Every 8-K that Mirum Pharmaceuticals (MIRM) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow MIRM and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full MIRM filings page.
Mirum Pharmaceuticals, Inc. (MIRM) reports a leadership transition in its medical organization. The board appointed Rob Myers, M.D. to succeed Joanne Quan, M.D. as Chief Medical Officer, effective when Dr. Myers begins employment, which is expected on September 21, 2026. Dr. Quan ceased serving as Chief Medical Officer on September 2, 2026, and her employment termination is expected on October 19, 2026, the defined “Separation Date.”
Mirum expects to enter into a Separation Agreement with Dr. Quan providing severance benefits under its Amended and Restated Severance Benefit Plan, subject to its terms. The compensation committee also approved a 12‑month post‑termination option exercise window for Dr. Quan’s vested options and payment of her 2026 annual target bonus at 100% achievement on the Separation Date, contingent on customary conditions.
Mirum Pharmaceuticals reported Q2 2026 net product sales of $176.2 million, up from $127.8 million in Q2 2025, and raised 2026 net product sales guidance to $680 million to $700 million. LIVMARLI generated $128.7 million and bile acid medicines $47.5 million, with year-over-year growth of 46% and 20%, respectively.
The company recorded a Q2 net loss of $67,227 (in thousands) as total operating expenses rose to $218.8 million, including $16.4 million of non-recurring acquired in-process R&D associated with a zilurgisertib license and higher R&D and SG&A. Mirum issued $690.0 million of 0.00% convertible senior notes due 2032, settled $237.2 million of 4.00% notes due 2029, and ended June 30, 2026 with unrestricted cash, cash equivalents and investments of $561.3 million.
Pipeline highlights include FDA Breakthrough Therapy and Orphan Drug designations for volixibat in PSC, a pre-NDA meeting where the agency recommended conducting a Phase 3 study with further FDA discussions planned before a potential NDA submission targeted in the first half of 2027, completion of enrollment in the VANTAGE PBC study, and a PDUFA target action date of September 26, 2026 for zilurgisertib in FOP.
Mirum Pharmaceuticals, Inc. reported the results of its 2026 Annual Meeting of Stockholders held on June 15, 2026. As of the April 20, 2026 record date, 60,977,841 shares of common stock were outstanding and entitled to vote.
Stockholders elected three Class I directors—Lon Cardon, William Fairey, and Timothy Walbert—to serve until the 2029 annual meeting and until their successors are duly elected and qualified. Mirum’s stockholders also ratified the selection of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, and approved, on an advisory basis, the compensation of the company’s named executive officers.
Mirum Pharmaceuticals issued $690.0 million of 0.00% Convertible Senior Notes due 2032 in a private 144A placement to qualified institutional buyers, including a $90.0 million overallotment option that was fully exercised. The company estimates net proceeds of approximately $671.6 million after discounts and expenses. The notes are senior unsecured, carry no regular interest, and mature on June 1, 2032, with multiple triggers that allow conversion into cash, stock, or a mix, at Mirum’s election. The initial conversion rate is 7.1971 shares per $1,000, implying a conversion price of about $138.94 per share, a 30% premium to the $106.88 stock price on May 12, 2026, and could rise to a maximum rate of 9.3562 shares upon certain events. Mirum plans to use about $475.0 million of proceeds plus 3,220,529 shares to exchange approximately $237.2 million principal of its 4.00% Convertible Senior Notes due 2029, with the balance earmarked for general corporate purposes, including potential acquisitions.
Mirum Pharmaceuticals reported first quarter 2026 net product sales of $159.9 million, up from $111.6 million a year earlier, and raised its 2026 net product sales guidance to $660–$680 million. Growth was driven by LIVMARLI sales of $113.8 million and bile acid medicines sales of $46.1 million.
Total operating expenses rose to $949.3 million, including $726.3 million of non-recurring in-process R&D from the Bluejay Therapeutics acquisition, resulting in a net loss of $790.2 million or $(13.43) per share. Mirum ended March 31, 2026 with $420.6 million in unrestricted cash, cash equivalents, and investments.
The company reported positive Phase 2b results for volixibat in primary sclerosing cholangitis and brelovitug in chronic hepatitis delta virus, with multiple Phase 3 readouts expected from H2 2026 through Q1 2027. Mirum also in-licensed worldwide rights to zilurgisertib for fibrodysplasia ossificans progressiva, paying $16 million upfront; the FDA granted Priority Review with a PDUFA date of September 26, 2026.
Mirum Pharmaceuticals reported that its VISTAS Phase 2b study of volixibat in primary sclerosing cholangitis met the primary endpoint for cholestatic itch relief. In the primary analysis cohort, volixibat 20 mg twice daily achieved a 2.72-point improvement on the Adult ItchRO scale versus 1.08 points for placebo, for a placebo-adjusted difference of 1.64 points (p<0.0001).
Statistically significant itch reductions appeared within two weeks and were also seen in patients with mild baseline itch. Safety was consistent with ileal bile acid transporter inhibition, with more gastrointestinal events and liver test elevations; diarrhea occurred in 40.3% of volixibat patients versus 8.6% on placebo, and more patients on volixibat discontinued treatment due to adverse events.
The company has a pre-New Drug Application meeting with the U.S. FDA for volixibat in PSC planned for summer 2026 and is targeting an NDA submission in the second half of 2026. Mirum also expects topline data from the VANTAGE Phase 2b volixibat study in primary biliary cholangitis in the first quarter of 2027.
Mirum Pharmaceuticals reported positive Phase 2b results from the AZURE-1 study of brelovitug in chronic hepatitis delta virus (HDV). Among the first 53 patients evaluated at Week 24, virologic response was seen in 100% of patients on 300 mg weekly and 75% on 900 mg every four weeks, versus 0% in the delayed treatment arm.
The composite primary endpoint of virologic response plus ALT normalization was achieved by 45% and 35% of patients in the 300 mg and 900 mg arms, respectively, compared with 0% in the delayed arm. Treatment was generally well tolerated, with few grade 3 or higher and serious adverse events. Mirum plans to present full Phase 2b results at the EASL Congress in late May 2026 and expects topline data from Phase 3 AZURE-1 and AZURE-4 in H2 2026, with potential BLA submission and U.S. commercial launch in 2027.
Mirum Pharmaceuticals filed an amended report to add full financial details for its acquisition of Bluejay Therapeutics and a related equity financing. The filing includes Bluejay’s audited 2025 statements, showing $85.6 million in assets and a net loss of $101.7 million, highlighting its clinical-stage profile.
The amendment also provides unaudited pro forma results combining Mirum and Bluejay and reflecting Mirum’s $280.8 million upfront cash paid in the deal and a concurrent private placement of 3,385,149 shares and 536,412 pre-funded warrants, which generated approximately $268.5 million in gross proceeds.
Mirum Pharmaceuticals reported strong 2025 growth while remaining loss-making. Net product sales rose to $521.3 million from $336.4 million, driven by LIVMARLI at $360.0 million and bile acid medicines at $161.3 million. For 2026, the company guides to global net product sales of $630 million to $650 million.
Total operating expenses increased to $543.4 million from $424.5 million, including $95.0 million of non-cash items, leading to a narrowed full-year net loss of $23.4 million versus $87.9 million in 2024. Unrestricted cash, cash equivalents and investments were $391.4 million as of December 31, 2025, up from $292.8 million, supported by two private placements totaling $268.5 million.
The update highlights multiple late-stage catalysts in 2026, including volixibat VISTAS topline data in PSC in Q2 2026, LIVMARLI EXPAND topline data in Q4 2026, volixibat VANTAGE enrollment completion in H2 2026, and brelovitug AZURE topline HDV data in H2 2026, alongside progress with CTEXLI and MRM-3379.
Mirum Pharmaceuticals has completed its acquisition of Bluejay Therapeutics, using a mix of cash, stock and potential future milestone payments. At closing, Mirum acquired Bluejay’s net cash of approximately $56.6 million and agreed to pay Target security holders up to $280.8 million in cash and 4,673,597 shares of Mirum common stock as upfront consideration, plus up to $25.8 million in cash and 522,375 shares as holdback consideration. The deal also includes up to $200 million in cash milestone payments tied to net sales. Following the mergers and related private placements, 59,879,958 shares of Mirum common stock were issued and outstanding as of January 23, 2026. Certain funds affiliated with Frazier Life Sciences, linked to a Mirum director and owning more than five percent of Mirum’s stock, participated as Bluejay security holders and will receive their pro rata share of the merger consideration.
Mirum Pharmaceuticals furnished a current report describing new investor information. The company issued a press release with preliminary unaudited net product sales for the year ended December 31, 2025, including sales for its liver disease medicines LIVMARLI (maralixibat), CHOLBAM and CTEXLI, along with preliminary unaudited cash, cash equivalents and investments.
Mirum also posted an updated corporate slide presentation on its website in connection with the J.P. Morgan Healthcare Conference, and furnished this presentation as an exhibit. Both the press release and the investor presentation are being furnished rather than filed, which means they are not automatically incorporated into other SEC reports unless specifically referenced.
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics through a two-step merger, adding worldwide rights to brelovitug, a late-stage antibody for chronic hepatitis D and B. At closing Mirum will pay Target security holders an upfront $250 million in cash plus up to 5,196,009 Mirum shares, valued at about $370 million based on a recent volume-weighted average price, with up to $200 million in additional cash milestones tied to future net sales. The deal is subject to antitrust clearance, Bluejay shareholder approval and other customary conditions, with closing expected in the first quarter of 2026.
To help fund the transaction, Mirum arranged a $200 million private placement, selling 2,385,149 common shares and pre-funded warrants for 536,412 shares at $68.48 per share (or $68.4799 per warrant). The brelovitug program has FDA breakthrough therapy designation and EMA PRIME status for HDV and is in a global Phase 3 AZURE program, with key interim and top-line data readouts anticipated from 2026 through 2028. Mirum also highlighted upcoming clinical catalysts across volixibat, Livmarli and MRM-3379, including planned regulatory filings and potential launches if approvals are obtained.
Mirum Pharmaceuticals, Inc. reported that it received a Paragraph IV Certification Notice Letter from Sandoz, Inc., which has filed an Abbreviated New Drug Application with the U.S. FDA seeking approval to market a generic version of Mirum’s drug Livmarli (maralixibat). Sandoz alleges that five Livmarli patents listed in the FDA Orange Book are invalid, unenforceable, or not infringed by its proposed generic. Under U.S. law, Mirum may file a patent infringement lawsuit within 45 days of receiving the notice, which would trigger an automatic 30-month stay on final FDA approval of the ANDA. Mirum states that it plans to vigorously enforce its intellectual property, promptly sue Sandoz and any other ANDA filers, and seek a permanent injunction against generic versions that would infringe its patents.
Mirum Pharmaceuticals, Inc. furnished a press release that provides a corporate update and announces its financial results for the quarter ended September 30, 2025. The press release is included as Exhibit 99.1 and is incorporated by reference into this report. The company also specifies that this information is being furnished, not filed, which limits how it is treated under securities laws and how it may be incorporated into other regulatory documents.