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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VNDA
News
- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $18.00 price target on the stock.MarketBeat
- Vanda Pharmaceuticals Announces Orphan Drug Designation Granted for VGT-1849A, a Novel and Selective Antisense Oligonucleotide Candidate for the Treatment of Polycythemia Vera [Yahoo! Finance]Yahoo! Finance
- Vanda Pharmaceuticals Announces Orphan Drug Designation Granted for VGT-1849A, a Novel and Selective Antisense Oligonucleotide Candidate for the Treatment of Polycythemia VeraPR Newswire
- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Glancy Prongay & Murray LLP Announces Investigation of Vanda Pharmaceuticals Inc.Business Wire
VNDA
Earnings
- 11/6/24 - Beat
VNDA
Sec Filings
- 11/18/24 - Form 4
- 11/14/24 - Form 144
- 11/7/24 - Form 10-Q
- VNDA's page on the SEC website