Keenova Announces Positive Phase 3 Results in Clinical Trial of XIAFLEX® (collagenase clostridium histolyticum) for Treating Plantar Fibromatosis

Rhea-AI Summary

Keenova Therapeutics (NYSE:MNK) reported positive Phase 3 results for XIAFLEX in treating plantar fibromatosis. The pivotal trial met its primary endpoint, showing statistically significant and clinically meaningful pain reduction versus placebo on the NRS scale, and achieved key ranked secondary endpoints on the FFI.

Additional secondary measures, including FFI pain subscale, global improvement and disease severity, treatment satisfaction, and nodule characteristics, also improved significantly. The safety profile matched known XIAFLEX data, with mostly mild to moderate adverse events and no treatment-related serious events. Keenova plans an FDA submission in Q4 2026 and targets a 2028 launch.

Positive

• Phase 3 trial met primary endpoint for pain reduction versus placebo on NRS
• Key ranked secondary endpoints on Foot Function Index (FFI) were achieved
• Statistically significant improvements in additional secondary measures, including FFI pain subscale
• Safety profile consistent with known XIAFLEX data; no treatment-related serious adverse events
• Planned FDA submission for plantar fibromatosis indication in Q4 2026
• Company projects about 300,000 potential treated patients in 2028 at expected launch

Negative

• None.

Market Context

Pivotal Phase 3 success for XIAFLEX in plantar fibromatosis, coupled with a planned FDA filing by Q4...

Analysis

Pivotal Phase 3 success for XIAFLEX in plantar fibromatosis, coupled with a planned FDA filing by Q4 2026 and a projected 300,000-patient care population in 2028, underscores a new indication opportunity while regulatory and launch execution remain key watchpoints.

Key Figures

Phase: Phase 3 Regulatory timing: Q4 2026 Expected launch year: 2028 +1 more

4 metrics

Phase Phase 3 Pivotal plantar fibromatosis trial of XIAFLEX

Regulatory timing Q4 2026 Planned FDA submission for plantar fibromatosis indication

Expected launch year 2028 Company expectation for XIAFLEX plantar fibromatosis launch

Addressable patients 300,000 people Projected to see a healthcare provider for plantar fibromatosis in 2028

Key Terms

collagenase clostridium histolyticum, numeric rating scale, foot function index, ffi, +1 more

5 terms

collagenase clostridium histolyticum medical

"Phase 3 clinical trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment"

An injectable enzyme produced from the bacterium Clostridium histolyticum that breaks down excess collagen in scar-like tissue, used to treat certain fibrous disorders. Think of it as microscopic scissors that cut the tough connective fibers causing abnormal lumps or contractures. It matters to investors because its approval, patent protection, manufacturing complexity, and clinical effectiveness directly affect a drug maker’s sales potential, regulatory risk, and competitive position in the market.

numeric rating scale medical

"improvement in pain versus placebo, as measured by the Average Daily Pain Intensity on the Numeric Rating Scale (NRS)"

A numeric rating scale is a simple system that converts opinions or measurements into numbers so different items can be compared and tracked over time. For investors, it turns qualitative judgments—like analyst recommendations, credit risk, or clinical outcomes—into a clear score you can sort, average, or watch for changes, much like using a thermometer or star rating to quickly judge and compare options when making decisions.

foot function index medical

"key ranked secondary endpoints related to difficulty and activity limitation as measured by the Foot Function Index (FFI) scale"

A standardized patient questionnaire that measures how foot pain and dysfunction affect daily activities, pain levels, and mobility, usually summarized as a numerical score. For investors, it matters because the score is a measurable clinical outcome used in trials and product evaluations—like a ruler for patient improvement—helping assess whether a treatment or device produces meaningful, documented benefits that can influence regulatory, reimbursement, and market potential.

ffi medical

"difficulty and activity limitation as measured by the Foot Function Index (FFI) scale"

A Foreign Financial Institution (FFI) is a bank, investment fund, insurance company, or other financial intermediary that is incorporated or operates outside the investor’s home country. It matters to investors because FFIs are subject to cross-border tax reporting rules and compliance standards that can affect account access, withholding on payments, disclosure of holdings, and the ease of doing business with overseas counterparties—like how different traffic rules change how you navigate a foreign city.

adverse events medical

"Most adverse events were rated by the investigators as mild to moderate"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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DUBLIN, July 8, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today positive results from its Phase 3 clinical trial of XIAFLEX^® (collagenase clostridium histolyticum) for the treatment of plantar fibromatosis, a chronic medical condition that causes nodules composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot.

The Results

• The pivotal trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in pain versus placebo, as measured by the Average Daily Pain Intensity on the Numeric Rating Scale (NRS).
• It also met key ranked secondary endpoints related to difficulty and activity limitation as measured by the Foot Function Index (FFI) scale.
• The treatment benefit observed on the primary pain endpoint and key functional secondary endpoints was further supported by statistically significant improvements in additional secondary measures, including the FFI pain subscale, global assessments of improvement and disease severity, treatment satisfaction, and nodule characteristics.
• The safety profile of XIAFLEX in this study was consistent with the known safety profile of XIAFLEX from approved indications. Most adverse events were rated by the investigators as mild to moderate and there were no treatment-related serious adverse events.

"We are excited to share the positive outcome for our Phase 3 clinical trial of plantar fibromatosis, a disease for which limited treatment options exist beyond symptom relief measures or surgery," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "With these encouraging results, we intend to submit our application for this indication to the FDA in the fourth quarter of 2026 as part of an effort to expand our XIAFLEX portfolio and help address unmet patient needs."

Based on claims data and projections, the company believes about 300,000 people will see a healthcare provider for their plantar fibromatosis in 2028, when Keenova expects to launch XIAFLEX for the indication.

XIAFLEX is currently approved by the U.S. Food & Drug Administration for urological and orthopedic conditions.

About EN3835-309 PFI
EN3835-309 was a double-blind, placebo-controlled Phase 3 trial to assess the overall reduction in the intensity of foot pain of XIAFLEX in the treatment of plantar fibromatosis.

The pivotal trial enrolled 436 participants with plantar fibromatosis and at least one measurable, hard or firm, palpable fibrous nodule on clinical examination. Participants were randomly assigned to one of two treatment groups, with one group receiving XIAFLEX and the other receiving placebo. Each group received up to two treatments, with each treatment separated by a minimum of 28 days.

Participants captured pain intensity on the Numeric Rating Scale (NRS) each day, and during several pre-determined follow-up visits, they completed additional questionnaires—including Subject Satisfaction With Treatment, Foot Function Index (FFI), Patient Global Impression of Severity (PGIS), and Patient Global Impression of Change (PGIC)—to report measures related to disability and activity limitation.

About Plantar Fibromatosis
Plantar fibromatosis, or Ledderhose disease, is a hyperproliferative fibrous tissue disorder resulting in the formation of collagen nodules along the plantar fascia, the thick connective tissue that supports the arch of the foot. The condition is chronic and progressive, leading to pain, walking impairment, and reductions in quality of life. There currently are no approved pharmacological treatments for plantar fibromatosis. Symptom management options include custom insoles (orthotics), topical treatments, over-the-counter pain and anti-inflammatory medications, radiation therapy, steroid injections, and, ultimately, surgery may be required to remove the nodules.

About Keenova
Keenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.

Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.

Headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania, and Wisconsin. To learn more, please visit www.keenova.com. 

Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations, and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. 

Information Regarding Forward-Looking Statements
This release contains forward-looking statements, including with regard to XIAFLEX, the efficacy, potential treatments or indications, therapeutic outcomes or treatment responses of this product, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with XIAFLEX; and other risks identified and described in more detail in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Keenova's most recent Annual Reports on Form 10-K, and other filings and furnishings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website (www.sec.gov). The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

Contacts
Media:	Investors:
media.relations@keenova.com	investor.relations@keenova.com

 

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SOURCE Keenova Therapeutics

FAQ

What Phase 3 results did Keenova (MNK) announce for XIAFLEX in plantar fibromatosis on July 8, 2026?

Keenova announced that XIAFLEX met the primary Phase 3 endpoint, significantly reducing pain versus placebo in plantar fibromatosis. According to Keenova, the trial also met key ranked secondary endpoints on the Foot Function Index and showed significant gains on multiple additional secondary measures.

How effective was XIAFLEX in reducing pain in Keenova (MNK) Phase 3 plantar fibromatosis trial?

XIAFLEX demonstrated statistically significant and clinically meaningful pain improvement versus placebo, measured by Average Daily Pain Intensity on the NRS. According to Keenova, these pain benefits were supported by improvements in the FFI pain subscale and other patient- and physician-reported outcome measures.

What secondary endpoints did Keenova (MNK) achieve in the XIAFLEX Phase 3 plantar fibromatosis study?

The study met key ranked secondary endpoints related to difficulty and activity limitation on the Foot Function Index. According to Keenova, additional secondary measures improved, including FFI pain subscale, global improvement and disease severity assessments, treatment satisfaction, and nodule characteristics.

What was the safety profile of XIAFLEX in Keenova (MNK) Phase 3 plantar fibromatosis trial?

The safety profile of XIAFLEX matched its known profile in approved uses, with mostly mild to moderate adverse events. According to Keenova, investigators reported no treatment-related serious adverse events in this plantar fibromatosis Phase 3 trial.

When does Keenova (MNK) plan to submit XIAFLEX for FDA approval in plantar fibromatosis?

Keenova plans to submit an FDA application for XIAFLEX in plantar fibromatosis in the fourth quarter of 2026. According to Keenova, this submission is part of a strategy to expand the XIAFLEX portfolio into additional indications with unmet medical needs.

When could XIAFLEX for plantar fibromatosis potentially launch, according to Keenova (MNK)?

Keenova expects to launch XIAFLEX for plantar fibromatosis in 2028, pending regulatory review and approval. According to Keenova, claims data and projections suggest about 300,000 people may seek care for this condition in 2028, representing the potential treated population.

How large is the potential patient population for Keenova (MNK) XIAFLEX in plantar fibromatosis?

Keenova believes around 300,000 people will see a healthcare provider for plantar fibromatosis in 2028. According to Keenova, this estimate is based on claims data and projections and aligns with the timeframe when XIAFLEX is expected to launch for this indication.