US Market News
3月前
HLS Therapeutics Announces NILEMDOTM (bempedoic acid) is now available in Canada for the Reduction of LDL-Cholesterol in Patients at Risk of Cardiovascular DiseaseMarch 5, 2026 7:00 AM
PR Newswire (Canada)
First-in-class, once-daily oral non-statin therapy now available by prescription across CanadaAddresses a significant unmet need for over half a million Canadians who can not get to their LDL-C goal on statin-based therapy or who are statin intolerantSupported by the landmark CLEAR Outcomes trial demonstrating reduction in major adverse cardiovascular events in nearly 14,000 patientsTORONTO, March 5, 2026 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, today announced the commercial launch of NILEMDO™ (bempedoic acid) in Canada. NILEMDO is now available by prescription nationally. HLS in-licensed the exclusive rights to NILEMDO and NEXLIZET® (bempedoic acid and ezetimibe) for the Canadian market from Esperion Therapeutics Inc. ("Esperion") (NASDAQ: ESPR) in May 2025.Health Canada approved NILEMDO in November 2025. NILEMDO is indicated to reduce LDL-C and the risk of major cardiovascular events in adults who require additional low-density lipoprotein cholesterol ("LDL-C") lowering due to an inability to reach target levels with currently available therapies or due to statin intolerance. Cardiovascular disease is the second leading cause of death in Canada, yet many high-risk patients still cannot achieve guideline-recommended LDL-C targets.1 HLS estimates that more than half a million Canadians may benefit from NILEMDO.2"Despite considerable evidence and guideline recommendations, too many Canadians are still not reaching their LDL-C targets" said Dr. Lawrence Leiter, Professor of Medicine and Nutritional Sciences at the University of Toronto. "Bempedoic acid (NILEMDO) offers a new option for Canadian patients who cannot achieve their LDL-C goal or are intolerant to statins. We now have a well-tolerated, once-daily oral therapy that is supported by strong clinical evidence including the large CLEAR Outcomes trial, that provides clinicians and their patients with a new means of reducing cardiovascular risk."A NOVEL MECHANISM ADDRESSING A LARGE UNMET NEED
NILEMDO provides a novel, oral pathway for LDL-C lowering while being less likely to cause muscle-related side effects that limit statin adherence for many patients. In clinical practice, physicians typically initiate therapy with a statin, then add ezetimibe if additional LDL-C lowering is needed. NILEMDO fits directly into this established treatment paradigm, providing a meaningful step-up option for patients who remain above their LDL-C target on combination therapy or who cannot tolerate adequate statin doses. NILEMDO can be used alone or in combination with other LDL-lowering agents, including statins, ezetimibe, and PCSK9 inhibitors.The approval of NILEMDO is supported by the CLEAR Outcomes trial, a landmark randomized, double-blind cardiovascular outcomes study in nearly 14,000 patients with high cardiovascular risk who were unable to take recommended statin therapy. The trial demonstrated that bempedoic acid significantly reduced the risk of major adverse cardiovascular events ("MACE"), including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization.3"With the launch of NILEMDO, Canadians who have been unable to reach their LDL-C targets now have a new oral treatment option supported by robust cardiovascular outcomes data," said Craig Millian, CEO of HLS Therapeutics. "NILEMDO strengthens our cardiovascular portfolio and, along with Vascepa®, positions HLS as a leader in bringing novel oral cardiovascular medicines to the Canadian market. Importantly, we believe this medicine will help more Canadians achieve their LDL-C goals and reduce their cardiovascular risk."Nilemdo has been submitted for reimbursement under private and public plans and is currently under review. HLS is expecting meaningful private payer coverage in Q2 and potential for public reimbursement in late 2026. LOOKING AHEAD: NEXLIZET
HLS is also advancing its regulatory submission for NEXLIZET (bempedoic acid and ezetimibe), a once-daily combination pill that combines two complementary LDL-lowering mechanisms. NEXLIZET demonstrated approximately 38% LDL-C reduction in clinical trials. HLS is working with its partner Esperion Therapeutics, Inc. to respond to Health Canada's outstanding requirements as expeditiously as possible and anticipates a 2027 commercial launch.ABOUT NILEMDO (bempedoic acid)
NILEMDO (bempedoic acid) is a once-daily oral medicine indicated in Canada to reduce LDL-C and the risk of major cardiovascular events in adults who require additional LDL-C lowering due to an inability to reach target levels with currently available therapies or due to statin intolerance. NILEMDO is approved and marketed globally, including in the United States (as NEXLETOL®) and in Europe, where it has been available since 2020. In Canada, NILEMDO will benefit from eight years of data protection starting from its November 17, 2025, approval date. This period, combined with existing and pending patents, provides market exclusivity for the drug extending until 2040.To view the full Nilemdo product monograph, please click here.ABOUT HLS THERAPEUTICS INC.
Formed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: www.hlstherapeutics.comFORWARD LOOKING INFORMATION
This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 12, 2025, and Management's Discussion and Analysis dated November 12, 2025, both of which have been filed on SEDAR+ and can be accessed at www.sedarplus.ca. Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.REFERENCEShttps://www150.statcan.gc.ca/n1/daily-quotidien/250305/t001a-eng.htm?utm_source=chatgpt.comInternal Company estimates https://www.nejm.org/doi/full/10.1056/NEJMoa2215024?utm_source=chatgpt.com
SOURCE HLS Therapeutics Inc.
Original: HLS Therapeutics Announces NILEMDOTM (bempedoic acid) is now available in Canada for the Reduction of LDL-Cholesterol in Patients at Risk of Cardiovascular Disease
US Market News
3月前
Esperion Therapeutics and Corstasis Therapeutics Announce Esperion’s Definitive Agreement to Acquire Corstasis, Expanding Its Cardiovascular Franchise with Enbumyst™ (bumetanide nasal spray)March 3, 2026 6:00 AM
Business Wire
– Enbumyst™ Is the First and Only FDA-Approved Nasal Spray Loop Diuretic for Edema Associated with Congestive Heart Failure, Expected to Leverage Esperion’s Established Cardiovascular Commercial Infrastructure, Synergistically Expand Product Portfolio and Accelerate Double-Digit Revenue Growth –
– Upfront Cash Payment of $75 Million, Royalties on Worldwide Enbumyst Sales and Up to $180 Million in Potential Milestone Payments Tied to Certain Commercial and Regulatory Achievements –
– Esperion to Host Conference Call on Tuesday, March 3, 2026 at 8:00 am ET –
Esperion (NASDAQ: ESPR) and Corstasis Therapeutics Inc., a privately-held, commercial-stage biopharmaceutical company advancing innovative outpatient therapies for the treatment of edema associated with cardiovascular, and hepatic and renal disease, today announced they have entered into a definitive agreement for Esperion to acquire Corstasis.
Under the terms of the agreement, Esperion will acquire Corstasis, which developed and is commercializing Enbumyst™ (bumetanide nasal spray), the first and only nasal spray diuretic approved by the U.S. Food and Drug Administration (FDA) in September 2025 as a treatment for edema associated with congestive heart failure (CHF), and hepatic and renal disease in adults.
Enbumyst offers a differentiated, self-administered outpatient diuretic therapy that may help bridge the gap between oral and IV diuretic therapies for treating patients living with edema associated with CHF, liver disease and kidney disease.
The transaction is expected to close in the second quarter of 2026.
“This acquisition represents a compelling and strategically aligned opportunity that accelerates Esperion’s momentum and advances our long-term Vision 2040. Enbumyst brings meaningful innovation to millions of patients who continue to struggle with the daily burden of diuretic therapy. Enbumyst’s novel intranasal delivery, established regulatory approval, and expanding clinical footprint make it a natural fit for our cardiovascular franchise,” stated Sheldon Koenig, President and Chief Executive Officer of Esperion. “We expect that by integrating Enbumyst into our proven commercial platform, we will drive sustained double-digit growth, strengthen our leadership in cardiovascular care, and create durable value for all of our stakeholders - from patients and providers to employees and shareholders.”
“Enbumyst was purpose-built in partnership with the cardiology community to address a clear unmet need. Today's acquisition validates our team's vision and approach,” said Ben Esque, Chief Executive Officer of Corstasis Therapeutics. “We are excited about the future of Enbumyst in Esperion’s hands and its ability to intervene in the patient setting to treat worsening heart failure at home.”
Strategic Rationale and Commercial Plans
There are an estimated 6.7 million American adults living with CHF and edema is one of the most common and defining clinical features of CHF, particularly as disease severity increases. Enbumyst addresses a large and growing population whose medical needs align directly with Esperion’s commercial and pipeline focus. The product allows Esperion to target a U.S. market with a potential opportunity exceeding $4 billion, and the ability to expand across hepatic and renal indications including nephrotic syndrome.
The acquisition strengthens Esperion’s commercial portfolio, enhances potential long-term revenue growth, and is aligned with the company’s recently introduced Vision 2040, which outlines a pathway for delivering differentiated, accessible cardiovascular innovations for high need patient populations. Enbumyst complements Esperion’s established cardiovascular commercial infrastructure and builds on the company’s expanding presence in metabolic, hepatic, and renal disease, including its recently announced initiative in Primary Sclerosing Cholangitis (PSC).
In addition, Corstasis is advancing a sub-cutaneous pipeline, including a multidose pen injector, which has the potential to unlock additional market opportunities.
“Edema and congestion remain the most burdensome and persistent symptoms for patients living with heart failure, often driving hospitalizations, impairing quality of life, and complicating day-to-day disease management. As a clinician who cares for these patients, it is challenging when they call in with worsening symptoms, as current oral diuretic options can be limited by delayed onset or absorption challenges. The availability of an FDA-approved intranasal diuretic like Enbumyst represents an important therapeutic advance. Its novel intranasal delivery route offers the potential for more flexible, rapid, and patient-friendly fluid management that can be done at home - precisely the kind of innovation we need to better support patients across the spectrum of cardiovascular and renal disease, and hopefully avoid the need for hospitalization,” noted James Udelson, MD, Chief of Cardiology, Tufts Medical Center.
Transaction Terms
Under the terms of the agreement, Esperion, through a subsidiary, will acquire all outstanding stock of Corstasis in exchange for an upfront payment of $75 million in cash. Corstasis shareholders also will be eligible to receive a total of up to an additional $180 million upon the attainment of certain regulatory and commercial milestones, as well as low double-digit royalties on sales of Enbumyst and follow-on products.
Esperion will finance the acquisition through its existing credit facilities and royalty monetization of its Japanese royalties with funds managed by Athyrium Capital Management and HealthCare Royalty.
The transaction is expected to close in the second quarter of 2026, subject to customary closing conditions. Jefferies LLC served as the exclusive financial advisor to Esperion and PJT Partners served as the exclusive financial advisor to Corstasis Therapeutics. Gibson, Dunn & Crutcher LLP served as legal advisors to Esperion and Arnold & Porter Kaye Scholer LLP served as legal advisor to Corstasis.
Conference Call and Webcast Information
Esperion will host a conference call and webcast today at 8:00 a.m. ET to discuss the acquisition.
A live audio webcast can be accessed on the investor relations section of the Esperion website. The webcast replay will be available approximately two hours after completion of the call and will be archived on the Esperion's website for approximately 90 days.
About ENBUMYST™ (bumetanide nasal spray)
ENBUMYST (bumetanide nasal spray) is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR ENBUMYST™ (BUMETANIDE NASAL SPRAY)
INDICATION
ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.
IMPORTANT SAFETY INFORMATION
ENBUMYST is contraindicated in patients with anuria, who are in hepatic coma and have a history of hypersensitivity to bumetanide.
ENBUMYST is a diuretic that may cause fluid, electrolyte, and metabolic abnormalities. Excessive fluid loss can lead to dehydration, decreased blood volume, and increased risk of blood clots. Abnormalities may include changes in blood electrolytes, nitrogen, glucose, and uric acid. The chance of getting these abnormalities is higher in people who are elderly, use higher doses or who do not get enough electrolytes by mouth.
If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide.
Although unlikely at the recommended doses, the potential for ototoxicity must be considered a risk of intravenous therapy, at high doses, repeated frequently in the face of renal excretory function impairment.
Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause.
Advise lactating women treated with ENBUMYST to monitor their infants for excessive urine output, dehydration, and lethargy.
Most common adverse reactions are hypovolemia, headache, muscle cramps, dizziness, hypotension, nausea and encephalopathy (in patients with pre-existing liver disease).
These are not all of the possible side effects of ENBUMYST. To report suspected adverse reactions, contact Corstasis Therapeutics at 1-877-300-5339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information for ENBUMYST.
About Corstasis Therapeutics
Corstasis Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on transforming the management of fluid overload in patients with heart failure, liver disease, and kidney disease, including nephrotic syndrome, in adults. Its lead product, ENBUMYST™, was approved by the FDA on September 12, 2025. Visit www.corstasis.com for more information.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company dedicated to developing and delivering innovative cardiometabolic and rare/orphan disease therapies. The Company leverages deep domain expertise in ACLY biology to develop and commercialize transformative medicines for patients worldwide. Esperion currently markets two oral, once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels and are at risk of cardiovascular disease.
With a broad U.S. commercial infrastructure and global approvals across more than 40 countries, Esperion is well positioned to serve as a partner-of-choice for global innovators seeking U.S. market access through acquisition, in-license, co-promotion and revenue share opportunities. In tandem, the Company is advancing its leadership in ACLY biology to build a diversified pipeline of novel product candidates, including treatments for Primary Sclerosing Cholangitis and renal diseases. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
About Athyrium Capital Management
Athyrium is a specialized asset management company formed in 2008 to focus on investment opportunities in the global healthcare sector. Athyrium advises funds with over $4.6 billion in committed capital. The Athyrium team has substantial investment experience across a wide range of asset classes including public equity, private equity, fixed income, royalties, and other structured securities. Athyrium invests across all healthcare verticals including biopharma, medical devices and products, healthcare focused services, and healthcare information technology. For more information, please visit www.athyrium.com.
About HealthCare Royalty
HealthCare Royalty (“HCRx”) is a leading royalty acquisition company founded in 2006 that is majority owned by KKR & Co. Inc. (NYSE: KKR). Over two decades, the HCRx team has developed a strong track record of investing in commercial-stage and near-commercial-stage biopharmaceutical assets, committing $7+ billion in over 110 biopharmaceutical products. With offices in New York, Stamford, San Francisco, Boston, London and Miami, HCRx continues to advance biopharmaceutical innovation by providing innovative capital solutions to counterparties. For more information, visit https://www.hcrx.com. HEALTHCARE ROYALTY®, HEALTHCARE ROYALTY PARTNERS® and HCRx® are registered trademarks of HealthCare Royalty Management, LLC.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization and business development plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, expectations regarding the acquisition of Corstasis and the prospects associated with Enbumyst, including the potential size of the CHF market opportunity, plans to submit a Supplemental New Drug Application, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are not guarantees of future performance and involve numerous evolving risks and uncertainties that Esperion may not be able to accurately predict or assess, and that could cause Esperion’s actual results to differ materially from those projected, including, without limitation, the failure to consummate the Corstasis transaction or to achieve anticipated sales of Enbumyst, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, business development, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260303929470/en/
Esperion Contact Information:
Investors and Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
Corstasis Contact Information:
Sasha Damouni Ellis
sasha@damounigroup.com
Original: Esperion Therapeutics and Corstasis Therapeutics Announce Esperion’s Definitive Agreement to Acquire Corstasis, Expanding Its Cardiovascular Franchise with Enbumyst™ (bumetanide nasal spray)
Hot Features
プレミアム
登録してリアルタイムのアラート、カスタムポートフォリオ、市場の動きを入手してください。
Gregg4
1月前
Zardiw
1月前
iHub News
3月前
SwingSensei
4月前
glenn1919
6月前
TrendTrade2016
6月前
メールアドレスで登録
