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PARSIPPANY, N.J. - Teva Pharmaceuticals, a prominent player in the pharmaceutical industry with annual revenue of $16.54 billion and a market capitalization of $15.86 billion, has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab-vfrm), aiming to expand its use for the prevention of episodic migraine in pediatric patients aged 6-17 years weighing at least 45 kilograms (99 pounds). According to InvestingPro analysis, Teva maintains a strong gross profit margin of 48.74% and has shown revenue growth of 4.4% over the last twelve months. If authorized, AJOVY would be the first calcitonin gene-related peptide (CGRP) antagonist available for both adult and pediatric migraine prevention.
The application is supported by results from the Phase 3 SPACE trial, which showed significant reductions in monthly migraine and headache days among pediatric patients, with a safety profile comparable to adults. AJOVY was first approved for migraine prevention in adults in the U.S. in 2018 and is also available in Europe and other international markets. InvestingPro analysis indicates the company is currently undervalued, with analysts maintaining positive expectations for future earnings growth. For detailed financial analysis and more exclusive insights, investors can access the comprehensive Pro Research Report, available to InvestingPro subscribers.
Migraine, a condition characterized by painful attacks, nausea, and sensitivity to light and sound, can disrupt children’s education and social activities. Current treatment options are limited, highlighting an unmet need for effective pediatric therapies. Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva, emphasized the importance of expanding AJOVY’s benefits to younger patients, potentially offering a solution for this underserved population.
AJOVY is available in two dosing options: monthly and quarterly, and can be administered by a healthcare professional or at home by a patient or caregiver. The most common adverse reactions in clinical trials were injection site reactions.
Teva Pharmaceutical Industries Ltd. is a global biopharmaceutical company that has been committed to improving health for over 120 years. The acceptance of the sBLA by the FDA marks a step forward for Teva in addressing the needs of patients with migraine, including children and adolescents. InvestingPro data shows the company maintains a GOOD overall financial health score, suggesting strong operational stability. Subscribers to InvestingPro can access over 30 additional financial metrics and exclusive ProTips about Teva’s market position and growth potential.
This news is based on a press release statement from Teva Pharmaceutical Industries Ltd.
In other recent news, Teva Pharmaceutical Industries Ltd. reported fourth-quarter earnings that exceeded analyst expectations, with adjusted earnings per share of $0.71 compared to the consensus estimate of $0.69. Revenue for the quarter reached $4.23 billion, surpassing projections of $4.1 billion. Despite this, Teva’s 2025 guidance fell short of Wall Street forecasts, with expected earnings per share of $2.35-$2.65 and projected revenue of $16.8-17.4 billion, both below analyst estimates. BofA Securities adjusted Teva’s price target to $20 from $23, maintaining a Buy rating while revising EBITDA growth estimates due to competition affecting the profitability of generic Revlimid.
Additionally, Teva, in collaboration with Medincell, announced that the FDA accepted the supplemental New Drug Application for UZEDY for the maintenance treatment of bipolar I disorder in adults. This development builds on UZEDY’s current approval for treating schizophrenia. In another legal update, Teva reached a settlement with Axsome Therapeutics over patent litigation concerning AUVELITY®, allowing Teva to potentially introduce a generic version by 2039. Truist Securities maintained a Buy rating on Axsome, citing the settlement as a positive outcome. These recent developments highlight Teva’s ongoing strategic initiatives and regulatory progress in its product pipeline.
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