SAN DIEGO - Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX) shared interim results from the KINECT-HD2 study, indicating sustained improvements in the treatment of Huntington's disease chorea with INGREZZA (valbenazine) capsules. The findings, presented at the 2024 MDS International Congress of Parkinson's Disease and Movement Disorders in Philadelphia, show that these improvements persist through Week 104, regardless of patients' concurrent antipsychotic medication.
The KINECT-HD2 study is an open-label clinical trial assessing the long-term safety and efficacy of INGREZZA, a vesicular monoamine transporter 2 (VMAT2) inhibitor, for adults with chorea associated with Huntington's disease. The study is notable for including patients on antipsychotic therapy, a common treatment for the neuropsychiatric symptoms of Huntington's disease, which often goes alongside but does not directly address chorea.
Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences, emphasized the significance of the findings, stating that they reinforce the clinical safety and sustained chorea improvement with INGREZZA treatment. The data showed that more than half of the participants experienced "much improved" or "very much improved" symptoms from as early as Week 2, with a consistent response maintained to Week 104.
The KINECT-HD2 interim analysis revealed that INGREZZA reduced chorea scores from baseline by -3.4 at Week 2, -4.6 at Week 4, and sustained efficacy with -5.2 at Week 104. The most common adverse events reported were falls, somnolence, and fatigue, consistent with prior findings from the KINECT-HD study.
Huntington's disease is a genetic neurodegenerative disorder characterized by involuntary movements (chorea), cognitive decline, and psychiatric symptoms. It is estimated to affect approximately 41,000 adults in the U.S.
This information is based on a press release statement from Neurocrine Biosciences, Inc. The company continues to focus on developing treatments for neurological and neuropsychiatric disorders, with a portfolio that includes FDA-approved treatments for tardive dyskinesia and Huntington's disease chorea.
In other recent news, Neurocrine Biosciences has experienced several significant developments. The company reported over 30% year-over-year growth in sales of their drug, INGREZZA, leading to an increase in their sales guidance for the year to a range of $2.25 billion to $2.3 billion. Neurocrine Biosciences also decided to halt the development of its drug luvadaxistat, which was being studied for cognitive impairment associated with schizophrenia (CIAS), due to inconsistent results in the ERUDITE Phase 2 clinical study.
On the analyst front, Mizuho maintained a Neutral rating on Neurocrine Biosciences, noting the impact of warnings on Bristol Myers (NYSE:BMY) Squibb's schizophrenia drug, Cobenfy's label. Despite this, Piper Sandler upgraded Neurocrine's stock from Neutral to Overweight, expressing confidence in the company's investigational drug NBI-1117568, also known as NBI-'568. However, BMO Capital Markets maintained a Market Perform rating for Neurocrine, reducing its price target due to uncertainties in trial results.
H.C. Wainwright also reaffirmed its Buy rating for Neurocrine, following a dose-finding study for NBI-1117568, which indicated a statistically significant improvement. These recent developments highlight the evolving landscape of Neurocrine Biosciences as it navigates the challenges and opportunities in the development of new treatments for schizophrenia.
InvestingPro Insights
The positive clinical results for INGREZZA in treating Huntington's disease chorea align with Neurocrine Biosciences' strong financial performance. According to InvestingPro data, the company's revenue growth is impressive, with a 26.69% increase in the last twelve months as of Q2 2024, and an even more robust 30.37% growth in Q2 2024 alone. This growth trajectory supports the InvestingPro Tip that net income is expected to grow this year.
The company's financial health appears solid, with an adjusted market capitalization of $11.62 billion USD. Neurocrine's profitability is noteworthy, as indicated by the InvestingPro Tip that the company has been profitable over the last twelve months. This is further reinforced by the strong gross profit margin of 68.55% and an operating income margin of 25.7% for the same period.
Investors should note that while Neurocrine Biosciences trades at a P/E ratio of 33.83, which might seem high, the PEG ratio of 0.38 suggests the stock may be undervalued relative to its growth prospects. This aligns with another InvestingPro Tip indicating that the company is trading at a low P/E ratio relative to near-term earnings growth.
For those interested in a deeper analysis, InvestingPro offers 12 additional tips for Neurocrine Biosciences, providing a more comprehensive view of the company's financial position and market performance.
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