Keenova Announces New Presentations at the Sexual Medicine Society of North America Annual Meeting

DUBLIN, Oct. 8, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today that it will share data and insights related to men's health during three speaker presentations at the Sexual Medicine Society of North America annual meeting, taking place October 8-11, 2026.

Two presentations will highlight clinical studies and real-world treatment experience supporting the use of XIAFLEX^® (collagenase clostridium histolyticum) as a nonsurgical treatment option for men with Peyronie's disease, including those with ventral curvature.

The third presentation will feature Keenova's Men's Sexual Health Screener, a clinician-patient communication resource designed to help facilitate more efficient assessment and discussion of sexual health concerns in healthcare settings.

"We're pleased to share these insights with the medical community," said leading author Jesse Mills, MD, Clinical Professor and Director of the Men's Clinic at UCLA Health. "Supporting men's sexual health requires effective treatment options and practical resources that help clinicians identify concerns, engage patients in discussion, and guide informed treatment decisions."

Presentation Details

• Title: Collagenase Clostridium Histolyticum for Ventral Curvature of the Penis Due to Peyronie's Disease: Subgroup Analysis of a Multicenter Retrospective Phase 4 Observational Study
  • Authors: Billy H. Cordon-Galiano, MD; Matthew J. Ziegelmann, MD; Faysal A. Yafi, MD, FRCSC; John P. Mulhall, MD; Bruce R. Kava, MD; Petar Bajic, MD; Nelson E. Bennett, Jr., MD; Richard C, Bennett, MD; Helen L. Bernie, DO, MPH; Kristen Gumpf, PA-C; Stanton C. Honig, MD; Majdee M. Islam, MD; Mohit Khera, MD, MBA, MPH; Marcelo Mass Lindenbaum, MD; Muhammed A. M. Hammad, MBBCh; Alexander J. Tatem, MD; Jeffrey Andrews, MS; David Hurley, MD; Marian Ayad, PharmD, BCPS; Jesse N. Mills, MD
    
    
    
    
• Title: Collagenase Clostridium Histolyticum for Ventral Curvature of the Penis Due to Peyronie's Disease: Literature Review of Real-World and Multicenter Phase 4 Outcomes
  • Authors: Matthew J. Ziegelmann, MD; Billy H. Cordon, MD; Faysal A. Yafi, MD, FRCSC; Bruce R. Kava, MD; John P. Mulhall, MD; Marian Ayad, PharmD, BCPS; Jesse N. Mills, MD
    
    
    
    
• Title: Qualitative Development of a Brief, Integrated, Patient- and Provider-Informed Screening Tool for Peyronie's Disease, Erectile Dysfunction, and Low Testosterone
  • Authors: Majdee M. Islam, MD; Petar Bajic, MD; Abram McBride, MD; David Hurley, MD; Jill Davis, MS; Tina Rezakhani, PharmD, MBA; Jennifer Dine, PhD, RN; Bonita Basnyat, PhD; Dana DiBenedetti, PhD; Kristen Gumpf, PA-C; Mohit Khera, MD, MBA, MPH

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

XIAFLEX^® PD Professional 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

• 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, safety, 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 "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 on the SEC's website (www.sec.gov) and Keenova's website (www.keenova.com). The forward-looking statements made herein speak only as of the date hereof and Keenova 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.

* 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.

 

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