Geron Corp. (NASDAQ: GERN) is one of the few biopharma winners on Tuesday, with the health care sector in general pushing slightly lower on the day. The reason for Geron’s move is a crucial U.S. Food and Drug Administration (FDA) approval that came at just the right time for this stock.
There are a few other biopharmaceutical companies that could see much more volatility lined up over the next few weeks with key FDA decisions pending. 24/7 Wall St. puts together a monthly calendar of these events and what to look for before the news hits.
Such decisions have the potential to make or break companies. There is a fair amount to a great amount of risk involved, should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.
In terms of Geron, the FDA granted a Fast Track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes that are non-del(5q) and that are refractory or resistant to treatment with an erythropoiesis stimulating agent.
For some quick background: imetelstat is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech, a subsidiary of Johnson & Johnson (NYSE: JNJ), on a worldwide basis. Janssen sponsored the application for Fast Track designation utilizing preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk myelodysplastic syndromes.
Through the Fast Track program, a product candidate may be eligible for priority review, if supported by the clinical data, and for the ability to submit completed sections of a New Drug Application (NDA) on a rolling basis as data become available prior to completion of the full application.
Shares of Geron were last seen trading up 7.5% at $2.21, with a consensus analyst price target of $3.75 and a 52-week trading range of $1.81 to $3.15.
Johnson & Johnson traded at $139.36 a share. The stock has a 52-week range of $109.32 to $144.35 and a consensus price target of $144.81.