Meetings with the United States Food and Drug Administration are always key events for any pharmaceutical company, and it is especially so when it comes to a pre-New Drug Application (NDA). On Monday this week, Mirum Pharmaceuticals Inc (NASDAQ:MIRM) made an announcement with regards to one of its medicines, and MIRM stock price has been on a remarkable rally since then.
Big News
The company announced that it had successfully completed its pre-NDA meeting with the US FDA for its medicine maralixibat. Maralixibat is to be used to treat pruritus that is associated with Alagille syndrome.
The company announced that the meeting proved to be a success, and that is a significant development for Mirum. The company also stated that the FDA has granted a Rare Pediatric Disease Designation to maralixibat for the treatment of Alagille syndrome.
The optimism inspired by this development has been reflected in MIRM stock, which has rallied by as much as 210% since the announcement. It has clearly emerged as one of the stocks to watch this week, and it remains to be seen if it can further extend its gains in the coming days.
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The Chief Executive Officer and President of the company, Chris Peetz, spoke about the developments: “We are pleased that the FDA recommended that we change the classification of our requested Type C meeting to a pre-NDA meeting and that we have a path to a rolling NDA submission for maralixibat beginning in the third quarter of 2020.”
However, he went on to add that the company would keep working closely working with the FDA and hoped that Mirum Pharmaceuticals will be able to bring the treatment for Alagille syndrome to the market as soon as possible. The company hopes to start an expanded access program at some point in the last six months of next year.
The positivity around the stock is no surprise. MIRM stock is up a whopping 54% at $25.20 in Wednesday’s trading session and made a new high of $27.28.
Featured image: DepositPhotos © stevanovicigor
