 SPRING trial in patients with primary sclerosing cholangitis (PSC) was presented at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024.
AI Summary
Chemomab Therapeutics presented encouraging Phase 2 SPRING trial data at the AASLD The Liver Meeting® 2024. The trial evaluated CM-101 in 76 patients with primary sclerosing cholangitis (PSC) using two doses—10 mg/kg and 20 mg/kg—administered every three weeks over 15 weeks. Results showed that CM-101 has a favorable safety profile and demonstrated dose-dependent anti-fibrotic, anti-inflammatory, and anti-cholestatic effects. In particular, the higher 20 mg/kg dose led to significant improvements in liver stiffness, ELF scores, and reductions in key fibrosis-related biomarkers among patients with moderate to advanced PSC. These findings indicate that CM-101 may reduce fibrosis and cholestasis while alleviating symptoms, supporting its further clinical development. Chemomab plans to engage with the FDA soon to discuss a path forward for a PSC registrational trial, potentially bringing a much-needed treatment option to PSC patients.
Read Announcement- Drug:
- CM-101 (PSC)
- Announced Date:
- July 25, 2024
- Indication:
- Primary Sclerosing Cholangitis
Announcement
Chemomab Therapeutics reported positive topline results from the Phase 2 SPRING trial assessing its first-in-class monoclonal antibody, CM-101, in patients with primary sclerosing cholangitis (PSC).
AI Summary
Chemomab Therapeutics recently announced positive topline results from its Phase 2 SPRING trial in patients with primary sclerosing cholangitis (PSC). The trial successfully met its primary endpoint, demonstrating that the first-in-class monoclonal antibody, CM-101, is safe and generally well-tolerated over a 15‐week period. In addition to establishing a strong safety profile, CM-101 showed significant improvements in liver stiffness—a key biomarker for PSC progression—as well as beneficial effects on pruritis, total bilirubin, and overall liver function. These results suggest that CM-101 has anti-fibrotic, anti-inflammatory, and anti-cholestatic properties, addressing multiple components of PSC in a single treatment. The positive clinical proof-of-concept supports the potential of CM-101 as a disease-modifying therapy, paving the way for further discussions with the FDA and advancement to a Phase 3 trial in the near future.
Read Announcement- Drug:
- CM-101 (PSC)
- Announced Date:
- June 18, 2024
- Estimated Event Date Range:
- January 1, 2024 - June 30, 2024
- Target Action Date:
- H1 2024
- Indication:
- Primary Sclerosing Cholangitis
Announcement
Chemomab Therapeutics announced that CM-101 Phase 2 PSC Trial Topline Data Readout Expected Midyear 2024
AI Summary
Chemomab Therapeutics announced that its Phase 2 trial for CM-101, a novel CCL24-neutralizing antibody, is on track with topline data expected by midyear 2024. This milestone is a key step in the development of a new treatment for primary sclerosing cholangitis (PSC), a rare liver disease with no FDA-approved therapies. Recent research highlights that high levels of the protein CCL24 are linked to increased inflammation, fibrosis, and even cirrhosis in PSC patients. The data supports the idea that CM-101’s dual anti-fibrotic and anti-inflammatory action can help slow the progression of the disease. If the upcoming results prove successful, it could provide the first strong clinical evidence for CM-101’s potential as a promising treatment for PSC, addressing a high unmet medical need for patients suffering from this challenging condition.
Read Announcement
nebokitug - FDA Regulatory Timeline and Events
nebokitug is a drug developed by Chemomab Therapeutics for the following indication: In Sclerosing Cholangitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- nebokitug
- Announced Date:
- June 30, 2025
- Indication:
- In Sclerosing Cholangitis
Announcement
Chemomab Therapeutics, Ltd announced that data from the company's Phase 2 SPRING trial of nebokitug (CM-101) in patients with primary sclerosing cholangitis (PSC) was presented in an oral session1 at BSG Live'25, the annual scientific meeting of the British Society for Gastroenterology, in Glasgow, UK.
AI Summary
Chemomab Therapeutics recently shared promising Phase 2 data from its SPRING trial of nebokitug (CM-101) at BSG Live’25 in Glasgow, UK. The trial focused on patients with primary sclerosing cholangitis (PSC), a progressive and serious liver disease with few treatment options. During an oral session, Professor Douglas Thorburn highlighted that nebokitug was well-tolerated for up to 48 weeks and demonstrated significant improvements in multiple biomarkers related to fibrosis and inflammation. In a double-blind, placebo-controlled segment lasting 15 weeks, nebokitug’s safety profile was similar to placebo, while the open-label extension confirmed its ongoing tolerability and beneficial effects. These encouraging results, particularly in patients with moderate to advanced PSC, point to the drug’s potential to slow disease progression and support its advancement to a Phase 3 registration trial.
Read Announcement- Drug:
- nebokitug
- Announced Date:
- June 3, 2025
- Indication:
- In Sclerosing Cholangitis
Announcement
Chemomab Therapeutics, announced that its lead product nebokitug (formerly CM-101) has been awarded new patent protections in China and Russia.
AI Summary
Chemomab Therapeutics announced that its lead product, nebokitug (formerly CM-101), has been granted new patent protections in China and Russia. In China, Patent No. ZL 2018 8 0018207.8 covers the use of anti-CCL24 (Eotaxin 2) antibodies for treating liver diseases, including primary sclerosing cholangitis, with protection until 2038. In Russia, RU Patent 2022125176 protects various formulations and doses of nebokitug and extends coverage through 2041.
These patents add to the company’s growing portfolio, which already includes protections in the U.S., Europe, Japan, and other key markets. Chemomab believes that these new patents further secure nebokitug’s strategic position for treating severe liver diseases and support its plans for future clinical trials and partnerships, particularly as it moves closer to a Phase 3 trial in primary sclerosing cholangitis.
Read Announcement- Drug:
- nebokitug
- Announced Date:
- April 28, 2025
- Indication:
- In Sclerosing Cholangitis
Announcement
Chemomab Therapeutics, today reported data from two study abstracts that will be presented as posters at EASL 2025, the Annual Congress of the European Association for the Study of the Liver, that will be held May 7–10, 2025, in Amsterdam, the Netherlands.
AI Summary
Chemomab Therapeutics announced that it will present new clinical data at EASL 2025, the Annual Congress of the European Association for the Study of the Liver, in Amsterdam from May 7–10, 2025. The company disclosed findings from two study abstracts based on its Phase 2 SPRING trial in patients with primary sclerosing cholangitis (PSC). One poster highlights that treatment with nebokitug (CM-101) leads to significant, dose-dependent improvements in a range of inflammatory and fibrotic biomarkers. This comprehensive profile of about 3,000 circulating proteins shows that nebokitug may effectively reduce fibrosis and inflammation by downregulating processes such as cell adhesion, extracellular matrix formation, and cytokine activity. The second poster focuses on the pharmacokinetics and pharmacodynamics of nebokitug, demonstrating its effective antibody-target engagement and a clear dose-response relationship, further supporting nebokitug’s potential as a first-in-class treatment for PSC and other fibro-inflammatory diseases.
Read Announcement- Drug:
- nebokitug
- Announced Date:
- March 6, 2025
- Indication:
- In Sclerosing Cholangitis
Announcement
Chemomab Therapeutics, announced a new scientific presentation that further confirms the potential of nebokitug (CM-101) as a novel treatment for systemic sclerosis (SSc).
AI Summary
Chemomab Therapeutics recently announced a new scientific presentation that confirms the potential of its drug nebokitug (CM-101) as an innovative treatment for systemic sclerosis (SSc). The presentation, shared at a leading international congress, highlighted how nebokitug, a first-in-class monoclonal antibody, works by blocking the protein CCL24. This protein plays a key role in triggering the inflammatory and fibrotic pathways responsible for SSc, a serious autoimmune disease that causes skin thickening and internal organ damage.
The new data, gathered from both patient samples and animal studies, shows that nebokitug may reduce inflammation and fibrosis in affected tissues. These encouraging results add to a growing body of research that supports the idea that targeting CCL24 could be a key strategy in modifying disease progression in SSc patients. This presentation reinforces Chemomab’s commitment to developing effective treatments for challenging fibro-inflammatory diseases.
Read Announcement- Drug:
- nebokitug
- Announced Date:
- March 3, 2025
- Indication:
- In Sclerosing Cholangitis
Announcement
Chemomab Therapeutics provided a corporate update.
AI Summary
Chemomab Therapeutics recently provided a corporate update highlighting its strong progress and promising outlook. The company reported its full-year and fourth-quarter financial and operating results for 2024. It noted reductions in both research and development and general administrative expenses. The update emphasized rapid patient enrollment in the nebokitug Phase 2 SPRING trial for primary sclerosing cholangitis (PSC), with the trial achieving its primary endpoint and showing improvements across multiple secondary endpoints. The FDA End-of-Phase 2 meeting was positive and helped shape a streamlined approach for a single pivotal Phase 3 trial. This novel design will not require liver biopsies or additional confirmatory studies, making the development both feasible and efficient. Chemomab is also in active discussions with potential strategic partners while preparing to release further clinical data from the trial's open label extension in early 2025.
Read Announcement
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