Shares of Mirum Pharmaceuticals, Inc. MIRM have rallied 90.9% in the past six months compared with the industry’s increase of just 1.1%.

The company’s lead product is Livmarli (maralixibat), an orally administered ileal bile acid transporter (“IBAT”) inhibitor approved for the treatment of cholestatic pruritus in patients with Alagille syndrome worldwide.

In March 2024, the FDA approved Livmarli for the treatment of cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC), a rare genetic disorder that causes liver failure.

Livmarli sales have been rising steadily since its approval and launch worldwide.

Factors Driving MIRM Stock

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The majority of Mirum’s revenues are now being driven by Livmarli. In the first nine months of 2024, Livmarli generated sales worth $149.2 million, up 48.7% on a year-over-year basis. The continued demand for Livmarli is driving the top line and the momentum is expected to continue in the future quarters.

Management expects Livmarli product revenues to increase in future quarters owing to the strong global adoption of the product.

Mirum recently initiated the phase III EXPAND study, which is a label expansion opportunity for Livmarli in additional settings of cholestatic pruritus.

The European Commission approved Livmarli oral solution for the treatment of PFIC in patients aged three months and above in July 2024. The drug is also approved for treating cholestatic pruritus in PFIC patients aged 12 months and above in the United States.

Per management, the approval of Livmarli for the PFIC indication should help Mirum tap a space with significant potential.

MIRM's Other Pipeline Updates

In August 2023, Mirum acquired all assets of Travere Therapeutics’ bile acid products, which added two other products to its commercial portfolio — Cholbam (cholic acid) capsules and Chenodal (chenodiol) tablets. Cholbam is approved for treating bile acid synthesis disorders and Zellweger spectrum disorders.

In June 2024, a new drug application for chenodiol for treating cerebrotendinous xanthomatosis (CTX) patients was filed in the United States. The FDA has set a target action date of Dec. 28, 2024.

Chenodiol is not currently approved but has received a medical necessity medicine status from the FDA for the treatment of CTX, a rare autosomal genetic disorder.

Mirum’s pipeline candidate, volixibat, is currently being evaluated in two phase IIb studies for treating patients with primary biliary cholangitis (the VANTAGE study) and primary sclerosing cholangitis (the VISTAS study).

Strong uptake of Livmarli, potential diversification of its commercial portfolio as well as the successful development of volixibat should push the stock upward in 2025.

MIRM's Zacks Rank & Key Picks

Mirum currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 23.1%.

SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 41%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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