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Vanda (VNDA) Rises as FDA Accepts NDA for Gastroparesis Drug
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Vanda Pharmaceuticals Inc. (VNDA - Free Report) announced that the FDA accepted its NDA filing seeking approval for its NK-1R antagonist, tradipitant, for the treatment of symptoms of gastroparesis.
The FDA gave the application a standard review and a decision from the regulatory body is expected on Sep 18, 2024.
Shares of the company were up 5.4% in the after-hours trading session on Dec 4 following the announcement of the news.
Upon potential approval, tradipitant is likely to become the first novel drug to be approved by the FDA for treating gastroparesis in more than four decades. Gastroparesis is a severe medical condition affecting the stomach nerves and muscles.
Per the company, the FDA accepted this filing for review, which included VNDA’s non-animal preclinical toxicity data from advanced human-relevant microphysiological systems in the absence of a nine-month dog study.
The NDA for tradipitant was supported by data from clinical efficacy studies 2301 and 3301, as well as proof from a 12-week open-label study and data from the Expanded Access program with patient exposures of more than two years.
Per the press release, around 6 million patients are estimated to be diagnosed with gastroparesis in the United States. If approved by the FDA, tradipitant can address an area of significant unmet medical need.
Tradipitant is also being developed in a phase III study for the treatment of motion sickness.
Shares of Vanda have lost 47.9% year to date compared with the industry’s decline of 21.2%.
Image Source: Zacks Investment Research
We note that Vanda records revenues from the sale of its two commercial products — Hetlioz and Fanapt.
Hetlioz is approved for the treatment of non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis syndrome. Fanapt is approved for the treatment of schizophrenia.
As Hetlioz is facing the risk of generic launches, the company is working to expand the label of the approved drugs to overcome these challenges.
A supplemental new drug application (“sNDA”) seeking approval for Hetlioz in insomnia is currently under review by the FDA. A decision from the regulatory body is due on Mar 4, 2024. The company is also looking to pursue the FDA’s approval for Hetlioz in jet lag disorder.
Meanwhile, a sNDA seeking approval for Fanapt for treating adult patients with bipolar I disorder is also under review, with a decision from the FDA expected on Apr 2, 2024.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 6 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 21 cents. Year-to-date, shares of CTMX have lost 10%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year-to-date, shares of TRDA have increased by 1%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 73 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year-to-date, shares of PBYI have lost 10.2%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Vanda (VNDA) Rises as FDA Accepts NDA for Gastroparesis Drug
Vanda Pharmaceuticals Inc. (VNDA - Free Report) announced that the FDA accepted its NDA filing seeking approval for its NK-1R antagonist, tradipitant, for the treatment of symptoms of gastroparesis.
The FDA gave the application a standard review and a decision from the regulatory body is expected on Sep 18, 2024.
Shares of the company were up 5.4% in the after-hours trading session on Dec 4 following the announcement of the news.
Upon potential approval, tradipitant is likely to become the first novel drug to be approved by the FDA for treating gastroparesis in more than four decades. Gastroparesis is a severe medical condition affecting the stomach nerves and muscles.
Per the company, the FDA accepted this filing for review, which included VNDA’s non-animal preclinical toxicity data from advanced human-relevant microphysiological systems in the absence of a nine-month dog study.
The NDA for tradipitant was supported by data from clinical efficacy studies 2301 and 3301, as well as proof from a 12-week open-label study and data from the Expanded Access program with patient exposures of more than two years.
Per the press release, around 6 million patients are estimated to be diagnosed with gastroparesis in the United States. If approved by the FDA, tradipitant can address an area of significant unmet medical need.
Tradipitant is also being developed in a phase III study for the treatment of motion sickness.
Shares of Vanda have lost 47.9% year to date compared with the industry’s decline of 21.2%.
We note that Vanda records revenues from the sale of its two commercial products — Hetlioz and Fanapt.
Hetlioz is approved for the treatment of non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis syndrome. Fanapt is approved for the treatment of schizophrenia.
As Hetlioz is facing the risk of generic launches, the company is working to expand the label of the approved drugs to overcome these challenges.
A supplemental new drug application (“sNDA”) seeking approval for Hetlioz in insomnia is currently under review by the FDA. A decision from the regulatory body is due on Mar 4, 2024. The company is also looking to pursue the FDA’s approval for Hetlioz in jet lag disorder.
Meanwhile, a sNDA seeking approval for Fanapt for treating adult patients with bipolar I disorder is also under review, with a decision from the FDA expected on Apr 2, 2024.
Zacks Rank & Stocks to Consider
Vanda currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CytomX Therapeutics, Inc. (CTMX - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 6 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 21 cents. Year-to-date, shares of CTMX have lost 10%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year-to-date, shares of TRDA have increased by 1%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 73 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year-to-date, shares of PBYI have lost 10.2%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.