Neurocrine Biosciences, Inc. (NASDAQ:NBIX) investors have a smile on their faces this morning, following the news that the FDA has approved INGREZZA (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel, selective vesicular monoamine transporter 2 inhibitor, is the first and only FDA-approved product indicated for the treatment of adults with TD.
Neurocrine shares reacted to the news, rising nearly 22% to $50.55 in Wednesday’s trading session.
The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten. The approval of INGREZZA represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope,” said Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences. “For the past 20 years, Neurocrine has been devoted to developing treatments for difficult to manage conditions in underserved patient populations. We are committed to ensuring that those impacted by the disruptive effects of TD have access to INGREZZA.”
“Until now, one of the few options for physicians, when managing TD, was to stop, change or lower the dose of antipsychotic medication, potentially jeopardizing patients’ psychiatric stability,” said Christoph U. Correll, MD, Professor, Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine. “In clinical trials, INGREZZA significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 48 weeks of treatment without compromising underlying psychiatric care. These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD.”
Clinical studies have shown that INGREZZA provides significant, rapid and meaningful improvement in TD signs and symptoms compared to placebo through six weeks, with continued reductions in TD observed through 48 weeks of treatment. INGREZZA was generally well tolerated, with somnolence as the only adverse event occurring at a rate greater than or equal to 5 percent and twice placebo. In clinical trials, no worsening in safety scale scores for depression, suicidal ideation or behaviors was observed. INGREZZA has been studied in over 1,000 individuals and more than 20 clinical trials.
“A treatment for tardive dyskinesia is a welcome and exciting step in the continued effort to destigmatize mental health conditions,” said Paul Gionfriddo, President & CEO of Mental Health America. “With an FDA approved treatment now available, individuals and doctors can have more productive and proactive conversations about TD.”
“The FDA’s approval of INGREZZA represents the culmination of over ten years of dedicated effort from the Neurocrine research and development teams,” said Christopher F. O’Brien, MD, Neurocrine’s Chief Medical Officer. “Neurocrine would like to thank the many clinical investigators and TD patients who participated in our clinical trials. Without their partnership and commitment, we would not have been able to achieve this tremendous breakthrough.”
On the ratings front, NBIX has been the subject of a number of recent research reports. In a report released today, Jefferies analyst Biren Amin maintained a Buy rating on NBIX, with a price target of $65, which represents a potential upside of 26% from where the stock is currently trading. Also today, J.P. Morgan’s Anupam Rama maintained a Buy rating on the stock and has a price target of $60.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Biren Amin and Anupam Rama have a yearly average return of 1.6% and a loss of 3.4% respectively. Amin has a success rate of 46% and is ranked #1846 out of 4560 analysts, while Rama has a success rate of 44% and is ranked #3911.
Overall, 11 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $75.00 which is 45% above where the stock opened today.
Neurocrine Biosciences, Inc. operates as a product based biopharmaceutical company. It discovers, develops and intends to commercialize drugs for the treatment of neurological and endocrine related diseases and disorders.