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PARIS - AB Science SA (Euronext:AB), a pharmaceutical company with a market capitalization of $4.62 billion and an impressive InvestingPro Financial Health Score of "GREAT," has received authorization from several European countries to initiate its confirmatory Phase 3 study of masitinib in amyotrophic lateral sclerosis (ALS), the company announced Thursday.
The approval from Spain, Greece, and Slovenia follows the European Medicines Agency’s validation of the harmonized protocol and previous authorization from the U.S. Food and Drug Administration. This allows AB Science to begin the registration study in both Europe and the United States. The company’s stock has shown strong momentum, trading near its 52-week high of $42.60, with a year-to-date return of 18.16%. For deeper insights into AB Science’s market performance and growth potential, including 8 additional exclusive ProTips, visit InvestingPro.
The study, designated AB23005, will evaluate masitinib at a dose of 4.5 mg/kg/day in combination with riluzole compared to riluzole with placebo over a 48-week treatment period. The trial will enroll 408 patients randomized 1:1, focusing on ALS patients with normal disease progression and without total loss of function.
According to Professor Albert Ludolph from the University of Ulm, Germany, the principal investigator, the study design is based on results from a previous Phase 2B/3 trial that showed significant survival benefits of several months in the targeted patient population.
The confirmatory study will focus on patients with normal disease progression (defined as functional decline of less than 1.1 points per month) and without complete loss of function. This population represents approximately 75% of total ALS patients and showed the strongest response to masitinib in previous trials, with data indicating a median survival increase of 12 months.
AB Science has secured patent protection for masitinib in ALS treatment until 2037 across major markets, with possible extensions for an additional five years in certain countries. The drug has also received orphan drug designation from both European and U.S. regulatory authorities.
The company stated in its press release that masitinib’s mechanism of action targets mast cells and microglia, which has been demonstrated to preserve neuromuscular function in preclinical studies. With a P/E ratio of 11.33 and positive earnings over the last twelve months, AB Science maintains a solid financial foundation for its drug development programs, though analysts expect some pressure on net income in the coming year. A comprehensive analysis of AB Science’s financial metrics and future prospects is available in the exclusive Pro Research Report on InvestingPro, part of the platform’s coverage of over 1,400 US equities.
In other recent news, AllianceBernstein reported that its assets under management rose to $829 billion at the end of June 2025, marking a 3% increase from $803 billion in May. This growth was attributed to market appreciation and modest net inflows, despite some outflows in retail and private wealth management segments. Additionally, AllianceBernstein expanded its exchange agreement with Equitable Holdings, increasing the number of units available for exchange from 4,788,806 to 19,682,946 units. In a separate development, Goldman Sachs downgraded AllianceBernstein’s stock from Buy to Neutral, citing slowing growth despite the firm’s strong positioning and partnerships. The downgrade maintained a price target of $40.00. Furthermore, AllianceBernstein announced changes to its Board of Directors, with Jeff Hurd resigning as a Non-Independent Director. His resignation was described as routine business.
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