Bayer AG (BAYRY - Free Report) announced that the FDA has approved Jivi (BAY94-9027) for the routine prophylactic treatment of hemophilia A in previously-treated adults and adolescents 12 years of age or older, in the United States. The FDA also approved Jivi for on-demand treatment and perioperative management of bleeding in the same population.
Jivi is a long acting PEGylated recombinant human Factor VIII (rFVIII) replacement therapy. It replaces the reduced or missing FVIII in adults and adolescents aged 12 years or older suffering from hemophilia A.
The recommended initial prophylactic regimen for Jivi is twice weekly, with the scope to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes.
Bayer submitted a Biologics License Application (BLA) for Jivi in August 2017, which was accepted by the FDA in November 2017.
The FDA approval was based on results from the phase II/III PROTECT VIII study. Bayer has also submitted marketing authorization applications for Jivi in the European Union and Japan.
Shares of Bayer have decreased 24.3% against with the industry’s growth of 5.1% year to date.
In July, Bayer also received approval for Kovaltry by the Chinese regulatory authorities for use in adults and children with hemophilia. Kovaltry is a full-length recombinant Factor VIII product. Kovaltry has been approved in many countries including the United States, Europe and Japan. Another FVIII treatment in Bayer’s portfolio is Kogenate FS.
Zacks Rank & Stocks to Consider
Bayer has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. (GILD - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Celgene Corp. (CELG - Free Report) . While Gilead and Ligand sport a Zacks Rank #1 (Strong Buy), Celgene carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.11 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 6.5% so far this year.
Ligand’s earnings per share estimates have moved up from $4.93 to $5.64 for 2018 and from $5.39 to $5.59 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%. Share price of the company has increased 88.1% year to date.
Celgene’s earnings per share estimates have increased from $8.52 to $8.76 for 2018 and from $10.18 to $10.65 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 2.38%.
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