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VNDA

Vanda Pharmaceuticals

$15.21

0.3 (2.01%)

07:03
08/19/19
08/19
07:03
08/19/19
07:03

Vanda Pharmaceuticals receives CRL from FDA on sNDA for HETLIOZ

Vanda Pharmaceuticals announced that on August 16, it received a Complete Response Letter from the U.S. FDA as part of its ongoing review of Vanda's supplemental New Drug Application for HETLIOZ for the treatment of Jet Lag Disorder. As Vanda previously reported on May 23, 2018, JLD patients reported sleeping nearly three hours longer over the three nights following their transatlantic trip when treated with Hetlioz than they did over the three nights following their untreated transatlantic trip, consistent with Vanda's jet lag simulation studies. In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance. The FDA's conclusions regarding the clinical significance of improved sleep in JLD are not the FDA's only observations made with respect to the sNDA. The CRL contains additional observations on various aspects of Vanda's sNDA. Vanda intends to consider each observation as it plans for continued engagement with the FDA on this matter. "We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program," said Mihael Polymeropoulos, M.D. Vanda's President and CEO. "Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need."

VNDA Vanda Pharmaceuticals
$15.21

0.3 (2.01%)

07/24/19
STFL
07/24/19
DOWNGRADE
Target $17
STFL
Hold
Vanda Pharmaceuticals downgraded to Hold from Buy at Stifel
Stifel analyst Derek Archila downgraded Vanda Pharmaceuticals to Hold and lowered his price target to $17 from $26. The analyst says his prior stance was "overly bullish" in assuming that the company's pipeline was de-risked and sees the prospects on the stock remaining "highly levered" to its base business, which offers limited growth potential. Archila adds that Vanda's tradipitant program contains higher clinical, safety, and timing risk than assumed based on the disclosure of information from the company's FDA lawsuit.
08/01/19
SBSH
08/01/19
UPGRADE
SBSH
Buy
Vanda Pharmaceuticals upgraded to Buy from Neutral at Citi
Citi analyst Joel Beatty upgraded Vanda Pharmaceuticals to Buy from Neutral.
08/01/19
SBSH
08/01/19
UPGRADE
Target $19
SBSH
Buy
Citi upgrades Vanda Pharmaceuticals to Buy, says sentiment at 'rock bottom'
Citi analyst Joel Beatty upgraded Vanda Pharmaceuticals to Buy from Neutral with an unchanged price target of $19. The current stock price is undervaluing Vanda's "profitable" base business due to "very poor" investor sentiment related to pipeline agent tradipitant, Beatty tells investors in a research note titled "We Believe Sentiment Has Hit Rock Bottom." The analyst sees "limited downside to buying the stock now," with potential for a "simple course change on tradipitant to lead to immediate and significant upside." Either starting an animal toxicity study or discontinuing tradipitant development completely would add $4 per share, estimates Beatty.
08/01/19
08/01/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Spotify (SPOT) upgraded to Hold from Sell at Loop Capital with analyst Alan Gould saying the company's Q2 marked "another good quarter" as it reached renewal deals with 2 of 4 major labels for global recording. 2. Crown Castle (CCI) upgraded to Overweight from Neutral at JPMorgan. 3. Vanda Pharmaceuticals (VNDA) upgraded to Buy from Neutral at Citi with analyst Joel Beatty saying the current stock price is undervaluing Vanda's "profitable" base business due to "very poor" investor sentiment related to pipeline agent tradipitant. 4. United Therapeutics (UTHR) upgraded to Hold from Underperform at Jefferies with analyst Eun Yang citing valuation. 5. Five9 (FIVN) upgraded to Overweight from Neutral at JPMorgan and to Buy from Neutral at Dougherty. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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FGEN

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