Viatris Expands Innovative Portfolio in Cardiovascular Diseases with the Company's First Launch of Inpefa® (Sotagliflozin) for the Treatment of Heart Failure

Rhea-AI Summary

Viatris (Nasdaq: VTRS) announced the launch of Inpefa (sotagliflozin) in the United Arab Emirates, the first market within Viatris territories to commercialize the drug, with additional launches planned across multiple countries over the next several years.

Inpefa is the first dual SGLT1/2 inhibitor approved to reduce risk of cardiovascular death, heart failure hospitalization, and urgent heart failure visits. Approval is supported by two Phase 3 trials (SOLOIST-WHF and SCORED; >11,800 patients) showing a 33% reduction in the composite endpoint in SOLOIST-WHF (up to 51% when initiated prior to discharge), 25% reduction in SCORED, and a 23% reduction in MACE, including 32% reduction in MI and 34% reduction in stroke.

Positive

• SOLOIST-WHF: composite endpoint reduced by 33%
• SOLOIST-WHF: benefit up to 51% when started before discharge
• SCORED: composite endpoint reduced by 25%
• MACE reduced by 23%, MI by 32% and stroke by 34%
• First commercial launch in UAE with planned launches in multiple countries
• Regulatory filings submitted in Canada, Australia, and Mexico

Negative

• Commercial availability currently limited to the UAE; broader access will occur over several years
• Efficacy evidence derives from high-risk trial populations (>11,800 patients), which may limit immediate generalizability to lower-risk groups

News Market Reaction

-4.38% 2.5x vol

67 alerts

-4.38% News Effect

+30.2% Peak in 25 hr 58 min

-$27M Valuation Impact

$596M Market Cap

2.5x Rel. Volume

On the day this news was published, LXRX declined 4.38%, reflecting a moderate negative market reaction. Argus tracked a peak move of +30.2% during that session. Our momentum scanner triggered 67 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $27M from the company's valuation, bringing the market cap to $596M at that time. Trading volume was elevated at 2.5x the daily average, suggesting increased selling activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase 3 enrollment: more than 11,800 patients Composite risk reduction: 33% Pre-discharge benefit: 51% +5 more

8 metrics

Phase 3 enrollment more than 11,800 patients SOLOIST-WHF and SCORED pivotal trials

Composite risk reduction 33% SOLOIST-WHF composite of HF hospitalization, urgent visits, CV death vs placebo

Pre-discharge benefit 51% Risk reduction when initiated prior to discharge in SOLOIST-WHF

Early benefit window 30 days Benefits evident within 30 days post-discharge in SOLOIST-WHF

Composite risk reduction 25% SCORED composite endpoint in T2D and CKD patients

MACE reduction 23% Reduction in MACE (CV death, non-fatal MI, non-fatal stroke)

Myocardial infarction reduction 32% Reduction in non-fatal MI within MACE analysis

Stroke reduction 34% Reduction in non-fatal stroke within MACE analysis

Market Reality Check

Price: $1.16 Vol: Volume 2,894,452 vs 20-da...

high vol

$1.16 Last Close

Volume Volume 2,894,452 vs 20-day avg 1,718,090 (relative volume 1.68x). high

Technical Price 1.37 is trading above the 200-day MA at 1.07.

Peers on Argus

LXRX gained 7.03% while key biotech peers (AURA, FULC, ATXS, INBX, SLDB) showed ...

LXRX gained 7.03% while key biotech peers (AURA, FULC, ATXS, INBX, SLDB) showed intraday declines ranging from about -0.32% to -3.01%, indicating a stock-specific move rather than a sector-wide rally.

Historical Context

5 past events · Latest: Jan 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	Business update	Positive	+0.8%	Outlined Phase 3 timelines, ZYNQUISTA plans, cash position and Novo milestone.
Jan 09	Policy white paper	Neutral	-0.8%	Released chronic pain access white paper highlighting burden and policy needs.
Jan 07	Conference presentation	Positive	+2.6%	Announced upcoming JPM Healthcare Conference presentation and webcast access.
Dec 10	Preclinical data	Positive	+0.8%	Published ACSL5 preclinical data supporting LX9851’s metabolic effects.
Dec 05	Clinical data forum	Positive	-1.4%	Flagged upcoming HFpEF adipose distribution data presentation at CVCT 2025.

Pattern Detected

Recent news over the past two months has led to relatively modest one-day moves, mostly within a +/-3% band, suggesting this stronger reaction to today’s cardiovascular launch stands out versus prior updates.

Recent Company History

Over the last several months, Lexicon has highlighted steady progress across its pipeline and corporate strategy. A Dec 10, 2025 preclinical publication supported LX9851’s rationale, followed by a Dec 8–10, 2025 HFpEF data presentation. Early Jan 2026 brought JPM conference participation and a detailed business update, including SONATA-HCM Phase 3 timelines and ZYNQUISTA NDA plans, alongside cash runway commentary. Those events moved the stock between about -1.41% and +2.63%, making today’s reaction to the Inpefa launch comparatively larger.

Market Pulse Summary

This announcement highlights Viatris’ first launch of Inpefa in the UAE, underpinned by two large Ph...

Analysis

This announcement highlights Viatris’ first launch of Inpefa in the UAE, underpinned by two large Phase 3 studies totaling more than 11,800 patients and demonstrating substantial reductions in heart failure and cardiovascular events. For Lexicon, these data reinforce sotagliflozin’s differentiated profile alongside its broader cardiovascular development strategy. Investors may monitor future country launches, additional regulatory submissions, and how real-world utilization compares with the pivotal trial results, including the reported 33–51% composite risk reductions and MACE benefits.

Key Terms

sglt1/2 inhibitor, heart failure, type 2 diabetes mellitus, chronic kidney disease, +4 more

8 terms

sglt1/2 inhibitor medical

"Inpefa is the first and only dual SGLT1/2 inhibitor approved for the treatment"

SGLT1/2 inhibitors are medicines that block two proteins (SGLT1 and SGLT2) that normally help the body reabsorb sugar from the gut and kidneys, so more glucose is expelled in urine and blood sugar falls. Investors watch these drugs because their clinical benefits, safety profile, regulatory approvals and label expansions for diabetes, heart and kidney disease directly influence sales, market share and valuation—like a new feature that can expand a product’s customer base.

heart failure medical

"for the treatment of heart failure. The treatment is approved in the U.S. and UAE"

A condition in which the heart cannot pump enough blood to meet the body's needs, causing fatigue, shortness of breath, fluid buildup, and reduced activity. It matters to investors because it drives demand for medicines, medical devices, hospital care, and long-term support services; outcomes, trial results, approvals, or changes in treatment guidelines can materially affect company revenues, healthcare costs, and market valuations. Think of it as a central pump losing efficiency and changing the economics of care.

type 2 diabetes mellitus medical

"in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease"

A chronic metabolic condition in which the body cannot use insulin effectively, causing persistently high blood sugar levels that damage organs and increase risk of heart disease, kidney failure and other complications; think of insulin as a key and cells as locks that stop responding, so sugar stays in the bloodstream instead of fueling tissues. Investors care because the large, growing patient population drives demand for drugs, devices, diagnostics and long‑term healthcare spending, influencing pharmaceutical pipelines, regulatory reviews, reimbursement, and insurer costs.

chronic kidney disease medical

"type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk"

Chronic kidney disease is a long-term, progressive loss of kidney function that reduces the organs’ ability to filter waste, control fluid levels and balance body salts. For investors, CKD matters because it creates sustained demand for tests, drugs, dialysis machines and transplants; advances in treatment or regulatory decisions can meaningfully change revenue prospects for companies—like a car that needs ongoing repairs, it creates predictable, long-term market needs.

phase 3 medical

"The approval of Inpefa is based on two pivotal Phase 3 trials—SOLOIST-WHF"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

placebo medical

"reduced the composite risk ... by 33% versus placebo in patients recently"

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

mace medical

"MACE—defined as CV death, non-fatal MI, and non-fatal stroke—was reduced"

MACE stands for Major Adverse Cardiovascular Events — a composite medical endpoint that counts serious heart-related outcomes such as heart attack, stroke and cardiovascular death. Investors use MACE as a single safety and efficacy yardstick for drugs or devices aimed at the heart or blood vessels; like a vehicle crash-test score, a lower MACE rate signals fewer serious harms and can strongly influence regulatory approval, market adoption and commercial value.

cardiovascular death medical

"reduce the risk of cardiovascular death, hospitalization for heart failure"

Death directly caused by disease or malfunction of the heart or blood vessels, such as heart attack, stroke, heart failure, or sudden cardiac arrest. Investors care because this outcome is a key safety and effectiveness measure for drugs, devices and treatments — like a warranty test for a product — and can drive regulatory decisions, market size, legal exposure and a company’s future revenue and valuation.

AI-generated analysis. Not financial advice.

Builds on Viatris' Scientific Leadership and Commercial Legacy in Cardiovascular Diseases

PITTSBURGH, Jan. 20, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced the launch of Inpefa^® (sotagliflozin) in the United Arab Emirates (UAE), the first country within the Viatris territories to commercialize the treatment. Future launches are planned in multiple countries over the next several years, supporting Viatris' strategy to expand access to the treatment in key markets outside of the U.S. and Europe.

Inpefa is the first and only dual SGLT1/2 inhibitor approved for the treatment of heart failure. The treatment is approved in the U.S. and UAE to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

"The launch of Inpefa in the UAE marks another important step as we continue to deliver innovative medicines for patients around the world," said Corinne Le Goff, Viatris Chief Commercial Officer. "Heart failure is the world's leading cause of hospitalization, and as such there is an ongoing need for new treatments to help address this burden. This milestone also builds upon our robust legacy in cardiovascular diseases, reinforcing our commitment to expand the impact of Inpefa to help address the needs of patients around the world."

"Our success in extending the global reach of Inpefa is evidence of our growing innovative pipeline, which includes several late-stage programs that are advancing at a very strong pace," said Philippe Martin, Viatris Chief R&D Officer. "With its dual SGLT inhibition, Inpefa provides cardiologists with a unique therapeutic option that provides early benefit in reducing heart failure-related outcomes, potentially offering a meaningful role in reducing healthcare burden. We have already submitted regulatory filings across several countries, including Canada, Australia and Mexico, and will continue to broaden our global submissions over the coming years."

The approval of Inpefa is based on two pivotal Phase 3 trials—SOLOIST-WHF and SCORED—enrolling more than 11,800 patients globally and significantly reducing the risk of major cardiovascular events in high-risk populations. In SOLOIST-WHF, Inpefa reduced the composite risk of heart failure hospitalization, urgent visits, and cardiovascular death by 33% versus placebo in patients recently hospitalized for worsening heart failure, with benefits increasing up to 51% when initiated prior to discharge and evident within 30 days post-discharge. In SCORED, among patients with type 2 diabetes and chronic kidney disease with additional cardiovascular risk factors—both with and without heart failure—Inpefa achieved a 25% reduction in the same composite endpoint. Consistent with its dual SGLT1 and SGLT2 inhibition, MACE—defined as CV death, non-fatal MI, and non-fatal stroke—was reduced by 23%, with benefits observed as early as 94 days. It is the first SGLT inhibitor to show a significant reduction in both MI (32%) and stroke (34%).

About Heart Failure
Heart failure is the world's leading cause of hospitalization, affecting more than 64 million people worldwide. It is a serious condition that usually has no cure and occurs when the heart is not pumping as well as it should, hence compromising blood and oxygen supply to the tissues. It is estimated that one in every five people will develop heart failure during their lifetime. After hospital discharge, both mortality and readmission rates remain substantial worldwide. The 30-day post-discharge mortality is approximately 6.7%, and readmission rates average 13%, underscoring the ongoing risk during the vulnerable post-hospitalization period. At one year post-discharge mortality increases to an average 23%, and readmission rates increase to an average of 36%.

About Inpefa (sotagliflozin)
Sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is primarily responsible for absorbing glucose and sodium in the small intestine, as well as for reabsorbing a small amount of glucose in the kidney's distal tubule. SGLT1 is also found in the heart and vascular endothelium, where it may influence cellular stress and inflammatory pathways—suggesting roles beyond glucose control. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. It was approved by the by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

Viatris and Lexicon Licensing Agreement
In October 2024, Viatris announced it had entered into an exclusive licensing agreement with Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) for sotagliflozin in all markets outside of the U.S. and Europe. Inpefa is marketed by Lexicon Pharmaceuticals in the U.S. 

About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter).

Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that Viatris expands innovative portfolio in cardiovascular diseases with the Company's first launch of Inpefa^® (Sotagliflozin) for the treatment of heart failure; builds on Viatris' scientific leadership and commercial legacy in cardiovascular diseases; launch of Inpefa^® (sotagliflozin) in the UAE, the first country within the Viatris territories to commercialize the treatment; future launches are planned in multiple countries over the next several years, supporting Viatris' strategy to expand access to the treatment in key markets outside of the U.S. and Europe; Inpefa is the first and only dual SGLT1/2 inhibitor approved for the treatment of heart failure; the launch of Inpefa in the UAE marks another important step as we continue to deliver innovative medicines for patients around the world; this milestone also builds upon our robust legacy in cardiovascular diseases, reinforcing our commitment to expand the impact of Inpefa to help address the needs of patients around the world; our success in extending the global reach of Inpefa is evidence of our growing innovative pipeline, which includes several late-stage programs that are advancing at a very strong pace; with its dual SGLT inhibition, Inpefa provides cardiologists with a unique therapeutic option that provides early benefit in reducing heart failure-related outcomes, potentially offering a meaningful role in reducing healthcare burden; we have already submitted regulatory filings across several countries, including Canada, Australia and Mexico, and will continue to broaden our global submissions over the coming years; and the outcome of clinical trials. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

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SOURCE Viatris Inc.

FAQ

What did Viatris (VTRS) announce about Inpefa on January 20, 2026?

Viatris announced the commercial launch of Inpefa (sotagliflozin) in the UAE and plans for additional launches in multiple countries over the next several years.

How effective was Inpefa in the SOLOIST-WHF trial reported by Viatris?

In SOLOIST-WHF, Inpefa reduced the composite of heart failure hospitalization, urgent visits, and CV death by 33%, rising to 51% when initiated prior to discharge.

What were the SCORED trial results for Inpefa according to Viatris?

In SCORED, Inpefa lowered the same composite endpoint by 25% in patients with type 2 diabetes and chronic kidney disease with additional cardiovascular risk factors.

Does Inpefa reduce major adverse cardiovascular events (MACE)?

Yes; Inpefa showed a 23% reduction in MACE, with subgroup results showing 32% reduction in MI and 34% reduction in stroke.

Which countries has Viatris filed regulatory submissions for Inpefa?

Viatris reported regulatory filings in Canada, Australia, and Mexico, and plans to broaden global submissions over coming years.

What does the UAE launch of Inpefa mean for Viatris investors (VTRS)?

The UAE launch marks Viatris' first commercial market for Inpefa within its territories and represents the start of a multi-year rollout strategy outside the U.S. and Europe.