The biotech sector has seen a pullback in trading today, tracking losses in the broader market. However, the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ:IBB) did break through a key resistance level on Friday.
The IBB had seen a sharp selloff at the start of this year, dropping well below $300. Although the sector did rebound, it failed to break through $300 until last week. The sector has been driven higher by a spate of positive news relating to the sector. In the past few months, we have seen several acquisitions announced, which should provide support to the sector. We also seen some positive sentiment due to recent drug approvals.
Lipocine Inc. (NASDAQ:LPCN) is a Salt Lake City, Utah-based biotechnology company focusing on applying its oral drug delivery technology for the development of pharmaceutical products in the area of men’s and women’s health. The company’s primary development programs are based on oral delivery solutions for bioavailable drugs.
Lipocine shares are soaring in trading today after the company announced positive top-line results from a Phase 2b clinical study of LPCN 1111, a novel oral testosterone replacement therapy ("TRT") product candidate. The primary objectives of the study were to determine the Phase 3 dose of LPCN 1111 along with the safety and tolerability of LPCN 1111 and its metabolites following oral administration of single and multiple doses in hypogonadal males.
Each of the 12 subjects in a group received treatment for 14 days. Results of the Phase 2b study suggest that the primary objectives were met, including identifying the dose expected to be tested in a Phase 3 study. Good dose-response relationship was observed over the tested dose range in the Phase 2b study. The target Phase 3 dose met primary and secondary end points. LPCN 1111 was well tolerated with no drug-related severe or serious adverse events reported.
Dr. Mahesh Patel, President and CEO at Lipocine, said that the company is pleased to report positive top-line results, as these results reinforce its belief that LPCN 1111 represents a promising product candidate for once daily administration of testosterone. Dr. Patel further said that based on this progress, the company plans to meet with the U.S. Food and Drug Administration (FDA) to discuss Phase 3 development plans.
Lipocine shares are bucking the trend in the broader market today. At last check, the stock was trading 12.60% higher at $4.38 on volume of 1.50 million, which is nearly 10 times the daily average volume of 158,293.
