Keenova Unveils Clinical Data from Phase 2 Plantar Fibromatosis Study at the ACFAS Annual Meeting

Rhea-AI Summary

Keenova (NASDAQ:MNK) presented previously unpublished Phase 2 extension data on collagenase clostridium histolyticum (CCH) for plantar fibromatosis at the ACFAS Annual Meeting Feb 24–27, 2026. Findings suggest a safety profile consistent with earlier Phase 2 results and support potential long‑term safety, efficacy, and durability.

Keenova is conducting a pivotal Phase 3 trial for CCH in plantar fibromatosis, with topline results expected mid‑2026.

Positive

• Study 306 reports a safety profile consistent with earlier Phase 2 findings
• Data support potential long‑term efficacy and durability of CCH in plantar fibromatosis
• Pivotal Phase 3 trial underway with results expected mid‑2026

Negative

• CCH is not approved for plantar fibromatosis; regulatory outcome remains uncertain
• Primary endpoint of Study 306 was safety, limiting definitive efficacy claims
• Phase 3 results are pending, so commercial or approval timelines remain unconfirmed

Key Figures

Phase 2 study: Phase 2 Phase 3 trial: Phase 3 Study 306: Study 306 +5 more

8 metrics

Phase 2 study Phase 2 Earlier plantar fibromatosis trial underlying Study 306

Phase 3 trial Phase 3 Ongoing plantar fibromatosis trial with results expected mid-2026

Study 306 Study 306 Open-label extension of Keenova's phase 2 trial

Observation period 180-day Participants entered a 180-day observation period without treatment

Meeting dates February 24–27, 2026 ACFAS Annual Meeting presentation window

Results timing mid-2026 Expected timing for Phase 3 clinical trial results

Safety profile Consistent with Phase 2 CCH safety for initial and re-treatment aligned with earlier phase 2 study

Long-term profile Safety and efficacy Data support potential long-term safety, efficacy, and durability of CCH

Market Reality Check

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Market Pulse Summary

This announcement highlights additional Phase 2 extension data suggesting long-term safety, efficacy...

Analysis

This announcement highlights additional Phase 2 extension data suggesting long-term safety, efficacy, and durability for CCH in plantar fibromatosis, alongside an ongoing Phase 3 trial with results expected by mid-2026. With limited peer activity and no recent tagged historical events provided, the update mainly reinforces Keenova’s clinical trajectory. Investors may focus on Phase 3 design, durability outcomes from the 180-day observation phase, and subsequent regulatory steps as key future markers.

Key Terms

collagenase clostridium histolyticum, open‑label extension, primary endpoint, patient‑ and investigator‑reported outcomes, +2 more

6 terms

collagenase clostridium histolyticum medical

"support the potential long‑term safety and efficacy of collagenase clostridium histolyticum (CCH)"

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.

open‑label extension medical

"New findings from Study 306, an open‑label extension of Keenova's phase 2 trial"

An open-label extension is a follow-up period after a clinical trial in which participants and researchers know which treatment is being given rather than hiding or randomizing the therapy. It lets companies collect longer-term information about how well the drug works and whether there are safety issues over time — like extending a test drive so everyone can see how the product performs in everyday use. Investors watch these results because they can affect regulators’ approval decisions, the size of the drug’s market, and the stock’s risk profile.

primary endpoint medical

"The primary endpoint was safety."

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

patient‑ and investigator‑reported outcomes medical

"Additional efficacy was evaluated using patient‑ and investigator‑reported outcomes."

Patient‑ and investigator‑reported outcomes are results recorded during clinical studies that come directly from patients about symptoms, daily functioning and quality of life, alongside assessments made by investigators (clinicians or research staff) who document medical observations and test-based measures. Like a product’s customer review paired with an expert inspection, these two perspectives matter to investors because they shape evidence of a treatment’s real-world benefit, influence regulatory decisions and labeling, and affect commercial prospects.

phase 2 medical

"Study 306, an open‑label extension of Keenova's phase 2 trial"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 3 medical

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

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

• Previously unpublished clinical data support the potential long‑term safety and efficacy of collagenase clostridium histolyticum (CCH) for plantar fibromatosis.
• The findings will be presented at the ACFAS Annual Meeting, highlighting progress toward a potential nonsurgical treatment option for a painful condition.
• Keenova's Phase 3 clinical trial is currently underway, with results expected mid-2026.

DUBLIN, Feb. 24, 2026 /PRNewswire/ -- Keenova Therapeutics plc is presenting clinical data on plantar fibromatosis at the American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting, taking place February 24–27, 2026.

Why It Matters

Plantar fibromatosis is a progressive condition with no FDA-approved nonsurgical treatment options. Keenova is investigating collagenase clostridium histolyticum (CCH) as a potential therapy. CCH is not approved for treating plantar fibromatosis.

News You Should Know

New findings from Study 306, an open‑label extension of Keenova's phase 2 trial analysis show:

• Patients receiving initial treatment or re‑treatment with CCH demonstrated a safety profile consistent with the earlier phase 2 study.
• Data support the potential long‑term safety, efficacy, and durability of CCH in plantar fibromatosis.
• Keenova's Phase 3 clinical trial evaluating CCH for plantar fibromatosis is currently underway, with results expected mid-2026.

CSO Perspective

"We are pleased to share with the medical community these important data that help advance our understanding of this burdensome condition," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "We are progressing our program to pivotal Phase 3 study to advance a potential nonsurgical treatment option for patients with plantar fibromatosis, reinforcing our commitment to bring new therapies for challenging conditions."

Zoom in: About Study 306

• Builds on earlier phase 2 results showing improvements in nodule hardness, consistency, and other clinical measures, including the reduction of pain associated with the condition.
• Participants entered a 180‑day observation period without treatment, followed by an optional treatment phase for new or previously treated nodules.
• Participants who chose not to be retreated continued in long‑term observation without receiving additional treatment.
• The primary endpoint was safety.
• Additional efficacy was evaluated using patient‑ and investigator‑reported outcomes.

Presentation Details

• Title: Long-term safety, efficacy, and durability of collagenase clostridium histolyticum (CCH) in the treatment and re-treatment of plantar fibromatosis (PFI)
• Authors: C. James Anderson, DPM; Jason Levy, DPM, FACFAS; Sara E. Suttle, DPM, FACFAS; Nigel Jones, PharmD; Luis Ortega, MD; Gongfu Zhou, PhD; Joseph Caporusso, DPM

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) present about plantar fibromatosis at ACFAS Feb 24–27, 2026?

They presented previously unpublished Phase 2 extension data showing a safety profile consistent with earlier results. According to Keenova, the findings support potential long‑term safety, efficacy, and durability of CCH and inform ongoing Phase 3 development.

Does Keenova (MNK) have FDA approval for CCH in plantar fibromatosis?

No, CCH is not approved for treating plantar fibromatosis. According to Keenova, current evidence comes from Phase 2 and an open‑label extension; regulatory approval depends on Phase 3 outcomes expected mid‑2026.

What were the key outcomes of Study 306 reported by Keenova (MNK)?

Study 306 showed safety consistent with prior Phase 2 and signals of durable clinical benefit. According to Keenova, assessments included nodule hardness, consistency, and pain with safety as the primary endpoint.

When will Keenova (MNK) report results from its Phase 3 trial in plantar fibromatosis?

Keenova expects Phase 3 topline results in mid‑2026. According to Keenova, the ongoing pivotal study will determine whether CCH can support a potential nonsurgical treatment option for this condition.

How does Study 306 affect the outlook for Keenova (MNK) clinical program?

Study 306 strengthens the safety data package and supports continued development into Phase 3. According to Keenova, the extension data bolster rationale for pivotal evaluation but do not guarantee regulatory approval.

What clinical measures improved in Keenova's Phase 2 extension for plantar fibromatosis (MNK)?

Reported improvements included nodule hardness, consistency, and reduced pain in some patients. According to Keenova, these patient‑ and investigator‑reported outcomes were assessed alongside a primary safety endpoint in Study 306.