Why is Vendetta Pharmaceuticals Inc. stock higher today?

On Tuesday, the U.S. Food and Drug Administration (FDA) approved theMan Tat Drug Co.(Vanda) Pharmaceuticals Inc(Nasdaq Resonance: VNDA)'s Fanapt (ipecilidone) tablets are used for the acute treatment of manic or mixed name seizures associated with bipolar disorder type I in adults.

Fanapt is an atypical antipsychotic drug that has been used in the acute treatment of schizophrenic patients since it was approved by the U.S. Food and Drug Administration in 2009.

Bipolar disorder is a chronic psychiatric illness that affects approximately 2.81 TP3T of U.S. adults, of which 831 TP3T are classified as having severe bipolar disorder.

Bipolar disorder is a group of disorders characterized by alternating periods of high and low mood.

People with bipolar I disorder with manic or mixed episodes are a subset of the approximately 10 million people with bipolar disorder in the United States.

The approval of Fanapt for use in patients with bipolar I disorder with manic and mixed seizures significantly increases the commercial opportunity for Fanapt.

The approval of Fanapt for the acute treatment of bipolar disorder in adults with manic or mixed episodes is based on a pivotal study of approximately 400 randomly selected patients.

The primary endpoint measured at week 4 of treatment was assessed by the Young Mania Rating Scale (YMRS), a scale that rates the clinical severity of the core symptoms of bipolar disorder.

At the end of the study (week 4), fenaprop-treated patients showed greater improvement than placebo-treated patients, and this difference was highly statistically significant.

As early as the Week 2 evaluation, a statistically significant advantage was observed for the fenarcept-treated group over the placebo-treated group.

In this study, the safety profile of Fanapt was similar to the results of a previous study of Fanapt for the treatment of adult schizophrenia.

In 2023, Fanapt's net product sales were $90.9 million, down 4%.

Sales of Hetlioz, Vanda's sleep disorder drug, have been declining due to increased competition from cheaper versions of the drug. sales of Hetlioz fell 37.3% to $100.2 million.

These two drugs accounted for more than 99% of the company's revenue last year.

Price TrendVNDA shares rose 27.9% to close at $5 in Wednesday's pre-ban trading session.

Photo by Christina Victoria Craft on Unsplash

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