What Awaits Epizyme (EPZM), Aimmune Therapeutics (AIMT) This Week?

(RTTNews) - Shares of Epizyme Inc. (EPZM) have gained nearly 10 percent over the last 1 week as the Company awaits the FDA decision on its New Drug Application for Tazemetostat, slated to be announced on January 23, 2020.

Tazemetostat, which is under priority review, is proposed for the treatment of metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

Epizyme's NDA submission is based primarily on data from the 62-patient epithelioid sarcoma cohort of its ongoing phase II study of Tazemetostat.

Last month, an FDA panel voted 11-0 in favor of recommending approval of Tazemetostat. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

If approved, analysts expect Tazemetostat to bring in peak sales of about $100 million in the epithelioid sarcoma indication.

The Company is also exploring Tazemetostat as a potential treatment for follicular lymphoma, and a New Drug Application in this indication was submitted last month. Tazemetostat could reach peak sales of around $1 billion, if approved for broader indications, according to some analysts.

EPZM closed Friday's (Jan.17, 2020) trading at $26.72, up 4.62%.

Shares of Aimmune Therapeutics Inc. (AIMT) are down over 4 percent from their 52-week high of $37, recorded on January 16, 2020.

The Company's peanut allergy treatment Palforzia is at the FDA altar, with a decision due late this month.

On September 13, 2019, an FDA panel voted 7 to 2 that the efficacy data and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of Palforzia. The FDA is not bound by the panel's recommendations but takes its advice into consideration when making the final decision.

If approved, Palforzia will be the first medicine for peanut allergy. Its market opportunity is estimated to be in excess of $1 billion peak sales in the U.S. alone, according to the Company.

AIMT closed Friday's (Jan.17, 2020) trading at $34.92, down 4.49%.