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Teva Seeks FDA Nod for Ecopipam in Pediatric Tourette Syndrome
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Key Takeaways
Teva submitted an NDA for ecopipam to the FDA for treating pediatric Tourette syndrome.
Ecopipam demonstrated statistically significant benefit in a phase III study's primary efficacy endpoint.
Teva gained ecopipam through the Emalex acquisition. The therapy has FDA Fast Track and Orphan Drug tags.
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that it has submitted a new drug application (NDA) to the FDA seeking approval for ecopipam for treating pediatric Tourette syndrome.
The NDA for ecopipam was based on positive data from a phase III study, which was recently published in JAMA Neurology.
Data from the study showed that treatment with ecopipam significantly delayed time to relapse versus placebo in pediatric patients with Tourette syndrome who had achieved a clinical response during the open-label treatment period. Treatment with ecopipam led to a statistically significant benefit on the study’s primary efficacy endpoint in pediatric patients and was generally well tolerated.
A potential approval of ecopipam could provide the first FDA-approved treatment for pediatric Tourette syndrome in more than a decade, addressing a high unmet need in a specialized neuroscience segment.
TEVA Price Performance
Year to date, shares of Teva have risen 0.9% against the industry’s decline of 3.5%.
Image Source: Zacks Investment Research
TEVA’s Recent Acquisition of Ecopipam
Earlier this month, Teva completed its previously announced acquisition of Emalex Biosciences, gaining access to the latter’s late-stage candidate ecopipam. Per the terms of the deal, Teva paid $700 million upfront and could make up to $200 million in additional milestone payments, along with royalties tied to future net sales.
The deal is likely to strengthen Teva’s innovative medicines pipeline.
Ecopipam is a first-in-class investigational therapy that works by blocking dopamine activity at the D1 receptor. Increased sensitivity of this receptor is thought to contribute to the repetitive and compulsive behaviors commonly associated with Tourette syndrome.
Ecopipam’s unique mechanism as a selective dopamine D1 receptor antagonist sets it apart from existing treatments that primarily target D2 receptors, potentially offering improved symptom control with a differentiated safety profile.
The FDA has granted Orphan Drug and Fast Track designations to ecopipam for the treatment of pediatric patients with Tourette syndrome.
Tourette syndrome is a childhood-onset neurological disorder characterized by involuntary motor and vocal tics. Although some treatment options are available, many patients continue to experience insufficient symptom control or treatment-limiting side effects.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $3.33 to $4.05, while estimates for 2027 have increased from $3.66 to $4.27 during the same time. INDV shares have risen 6.7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 17.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 106.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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Teva Seeks FDA Nod for Ecopipam in Pediatric Tourette Syndrome
Key Takeaways
Teva Pharmaceutical Industries Limited (TEVA - Free Report) announced that it has submitted a new drug application (NDA) to the FDA seeking approval for ecopipam for treating pediatric Tourette syndrome.
The NDA for ecopipam was based on positive data from a phase III study, which was recently published in JAMA Neurology.
Data from the study showed that treatment with ecopipam significantly delayed time to relapse versus placebo in pediatric patients with Tourette syndrome who had achieved a clinical response during the open-label treatment period. Treatment with ecopipam led to a statistically significant benefit on the study’s primary efficacy endpoint in pediatric patients and was generally well tolerated.
A potential approval of ecopipam could provide the first FDA-approved treatment for pediatric Tourette syndrome in more than a decade, addressing a high unmet need in a specialized neuroscience segment.
TEVA Price Performance
Year to date, shares of Teva have risen 0.9% against the industry’s decline of 3.5%.
Image Source: Zacks Investment Research
TEVA’s Recent Acquisition of Ecopipam
Earlier this month, Teva completed its previously announced acquisition of Emalex Biosciences, gaining access to the latter’s late-stage candidate ecopipam. Per the terms of the deal, Teva paid $700 million upfront and could make up to $200 million in additional milestone payments, along with royalties tied to future net sales.
The deal is likely to strengthen Teva’s innovative medicines pipeline.
Ecopipam is a first-in-class investigational therapy that works by blocking dopamine activity at the D1 receptor. Increased sensitivity of this receptor is thought to contribute to the repetitive and compulsive behaviors commonly associated with Tourette syndrome.
Ecopipam’s unique mechanism as a selective dopamine D1 receptor antagonist sets it apart from existing treatments that primarily target D2 receptors, potentially offering improved symptom control with a differentiated safety profile.
The FDA has granted Orphan Drug and Fast Track designations to ecopipam for the treatment of pediatric patients with Tourette syndrome.
Tourette syndrome is a childhood-onset neurological disorder characterized by involuntary motor and vocal tics. Although some treatment options are available, many patients continue to experience insufficient symptom control or treatment-limiting side effects.
TEVA’s Zacks Rank & Stocks to Consider
Teva currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $3.33 to $4.05, while estimates for 2027 have increased from $3.66 to $4.27 during the same time. INDV shares have risen 6.7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 17.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 106.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.