Fly News Breaks for June 15, 2018
Jun 15, 2018 | 10:46 EDT
As previously reported, Janney Montgomery Scott analyst Ken Trbovich downgraded Amag Pharmaceuticals to Neutral from Buy after the company announced it has agreed to divest Cord Blood Registry to a private equity investment firm for $530M in cash. The sale loses a positive contributor for the company at a price below which CBR was acquired, said Trbovich, who maintains a $20 fair value estimate on Amag shares, which are down about 5% to $23.60 in morning trading.
News For AMAG From the Last 2 Days
Nov 13, 2018 | 10:16 EDT
Piper Jaffray analyst Christopher Raymond keeps a Neutral rating on Amag Pharmaceuticals after the company's disclosure of a delay to Vyleesi timelines as a result of an FDA request for additional clinical safety data. The analyst says that while management has touted this drug's potential as a major contributor, he remains "skeptical," given the uncertainty around the female sexual dysfunction market and the drug's side effect and convenience profile. Raymond is keeping Vyleesi out of his model and remains "cautious" on Amag shares with a $20 price target.
Nov 13, 2018 | 10:12 EDT
Amag Pharmaceuticals disclosed this morning that as part of its discussions with the FDA regarding its review of the New Drug Application submission for Vyleesi, the agency has requested that additional data be generated from a "small" Phase 1 study with premenopausal volunteers assessing 24-hour ambulatory blood pressure with short term daily use of Vyleesi. As part of its ongoing review, the FDA has indicated that these data are required to help better characterize the impact of frequent dosing, including to help inform the Vyleesi label, Amag said in a regulatory filing. The company believes that this study can be conducted and data submitted prior to March 23, 2019, the currently scheduled Prescription Drug User Fee Act date. The FDA will assess the need for an Advisory Committee meeting after receipt and review of the requested data, and has informed the company that the previously communicated January 2019 Advisory Committee meeting will not take place, said Amag. It added, "Although the Company's discussions to date with the FDA are preliminary, and the Company will continue to have further discussions with the FDA on this matter, the Company believes that this submission of additional data could cause a delay of the potential approval of Vyleesi by three to six months." Shares of Amag Pharmaceuticals are up 2c to $18.00 in morning trading.