TEL AVIV - Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) revealed successful topline results from its Phase 3 SPACE study, which examined the efficacy of AJOVY (fremanezumab) in preventing episodic migraines in pediatric patients. The study, involving children and adolescents aged 6-17, met its primary endpoint, showing a significant reduction in Monthly Migraine Days over a 12-week period compared to placebo.
The safety profile of AJOVY in the trial was consistent with previous findings in adult studies, with no new safety concerns identified. These results mark the first Phase 3 evidence for an anti-CGRP monoclonal antibody in treating pediatric migraines, addressing a gap in available preventive treatments for this age group. Full study details are expected to be presented at a medical conference later in 2024.
Migraines are prevalent in children, affecting an estimated 7.7% overall, and can lead to significant disability, including missed school and social activities. The SPACE study's positive outcome is particularly meaningful for younger migraine sufferers who have limited treatment options.
AJOVY is currently approved for migraine prophylaxis in adults experiencing at least four migraine days per month. It is administered via subcutaneous injection, with dosing options of either 225 mg monthly or 675 mg quarterly. The medication can be given by healthcare professionals or self-administered by patients or caregivers.
Teva continues to evaluate AJOVY's impact on pediatric patients with chronic migraines as part of its broader research efforts. The company, with a history spanning over 120 years, remains focused on innovation and delivering quality medicines to improve health outcomes for millions of patients.
The information in this article is based on a press release statement from Teva Pharmaceutical Industries Ltd.
In other recent news, Teva Pharmaceutical Industries has seen a flurry of activity. The company has resolved a longstanding tax dispute with the Israeli Tax Authority, agreeing to a payment of $750 million spanning from 2024 to 2029. This settlement allows Teva to continue focusing on its "Pivot to Growth" strategy without lingering tax litigation.
Analysts from Piper Sandler and UBS have maintained an Overweight and Buy rating on Teva shares, respectively. Piper Sandler's optimism is rooted in Teva's solid position in the long-acting injectable (LAI) antipsychotic market, with products such as Uzedy and TEV-749 showing promise.
UBS, on the other hand, has raised its price target for Teva shares to $24, buoyed by anticipated sales of Teva's active pharmaceutical ingredient (API) business and positive trial outlook for TL1a.
Teva also made headlines with its PEARL study, suggesting that pauses in migraine prevention treatment could lead to increased migraine days and reduced effectiveness upon treatment reinitiation. Meanwhile, the company has initiated an antitrust lawsuit against Corcept Therapeutics (NASDAQ:CORT), alleging a monopoly over the Korlym market, a treatment for Cushing's syndrome.
In other corporate news, Teva has launched the first generic version of the diabetes drug Victoza, providing a more affordable option for patients and healthcare providers. Moreover, Matthew Shields has been appointed as the Executive Vice President of Teva Global Operations. These are the recent developments involving Teva Pharmaceuticals.
InvestingPro Insights
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), a key player in the Pharmaceuticals industry, has shown promising results with its AJOVY treatment, potentially expanding its market to pediatric patients.
As the company anticipates new growth opportunities, InvestingPro data reveals a market capitalization of $18.7 billion and a notable revenue growth of 7.23% over the last twelve months as of Q1 2024. This financial strength is underpinned by a gross profit margin of 48.96%, indicating Teva's ability to maintain profitability in its operations.
InvestingPro Tips suggest that analysts expect net income growth this year for Teva, aligning with the company's positive clinical outcomes. Moreover, the company has experienced a strong return over the last year, with a price total return of 101.48%. These metrics underscore Teva's robust performance in the market and could be indicative of its future trajectory following the successful trial of AJOVY in younger patients.
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