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Expert Financial Analysis and Reporting

Tag archive for ‘ATRS’

Antares: Recent Launch of Makena Subcu Auto Injector and Probable Launches of Xyosted and AB Rated Generic to EpiPen Could Make for an Outstanding Price Performance in 2018 (ATRS, Buy, $2.36)

Key Investment Issues In this report I focus on three very important product related issues that will likely drive the stock price performance of Antares in 2018. Roughly in order of importance they are: The launch trajectory of the Makena subcutaneous auto injector, Probable approval of the Teva’s AB rated generic to EpiPen, and The […]

Antares: FDA Comments from Type A Meeting Are a Best Case Outcome for Xyosted (ATRS, $2.13, Buy)

Management Comments on Type A Meeting Antares released the following comment on March 27, 2018 that deals with the Complete Response Letter on Xyosted that was received in October 2017 just before its PDUFA date and necessitated a Type A meeting with the FDA to discuss the CRL. It says. ”Antares Pharma today announced that […]

Antares Pharma: My Hypothesis on Issues that Resulted in the CRL for Xyosted and Potential Timing of Approval (ATRS. Buy, $1.63)

Investment Thesis Xyosted is viewed by investors as the most important product in Antares” broad pipeline. In anticipation of approval on the PDUFA date of October 20, 2017 the stock price reached a high of $3.96 on October 10. Unexpectedly, Antares announced on October 11 that the FDA had identified deficiencies that prevented going forward […]

Antares: Approval of Xyosted is a Matter of When, Not If (ATRS, $2.12, Buy)

The Issue Antares received a complete response letter for Xyosted that did not cite any questions relating to efficacy, manufacturing, quality control or the device used to deliver testosterone. Surprisingly, the FDA raised concerns that Xyosted could cause a clinically meaningful increase in blood pressure and might also be linked to depression and suicidality. Let […]

Antares Pharma: FDA Action to not Approve Xyosted on its October 20, 2017 PDUFA Date is Perplexing (ATRS, Buy, $2.23)

Overview Investors have had high confidence that Xyosted would be approved by the FDA on its October 20, 2017 PDUFA date. A press release and 8-K from Antares published on October 12 shattered this expectation. Antares’ stock promptly dropped 38% from $3.73 to $2.32 after the Company alerted investors to an issue with the Xyosted […]

Antares: AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-Injector for Subcutaneous Use: (Antares (ATRS, Buy, $2.86)

AMAG announced on April17, 2017 that it had submitted a sNDA for the Makena Auto-Injector. This was in line with guidance.  AMAG anticipates a six-month FDA review timeline with the potential for approval and launch in the fourth quarter of 2017. AMAG developed the Makena auto-injector using an auto-injector developed by Antares. AMAG revealed that it will […]

Antares: Pipeline is Bursting with Late Stage Products (ATRS, $2.77, Buy)

Key Points: Antares has an impressive portfolio of seven new products that could lead to explosive growth over the next four years. I am projecting that revenues of five partnered products could increase from $17.0 million in 2016 to $142.0 million in 2021 (a nearly five fold increase) and that revenues from two wholly owned […]

AMAG Pharmaceuticals: Will FDA Approve Makena SC (AMAG, Neutral, $21.75)

Importance of Makena SC to AMAG? AMAG is engaged in a high stakes clinical development program in which it is endeavoring to gain approval of a subcutaneous dosage form of its key drug Makena. Management has guided that sales of Makena reached $333 to $336 million in 2016 (about 63% of total sales) and issued […]

AMAG and Antares: Update on the Development of Makena SC (AMAG, Neutral, $24.40) (ATRS, Buy, $2.04)

Key Points: Recent announcement that AMAG will not pursue Orphan Drug Exclusivity for Makena SC has hammered the stock of AMAG, but has had only a modest effect on ATRS. I believe that this does not change the commercial opportunity for Makena SC over the next two to three years. This potentially could move the […]

Antares: Teva Projects Launch of AB Rated Generic to EpiPen in Early 2018 (ATRS, Buy, $1.87)

Eyal Desheh is the Chief Financial Officer of Teva. During the recent third quarter conference call, he answered a question from an analyst about the development status of the AB rated generic to EpiPen. He said: “In terms of EpiPen, we are working very closely with the FDA. I haven’t changed my view. My expectation […]