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From $7 To $22: Did Mirum Pharma's ICONIC Jump Make Big Money For You?

mirum dec17 lt

Shares of Mirum Pharmaceuticals Inc. (MIRM) touched an all-time high of $22.43 in intraday trading on Monday, before closing at $17.28, gaining a whopping 110%.

Here's why...

The Company announced that it has completed a successful pre-NDA meeting with the FDA for Maralixibat.

Maralixibat has completed a long-term phase IIb study in Alagille syndrome, dubbed ICONIC, and updated results were presented in April of this year. The study demonstrated that Maralixibat treatment led to a profound and durable improvement in pruritis, xanthomas (lipid accumulation in the skin) and bile acids over 48 weeks.

Alagille syndrome is a rare genetic disorder in which bile ducts are abnormally narrow, malformed and reduced in number, which leads to bile accumulation in the liver and ultimately progressive liver disease. The signs and symptoms associated with this disorder may include jaundice, pruritus (itching) and xanthomas.

Mirum Pharma has been in discussions with the FDA regarding the adequacy of the phase IIb data to support an NDA submission for Maralixibat for pruritus associated with Alagille syndrome.

Following the successful discussions with the FDA, the Company is planning a rolling NDA submission for Maralixibat in Alagille syndrome, which will be initiated in the third quarter of 2020.

Maralixibat is also being evaluated in a phase III study in pediatric patients with progressive familial intrahepatic cholestasis (PFIC), dubbed MARCH-PFIC. Enrollment in this trial is expected to be completed by mid-2020, with topline results expected by the end of 2020.

We alerted our readers to Mirum on November 1, 2019, when it was trading around $7. The stock closed yesterday's trading at $17.28, up 110.99%.

Did you ride the rally?

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