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VNDA

Vanda Pharmaceuticals

$12.99

-0.3 (-2.26%)

07:15
07/22/19
07/22
07:15
07/22/19
07:15

Vanda announces FDA identified deficiencies in HETLIOTZ sNDA

Vanda Pharmaceuticals announced that on July 19 it received a notification from the FDA stating that as part of its ongoing review of Vanda's supplemental New Drug Application, or sNDA, for HETLIOZ, or tasimelteon, for the treatment of Jet Lag Disorder, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in this notification, and the FDA stated that this notification does not reflect a final decision on the information under review. In a letter dated December 19, 2018, the FDA had assigned a Prescription Drug User Fee Act, or PDUFA, target date for completion of its review by August 16. Vanda anticipates receiving additional communication from the FDA identifying specific deficiencies in the sNDA. Vanda hopes that it will be able to work expeditiously with the FDA to resolve any such deficiencies.

  • 16

    Aug

VNDA Vanda Pharmaceuticals
$12.99

-0.3 (-2.26%)

02/06/19
CANT
02/06/19
DOWNGRADE
Target $30
CANT
Neutral
Cantor downgrades Vanda on reduced visibility after FDA complaint
Cantor Fitzgerald analyst Charles Duncan downgraded Vanda Pharmaceuticals to Neutral from Overweight and lowered his price target for the shares to $30 from $38. The company's complaint against the FDA reduces visibility on development timelines for tradipitant in gastroparesis, perhaps even pruritus, and may also affect Hetlioz label expansion efforts, Duncan tells investors in a research note. The "challenged" FDA interactions are a result of management disagreement with the agency over the scientific merits of conducting certain nonclinical testing, says the analyst.
02/06/19
02/06/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. PayPal (PYPL) downgraded to Neutral from Buy at Guggenheim with the firm citing balanced risk/reward. 2. Arlo Technologies (ARLO) downgraded to Underperform from Neutral at BofA/Merrill and to Market Perform from Outperform at Cowen. 3. Celanese (CE) downgraded to Market Perform from Outperform at Cowen with analyst Charles Neivert saying recent subtle changes in industry fundamentals and the macro outlook have made him more cautious. 4. Estee Lauder (EL) downgraded to Hold from Buy at Berenberg with analyst Rosie Edwards saying that while the company's Q2 results were "strong across the board," she expects top-line growth to moderate, due mainly to skincare and Asia-Pacific. 5. Vanda Pharmaceuticals (VNDA) downgraded to Neutral from Overweight at Cantor Fitzgerald with analyst Charles Duncan saying the company's complaint against the FDA reduces visibility on development timelines for tradipitant in gastroparesis, perhaps even pruritus, and may also affect Hetlioz label expansion efforts. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
02/14/19
OPCO
02/14/19
NO CHANGE
Target $21
OPCO
Perform
Vanda Pharmaceuticals price target lowered to $21 from $29 at Oppenheimer
Oppenheimer analyst Esther Rajavelu lowered her price target for Vanda Pharmaceuticals to $21 from $29 after the company reported Q4 results that were higher than her estimates and provided 2019 guidance which came in below her estimates. While the analyst acknowledges management's comments that scripts for sighted N24 patients continue to grow robustly, Rajavelu is somewhat concerned by continued payor pushback on coverage for this patient pool despite Vanda Pharmaceuticals' efforts to increase access. She remains constructive on the potential for Hetlioz use in SMS patients and reiterates a Perform rating on the shares.
05/02/19
SBSH
05/02/19
DOWNGRADE
SBSH
Neutral
Vanda Pharmaceuticals downgraded to Neutral from Buy at Citi

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SPOT

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AMD

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$NSD

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$0.00

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13:17
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$NYE

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NVO

Novo Nordisk

$53.06

0.11 (0.21%)

13:05
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Novo Nordisk call volume above normal and directionally bullish »

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IPHI

Inphi

$60.80

-2.69 (-4.24%)

, AMZN

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$1,789.48

-4.16 (-0.23%)

12:59
09/23/19
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09/23/19
12:59
Recommendations
Inphi drops after Northland sees 'large cut' to Amazon 400G rollout plans »

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$60.80

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NLY

Annaly Capital

$9.02

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TRT

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IPHI

Inphi

$61.21

-2.28 (-3.59%)

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TRT

Trio-Tech

$3.79

0.08 (2.16%)

12:41
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BA

Boeing

$377.77

-1.56 (-0.41%)

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$18.27

-0.46 (-2.46%)

12:37
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OBAS

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LLY

Eli Lilly

$114.56

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12:35
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Eli Lilly put volume heavy and directionally bearish »

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TRT

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CDE

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12:20
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