Keenova Announces Publication of New Acthar® Gel (repository corticotropin injection) Manuscript in the Journal of Comparative Effectiveness Research

Rhea-AI Summary

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.

Market Context

Keenova’s publication of real‑world evidence on Acthar Gel use in severe autoimmune diseases adds pe...

Analysis

Keenova’s publication of real‑world evidence on Acthar Gel use in severe autoimmune diseases adds peer‑reviewed support around treatment patterns and outcomes. With limited historical news context, investors may watch for any follow‑on labeling, guideline, or payer‑coverage implications.

Key Terms

repository corticotropin injection, systemic lupus erythematosus, dermatomyositis/polymyositis, retrospective, +2 more

6 terms

repository corticotropin injection medical

"Acthar Gel (repository corticotropin injection) to treat certain severe autoimmune"

A repository corticotropin injection is a long-acting injectable form of ACTH, a hormone that tells the adrenal glands to release cortisol and other stress-response chemicals; think of it like a thermostat signal that raises the body’s anti-inflammatory response. Investors care because its approved uses, pricing, supply, patent or exclusivity status, and competition from alternatives or generics directly affect sales, regulatory risk, and future revenue for companies that sell it.

systemic lupus erythematosus medical

"individuals with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE),"

Systemic lupus erythematosus is a chronic autoimmune disease in which the body's immune system mistakenly attacks healthy tissue, causing inflammation that can affect skin, joints, kidneys, heart, lungs and other organs. It matters to investors because disease severity, prevalence, and gaps in effective treatments drive demand for new drugs and diagnostics—think of it as a large, persistent market need where a successful therapy can change patient outcomes and create significant commercial value.

dermatomyositis/polymyositis medical

"systemic lupus erythematosus (SLE), and dermatomyositis/polymyositis (DM/PM)"

Autoimmune inflammatory muscle diseases in which the body's immune system attacks skeletal muscle, causing progressive weakness and fatigue; dermatomyositis also features a distinctive skin rash while polymyositis primarily affects muscles. Like friendly fire on muscle tissue, these conditions can require long-term treatment, specialized diagnostics, and can drive clinical trials and drug development, making them relevant to investors tracking healthcare demand, regulatory milestones, or the commercial potential of new therapies.

retrospective medical

"the retrospective, physician-reported, survey-based medical chart review study"

A retrospective analysis or study looks backward at information that already exists — such as past sales, clinical records, or historical financial data — rather than collecting new data going forward. For investors, it matters because findings based on past records can be produced quickly and cheaply but may be less reliable than forward-looking studies; think of it like reviewing security-camera footage to explain what happened rather than running a live experiment to predict what will happen next.

real‑world clinical data medical

"study covered in the manuscript used real‑world clinical data to evaluate"

Data gathered about how treatments, medical devices, or health interventions perform in everyday clinical practice rather than in controlled clinical trials, coming from sources such as electronic health records, insurance claims, patient registries, wearable devices, and patient-reported outcomes. It matters to investors because it shows real-world safety, effectiveness, usage patterns, and patient demand—similar to combining product reviews and sales data to judge whether a medical product performs and sells as expected, which can influence regulatory, reimbursement, and revenue expectations.

rheumatoid arthritis medical

"individuals with rheumatoid arthritis (RA), systemic lupus erythematosus"

A long-term autoimmune disease that causes the immune system to mistakenly attack the lining of joints, leading to pain, swelling, stiffness and progressive joint damage; it can also affect other organs. For investors, it matters because the condition drives sustained demand for treatments, influences clinical trial and regulatory outcomes, and affects healthcare spending and workplace disability—so drug approvals, new therapies or cost shifts can materially change the market value of companies involved.

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DUBLIN, July 13, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced the publication of a new manuscript about the use of Acthar Gel (repository corticotropin injection) to treat certain severe autoimmune diseases. Sponsored by Keenova, the retrospective, physician-reported, survey-based medical chart review study covered in the manuscript used real‑world clinical data to evaluate patient characteristics, treatment patterns, and physicians' assessments of outcomes among individuals with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis/polymyositis (DM/PM) who received Acthar Gel. The manuscript appears in the peer-reviewed Journal of Comparative Effectiveness Research and is available here.

Please see indications and Important Safety Information for Acthar Gel below.

"Real‑world evidence for Acthar Gel in RA, SLE, or DM/PM has been limited. This manuscript helps clarify how clinicians are using Acthar Gel in complex, often treatment‑refractory cases," said George J. Wan, Vice President, Evidence, Value & Outcomes at Keenova and senior author of the study. "These findings add to the available data evaluating Acthar Gel as an option for appropriate patients."

"Patients with severe autoimmune diseases deserve access to every effective therapy that can improve their quality of life," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "Acthar Gel remains a real option for eligible patients who have not responded to previous treatments, and we are committed to advancing the science behind this therapeutic."

Manuscript Details

• Title: Acthar Gel treatment in patients with rheumatoid arthritis, systemic lupus erythematosus, or dermatomyositis/polymyositis: Analysis of physician-reported charts
• Authors: Kyle Hayes, MS; Amit Patel, PhD; Priyanka P. Shanbhag, MS; Destri R. Evans, MBA; Mary Prince Panaccio, PhD; Johanna Purcell, PhD; George J. Wan, PhD, MPH

About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic autoimmune disease in which the immune system mistakenly attacks the lining of the joints. This inflammation leads to pain, stiffness, swelling, and progressive joint damage. An estimated 1.5 million adults in the U.S. are living with RA.¹

About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is the most common type of lupus. It's a chronic inflammatory condition that may affect joints, skin, and kidneys. No two cases are the same, and symptoms can vary widely and change over time.² In the U.S., an estimated 160,000 to 260,000 adults are affected by SLE.³

About Dermatomyositis/Polymyositis
Dermatomyositis and polymyositis (DM/PM) are rare inflammatory diseases that cause progressive muscle weakness,⁴ with the former also causing characteristic skin rashes and the latter primarily affecting the muscles closest to the trunk of the body.⁵ People of all ages can be affected, though DM and PM most often occur between ages 40 and 60 and are more common in women.⁶

INDICATIONS

Acthar Gel is indicated for:

• Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
• Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
• Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
• Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
• Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
• Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
• Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
• Symptomatic sarcoidosis

IMPORTANT SAFETY INFORMATION

Contraindications 

Acthar is contraindicated: 

• For intravenous administration
• In infants under 2 years of age who have suspected congenital infections
• With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
• In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin

Warnings and Precautions 

• The adverse effects of Acthar are related primarily to its steroidogenic effects
• Acthar may increase susceptibility to new infection or reactivation of latent infections
• Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment
• Cushing's syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
• Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels
• Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
• Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding
• Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated
• Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
• Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms
• Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity
• There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
• Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
• Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy

Adverse Reactions 

• Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased
• The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve

Pregnancy 

• Acthar may cause fetal harm when administered to a pregnant woman

Please see full Prescribing Information for additional Important Safety Information.

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 ACTHAR® Gel, its potential to improve health and treatment outcomes, and its potential impact on patients. 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 ACTHAR Gel; and other risks and uncertainties 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 Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, filed with the Securities and Exchange Commission (SEC) and other filings with the SEC, all of which are available on the SEC's website (www.SEC.gov) and our website (www.keenova.com). The forward-looking statements made herein speak only as of the date hereof and Keenova Therapeutics 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.

References

1. Arthritis Foundation. Rheumatoid Arthritis: Causes, Symptoms, Treatments and More. Accessed June 2026. https://www.arthritis.org/diseases/rheumatoid-arthritis
2. Lupus Research Alliance. About Lupus. Accessed June 2026. https://www.lupusresearch.org/understanding-lupus/what-is-lupus/about-lupus/
3. Izmirly PM, Parton H, Wang L, et al. Prevalence of systemic lupus erythematosus in the United States: estimates from a meta-analysis of the Centers for Disease Control and Prevention National Lupus Registries. Arthritis Rheumatol. 2021;73(6):991‑996. doi:10.1002/art.41632.
4. Mayo Clinic. Polymyositis. Available at: http://www.mayoclinic.org/diseases-conditions/polymyositis/basics/symptoms/con-20020710. Accessed June 2026.
5. Medline Plus. Myositis. Available at: https://medlineplus.gov/myositis.html. Accessed June 2026.
6. Bernatsky S, Joseph L, Pineau CA, et al. Estimating the prevalence of polymyositis and dermatomyositis from administrative data: age, sex and regional differences. Ann Rheum Dis. 2009;68(7):1192-1196.

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 Acthar Gel on July 13, 2026?

Keenova announced publication of a new Acthar Gel manuscript in the Journal of Comparative Effectiveness Research. According to Keenova, the study uses real-world chart data to describe patient characteristics, treatment patterns, and physician-assessed outcomes in severe autoimmune diseases treated with Acthar Gel.

Which autoimmune diseases were evaluated in the new Acthar Gel study from Keenova (MNK)?

The study evaluated Acthar Gel use in patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis/polymyositis (DM/PM). According to Keenova, physicians provided chart-based assessments of these patients’ treatment patterns and outcomes in real-world practice.

What type of study design was used in Keenova’s new Acthar Gel manuscript?

The manuscript is based on a retrospective, physician-reported, survey-based medical chart review using real-world clinical data. According to Keenova, this design captured how clinicians actually use Acthar Gel and how they assess outcomes in complex, often treatment-refractory autoimmune cases.

Why does Keenova say the new Acthar Gel data are important for patients and clinicians?

Keenova indicates the manuscript adds to limited real-world evidence for Acthar Gel in RA, SLE, and DM/PM. According to Keenova, the findings help clarify current clinical use and support Acthar Gel as an option for eligible patients who have not responded to previous therapies.

Where is the new Keenova Acthar Gel study published and who are the authors?

The manuscript is published in the Journal of Comparative Effectiveness Research. According to Keenova, authors include Kyle Hayes, Amit Patel, Priyanka P. Shanbhag, Destri R. Evans, Mary Prince Panaccio, Johanna Purcell, and senior author George J. Wan.