Biotech Implosion: Vanda Pharmaceuticals (VNDA)
Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) is seeing a major implosion this morning. The company has disclosed that it received a dreaded FDA not-approvable letter on its iloperidone. This was its late-stage schizoprenia candidate as well. The drug candidate is apparently too close to other drugs already on the market and the FDA said more safety data would be required to consider another application.
Vanda shares are down 59% at $1.35, which has gone from the good to the bad to the ugly. Its prior 52-week trading range was $2.70 to $19.62. Its current market cap after the drop is about $36 million. While that is well under its cash levels on the books, it will burn through much cash to fulfill its FDA obligations to proceed.
This one isn’t a biotech zombie yet, but you’d never know it if you just looked at its stock chart.
Jon Ogg
July 28, 2008
Vanda Scores on Insomnia Phase III Trials (VNDA)
Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) is seeing shares rise this morning on news that its Phase III data showed Tasimelteon significantly improves sleep in patients with chronic insomnia. The positive top-line results from a Phase III trial showed that its investigational drug candidate, Tasimelteon, which it calls a novel melatonin agonist, met the primary endpoint of the trial and significantly improved sleep in adult patients with chronic insomnia. This study also demonstrated that Tasimelteon was well-tolerated and exhibited a safety profile generally similar to placebo.
This was its Phase III, multi-center, placebo-controlled, 4-week trial that evaluated 322 patients with chronic primary insomnia. Patients were randomized to receive either 20 mg or 50 mg of Tasimelteon or placebo over the four weeks.
On Nights 1 and 8 of treatment, mean LPS improved by 45.0 minutes in the 20mg group (p<.001), by 46.4 minutes in the 50mg group (p<.001), and by 28.3 minutes in the placebo group. On Nights 22 and 29 of treatment, mean LPS improved by 49.4 minutes in the 20mg group (p<.001), by 45.1 minutes in the 50mg group (p=.016), and by 33.9 minutes in the placebo group. Importantly, this effect was also seen acutely on the first night of treatment. Patients in the 20mg and 50mg groups fell asleep 22.9 minutes (p<.001) and 25.9 minutes (p<.001) faster, respectively, than those in the placebo group.
Vanda shares are indicating higher with some 2-hours to the open. Shares closed at $4.99 and are indicated up at $5.90 in early trading (7:30 AM EST). Its 52-week trading range is $2.70 to $21.50. This one also has a substantial short interest so watch for that spring-loaded effect.
Jon Ogg
June 26, 2008