Keenova Announces Publication of XIAFLEX® (collagenase clostridium histolyticum) Manuscript in Translational Andrology and Urology

Rhea-AI Summary

Keenova Therapeutics (NYSE: MNK) announced the publication of a Keenova‑sponsored post hoc analysis of XIAFLEX® (collagenase clostridium histolyticum) data from the IMPRESS I/II studies in Translational Andrology and Urology. The manuscript evaluates whether baseline penile pain affects treatment outcomes in adult men with Peyronie's disease treated with XIAFLEX.

The study, led by senior author Dr. Landon Trost, suggests clinicians should not rely on pain and disease duration alone to determine treatment timing, but instead use a comprehensive clinical assessment. Keenova also reiterates the approved indication for XIAFLEX in Peyronie’s disease and provides extensive boxed warning and safety information, including risks of corporal rupture, severe penile hematoma, hypersensitivity reactions, bleeding risk in patients with coagulation abnormalities, acute post‑injection back pain reactions, syncope, and common adverse reactions such as penile hematoma, swelling, and pain. The company highlights its broader focus on rare and specialty diseases and reminds investors to monitor its website for time‑critical information.

Key Figures

Minimum curvature: 30 degrees Corporal rupture: 5 of 1044 patients (0.5%) Possible corporal rupture cases: 9 of 1044 patients (0.9%) +5 more

8 metrics

Minimum curvature 30 degrees XIAFLEX Peyronie's disease indication

Corporal rupture 5 of 1044 patients (0.5%) XIAFLEX-treated patients in clinical studies

Possible corporal rupture cases 9 of 1044 patients (0.9%) XIAFLEX-treated patients with related injury symptoms

Severe penile hematoma 39 of 1044 patients (3.7%) XIAFLEX-treated patients

Localized pruritus 4% vs. 1% placebo Double-blind, placebo-controlled Peyronie's disease trials

Penile hematoma 65.5% XIAFLEX-treated patients in controlled trials

Penile ecchymosis 14.5% XIAFLEX-treated patients in controlled trials

PD prevalence estimate 1 in 10 men Estimated U.S. prevalence of Peyronie's disease

Key Terms

post hoc analysis, corporal rupture, penile hematoma, risk evaluation and mitigation strategy, +1 more

5 terms

post hoc analysis technical

"The Keenova-sponsored posthoc analysis, which evaluated existing XIAFLEX clinical trial data"

Post hoc analysis is an exploratory look at data carried out after a study or trial is finished to search for patterns or effects that were not specified beforehand. Because it’s done after seeing the results, findings can arise by chance and are less reliable than preplanned tests; investors should treat post hoc claims as hypothesis-generating signals that may need confirmatory studies or regulatory review before they meaningfully affect a company’s value.

corporal rupture medical

"WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY"

A corporal rupture is a tear in the erectile tissue (corpora cavernosa) and its fibrous covering that usually happens when an erect penis is subjected to sudden blunt force; it is commonly described as a penile fracture and causes abrupt pain, swelling, and loss of erection. For investors, the term matters when it appears in clinical, regulatory, or liability contexts because it can drive demand for emergency urology services, surgical repair devices, prosthetic implants, insurance claims, and safety-related disclosures—think of it like a blowout in a pressure-filled tube that requires urgent repair.

penile hematoma medical

"Severe penile hematoma was also reported as an adverse reaction"

A penile hematoma is a localized collection of blood within the tissues of the penis, usually caused by trauma, injury, or surgical procedures; it appears as swelling, bruising, or a firm lump. Like a bruise under the skin, it represents bleeding that has pooled and become trapped rather than flowing away. For investors, it matters because such adverse events can affect clinical trial safety profiles, regulatory reviews, product liability, and public perception for companies in healthcare or medical-device sectors.

risk evaluation and mitigation strategy regulatory

"under a Risk Evaluation and Mitigation Strategy (REMS)"

A risk evaluation and mitigation strategy is the process a company uses to identify potential problems that could hurt its finances or operations, estimate how likely and severe those problems are, and put practical steps in place to reduce their chance or impact. For investors, it matters because a clear, credible plan is like good insurance and brakes on a car — it lowers the chance of sudden losses, improves predictability, and can make a business a safer, more attractive investment.

anaphylaxis medical

"Hypersensitivity Reactions, Including Anaphylaxis"

Anaphylaxis is a sudden, severe allergic reaction in which the body's defense system overreacts to a trigger (like a drug, food, or insect sting), causing widespread symptoms such as difficulty breathing, low blood pressure, and shock; it can be life‑threatening without prompt treatment. Investors care because anaphylaxis risks can affect a drug or product's safety profile, regulatory approval, liability exposure and market acceptance—similar to a sprinkler system going off and damaging the whole house rather than just one room.

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

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DUBLIN, Aug. 3, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced the publication of a new manuscript examining whether baseline penile pain influences treatment outcomes in men with Peyronie's disease treated with XIAFLEX^® (collagenase clostridium histolyticum). The Keenova‑sponsored posthoc analysis, which evaluated existing XIAFLEX clinical trial data, appears in Translational Andrology and Urology.

"These findings highlight the importance of looking beyond pain alone when evaluating Peyronie's disease," said Landon Trost, MD, Director of the Male Fertility and Peyronie's Clinic in Orem, Utah, and senior author of the study. "This reinforces that pain and disease duration, while important factors, should not be the sole determinants of treatment timing, but treatment decisions should be grounded in a comprehensive clinical assessment and the evolving understanding of Peyronie's disease."

Manuscript Details

• Title: Peyronie's Disease Patients With Pain: A Post Hoc Analysis of the IMPRESS I/II Studies
• Authors: Jesse N. Mills, MD; Gregory A. Broderick, MD; James P. Tursi, MD; Marian Ayad, PharmD, BCPS; Tina Rezakhani, PharmD, MBA; Jeffrey Andrews, MS; Sajel Patel, PharmD; Landon Trost, MD

About Peyronie's Disease
Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be bothersome during arousal and intimacy.¹ It is estimated that PD can affect as many as 1 in 10 men in the U.S.,^2* but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.³

Indication and Important Safety Information

INDICATION 
XIAFLEX^® is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

IMPORTANT SAFETY INFORMATION FOR XIAFLEX

WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE'S DISEASE

Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile "popping" sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients.

Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.

Because of the risks of corporal rupture or other serious penile injury, XIAFLEX is available for the treatment of Peyronie's disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program.

• Contraindications: XIAFLEX is contraindicated in the treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method
• Corporal Rupture or Other Serious Injury to the Penis: Injection of XIAFLEX into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX should be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing
• Hypersensitivity Reactions, Including Anaphylaxis: In the double-blind, placebo-controlled portions of the clinical trials in Peyronie's disease, a greater proportion of XIAFLEX-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX injection procedures). The incidence of XIAFLEX-associated pruritus was similar after each injection regardless of the number of injections administered
  • Because XIAFLEX contains foreign proteins, severe allergic reactions to XIAFLEX can occur. Anaphylaxis was reported in a post-marketing clinical trial in one patient who had previous exposure to XIAFLEX for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections. The safety of more than one treatment course of XIAFLEX is not known
• Risk of Bleeding in Patients with Abnormal Coagulation: In the XIAFLEX controlled trials in Peyronie's disease, 65.5% of XIAFLEX-treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX administration is not known. In addition, it is recommended to avoid use of XIAFLEX in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin)
• Acute Post-Injection Back Pain Reactions: Post-marketing reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie's disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention.
  Administer the smallest number of treatment cycles necessary to treat the patient's curvature deformity
• Syncope and Presyncope: Most, but not all cases of syncope and presyncope in patients with Peyronie's disease, occurred in association with post-injection penile pain and hematoma, penile pain with spontaneous erections, and pain during micturition. These potential triggers suggest a vasovagal mechanism. Make patients aware of the potential symptoms that could trigger syncope and presyncope after treatment with XIAFLEX. If presyncopal symptoms occur, patients should remain recumbent until symptoms resolve. Syncope may be associated with bodily injuries, including concussion, head abrasion, and other accidental injuries

Adverse Reactions

Clinical trials

• In the XIAFLEX clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain.

Post-marketing experience 

• Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatments
• Cases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention 
• Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie's disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reported

Click for full Prescribing Information, including Boxed Warning and Medication Guide.

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.

* Based on a survey of about 7,700 U.S. adult men with a PD diagnosis, PD-related symptoms, or a history of seeking treatment for the condition.

References

1. Hellstrom WJ. Int J Impot Res. 2003;15(Suppl 5):S91–S92.
2. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157.
3. DiBenedetti DB, Nguyen D, Zografos L, et al. Adv Urol. 2011; 2011:282503.

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

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SOURCE Keenova Therapeutics

FAQ

What did Keenova Therapeutics (MNK) announce about the new XIAFLEX study on August 3, 2026?

Keenova announced publication of a Keenova‑sponsored post hoc analysis of XIAFLEX® data in Peyronie’s disease. According to Keenova, the manuscript in Translational Andrology and Urology evaluates whether baseline penile pain influences treatment outcomes in men treated with XIAFLEX.

How does baseline penile pain relate to XIAFLEX treatment outcomes in Peyronie’s disease according to Keenova (MNK)?

The analysis examines whether baseline penile pain impacts XIAFLEX® treatment results in Peyronie’s disease. According to Keenova, findings support that pain and disease duration should not be the sole determinants of treatment timing, emphasizing comprehensive clinical assessment instead.

What is XIAFLEX indicated for in adult men with Peyronie’s disease (MNK)?

XIAFLEX® is indicated for adult men with Peyronie’s disease who have a palpable plaque and at least 30 degrees of curvature at therapy start. According to Keenova, treatment is specifically for this defined patient group and must follow prescribing and safety guidance.

What serious risks are highlighted in the boxed warning for XIAFLEX in Peyronie’s disease?

The boxed warning describes risks of corporal rupture (penile fracture) and other serious penile injury in XIAFLEX®‑treated patients. According to Keenova, some cases require prompt evaluation and possible surgical intervention, and XIAFLEX is available only through the XIAFLEX REMS Program.

What common adverse reactions occurred in XIAFLEX clinical trials for Peyronie’s disease?

In Peyronie’s disease trials, the most frequent adverse reactions (≥25%) with XIAFLEX® included penile hematoma, penile swelling, and penile pain. According to Keenova, these events were more common with XIAFLEX than placebo and are emphasized in the safety information.

Are there special precautions for using XIAFLEX in patients with bleeding risk or on anticoagulants?

Clinical trials excluded patients with abnormal coagulation except low‑dose aspirin, and most XIAFLEX® patients developed hematoma or ecchymosis. According to Keenova, efficacy and safety with other anticoagulants are unknown, and use is recommended to be avoided in coagulation disorders.

Where can investors find more information about Keenova Therapeutics (MNK) and XIAFLEX updates?

Investors can find press releases, presentations, and financial information on Keenova’s website, particularly the Investor Relations page. According to Keenova, the website is used to distribute time‑critical company information, sometimes in advance of SEC filings or separate press releases.