Vanda (VNDA) Up on FDA Nod for Fanapt in Bipolar I Disorder

Vanda Pharmaceuticals Inc. VNDA announced that the FDA has approved its marketed drug, Fanapt (iloperidone), for a new indication. The regulatory body has now approved Fanapt tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Shares of the company were up 30.4% in after-hours trading on Apr 2, following the announcement of the news.

Fanapt is already approved in the United States for the acute treatment of patients with schizophrenia.

The approval of Fanapt for bipolar disorder was based on data from a pivotal study, which evaluated around 400 patients with bipolar I disorder, a psychiatric chronic condition.

Data from the study showed that patients who were treated with Fanapt experienced a larger improvement in the core symptoms of mania than patients who received placebo at the end of week four, and this difference was highly statistically significant.

Meanwhile, the safety profile of Fanapt was similar to that seen in previous studies conducted for the treatment of schizophrenia.

As patients are still unable to find a suitable treatment for effectively managing bipolar disorder, therefore, the approval for Fanapt in the given indication could present a significant commercial opportunity for Vanda.

Shares of VNDA have lost 7.3% year to date compared with the industry’s decline of 0.1%.

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Last month, Vanda faced a major setback when the FDA issued a complete response letter to the supplemental new drug application (“sNDA”) for its other marketed product, Hetlioz (tasimelteon).

The sNDA sought approval for Hetlioz for the treatment of insomnia, which is characterized by difficulties with sleep initiation.

Hetlioz is currently approved for the treatment of non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis syndrome.

Zacks Rank & Other Stocks to Consider

Vanda currently sports a Zacks Rank #1 (Strong Buy).

Some other top-ranked stocks in the healthcare sector are ADMA Biologics, Inc. ADMA, Ligand Pharmaceuticals Incorporated LGND and ANI Pharmaceuticals, Inc. ANIP, each flaunting a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Year to date, shares of ADMA have rallied 42.5%.

ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.

In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have gained 2.5%.

Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have jumped 21%.

Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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