ACHN stock is leading in the biotech sector after Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) announced that the FDA has granted Breakthrough Therapy Designation (BTD) for danicopan (ACH-4471).
Investors Cheer the News
When a pharmaceutical company releases highly encouraging information with regards to any of its medicines, then its stock is almost always bound to rally, and that is what happened this morning with Achillion Pharmaceuticals stock. Danicopan, or ACH-4471, is one of the most important medicines in the company’s pipeline and in a new development, the United States Food and Drugs Administration granted it the designation of a Breakthrough Therapy.
The medicine is meant for the treatment of those suffering from paroxysmal nocturnal hemoglobinuria (PNH), and it goes without saying that the new designation is a major development for the company.
The market was also impressed by the development, and once the news spread, ACHN stock started climbing as well. Achillion stock zoomed by as much as 17% at $4.20 after the news broke, and investors may want to keep an eye on this stock for the rest of the week.
That being said, it is important to keep in mind that it is only the first step for the medicine and for Achillion Pharmaceuticals. There are plenty of more steps to go before it can be definitively said whether the medicine is going to hit the market.
That being said, the Breakthrough Therapy Designation is still a significantly important development for any medicine and could make it possible for Achillion to get much-needed assistance from the FDA with regards to the development of the medicine. For instance, the FDA could involve more senior personnel in the whole overseeing process and provide rolling reviews so that Achillion is well aware of the requirements when it comes to the marketing of the medicine.
The top-line data from the trials are going to be published by the company at some point in the fourth quarter this year, and once that is completed, a Phase 3 trial could be initiated early next year.
ACHN stock has soared 150% since the beginning of 2019 and made a new 52-week high of $5.03 last month.
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