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Keenova Therapeutics plc reports company news around its branded therapeutics portfolio for rare and unaddressed conditions. Recurring updates cover financial results, clinical publications, disease-awareness campaigns, and presentations involving products and programs such as Acthar Gel, XIAFLEX, TERLIVAZ, and collagenase clostridium histolyticum research.
The company's communications emphasize specialty therapeutic areas that include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care. News also covers integration activity following its business combination, U.S. manufacturing operations, and portfolio performance drivers across established branded medicines.
Keenova Therapeutics (NYSE: MNK) announced initiatives for the 2nd Annual National Hand Health Month, a U.S. observance each September focused on hand health and early detection of conditions such as Dupuytren's contracture. The company will debut DC Hand Anatomy, a next-generation mixed reality educational experience, at the American Society for Surgery of the Hand Annual Meeting, helping healthcare professionals visualize hand anatomy and better understand Dupuytren's contracture.
According to Keenova, additional efforts include targeted digital outreach, new educational content on Keenova.com and Everyday Health, and on-site engagement at the ASSH meeting, aiming to improve symptom recognition, encourage earlier intervention, and connect an estimated 13 million affected Americans with appropriate care.
Keenova Therapeutics (NYSE: MNK) reported that the first patient has been enrolled and dosed in KN3835-313, a randomized, double-blind, placebo-controlled Phase 3 trial of XIAFLEX (collagenase clostridium histolyticum) as an investigational nonsurgical treatment for adult hammer toe.
The study will assess efficacy, safety, and tolerability in approximately 550 participants across about 35 U.S. sites. The primary endpoint measures improvement in toe straightening via reduction of flexion contracture at the proximal interphalangeal (PIP) joint, with secondary endpoints covering foot function, activity limitations, and patient-assessed hammer toe severity.
Keenova highlights that no FDA-approved nonsurgical therapies are currently indicated for hammer toe. XIAFLEX remains investigational for this indication, although it is already FDA-approved for other urological and orthopedic conditions.
Keenova Therapeutics (MNK) reported second quarter 2026 net sales from continuing operations of $517 million, up $253 million year over year, driven by Acthar Gel net sales of $205 million (+17%) and XIAFLEX net sales of $150 million. Adjusted EBITDA from continuing operations was $206 million. Loss from continuing operations was $221 million, mainly due to a $208 million pre-tax impairment on the Percocet divestiture and $95 million of incremental non-cash fair value-related expenses.
Keenova raised 2026 Acthar Gel net sales growth guidance to 20–22%, expects XIAFLEX to grow at a high single-digit rate, and guides to pro forma 2026 net sales of $1.94–$2.00 billion and pro forma Adjusted EBITDA of $715–$745 million. The company reported positive Phase 3 XIAFLEX data in plantar fibromatosis, plans an sBLA filing in Q4 2026, and expects to start a Phase 3 hammer toe study in Q3 2026. Keenova realized $25 million in quarterly merger synergies, reiterates 2026 synergy targets, completed the Percocet divestiture to exit opioids, and now plans an NYSE listing in 2027.
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.
Keenova Therapeutics (NYSE: MNK) announced it will report its second quarter 2026 financial results on Tuesday, August 11, 2026, before the market opens. On the same day, the company will host an earnings conference call at 8:00 a.m. ET, accessible via webcast and pre-registered dial-in.
Keenova Therapeutics (NYSE:MNK) announced publication of a new manuscript on Acthar Gel (repository corticotropin injection) in the peer-reviewed Journal of Comparative Effectiveness Research. The Keenova-sponsored, retrospective, physician-reported, survey-based chart review analyzed real-world clinical data from patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis/polymyositis (DM/PM) treated with Acthar Gel.
The study evaluated patient characteristics, treatment patterns, and physicians’ assessments of outcomes in complex, often treatment-refractory cases. According to Keenova, these findings expand available evidence on how Acthar Gel is used as a treatment option for appropriate, eligible patients who have not responded to prior therapies.
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.
Keenova (NYSE:MNK) launched a Men's Health Month initiative focused on education and outreach about men's physical, mental, and sexual health, including Peyronie's disease.
Key elements include a Reddit AMA on June 18, a new Men's Sexual Health Screener for providers, targeted digital campaigns, new online content, and support for Wear Blue Day.
Keenova Therapeutics (MNK) announced new final updated data from a dedicated ventral curvature analysis of Peyronie's disease treated with XIAFLEX (collagenase clostridium histolyticum). Results to be presented at the American Urological Association 2026 meeting indicate clinical effectiveness and safety in ventral curvature consistent with other Peyronie's disease presentations.
Keenova Therapeutics (MNK) reported first-quarter 2026 net sales from continuing operations of $468 million, driven by Acthar Gel net sales of $170 million (up 47% YoY) and XIAFLEX net sales of $134 million.
The company posted a loss from continuing operations of $114 million, reflecting non-cash fair value adjustments and Endo-related costs, while adjusted EBITDA reached $174 million. Keenova realized $23 million of merger synergies, remains on track for $100 million in 2026, and reaffirmed 2026 net sales guidance of $1.94–$2.00 billion and adjusted EBITDA of $730–$760 million. XIAFLEX clinical milestones and an NYSE listing pursuit in H2 2026 also remain on track.