SAN DIEGO - Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX) revealed study results indicating that nearly 60% of participants achieved remission of tardive dyskinesia after 48 weeks of treatment with INGREZZA (valbenazine) capsules. This finding comes from the KINECT-4 study, a long-term clinical trial focusing on the treatment of this movement disorder.
Tardive dyskinesia (TD) is a condition characterized by involuntary, repetitive movements, often resulting from long-term use of certain antipsychotic medications. The KINECT-4 Phase 3 study involved 163 participants with moderate to severe TD, who received INGREZZA for 48 weeks. The study's primary endpoint was the change in the Abnormal Involuntary Movement Scale (AIMS) score, which assesses the severity of TD.
Results showed that 59.2% of participants had a score of 1 or less in each AIMS item at Week 48, indicating remission of symptoms. The remission rates varied slightly between the two dosage groups, with 65.0% in the 40 mg dose group and 57.8% in the 80 mg dose group. Complete resolution of symptoms, with a total AIMS score of 0, was observed in 10% of participants.
The study also reported on the safety and tolerability of INGREZZA. Treatment emergent adverse events (TEAEs) that occurred in more than 5% of participants included urinary tract infection and headache. The changes in psychiatric stability, vital signs, electrocardiogram parameters, and laboratory test values were generally minor and not considered clinically significant.
Neurocrine Biosciences presented additional data at the 2024 Psych Congress in Boston, including research on INGREZZA's impact on patients with dysphagia and the quality of life improvements in patients treated with the drug.
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.
This announcement is based on a press release statement from Neurocrine Biosciences, Inc. The company emphasizes that the findings add to the evidence supporting the effectiveness of INGREZZA in managing tardive dyskinesia over time.
In other recent news, Neurocrine Biosciences has been in the spotlight following a series of positive developments. The company's third-quarter 2024 earnings reported strong growth, with sales of its drug Ingrezza reaching $613 million. This led to an updated annual revenue guidance of $2.3 to $2.32 billion, marking a 25% growth compared to the previous year.
BMO Capital Markets increased its price target for Neurocrine Biosciences to $121 from the previous $114, maintaining a Market Perform rating. This adjustment was influenced by promising third-quarter results and the anticipation of FDA approval for crinecerfont, a treatment for congenital adrenal hyperplasia (CAH), which could potentially generate peak revenues of $600 million.
CEO Kyle Gano announced a $300 million share repurchase plan and emphasized the company's commitment to revenue growth and innovation. The company is also preparing for the launch of Crinecerfont for CAH, targeting pediatric and community endocrinology practices.
Additionally, Neurocrine Biosciences is investing in research and development, advancing its pipeline with Phase III studies for NBI-845 and NBI-568 slated for 2025. These recent developments highlight Neurocrine Biosciences' consistent progress and potential for significant revenue growth.
InvestingPro Insights
The positive clinical results for INGREZZA align well with Neurocrine Biosciences' strong financial performance. According to InvestingPro data, the company's revenue growth stands at an impressive 25.72% over the last twelve months as of Q3 2024, with quarterly revenue growth at 24.72%. This robust growth trajectory suggests that INGREZZA's success in treating tardive dyskinesia is translating into solid financial gains for the company.
InvestingPro Tips highlight that Neurocrine Biosciences is expected to see net income growth this year, and analysts have revised their earnings upwards for the upcoming period. These optimistic projections may be influenced by the positive clinical outcomes and the potential for increased INGREZZA adoption.
The company's financial health appears strong, with InvestingPro data showing a gross profit margin of 68.07% and an operating income margin of 26.85% over the last twelve months. This financial stability provides Neurocrine with the resources to continue investing in research and development for treatments like INGREZZA.
It's worth noting that while Neurocrine Biosciences trades at a relatively high P/E ratio of 32.26, it has a low PEG ratio of 0.33, suggesting that the stock may be undervalued relative to its growth prospects. This could be particularly interesting for investors considering the company's recent clinical success and strong financial performance.
For readers interested in a more comprehensive analysis, InvestingPro offers 11 additional tips for Neurocrine Biosciences, providing deeper insights into the company's financial position and market outlook.
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