FDA rejects Vanda's Hetlioz for jet lag disorder [Seeking Alpha]
Vanda Pharmaceuticals Inc. (VNDA)
Last vanda pharmaceuticals inc. earnings: 2/25 04:01 pm
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Source: Seeking Alpha
Vanda Pharmaceuticals (NASDAQ: VNDA ) has received a CR L from the FDA regarding its marketing application seeking approval to use HETLIOZ (tasimelteon) to treat jet lag disorder. The CRL cited that the measures used to demonstrate improved sleep are of "unclear clinical significance." It also cited other undisclosed issues with the application. The company is "perplexed" and "deeply disappointed" with the FDA's decision but will work with the agency on the matter. The FDA approved HETLIOZ in January 2014 for non-24-hour sleep-wake disorder in blind people. Shares are down premarket on light volume. See all stocks on the move » Now read: Goodbye To Gilead As ViiV, Merck Besiege Its HIV Citadel » Subscribe for full text news in your inbox
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News
- Vanda Pharmaceuticals to Announce First Quarter 2024 Financial Results on May 8, 2024 [Yahoo! Finance]Yahoo! Finance
- Vanda Pharmaceuticals to Announce First Quarter 2024 Financial Results on May 8, 2024PR Newswire
- Shareholder Capital Delivers Letter to Independent Members of the Board of Vanda Pharmaceuticals [Yahoo! Finance]Yahoo! Finance
- Shareholder Capital Delivers Letter to Independent Members of the Board of Vanda PharmaceuticalsGlobeNewswire
- Vanda Pharmaceuticals (VNDA) Stock Sinks As Market Gains: What You Should Know [Yahoo! Finance]Yahoo! Finance
VNDA
Earnings
- 2/7/24 - Beat
VNDA
Analyst Actions
- 2/9/24 - TheStreet
VNDA
Sec Filings
- 4/29/24 - Form ARS/A
- 4/29/24 - Form ARS
- 4/29/24 - Form DEF
- VNDA's page on the SEC website