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TEVA's Ajovy Meets Goal in Migraine Prevention Study for Kids

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Teva Pharmaceutical Industries’ (TEVA - Free Report) late-stage study evaluating Ajovy (fremanezumab) for the prevention of episodic migraine in pediatric and adolescent patients met its primary efficacy endpoint. The results demonstrated a statistically significant superior reduction in monthly migraine days over 12 weeks of treatment with Ajovy compared with placebo.

Please note that Ajovy is already approved in several countries as a 225 mg once-monthly dose or a 675 mg once-quarterly dose, both administered as subcutaneous injections for prophylaxis of migraine in adults who have at least four migraine days per month. Ajovy is an anti-CGRP monoclonal antibody,

Teva is looking to expand the eligible patient population of the drug to include children and adolescents aged six to 17 years.

In the SPACE study, Ajovy also demonstrated a favorable safety profile in the pediatric patient population for the migraine indication, which was consistent with that observed in adult patient populations. No new safety signals were identified. Teva expects to present detailed data from the SPACE study at a future medical conference.  

Year to date, shares of TEVA have shot up 56.5% compared with the industry’s 12.5% growth. 

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Per Teva, the SPACE data represent the first phase III study results demonstrating the safety and efficacy of Ajovy for treating migraines in a pediatric population. These findings are especially important as there are no approved preventive migraine treatments for children and adolescents at present. TEVA continues to explore the effects of Ajovy on pediatric patients suffering from chronic migraines.

Migraine is prevalent among children, with an overall rate of 7.7%. This rate rises from 5% in children aged five to 10 years to around 15% in adolescents. Migraines can significantly impair the day-to-day activities of children and adolescents which take a serious toll on their quality of life.

Other than Ajovy, Teva’s portfolio of branded new drugs includes Austedo, which was approved in 2017 as the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntington’s disease.

Sales of Ajovy and Austedo grew 18% and 28%, respectively, in 2023.

Although Teva has seen slower growth of Ajovy in the U.S. market in the past few quarters, the company expects sales to benefit from continued patient growth and launches in additional countries in the EU and international markets.

For Austedo, on the other hand, Teva expects to achieve annual revenues of more than $2.5 billion by 2027. The Austedo franchise got a boost from the launch of Austedo XR, a new once-daily formulation of Austedo, which was launched in May 2023. The company expects to launch Austedo in EU markets in 2026.

Zacks Rank & Stocks to Consider

Teva currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Adaptive Biotechnologies Corporation (ADPT - Free Report) and RAPT Therapeutics, Inc. (RAPT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals 2024 earnings per share (EPS) have improved from $4.41 to $4.44. EPS estimates for 2025 have improved from $4.85 to $5.42. Year to date, shares of ANIP have jumped 11.3%.

ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 53.90%.

In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, shares of ADPT have lost 13.7%.

ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.

In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, shares of RAPT have plunged 86.2%.

RAPT’s earnings beat estimates in two of the trailing four quarters and missed twice, the average surprise being 3.19%.

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