MIRM Mirum Pharmaceuticals Inc.

26.07
+0.79  (+3%)
Previous Close 25.28
Open 25.06
52 Week Low 6.5126
52 Week High 28.31
Market Cap $662,264,588
Shares 25,399,132
Float 11,863,184
Enterprise Value $486,173,056
Volume 57,807
Av. Daily Volume 95,953
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Upcoming Catalysts

Drug Stage Catalyst Date
Maralixibat - INDIGO (EASL)
Progressive Familial Intrahepatic Cholestasis (PFIC)
Phase 2
Phase 2
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Maralixibat
Alagille Syndrome (ALGS)
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
Volixiba
Cholestatic liver diseases
Phase 2
Phase 2
Phase 2 trial planned.
Maralixibat - MARCH
Progressive Familial Intrahepatic Cholestasis (PFIC)
Phase 3
Phase 3
Phase 3 ongoing.

Latest News

  1. Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced that Chris Peetz, president and chief executive officer at Mirum will present at the virtual Canaccord Genuity 40th Annual Growth Conference on August 13, 2020 at 3:00pm ET.

    A live audio webcast and an archive of the presentation will be available in the Investors & Media section of the company website at ir.mirumpharma.com.

    About Mirum Pharmaceuticals

    Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The…

    Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced that Chris Peetz, president and chief executive officer at Mirum will present at the virtual Canaccord Genuity 40th Annual Growth Conference on August 13, 2020 at 3:00pm ET.

    A live audio webcast and an archive of the presentation will be available in the Investors & Media section of the company website at ir.mirumpharma.com.

    About Mirum Pharmaceuticals

    Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The company's lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). For more information, visit mirumpharma.com. Follow Mirum on Twitter, Facebook and LinkedIn.

    View Full Article Hide Full Article
    • Rolling NDA submission for maralixibat in Alagille syndrome (ALGS) to be initiated in third quarter 2020; planning for potential launch in second half of 2021.
    • Submission of European marketing authorization application for maralixibat in PFIC2 planned for fourth quarter of 2020.
    • Expanded Access Program for maralixibat in ALGS planned to open for registration in September 2020.
    • Orphan Drug Designation received by European Medicines Agency for maralixibat in biliary atresia.
    • Cash, cash equivalents and investments of $149.3 million.

    Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced financial results…

    • Rolling NDA submission for maralixibat in Alagille syndrome (ALGS) to be initiated in third quarter 2020; planning for potential launch in second half of 2021.
    • Submission of European marketing authorization application for maralixibat in PFIC2 planned for fourth quarter of 2020.
    • Expanded Access Program for maralixibat in ALGS planned to open for registration in September 2020.
    • Orphan Drug Designation received by European Medicines Agency for maralixibat in biliary atresia.
    • Cash, cash equivalents and investments of $149.3 million.

    Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced financial results and business updates for the quarter ended June 30, 2020.

    "We made significant progress toward making maralixibat available as an alternative to liver transplantation in devastating pediatric cholestatic settings in the United States and Europe," said Chris Peetz, president and chief executive officer at Mirum. "In the United States, we are initiating a rolling NDA submission for maralixibat in ALGS and are planning to start an expanded access program broadening availability to this important medicine for eligible patients. By the end of this year, we intend to submit a marketing authorization application for maralixibat in PFIC2 in Europe, dramatically shifting our timeline for a potential launch in this region."

    Second Quarter Highlights

    • Released maralixibat data demonstrating five-year transplant-free survival for pediatric patients with PFIC2. Data will be presented at the upcoming Digital International Liver Congress, August 27-29, 2020.
    • Completed pre-submission meeting with European regulators resulting in feedback enabling submission of a marketing authorization application (MAA) for maralixibat in the treatment of patients with PFIC2 in Europe in the fourth quarter of 2020.
    • Investigational new drug (IND) application cleared by FDA for the initiation of a Phase 2 study evaluating volixibat in adult patients with pruritus associated with primary sclerosing cholangitis.
    • Received orphan drug designation in Europe for maralixibat in the study of patients with biliary atresia; planning for a Phase 2 study is underway.
    • As of June 30, 2020, Mirum had cash, cash equivalents and investments of $149.3 million.

    Upcoming Anticipated Program Milestones

    • Maralixibat in ALGS:
      • Initiation of rolling new drug application (NDA) submission for maralixibat in ALGS on track for third quarter of 2020.
        • Expect to complete NDA submission in the first quarter of 2021.
        • Planning for launch in ALGS in the second half of 2021.
      • Maralixibat ALGS Expanded Access Program planned to open for registration in the U.S. and Canada in September 2020.
    • Maralixibat in PFIC:
      • Submission of MAA to European regulators for maralixibat in the treatment of patients with PFIC2 on track for fourth quarter of 2020.
      • Enrollment ongoing in Phase 3 MARCH clinical trial in PFIC.
    • Maralixibat in biliary atresia:
      • Phase 2 study initiation planned.
    • Volixibat:
      • Planned expansion into adult patients with studies in primary sclerosing cholangitis and intrahepatic cholestasis of pregnancy.

    Digital International Liver Congress™ 2020

    New findings from maralixibat studies will be presented in a late-breaker and poster sessions at the Digital International Liver Congress 2020, August 27-29, 2020. Featured presentations to include the following abstracts:

    Late-breaker Oral Presentation

    August 29, 2020 – 1:45-2:00pm CET

    Oral Presentation LB008: Serum bile acid control in long-term maralixibat-treated patients is associated with native liver survival in children with progressive familial intrahepatic cholestasis due to bile salt export pump deficiency.

    Poster Presentations

    August 28, 2020

    Poster FRI-131: Psychometric evaluation of the adult itch reported outcome tool, a worst-itch numeric rating scale in adults with cholestatic liver disease.

    August 28, 2020

    Poster FRI-296: Differential expression of bile acid subspecies with maralixibat treatment in pruritus responders.

    About Maralixibat

    Maralixibat is a novel, minimally absorbed, orally administered investigational drug being evaluated in several rare cholestatic liver diseases. Maralixibat inhibits the apical sodium dependent bile acid transporter, resulting in more bile acids being excreted in the feces, leading to lower levels of bile acids systemically, thereby potentially reducing bile acid mediated liver damage and related effects and complications. More than 1,600 individuals have received maralixibat, including more than 120 children who have received maralixibat as an investigational treatment for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). In the ICONIC Phase 2b ALGS clinical trial, patients taking maralixibat had significant reductions in bile acids and pruritus compared to placebo. In a Phase 2 PFIC study, a genetically defined subset of BSEP (bile salt export pump) deficient (PFIC2), patients responded to maralixibat. The FDA has granted maralixibat Breakthrough Therapy designation for pruritus associated with ALGS in patients one year of age and older and for PFIC2. Maralixibat was generally well-tolerated throughout the studies. The most frequent adverse events were diarrhea, abdominal pain, and vomiting. For more information about the North American Expanded Access Program please visit ALGSEAP.com. For more information about the Phase 3 study for maralixibat in pediatric patients with PFIC, visit PFICtrial.com.

    About Mirum Pharmaceuticals

    Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The company's lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia. The company is also developing volixibat, also an oral ASBT-inhibitor, in primary sclerosing cholangitis and intrahepatic cholestasis of pregnancy. For more information, visit MirumPharma.com. Follow Mirum on Twitter, Facebook and LinkedIn.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results, conduct, progress and timing of Mirum's ongoing and planned studies for maralixibat and volixibat, as well as Mirum's Expanded Access Program for maralixibat, the regulatory approval path for maralixibat and volixibat, the strength of Mirum's balance sheet and the adequacy of cash, cash equivalents and investments on hand, the impacts of the COVID-19 pandemic, and commercial readiness activities. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans," "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum's business in general, the impact of the COVID-19 pandemic, and the other risks described in Mirum's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    Mirum Pharmaceuticals, Inc.

    Condensed Consolidated Statement of Operations Data

    (in thousands, except share and per share amounts)

    (Unaudited)

     

    Three Months Ended

     

    Six Months Ended

    June 30,

     

    June 30,

    2020

     

    2019

     

    2020

     

    2019

     
    Operating expenses:
    Research and development

    $

    18,555

     

    $

    11,589

     

    $

    35,895

     

    $

    16,452

     

    General and administrative

     

    5,042

     

     

    2,445

     

     

    9,734

     

     

    3,766

     

    Total operating expenses (1)

     

    23,597

     

     

    14,034

     

     

    45,629

     

     

    20,218

     

     
    Loss from operations

     

    (23,597

    )

     

    (14,034

    )

     

    (45,629

    )

     

    (20,218

    )

    Interest income

     

    405

     

     

    468

     

     

    1,154

     

     

    700

     

    Other income (expense), net

     

    (56

    )

     

    9

     

     

    (79

    )

     

    4

     

     
    Net loss before provision for income taxes

     

    (23,248

    )

     

    (13,557

    )

     

    (44,554

    )

     

    (19,514

    )

    Provision for income taxes

     

    3

     

     

    -

     

     

    7

     

     

    -

     

    Net loss

    $

    (23,251

    )

    $

    (13,557

    )

    $

    (44,561

    )

    $

    (19,514

    )

     
    Net loss per share, basic and diluted

    $

    (0.93

    )

    $

    (5.31

    )

    $

    (1.79

    )

    $

    (7.70

    )

     
    Weighted-average shares of common stock outstanding, basic and diluted

     

    25,056,123

     

     

    2,551,822

     

     

    24,880,387

     

     

    2,534,877

     

     

    (1)

    Amounts include stock-based compensation expense as follows:

     
    Research and development

    $

    1,260

     

    $

    638

     

    $

    2,301

     

    $

    709

     

    General and administrative

     

    1,714

     

     

    1,003

     

     

    3,246

     

     

    1,150

     

    Total stock-based compensation

    $

    2,974

     

    $

    1,641

     

    $

    5,547

     

    $

    1,859

     

    Mirum Pharmaceuticals, Inc.
    Selected Condensed Consolidated Balance Sheet Data
    (in thousands)
     

    June 30,

     

    December 31,

    2020

     

    2019

    (Unaudited)

     

     

     
    Cash, cash equivalents and investments

    $

    149,336

     

    $

    139,952

     

    Working capital

     

    135,495

     

     

    106,287

     

    Total assets

     

    155,766

     

     

    146,712

     

    Accumulated deficit

     

    (114,462

    )

     

    (69,901

    )

    Total stockholders' equity

     

    136,208

     

     

    130,349

     

     

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  2. Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases, today announced that the Compensation Committee of Mirum's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 70,900 shares of common stock to four new employees under Mirum's 2020 Inducement Plan. The Compensation Committee of Mirum's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each stock option has an exercise price per share equal to $19.03 per share, Mirum's closing trading price on July 10, 2020, and…

    Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases, today announced that the Compensation Committee of Mirum's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 70,900 shares of common stock to four new employees under Mirum's 2020 Inducement Plan. The Compensation Committee of Mirum's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each stock option has an exercise price per share equal to $19.03 per share, Mirum's closing trading price on July 10, 2020, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee's continued service relationship with Mirum through the applicable vesting dates. The awards are subject to the terms and conditions of Mirum's 2020 Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.

    About Mirum Pharmaceuticals

    Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The company's lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). For more information, visit MirumPharma.com. Follow Mirum on Twitter, Facebook and LinkedIn.

    View Full Article Hide Full Article
  3. Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases, today announced that the Compensation Committee of Mirum's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 60,000 shares of common stock to two new employees under Mirum's 2020 Inducement Plan. The Compensation Committee of Mirum's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each stock option has an exercise price per share equal to $18.46 per share, Mirum's closing trading price on June 10, 2020, and…

    Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM), a biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases, today announced that the Compensation Committee of Mirum's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 60,000 shares of common stock to two new employees under Mirum's 2020 Inducement Plan. The Compensation Committee of Mirum's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each stock option has an exercise price per share equal to $18.46 per share, Mirum's closing trading price on June 10, 2020, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee's continued service relationship with Mirum through the applicable vesting dates. The awards are subject to the terms and conditions of Mirum's 2020 Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.

    About Mirum Pharmaceuticals

    Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The company's lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). For more information, visit MirumPharma.com. Follow Mirum on Twitter, Facebook and LinkedIn.

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  4. - Maralixibat-treated patients achieving serum bile acid control have five-year native liver survival after treatment.

    - Data demonstrate normalization and reductions of liver enzymes, reduced pruritus, and improved growth.

    - Data selected for oral presentation at the Digital International Liver Congress 2020 being held August 27-29, 2020.

    Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) today reported an analysis from its Phase 2 INDIGO open-label study evaluating maralixibat in patients with bile acid salt export pump (BSEP) deficiency, or PFIC2. The data demonstrated that patients with long-term maralixibat treatment who achieved serum bile acid (sBA) control, have five-year transplant-free survival after treatment.

    "Patients need alternatives…

    - Maralixibat-treated patients achieving serum bile acid control have five-year native liver survival after treatment.

    - Data demonstrate normalization and reductions of liver enzymes, reduced pruritus, and improved growth.

    - Data selected for oral presentation at the Digital International Liver Congress 2020 being held August 27-29, 2020.

    Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) today reported an analysis from its Phase 2 INDIGO open-label study evaluating maralixibat in patients with bile acid salt export pump (BSEP) deficiency, or PFIC2. The data demonstrated that patients with long-term maralixibat treatment who achieved serum bile acid (sBA) control, have five-year transplant-free survival after treatment.

    "Patients need alternatives to surgery or transplant to treat PFIC2, otherwise known as BSEP deficiency, and the long-term maralixibat data demonstrate the therapy's potential to provide an efficacious and well-tolerated treatment for this condition," said Richard Thompson, Professor of Molecular Hepatology at King's College London. "The long-term control of serum bile acids underscores the potential for maralixibat to transform the way PFIC2 is treated, as well as provide additional benefit across many of the quality of life measures that can be debilitating and significantly impact patients' lives."

    A study recently published by the NAPPED Consortium established that sBA control (<102µmol/L or a 75% reduction) after interruption of the enterohepatic circulation by biliary diversion surgery was associated with native liver survival of up to 15 years. Similarly, maralixibat pharmacologically interrupts the enterohepatic circulation, and maralixibat responders from the INDIGO study surpassed the sBA thresholds described in the NAPPED study, which were statistically significant compared to baseline (p<0.05). In addition, maralixibat responders achieved normalization of liver enzyme and bilirubin levels, decreased pruritus, and improved z-scores in both height and weight.

    The data and analysis have been selected by the European Association for the Study of the Liver (EASL) as a late-breaker and oral presentation at the Digital International Liver Congress 2020 being held August 27-29, 2020.

    "We are thrilled with these data as they confirm our belief that maralixibat has the potential to treat PFIC2, preventing transplant and surgical diversion and alleviating many of the symptoms associated with the condition," said Chris Peetz, president and chief executive officer at Mirum. "Supporting this, we have cases of maralixibat-treated patients being removed from the liver transplant waiting list. There is a tremendous need for new medicines for the patients and families suffering from this disease, and it is our goal to develop a treatment that can address this rare and serious cholestatic liver disease."

    About the Maralixibat Phase 2 INDIGO Study

    The INDIGO Phase 2 study is an ongoing, open-label study evaluating the long-term treatment effects of interruption of enterohepatic circulation with maralixibat in children with PFIC. INDIGO included 19 PFIC2 patients with non-truncating BSEP mutations who received maralixibat 280 µg/kg once daily. Patients without response or with partial treatment response could escalate to 280 µg/kg twice daily in the optional extension period. Study endpoints were sBA, pruritus, quality of life, safety and tolerability.

    Week 237 (n=7)

    Mean Value

    Mean Reduction

    from Baseline

    P value

    Serum bile acid (SE) µmol/L

    44.2 (38.8)

    -234.4 (80.5)

    <0.05

    ALT (SE) U/L

    16.7

    -41.1 (14.3)

    <0.05

    AST (SE) U/L

    26.7

    -35.4 (11.5)

    <0.05

    Total bilirubin (SE) mg/dL

    0.7

    -0.1 (0.3)

    0.08

    Direct bilirubin (SE) mg/dL

    0.1

    -0.4 (0.2)

    0.13

    Patients treated with maralixibat exhibited a clinically meaningful and statistically significant acceleration in height growth as measured by height z-score (p<0.01), as well as a clinically meaningful and statistically significant reduction in pruritus (p<0.001).

    Of the enrolled patients, seven achieved sBA control and remained on study as of Week 237. Long-term treatment with maralixibat was well-tolerated. The most frequent treatment-emergent adverse events (TEAEs) were pyrexia, diarrhea, cough, abdominal pain, and vomiting. TEAEs were mild to moderate in severity.

    Patients with an sBA response continue to be treated with maralixibat for more than five years with improvements demonstrated across multiple parameters.

    About Maralixibat

    Maralixibat is a novel, minimally-absorbed, orally administered investigational drug being evaluated in several rare cholestatic liver diseases for pediatric populations. Maralixibat inhibits the apical sodium dependent bile acid transporter, resulting in more bile acids being excreted in the feces, leading to lower levels of bile acids systemically, thereby potentially reducing bile acid mediated liver damage and related effects and complications. More than 1,500 individuals have received maralixibat, including more than 100 children who have received maralixibat as an investigational treatment for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). In the ICONIC Phase 2b ALGS clinical trial, patients taking maralixibat had significant reductions in bile acids and pruritus compared to placebo. In a Phase 2 PFIC study, a genetically defined subset of BSEP (bile salt export pump) deficient (PFIC2), patients responded to maralixibat. The FDA has granted maralixibat Breakthrough Therapy designation for pruritus associated with Alagille syndrome in patients one year of age and older and for PFIC2. Maralixibat was generally well-tolerated throughout the studies. The most frequent adverse events were diarrhea, abdominal pain, and vomiting. For more information about the Phase 3 study for maralixibat in pediatric patients with PFIC, visit PFICtrial.com. For more information about the North American Expanded Access Program please visit ALGSEAP.com.

    About Mirum Pharmaceuticals

    Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. The company's lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). For more information, visit MirumPharma.com. Follow Mirum on Twitter, Facebook and LinkedIn.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results, conduct, progress and timing of Mirum's clinical trials and the regulatory approval path for maralixibat. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans," "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum's business in general, the impact of the COVID-19 pandemic, and the other risks described in Mirum's filings with the Securities and Exchange Commission. In addition, the COVID-19 pandemic continues to rapidly evolve and actual results are highly uncertain and cannot be predicted with confidence. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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