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ATRS

Antares Pharma

$2.18

0.06 (2.83%)

18:59
10/20/17
10/20
18:59
10/20/17
18:59

FDA cannot approve Antares Pharma's Xyosted NDA

Antares Pharma announced that it has received a complete response letter, or CRL from the FDA regarding the new drug application, or NDA, for Xyosted injection. The CRL indicates that the FDA cannot approve the NDA in its present form. The CRL identified two deficiencies related to clinical data. Based on findings in studies QST-13-003 and QST-15-005, the FDA is concerned that Xyosted could cause a clinically meaningful increase in blood pressure. In addition, the letter also raised a concern regarding the occurrence of depression and suicidality. The CRL did not cite any chemistry, manufacturing and controls device or efficacy issues with regard to Xyosted. The next step will be to request a meeting with the FDA to further evaluate the deficiencies raised and to agree upon a path forward for a potential approval of Xyosted.

  • 20

    Oct

ATRS Antares Pharma
$2.18

0.06 (2.83%)

05/10/17
JEFF
05/10/17
NO CHANGE
Target $6
JEFF
Buy
Jefferies sees Antares shares getting to $15 over time
Jefferies analyst Anthony Petrone views Antares Pharma's Q1 report as "solid" ahead of a "catalyst rich" second half of 2017. The better than expected results reflect continued strength in Sumatriptan device sales to Teva (TEVA) and a rebound in Otrexup, Petrone tells investors in a post-earnings research note. He believes four new products can win clearance in the second half of the year. Petrone sees the stock getting to $15 over time on successful launches from current pipeline products and keeps a Buy rating on Antares with a $6 price target. The stock in afternoon trading is down 4% to $2.67.
06/23/17
HCWC
06/23/17
INITIATION
Target $5
HCWC
Buy
Antares Pharma initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Corey Davis initiated Antares Pharma with a Buy and a $5 price target saying he sees further upside as its diversified business strategy finally matures in the near future. The analyst said Antares is a sum-of-the-parts story, and we believe several of those parts could come into clarity within months, including potential 3Q17 A/B-rated generic EpiPen approval, Antares' own Xyosted testosterone PDUFA date, Oct. 2017, partnered generic Byetta approval/launch, and partnered Makena auto injector Oct. 2017 PDUFA. Davis expects cash flow to breakeven in second half 2018, profitability in 2019, and said sum-of-the parts valuation results in a $5 price target.
10/13/17
HCWC
10/13/17
NO CHANGE
Target $5
HCWC
Buy
Antares worth $3.30 per share without Xyosted, says H.C. Wainwright
H.C. Wainwright analyst Oren Livnat says he's "at a loss" for what caused the FDA to send a letter to Antares Pharma over Xyosted deficiencies, well into labeling discussions and just nine days before the October 20 action date. However, with the stock indicating down over 40% to near $2 per share, the analyst highlights that his sum-of-the-parts valuation still yields $3.3 per share even if Xyosted is removed entirely from his model. Livnat keeps a Buy rating on Antares with a $5 price target.
10/17/17
JANY
10/17/17
NO CHANGE
JANY
Neutral
Antares issues with Xyosted could mean trouble for Amag, says Janney Capital
Janney Capital analyst Ken Trbovich noted that Antares Pharma's (ATRS) Xyosted and Amag Pharmaceuticals' (AMAG) Makena both rely upon Antares' QuickShot autoinjector technology, meaning that more detail from Antares' expected FDA action letter on, or around, Xyosted's PDUFA date of October 20 matters to Amag as well. If the FDA finds a deficiency with the autoinjector, it may have significant implications for Amag's Makena SQ sNDA, Trbovich tells investors, adding that the best case for Amag is that the FDA's finding of deficiencies related to Xyosted do not pertain to the autoinjector. He keeps a Neutral rating on Amag shares.

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