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ATRS

Antares Pharma

$1.98

-0.03 (-1.49%)

, AMAG

Amag Pharmaceuticals

$13.90

0.2 (1.46%)

07:12
02/15/18
02/15
07:12
02/15/18
07:12

Antares Pharma announces FDA approval of Amag Pharmaceuticals NDA for Makena

Antares Pharma (ATRS) announced the successful regulatory outcome of the Makena subcutaneous auto injector collaboration with AMAG Pharmaceuticals (AMAG). AMAG announced FDA approval for their supplemental New Drug Application for Makena subcutaneous auto injector drug-device combination product, which was designed as a ready-to-administer treatment to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past. This drug-device combination product utilizes the Antares Pharma QuickShot device which was specifically developed to deliver a rapid injection of highly viscous drug products such as progesterone in oil, through a fine gauge nonvisible needle.

ATRS

Antares Pharma

$1.98

-0.03 (-1.49%)

AMAG

Amag Pharmaceuticals

$13.90

0.2 (1.46%)

ATRS Antares Pharma
$1.98

-0.03 (-1.49%)

10/23/17
PIPR
10/23/17
NO CHANGE
Target $3
PIPR
Overweight
Antares shares 'can and should' recover, says Piper Jaffray
Piper Jaffray analyst David Amsellem believes shares of Antares Pharma "can and should" recover following the complete response letter from the FDA regarding its new drug application for Xyosted. The letter is a major delay and calls into question if the product will ever reach commercialization, Amsellem tells investors in a research note. The analyst, however, highlights the company's "myriad other value drivers," namely a potential AB-rated generic form of EpiPen. He lowered his price target for Antares shares to $3 from $4 and reiterates an Overweight rating on the name.
10/23/17
MSCO
10/23/17
NO CHANGE
Target $26
MSCO
Overweight
Antares CRL should have limited read through to Amag, says Morgan Stanley
After Antares Pharma (ATRS) announced that it has received a FDA complete response letter about the new drug application for Xyosted due to two deficiencies related to clinical data, Morgan Stanley analyst Thomas Smith said the CRL should have limited read through to Amag Pharmaceuticals (AMAG), which has partnered with Antares for technology being used in subcutaneous Makena. The CRL is not related to the device or manufacturing, noted Smith, who adds that investor relief over the minimal Makena read through could lead to a rally in Amag shares following the recent weakness. He keeps 60% probability of success for Makena SC and maintains an Overweight rating on Amag shares.
10/23/17
RAJA
10/23/17
NO CHANGE
Target $3.4
RAJA
Strong Buy
Antares Pharma maintained as a Strong Buy at Raymond James
Raymond James analyst Elliot Wilbur said the FDA's CRL on Antares Pharma (ATRS) XYOSTED was an unexpected and significant setback, but weakness in shares since the October disclosure effectively prices XYOSTED at zero, and substantially undervalues other development programs, especially ANDA products with Teva (TEVA). Wilbur is not writing-off XYSTED yet and is pushing out an expected launch to 2H19 from early 2018 previously, and is now discounting the probability of success at 50% versus 100% prior to the CRL. The analyst maintains asset values for Antares' non-XYOSTED assets are worth $2.50 per share using a sum-of-the-parts valuation and adjusted his price target to $3.40 from $4.20 on shares. Wilbur maintains a Strong Buy rating on Antares
10/23/17
JANY
10/23/17
NO CHANGE
JANY
Neutral
Antares CRL doesn't raise issues for Amag Pharmaceuticals, says Janney Capital
Janney Capital analyst Ken Trbovich noted that the FDA complete response letter issued to Antares (ATRS) for Xyosted did not pertain to the Quickshot subcutaneous autoinjector, which raises his confidence the FDA will not identify such issues as a short coming of the sNDA for Amag Pharmaceuticals' (AMAG) Makena SQ. However, he keeps a Neutral rating on Amag shares, noting that the primary uncertainty for the sNDA for Makena SQ is the fact that its peak plasma levels is higher than the upper bound the FDA uses to define bioequivalence.
AMAG Amag Pharmaceuticals
$13.90

0.2 (1.46%)

11/06/17
JEFF
11/06/17
NO CHANGE
Target $16
JEFF
Buy
Amag Pharmaceuticals price target lowered to $16 from $34 at Jefferies
Jefferies analyst Eun Yang lowered her price target for Amag Pharmaceuticals to $16 citing the company's "disappointing" Q3 results and lowered lowered guidance. The analyst keeps a Buy rating on the shares, however, saying the shares at current levels reflect little expectation for the company.
12/07/17
RILY
12/07/17
INITIATION
Target $16
RILY
Neutral
Amag Pharmaceuticals initiated with a Neutral at B. Riley FBR
B. Riley FBR started Amag Pharmaceuticals with a Neutral rating and $16 price target.
12/07/17
12/07/17
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Sogou (SOGO) initiated with an Overweight at JPMorgan. 2. Amag Pharmaceuticals (AMAG) initiated with a Neutral at B. Riley FBR. 3. Akebia (AKBA) initiated with a Buy at BTIG. 4. Synnex (SNX) initiated with a Buy at SunTrust. 5. Cancer Genetics (CGIX) initiated with a Buy at Maxim. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
02/05/18
PIPR
02/05/18
NO CHANGE
Target $15
PIPR
Neutral
Amag label doubles total addressable market, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond says FDA approval of broad label use for Amag Pharmaceuticals' Feraheme in eligible adult patients with iron deficiency anemia doubles the company's total addressable market. The analyst, however, already models for this as the news was expected. Company data values the iron deficiency anemia market at $390M, or the same size as the CKD-related iron deficiency market, Raymond tells investors in a research note. He keeps a Neutral rating on Amag with a $15 price target.

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