Epizyme Inc (NASDAQ: EPZM) is having an incredibly rough start to the trading session this morning after news broke that the company is at the center of an FDA clinical hold. Of course, this led to fear among investors, sending the stock tumbling toward the bottom. Today, we’ll talk about:
- The clinical hold;
- what we’re seeing from EPZM as a result; and
- what we’ll be watching for ahead.
EPZM Falls Hard On Clinical Hold
As mentioned above, Epizyme is having an incredibly rough day in the market today after news broke that the FDA has issued a partial hold affecting the progression of one of its treatments. In various reports issued this morning, news has been circulating that the FDA issued a partial clinical hold which has put a hold on enrollment of patients with genetically defined solid tumors and hematologic malignancies. In the meantime, EPZM must update the informed consent, investigator’s brochure, and study protocols.
The FDA informed the company that patients in the study who have not experienced disease progression may continue to receive tazemetostat. Currently, EPZM is working on making the modifications to address the clinical hold. However, before enrollment resumes in the United States, the company must confirm that the trial aligns with the FDA’s requirements.
The clinical hold was the result of a safety report submitted to the FDA and other regulatory authorities by Epizyme. The report surrounded a patient with advanced poorly differentiated chordoma in the company’s Phase 1 pediatric study. Unfortunately, the patient developed T-cell lymphoma while taking part in the study. At the time of the safety report, the patient had been involved in the study for approximately 15 months and had achieved a confirmed partial response.
What We’re Seeing From The Stock
When we start to work in the market, one of the first lessons that we learn is that the news causes moves. In this particular case, the news proved to be overwhelmingly negative. After all, a clinical hold means that the company is forced to stop development on a treatment that it is working on. That’s going to lead to some fear among investors. So, it’s no surprise that the stock is taking a dive in the market today. As is almost always the case, our partners at Trade Ideas were the first to alert us to the declines. At the moment (10:46), EPZM is trading at $13.37 per share after a loss of $1.93 per share (12.62%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on EPZM. In particular, we’re interested in following the story surrounding the company’s efforts to bring the trial out of the partial hold. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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