Dermira (DERM) is down over 60% after announcing that olumacostat glasaretil (DRM01) did not meet the co-primary endpoints in its two Phase 3 pivotal trials in patients ages nine years and older with moderate-to-severe acne vulgaris.
"We are surprised and extremely disappointed by the results of the Phase 3 program," said Tom Wiggans, chairman and chief executive officer of Dermira. "We are continuing to analyze the outcome of the olumacostat glasaretil Phase 3 program. However, based on the information we have to date, we expect to discontinue the development program."
Acne has proven to be a tough target for the medical field. Phase 2 results for DRM01 were positive, nothing like the failed data that were reported this morning. Novan (NOVN) and Foamix Pharma (FOMX) also recently reported unsuccessful Phase 3 acne data. Dermira management said it is hard to get excited about the acne market going forward -- there hasn't been a breakthrough for the condition in 30 years.
Dermira previously said it would hold an inaugural analyst and investor day in the second quarter of 2018 to review the company's commercial activities for glycopyrronium tosylate for hyperhidrosis and its pipeline. The company is preparing to launch its first product in the second half of the year as it waits to hear back from the FDA on glycopyrronium tosylate for the treatment of hyperhidrosis (excessive sweating). However, the acne market is much larger than the hyperhidrosis market.
Dermira has ~$6.50/share in net cash on the balance sheet. The company has said it has cash to last through the first half of 2019, when the company will announce top-line results for its other main drug, Lebrikizumab treating dermatitis, which is a competitive market.