Keenova Announces New Manuscript on Plantar Fibromatosis Treatment Patterns in Peer-Reviewed Journal of Foot and Ankle Surgery

Rhea-AI Summary

Keenova (NASDAQ:MNK) announced a peer‑reviewed manuscript in Journal of Foot and Ankle Surgery reporting real‑world treatment patterns for plantar fibromatosis and highlighted persistent symptoms after conservative care. The company said it is actively evaluating collagenase clostridium histolyticum (CCH) in a Phase 3 trial currently underway (Feb 16, 2026).

The study notes no FDA‑approved nonsurgical options and calls for more research on long‑term outcomes and effective therapies.

Positive

• Peer‑reviewed manuscript published on real‑world treatment patterns
• Phase 3 clinical trial of CCH currently underway (ongoing as of Feb 16, 2026)
• Highlights clear unmet need: no FDA‑approved nonsurgical options

Negative

• CCH is not approved for treating plantar fibromatosis
• Conservative treatments often continue after surgery, suggesting recurrence or persistent symptoms
• No official treatment guidelines exist for plantar fibromatosis

Key Figures

Trial phase: Phase 3 clinical trial

1 metrics

Trial phase Phase 3 clinical trial CCH for plantar fibromatosis

Market Reality Check

Vol: Volume 0 vs 20-day averag...

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Volume Volume 0 vs 20-day average of 126,789 shares before this news. normal

Technical Trading below 200-day moving average of 3.59 before this announcement.

Market Pulse Summary

This announcement highlights Keenova’s focus on plantar fibromatosis, a rare condition without FDA‑a...

Analysis

This announcement highlights Keenova’s focus on plantar fibromatosis, a rare condition without FDA‑approved nonsurgical treatments, and its ongoing Phase 3 trial of collagenase clostridium histolyticum. The new real‑world evidence manuscript underscores persistent symptoms and limited options. Investors may monitor future clinical readouts, safety and efficacy data, and any regulatory interactions related to this program to better understand its potential impact on the company’s outlook.

Key Terms

plantar fibromatosis, collagenase clostridium histolyticum, corticosteroids, phase 3 clinical trial

4 terms

plantar fibromatosis medical

"Plantar fibromatosis is a rare condition, and most newly diagnosed patients..."

Plantar fibromatosis is a non-cancerous thickening of the connective tissue in the sole of the foot that forms firm, often painful nodules under the skin, like small rubbery knots beneath a carpet. Investors should care because the condition can require ongoing medical management—from injections and physical therapy to repeat surgeries—creating demand for treatments, devices and services and affecting healthcare costs, reimbursement and market opportunities for related companies.

collagenase clostridium histolyticum medical

"Keenova is also investigating collagenase clostridium histolyticum (CCH) as a potential..."

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.

corticosteroids medical

"Most patients receive treatments such as injectable corticosteroids, oral corticosteroids, and..."

Corticosteroids are a class of hormones and synthetic medicines that dial down inflammation and the immune system, acting like a thermostat that lowers the body’s defensive response. They are used to treat conditions from asthma and allergies to autoimmune diseases and severe inflammation; their approved uses, safety profile, and manufacturing costs matter to investors because they affect drug sales, regulatory risk, patent value, and potential liability or demand shifts for healthcare companies.

phase 3 clinical trial medical

"Keenova is actively evaluating a nonsurgical treatment option... with a Phase 3 clinical trial..."

A phase 3 clinical trial is a large-scale study that tests a new medical treatment or drug to determine if it is safe and effective for widespread use. It often involves hundreds or thousands of participants and compares the new treatment to existing options or a placebo. For investors, the results of this phase are crucial, as successful outcomes can lead to regulatory approval and commercial success, while failures may halt development.

AI-generated analysis. Not financial advice.

• Plantar fibromatosis is a rare condition, and most newly diagnosed patients receive conservative (nonsurgical) treatments.
• Real-world treatment patterns suggest symptoms may persist or return, creating an opportunity for more research on long‑term outcomes and effectiveness.
• Keenova is actively evaluating a nonsurgical treatment option for plantar fibromatosis, with a Phase 3 clinical trial currently underway.

DUBLIN, Feb. 16, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced the publication of a new manuscript presenting real-world evidence on treatment patterns for patients with plantar fibromatosis. The peer‑reviewed article appears in The Journal of Foot and Ankle Surgery, available here.

Why It Matters

Plantar fibromatosis is a progressive condition with no FDA-approved nonsurgical treatment options. With no official treatment guidelines available, Keenova and its clinical partners are working to better understand how healthcare providers manage the condition in real‑world practice. Keenova is also investigating collagenase clostridium histolyticum (CCH) as a potential nonsurgical therapy. CCH is not approved for treating plantar fibromatosis.

CSO Perspective

"We believe patients with this rare condition deserve more treatment options, especially those seeking alternatives to surgery," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "That's why we are actively investigating a nonsurgical approach in our Phase 3 clinical trial, with the goal of supporting patient care and helping to improve quality of life for the people who need it most."

What We Learned

Findings from the manuscript show:

• Plantar fibromatosis is rare, but it appears consistently in real‑world data, indicating that it is regularly diagnosed and treated despite its low overall prevalence.
• Most patients receive treatments such as injectable corticosteroids, oral corticosteroids, and physical/occupational therapy.
• Although surgery is infrequent, conservative treatments often continue after surgery, which may suggest disease recurrence or persistent symptoms.
• These patterns indicate a need for more research to understand long‑term outcomes and identify effective treatments for people with refractory plantar fibromatosis.

Phase 3 Status

• Keenova's Phase 3 clinical trial evaluating CCH for plantar fibromatosis is currently underway.

Manuscript Details

• Title: Real-World Treatment Patterns Among Newly Diagnosed Patients With Plantar Fibromatosis in the United States
• Authors: Jill Davis, MS; Aimee Near, MPH; Jenny Tse, MS; Riddhi Doshi, PhD, MBBS, MPH; Elizabeth Wang, MS; Luis Ortega, MD; David Hurley, MD; David G. Armstrong, MD, PhD, MS

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, which is often painful. There is no cure for plantar fibromatosis. Symptom management options include custom insoles (orthotics), topical treatments, over-the-counter pain and anti-inflammatory medications, radiation therapy and steroid injections, and ultimately, surgery may be required to remove the nodules.

About Keenova
Keenova Therapeutics is a leading global developer and manufacturer of branded therapeutics that strives to help patients with rare or unaddressed conditions live happier and healthier lives.

The Company's diversified brands portfolio is focused across a wide range of therapeutic areas of significant unmet need, including endocrinology, gastroenterology, hepatology, immunology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology and urology. Globally 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
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the expected benefits and synergies of the business combination with Endo ("Business Combination") may not be fully realized in a timely manner, or at all; the Company's increased indebtedness as a result of the Business Combination and significant transaction costs related to the Business Combination; the expected growth opportunities, profit improvements, cost savings and other benefits as a result of the spin-off of Par Health may not be fully realized in a timely manner, or at all; unanticipated costs, litigation and/or regulatory inquiries and investigations as a result of the spin-off of Par Health; risks associated with being a smaller, less diversified company as a result of the spin-off of Par Health; potential changes in the Company's business strategy and performance; exposure to global economic conditions and market uncertainty; governmental investigations and inquiries, regulatory actions, and lawsuits, in each case related to the Company's or its officers; the Company's contractual and court-ordered compliance obligations that, if violated, could result in penalties; compliance with and restrictions under the global settlement to resolve all opioid-related claims; matters related to Acthar Gel, including the settlement with governmental parties to resolve certain disputes and compliance with and restrictions under the related corporate integrity agreement; the ability to maintain relationships with the Company's suppliers, customers, employees and other third parties; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of the Company's products due to legal changes or changes in insurers' or other payers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; any undesirable side effects caused by the Company's approved and investigational products, which could limit their commercial profile or result in other negative consequences; the Company's and its partners' ability to successfully develop, commercialize or launch new products or expand commercial opportunities of existing products, including Acthar Gel (repository corticotropin injection) SelfJect, the INOmax Evolve DS delivery system, and XIAFLEX; the Company's ability to successfully identify or discover additional products or product candidates; the Company's ability to navigate price fluctuations and pressures, including the ability to achieve anticipated benefits of price increases of its products; competition; the Company's and its partners' ability to protect intellectual property rights, including in relation to ongoing and future litigation; limited clinical trial data for Acthar Gel; the timing, expense and uncertainty associated with clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental laws and related liabilities; business development activities or other strategic transactions; attraction and retention of key personnel; the effectiveness of information technology infrastructure, including risks of external attacks or failures; customer concentration; the Company's reliance on certain individual products that are material to its financial performance; the Company's ability to receive sufficient procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers and related market disruptions; conducting business internationally; the Company's significant levels of intangible assets and related impairment testing; natural disasters or other catastrophic events; the Company's substantial indebtedness and settlement obligation, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions contained in the agreements governing the Company's indebtedness and settlement obligation on the Company's operations, future financings and use of proceeds; the Company's variable rate indebtedness; the Company's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; the comparability of the Company's post-emergence financial results and the projections filed with the U.S. Bankruptcy Court for the District of Delaware and the lack of comparability of the Company's historical financial statements and information contained in its financial statements after the adoption of fresh-start accounting following emergence from Mallinckrodt's and Endo's respective bankruptcy proceedings.

The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 27, 2024, its Quarterly Report on Form 10-Q for the quarterly period ended March 28, 2025, its Quarterly Report for the quarterly period ended June 27, 2025, its Quarterly Report for the quarterly period ended September 26, 2025, its Registration Statement on Form S-4, as amended, filed with the SEC, and other filings with the SEC, all of which are on file with the SEC and available from the SEC's website (www.sec.gov) and the Company's website (www.keenova.com), identify and describe in more detail the risks and uncertainties to which the Company's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and the Company does 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. Given these uncertainties, one should not put undue reliance on any forward-looking statements.

Contacts:

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

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SOURCE Keenova Therapeutics

FAQ

What did Keenova (MNK) publish on February 16, 2026 about plantar fibromatosis?

Keenova published a peer‑reviewed manuscript reporting real‑world treatment patterns for plantar fibromatosis. According to Keenova, the article in Journal of Foot and Ankle Surgery documents frequent use of injectable and oral corticosteroids and ongoing conservative care despite low prevalence.

Is Keenova (MNK) running a clinical trial for plantar fibromatosis and what phase is it?

Yes. According to Keenova, a Phase 3 clinical trial evaluating collagenase clostridium histolyticum (CCH) for plantar fibromatosis is currently underway. The company says the study is intended to assess a potential nonsurgical treatment option for this progressive condition.

Does the February 16, 2026 manuscript say there are FDA‑approved nonsurgical treatments?

No; there are no FDA‑approved nonsurgical treatments for plantar fibromatosis, according to Keenova. The manuscript emphasizes an unmet need and reports varied real‑world conservative treatments, supporting further research into long‑term effectiveness and outcomes.

What treatment patterns for plantar fibromatosis did Keenova report in the manuscript?

Most newly diagnosed patients received conservative care such as injectable and oral corticosteroids and therapy, according to Keenova. The study also found that conservative treatments frequently persist after surgery, indicating potential recurrence or ongoing symptoms.

How might Keenova's Phase 3 trial affect MNK shareholders if successful?

A successful Phase 3 could advance a nonsurgical option for plantar fibromatosis, potentially expanding treatment choices. According to Keenova, the trial aims to support better patient care, though the company has not reported regulatory outcomes or approvals to date.

Who authored the published manuscript on plantar fibromatosis treatment patterns cited by Keenova (MNK)?

The manuscript authors include Jill Davis, Aimee Near, Jenny Tse, Riddhi Doshi, Elizabeth Wang, Luis Ortega, David Hurley, and David G. Armstrong, according to Keenova. The article appears in Journal of Foot and Ankle Surgery and reports real‑world evidence from the US.