Mirum Pharmaceuticals, Inc. - MIRM STOCK NEWS

Mirum Pharmaceuticals (Nasdaq: MIRM) has announced inducement grants for eight new employees under its 2020 Inducement Plan. The Compensation Committee approved these awards on August 9, 2024, in accordance with Nasdaq Listing Rule 5635(c)(4). The grants include:

- Non-qualified stock options to purchase 59,000 shares of common stock
- 29,500 restricted stock units (RSUs)

The stock options have an exercise price of $40.02 per share, matching Mirum's closing price on August 9, 2024. They will vest over four years, with 25% vesting after one year and the remainder monthly over 36 months. The RSUs will vest over three years, with 33% vesting annually. Both are subject to continued employment with Mirum.

Mirum Pharmaceuticals (Nasdaq: MIRM) reported strong Q2 2024 financial results, with global net product sales of $77.8 million, a 139% increase year-over-year. The company is on track to achieve its full-year guidance of $310-$320 million. Key highlights include:

1. LIVMARLI Q2 net sales of $47.2 million, up 45% from Q2 2023
2. CHOLBAM and CHENODAL Q2 net sales of $30.5 million
3. Positive interim results for volixibat in VISTAS PSC and VANTAGE PBC studies
4. LIVMARLI approved in Europe for PFIC in patients 3 months and older
5. LIVMARLI approved in the US for cholestatic pruritus in PFIC patients 12 months and older
6. Initiating Phase 3 EXPAND study for LIVMARLI in additional cholestatic pruritus settings
7. NDA submitted for chenodiol in CTX

Mirum's cash position remains strong at $295.4 million as of June 30, 2024.

Mirum Pharmaceuticals (NASDAQ: MIRM) has announced that it will release its second quarter 2024 financial results on August 7, 2024. The company will also host a conference call on the same day at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and recent corporate progress. Investors can access the call via a toll-free U.S. number or an international number, using the passcode 771307. Additionally, a webcast of the call will be available on Mirum's website in the Events & Presentations section, with a replay accessible for 30 days after the event.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced FDA approval for an expanded label of LIVMARLI® (maralixibat) oral solution. The new label includes treatment for cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) aged 12 months and older. This expansion, based on the MARCH Phase 3 study, also includes a higher concentration formulation of LIVMARLI.

Chris Peetz, CEO of Mirum, expressed enthusiasm about the launch of LIVMARLI for PFIC patients, emphasizing the importance of early treatment initiation to reduce suffering from pruritus associated with this rare liver disease. The expanded label allows for treatment in younger patients, aligning with the typical early diagnosis of PFIC.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced inducement grants on July 10, 2024, under Nasdaq Listing Rule 5635(c)(4). The grants include non-qualified stock options for 40,800 shares of common stock and 20,400 restricted stock units (RSUs) to seven new employees. The stock options have an exercise price of $35.92 per share, based on Mirum's closing trading price on July 10, 2024. These options will vest over four years, starting with 25% on the one-year anniversary and the remaining vesting monthly over the next 36 months. The RSUs will vest over three years, with 33% vesting each year, contingent upon the employees' continued service. The grants fall under Mirum's 2020 Inducement Plan and are aligned with applicable award agreements.

The European Commission has granted marketing authorization for Mirum Pharmaceuticals' LIVMARLI (maralixibat) oral solution to treat progressive familial intrahepatic cholestasis (PFIC) in patients aged three months and older. This approval follows the positive opinion from the CHMP, noting LIVMARLI's significant clinical benefits over existing PFIC treatments. The decision also aligns with a positive COMP opinion recommending the continuation of Orphan Drug Designation for LIVMARLI in PFIC. Approval is based on data from the Phase 3 MARCH study, the largest randomized trial in PFIC, showing substantial reductions in pruritus and serum bile acids with LIVMARLI compared to placebo. The study included 93 patients with various genetic types of PFIC. Common adverse events were mild and transient diarrhea. LIVMARLI is also approved in the U.S. for treating cholestatic pruritus in PFIC patients aged five years and older.

Mirum Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for chenodiol, aiming to treat cerebrotendinous xanthomatosis (CTX), a rare genetic disorder of cholesterol metabolism. The submission is based on positive results from the Phase 3 RESTORE study, which showed a significant reduction in bile alcohols and improved serum cholestanol in patients treated with chenodiol. The study's primary endpoint was met with high statistical significance (p<0.0001), and chenodiol demonstrated a 20-fold difference in efficacy compared to placebo. Diarrhea and headache were the most common adverse events, generally mild or moderate. If approved, chenodiol would be the first and only therapy available in the US for CTX, offering hope for early diagnosis and treatment of this debilitating condition.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced positive interim results from two Phase 2b studies evaluating volixibat in patients with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).

In the VANTAGE PBC study, volixibat demonstrated a statistically significant improvement in pruritus with a 3.82 point reduction (p<0.0001) and a 2.32 point placebo-adjusted difference (p=0.0026). 75% of patients on volixibat achieved over 50% reduction in serum bile acids. Fatigue also improved significantly at week 16, with no new safety signals. The most common adverse event was mild to moderate diarrhea (77%).

The VISTAS PSC study exceeded the efficacy threshold for continuation. The independent data review committee recommended continuing the study with the current dose of 20 mg twice daily. Mirum will discuss these findings in a conference call on June 17 at 8:30 a.m. ET.

Mirum Pharmaceuticals (NASDAQ: MIRM) will host an investor call on June 17, 2024, at 8:30 a.m. ET to present interim results from two Phase 2b studies: the Volixibat VANTAGE study for primary biliary cholangitis (PBC) and the Volixibat VISTAS study for primary sclerosing cholangitis (PSC). Dial-in options are available, and a webcast will be accessible on Mirum's website. The replay of the call will be available for 30 days.