PITTSBURGH - Viatris Inc. (NASDAQ: NASDAQ:VTRS), a $15 billion market cap pharmaceutical company that has seen its shares surge nearly 28% over the past six months, has announced the publication of results from its Phase 2b CARE study evaluating cenerimod, an investigational drug for moderate-to-severe systemic lupus erythematosus (SLE). According to InvestingPro analysis, the company appears undervalued at current levels, with additional ProTips available for subscribers. The study, published in Lancet Rheumatology, revealed that cenerimod at a 4 mg dosage provided a clinically meaningful improvement in SLE disease activity over placebo, alongside stable background therapy.
The CARE study was a double-blind, placebo-controlled trial involving adults aged 18-75 with SLE. Of the 810 patients screened, 427 were randomly assigned to receive varying doses of cenerimod or placebo for a 12-month period. The primary endpoint was the change from baseline to month 6 in the modified SLE Disease Activity Index 2000 (mSLEDAI-2K) score.
At the 6-month mark, the 4 mg cenerimod group showed the most significant change from baseline in mSLEDAI-2K scores. Subgroup analysis indicated that patients with a high IFN-1 gene expression signature experienced a greater reduction in disease activity. Cenerimod also notably reduced IFN-γ-associated proteins and IFN-1 protein and gene expression signature biomarkers after 6 months, aligning with the stronger clinical response observed in the IFN-1 high population.
Throughout the 12-month treatment and follow-up period, most adverse events were mild to moderate, with no serious adverse events linked to cenerimod. The drug was well tolerated across all doses.
These findings have informed the ongoing Phase 3 OPUS program, which aims to further assess the efficacy, safety, and tolerability of cenerimod in SLE patients. With annual revenues exceeding $15 billion and analysts projecting net income growth this year, Viatris continues to demonstrate strong financial fundamentals. For deeper insights into Viatris's financial health and growth prospects, including exclusive ProTips and comprehensive analysis, visit InvestingPro, where you'll find detailed research reports covering 1,400+ top stocks.
SLE is an autoimmune disease that leads to immune system abnormalities, including lymphocyte activation and inflammatory cytokine pathways. Cenerimod, as an oral S1P1 receptor modulator, aims to address SLE pathogenesis with its immunomodulatory effects.
The Viatris-led investigation into cenerimod's potential as an SLE treatment has received Fast-Track designation from the U.S. Food and Drug Administration, highlighting the need for new treatment options for this complex condition.
This article is based on a press release statement from Viatris Inc. detailing the publication of the CARE study results.
In other recent news, Viatris Inc. reported robust financial results for the third quarter of 2024, with total revenues reaching $3.8 billion, marking a 3% increase in operational revenue. Adjusted EBITDA rose by 4% to $1.3 billion, and adjusted earnings per share improved by 6% to $0.75. The company's performance was further underscored by the generation of $866 million in free cash flow and a significant debt repayment of approximately $1.9 billion.
Viatris has also entered a licensing agreement with Lexicon Pharmaceuticals (NASDAQ:LXRX) for sotagliflozin, enhancing its cardiovascular portfolio. Despite potential challenges in the fourth quarter due to product seasonality and increased competition, Viatris continues to show promise with strong performance in the MENA and Emerging Asia regions, and ongoing trials for selatogrel and Cenerimod.
At its annual shareholder meeting, Viatris received approval for an amendment to its stock incentive plan, including an increase of 49 million shares available for issuance. However, the company's executive compensation proposal was rejected by shareholders. The meeting also confirmed the election of twelve director nominees and ratified the selection of Deloitte & Touche LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2024. These are among the recent developments for Viatris Inc.
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