Wednesday Morning’s Biotech Insights: Galena Biopharma Inc (GALE), Esperion Therapeutics Inc (ESPR), Lipocine Inc (LPCN)
Galena Biopharma Inc (NASDAQ:GALE) is plummeting 80% in early morning trading after the company discontinued its phase 3 interim analysis on Neuvax, its breast cancer vaccine, after an independent data monitoring committee recommended to do so. The committee recommended that the phase three trial be stopped due to futility. The data concluded that the vaccine was ineffective at preventing tumors from recurring compared to the placebo. Neuvax is the company’s most important pipeline product. The analysis also suggested the Neuvax may have been inferior to the placebo.
According to TipRanks’ statistics, all 3 analysts who have rated the stock in the past 3 months gave a Buy rating. The average 12-month price target is $4.67 marking a 130% upside from current levels.
Esperion Therapeutics Inc (NASDAQ:ESPR) is down 33% in early morning trading after the company and the FDA did not reach an agreement for an approval path for ETC-1002, the company’s cholesterol-lowering pill. The FDA will not approve the drug only on its effectiveness at cutting cholesterol, potentially delaying its commercialization by 6 years. The company may have to provide results of a trial examining the cardiovascular benefits, such as the prevention of heart attacks and cardiovascular disease, in order to win approval. However, this trial will not be completed until 2021.
Following this news, analyst Vamil Divan of Credit Suisse downgraded the stock from Neutral to Underperform and drastically slashed his price target form $23 to $10. He states, “We are surprised that the FDA may not be willing to allow LDL-C as a surrogate endpoint for initial approval but believe there will be significant pressure (and limited upside) on ESPR shares until that certainty is obtained, and that process may take years to play out… We do not expect ESPR to be profitable on a continuing basis until 2024.”
According to TipRanks, out of the 5 analysts who have rated the company in the past 3 months, 2 gave a Buy rating, 1 gave a Sell rating, and 2 remain on the sidelines. The average 12-month price target for the stock is $25.80, marking a 150% upside from current levels.
Lipocine Inc (NASDAQ:LPCN) is falling 52% in early morning trading after the company failed to receive approval for its testosterone drug, LPCN 1021. The rejection pointed to deficiencies related to the company’s dosing algorithm for the label. The company plans to request a meeting with the FDA to examine the issues and determine a path forward to gain approval for LPCN 1021. According to TipRanks, only one analyst rated the company in the past 3 months with a Buy rating and $15 price target, marking a 437% upside from current levels.