AJOVY® (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine

Rhea-AI Summary

Teva (NYSE: TEVA) announced publication in the New England Journal of Medicine of Phase 3 SPACE trial results showing AJOVY (fremanezumab-vfrm) significantly reduced monthly migraine days and monthly headache days versus placebo in children and adolescents with episodic migraine.

Key results: MMD reduction 2.5 days with AJOVY vs 1.4 days placebo (difference 1.1 days; P=0.02); MHD reduction 2.6 vs 1.5 days (difference 1.1 days; P=0.02); ≥50% MMD responder rate 47.2% vs 27.0% (P=0.002). The 3-month trial enrolled 237 patients. The data supported FDA approval in August 2025 for preventive treatment of episodic migraine in patients aged 6–17 years weighing ≥45 kg. No new safety signals identified.

Positive

• FDA approval for pediatric episodic migraine (Aug 2025)
• ≥50% MMD responder rate 47.2% with AJOVY
• No new safety signals vs adult studies

Negative

• Absolute treatment difference 1.1 days in MMD
• Study duration limited to 3 months
• FDA label restricted to patients weighing ≥45 kg

News Market Reaction – TEVA

-0.89%

1 alert

-0.89% News Effect

On the day this news was published, TEVA declined 0.89%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

MMD reduction – AJOVY: 2.5 days MMD reduction – placebo: 1.4 days MMD difference p-value: P = 0.02 +5 more

8 metrics

MMD reduction – AJOVY 2.5 days Change in monthly migraine days over 12 weeks vs baseline

MMD reduction – placebo 1.4 days Change in monthly migraine days over 12 weeks vs baseline

MMD difference p-value P = 0.02 AJOVY vs placebo monthly migraine days

MHD reduction – AJOVY 2.6 days Monthly headache days ≥ moderate severity

MHD reduction – placebo 1.5 days Monthly headache days ≥ moderate severity

≥50% MMD responders AJOVY 47.2% Proportion achieving ≥50% reduction in monthly migraine days

≥50% MMD responders placebo 27.0% Proportion achieving ≥50% reduction in monthly migraine days

SPACE trial enrollment 237 patients Children and adolescents aged 6–17 years with episodic migraine

Market Reality Check

Price: $34.22 Vol: Volume 9,870,141 is modes...

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$34.22 Last Close

Volume Volume 9,870,141 is modestly above the 20-day average of 9,204,664, suggesting slightly elevated interest ahead of this news. normal

Technical Shares at $32.64 are trading above the 200-day MA of $19.94 and sit about 2.33% below the 52-week high of $33.42.

Peers on Argus

TEVA was down 0.98% while peers showed mixed moves: UTHR -0.18%, VTRS -1.65%, RD...

TEVA was down 0.98% while peers showed mixed moves: UTHR -0.18%, VTRS -1.65%, RDY +0.91%, NBIX +2.39%, TAK +1.42%, indicating stock-specific dynamics rather than a broad sector swing.

Historical Context

5 past events · Latest: Jan 11 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 11	Growth outlook	Positive	+2.4%	Shared detailed 2025 guidance and multi-year Pivot to Growth targets.
Jan 11	Pipeline funding deal	Positive	+2.4%	Up to $500M Royalty Pharma funding to accelerate TEV-’408 development.
Jan 05	Conference presentation	Positive	+0.2%	Announcement of CEO presentation at the J.P. Morgan Healthcare Conference.
Dec 24	Credit rating upgrade	Positive	+0.6%	S&P upgrade to BB+ and Moody’s positive outlook on deleveraging progress.
Dec 19	Biosimilar settlement	Positive	+0.1%	Settlement setting U.S. entry timing for AVT06 Eylea biosimilar, pending FDA approval.

Pattern Detected

Recent positive strategic, rating, and pipeline news has generally aligned with modestly positive price reactions.

Recent Company History

Over the past month, TEVA has highlighted its Pivot to Growth strategy, including 2025 outlook targets such as revenues of $16.8–$17.0B, adjusted EBITDA of $4.8–$5.0B, and diluted EPS of $2.55–$2.65. A collaboration with Royalty Pharma for up to $500M in funding for TEV-’408 and an S&P upgrade to BB+ with a positive Moody’s outlook underscored improving fundamentals. Biosimilar progress for AVT06 added to branded and biosimilar momentum. Today’s AJOVY pediatric data extends this trend of innovation-focused news.

Market Pulse Summary

This announcement spotlights pivotal Phase 3 SPACE trial data showing AJOVY’s statistically signific...

Analysis

This announcement spotlights pivotal Phase 3 SPACE trial data showing AJOVY’s statistically significant reductions in monthly migraine and headache days in 6–17-year-olds, with no new safety signals and prior FDA approval in this group. It adds to TEVA’s recent string of innovation and pipeline updates alongside growth guidance and rating upgrades. Investors may watch how AJOVY’s pediatric indication contributes to the broader branded portfolio and whether subsequent prescription and revenue trends validate these clinical results.

Key Terms

calcitonin gene-related peptide (CGRP), CGRP antagonist, Phase 3, placebo-controlled, +4 more

8 terms

calcitonin gene-related peptide (CGRP) medical

"the first and only calcitonin gene-related peptide (CGRP) antagonist treatment option"

Calcitonin gene-related peptide, or CGRP, is a small signaling protein the body releases to widen blood vessels and amplify pain signals, notably during migraine attacks. For investors, CGRP matters because medicines that block or tone down this chemical can prevent or reduce migraines and related vascular pain, making CGRP-targeting therapies a major commercial and clinical development area—like cutting off a key messenger that triggers painful reactions.

CGRP antagonist medical

"the first and only calcitonin gene-related peptide (CGRP) antagonist treatment option"

A CGRP antagonist is a type of medicine that blocks the action of a brain chemical called calcitonin gene‑related peptide (CGRP), which is involved in causing migraine pain and blood vessel dilation. Think of it as putting a dam in a stream that carries pain signals: by stopping that chemical pathway, these drugs can prevent or reduce migraine attacks. For investors, they matter because they represent a growing market with recurring use, regulatory and patent considerations, competition by pill versus injectables, and potential impact on healthcare spending and drugmakers’ revenue.

Phase 3 medical

"has published pivotal Phase 3 data on AJOVY, highlighting its efficacy"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

placebo-controlled medical

"The 3-month, randomized, placebo-controlled SPACE study enrolled 237 children"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

subcutaneous medical

"randomized to receive monthly subcutaneous injections of fremanezumab"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

pediatric medical

"treatment of episodic migraine in pediatric patients aged 6-17 years"

Relating to the medical care, products, or research specifically for infants, children, and adolescents. It matters to investors because treatments, devices, or drugs designed for this age group face different safety standards, testing requirements and market dynamics than adult products—think of it like tailoring clothing to fit a child rather than an adult, which changes design, approval hurdles and potential customer size, affecting regulatory risk and revenue prospects.

episodic migraine medical

"with episodic migraine compared to placebo in the SPACE Trial"

Episodic migraine is a neurological condition marked by recurrent, often intense headaches that occur on fewer than 15 days per month and can be accompanied by nausea, sensitivity to light or sound, and visual disturbances. It matters to investors because it defines the size and pattern of patient demand for treatments—think of it like an intermittent but recurring market need—affecting drug sales, development priorities, and regulatory attention in the healthcare sector.

FDA regulatory

"The U.S. Food and Drug Administration (FDA) approved AJOVY in August 2025"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. Not financial advice.

• AJOVY demonstrated efficacy and a consistent safety profile in the SPACE trial, making it the first and only calcitonin gene-related peptide (CGRP) antagonist treatment option for both pediatric and adult patients.^1,2
• Results from the SPACE trial found AJOVY significantly reduced monthly migraine days and monthly headache days versus placebo over a 12-week period in pediatric patients with episodic migraine.¹
• The U.S. Food and Drug Administration (FDA) approved AJOVY in August 2025 for the preventive treatment of episodic migraine in children and adolescents aged 6-17 years who weigh 45 kilograms (99 pounds) or more, building on its initial approval for the preventive treatment of migraine in adults.²
  
  

PARSIPPANY, N.J. and TEL AVIV, Israel, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the New England Journal of Medicine (NEJM) has published pivotal Phase 3 data on AJOVY, highlighting its efficacy and safety in children and adolescents with episodic migraine. The data from the SPACE study supported the FDA approval of AJOVY for the preventive treatment of episodic migraine in pediatric patients aged 6-17 years weighing 45 kilograms (99 pounds) or more, making it the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for preventive treatment of episodic migraine in pediatric patients and migraine in adults.^1,2

"With an estimated 1 in 10 children and adolescents in the U.S. living with migraine, the need for effective preventive options is critical as this condition can disrupt daily life for patients and families," said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva.³ "The SPACE trial results published in the New England Journal of Medicine add to the growing body of evidence supporting AJOVY and build on its established use in adults. Teva is proud to be leading the charge and continuing to innovate for the migraine community."

In the SPACE trial, AJOVY reduced monthly migraine days (MMD) by 2.5 days compared to 1.4 days with placebo (difference: 1.1 days; P = 0.02) and reduced monthly headache days (MHD) of at least moderate severity by 2.6 days versus 1.5 days (difference: 1.1 days; P = 0.02). A significantly higher proportion of participants achieved a ≥ 50% reduction in MMD (47.2%) with AJOVY compared to placebo (27.0%) (P = 0.002). No new safety signals were identified, and the safety profile remained consistent with that observed in adult studies.¹

The 3-month, randomized, placebo-controlled SPACE study enrolled 237 children and adolescents aged 6-17 years with episodic migraine. Participants were randomized to receive monthly subcutaneous injections of fremanezumab (120 mg for those weighing < 45 kg; 225 mg for those weighing ≥ 45 kg) or matched placebo.¹

"Helping to prevent migraine attacks in children and adolescents is critical to supporting their healthy development and education, including missed school days, disability and overall social well-being," said the study’s lead author, Andrew D. Hershey, M.D., Ph.D., and Endowed Chair and Director of Neurology at Cincinnati Children’s Hospital Medical Center. "The SPACE trial demonstrates that a CGRP-targeted preventive therapy like fremanezumab-vfrm (AJOVY) can significantly reduce the frequency of attacks of migraine in youth, giving physicians critical evidence to guide care for this underserved population."

For more information on the SPACE study results published online in the New England Journal of Medicine, click here.

About Migraine

Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks.⁴ Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.⁵

About SPACE

SPACE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy, safety and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12-week period for the preventive treatment of episodic migraine in 237 pediatric patients aged 6 to 17 years.

About AJOVY

AJOVY is indicated for preventive treatment of migraine in adults and episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. AJOVY can be administered either by a healthcare professional or at home by a patient 13 years of age or older or caregiver. No starting dose is required to begin treatment. For full prescribing information, visit https://www.ajovy.com/globalassets/ajovy/ajovy-pi.pdf

INDICATION AND USAGE

AJOVY is indicated for:

• the preventive treatment of migraine in adults, and
• the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.
  
  

IMPORTANT SAFETY INFORMATION

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the postmarketing setting.

Monitor patients treated with AJOVY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of AJOVY is warranted.

Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AJOVY. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.

AJOVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.

Please click here for full U.S. Prescribing Information for AJOVY (fremanezumab-vfrm) injection.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AJOVY (fremanezumab-vfrm) injection for the prevention of episodic migraine in children and adolescents; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1. Hershey, A. D., Szperka, C. L., Barbanti, P., Pozo‑Rosich, P., Bittigau, P., Barash, S., Bryson, J., Kessler, Y., Schwartz, Y. C., Campos, V. R., & Ning, X. (2026). Fremanezumab in Children and Adolescents with Episodic Migraine. New England Journal of Medicine.
2. AJOVY (fremanezumab-vfrm) injection, for subcutaneous use. Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.
3. Al Khalili Y, Asuncion RMD, Chopra P. Migraine Headache in Childhood. [Updated 2023 Mar 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557813/
4. Jaimie D Steinmetz, Katrin Seeher, Nicoline Schiess, Emma Nichols, Bochen Cao, Chiara Servili, Vanessa Cavallera, Christopher J L Murray, Kanyin Liane Ong, Valery L Feigin, Theo Vos, and Tarun Dua on behalf of the GBD network. Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Neurol. (in press).
5. Pediatric Migraine, An Update. Greene, Kaitlin. et al; Neurology clinics, Volume 37, Issue 4, 815-833. August 31, 2019. https://doi.org/10.1016/j.ncl.2019.07.009
   
   

Teva Media Inquiries:

TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquires

TevaIR@Tevapharm.com

FAQ

What did Teva announce about AJOVY (TEVA) on January 14, 2026?

Teva announced NEJM publication of SPACE Phase 3 results showing AJOVY significantly reduced monthly migraine and headache days in ages 6–17.

What were the key efficacy results for AJOVY in the SPACE trial (TEVA)?

AJOVY reduced MMD by 2.5 days vs 1.4 days with placebo (difference 1.1 days; P=0.02) and had a 47.2% ≥50% responder rate vs 27.0%.

What age and weight group did the FDA approve AJOVY for (TEVA) and when?

The FDA approved AJOVY in August 2025 for preventive treatment of episodic migraine in patients aged 6–17 years weighing ≥45 kg.

How large and how long was the SPACE trial published in NEJM (TEVA)?

SPACE was a 3-month, randomized, placebo-controlled trial that enrolled 237 children and adolescents aged 6–17 with episodic migraine.

Did the SPACE trial identify new safety concerns for AJOVY (TEVA)?

No new safety signals were identified; the safety profile remained consistent with adult studies.

What are limitations investors should note about AJOVY’s pediatric data (TEVA)?

Limitations include a modest absolute treatment difference (1.1 days), a 3-month follow-up, and FDA weight-based labeling (≥45 kg).