– Takeda regains a majority of XOMA Royalty’s royalty interest in mezagitamab (TAK-079) –– XOMA Royalty will be entitled to payments based on a share of milestones and royalties associated with nine development-stage assets held within Takeda’s externalized assets portfolio – EMERYVILLE, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has amended its collaboration, originally established in 2006, with Takeda through a stra ...

Key Takeaways Mirum's revenues hinge on Livmarli, which generated $253.6M in the first nine months of 2025.MIRM expects continued Livmarli growth as increasing global adoption supports demand.Cholbam and Ctexli sales also rose, adding to Mirum's expanding rare-disease drug portfolio.Mirum Pharmaceuticals’ (MIRM) revenue base is largely supported by its lead product, Livmarli (maralixibat), which has been witnessing steady sales uptake since its launch. The drug remains a key top-line driver for the company. ...

Core Insights - Mirum Pharmaceuticals Inc. is identified as a high short interest stock with significant investment potential, particularly following the acquisition of Bluejay and the addition of the drug brelovitug to its pipeline [1][3] - The company reported a strong Q3 2025 earnings performance, with quarterly revenue reaching $133 million, reflecting a ~50% year-over-year increase and a positive net income of ~$3 million [2][3] Financial Performance - Q3 2025 revenue totaled $133 million, marking a ~50% increase year-over-year [2] - The primary revenue driver was product sales, with LIVMARLI net product sales at $92 million, including $64 million from the US and $28 million from international sales [2] - Additional sales from Bile Acid Medicines contributed $41 million to net product sales [2] Strategic Developments - Morgan Stanley raised the price target for Mirum Pharmaceuticals to $95 from $81, citing the strategic significance of the Bluejay acquisition and the promising potential of brelovitug in treating hepatitis delta virus [1][3] - The acquisition is expected to enhance the company's rare liver disease pipeline and create valuable synergies [1] Market Challenges - Despite strong performance, the company faces commercial variability, particularly with international sales of LIVMARLI due to large periodic orders from distributors [3] - Management anticipates a sequential decline in revenue for Q4 and does not expect additional sales to its partner, Takeda, in Japan during that quarter [3] - There is ongoing uncertainty regarding the pricing strategy for the investigational drug volixibat as the company analyzes market dynamics [3]

Core Insights - Mirum Pharmaceuticals is a mid-cap biotech stock that has seen significant gains, with a nearly 70% increase in 2025, and is expected to perform even better in 2026 [2][3] Company Performance - The current market capitalization of Mirum Pharmaceuticals is $4 billion, with a current stock price of $69.88 and a gross margin of 79.85% [3] - Livmarli, one of Mirum's three approved products, is the primary growth driver, with sales increasing by 56% year-over-year in Q3 2025 to $92.2 million, accounting for approximately 69% of total sales [3][4] - Combined sales for Mirum's other two bile acid medicines, Cholbam and Ctexli, rose by 31% year-over-year in Q3 to $40.8 million [6] Product Approvals and Pipeline - Livmarli was first approved by the FDA in September 2021 for treating cholestatic pruritus in patients with Alagille syndrome, a rare genetic disorder [4] - In 2024, Mirum received two additional FDA approvals for Livmarli for treating Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged five years and older, and for a tablet version of Livmarli [5] - The company has two promising pipeline candidates, voloxibat and MRM-3379, which could also contribute significantly to future revenue [8][10] Future Outlook - The introduction of a tablet formulation of Livmarli is expected to enhance sales, with early indications of strong uptake [7] - Mirum anticipates that Livmarli could generate annual sales exceeding $1 billion [8] - Positive topline data from ongoing Phase 2 studies for voloxibat and MRM-3379 could serve as catalysts for further stock performance [9][10]

Core Insights - Mirum Pharmaceuticals has initiated the phase II BLOOM study for MRM-3379, a PDE4D inhibitor aimed at treating Fragile X syndrome (FXS), with the first patient enrolled [1][6] - The study will focus on safety, tolerability, and potential clinical benefits, with top-line data expected in 2027 [2][6] - FXS affects approximately 50,000 males in the U.S. and Europe, and currently, there are no approved therapies for this condition [2] Company Developments - MRM-3379 has shown promise in improving cognitive and behavioral symptoms associated with FXS in preclinical studies, indicating a potential novel treatment approach [3] - Mirum's lead product, Livmarli, is approved for treating cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis, generating significant revenue [7][8] - Livmarli's net product sales reached $253.6 million in the first nine months of 2025, reflecting a 70% year-over-year increase [8] Pipeline Progress - Mirum is advancing other products, including Cholbam capsules and Ctexli tablets, which are also approved for rare diseases, contributing to revenue growth [9] - The lead pipeline candidate, volixibat, is undergoing evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis, with top-line data expected in 2026 [9][10] Market Performance - Year-to-date, Mirum's shares have increased by 69.3%, outperforming the industry average rise of 20.3% [4]

Core Insights - Mirum Pharmaceuticals reported earnings of 5 cents per share for Q3 2025, surpassing the Zacks Consensus Estimate of a loss of 10 cents, and improved from a loss of 30 cents per share in the same quarter last year [1][8] - Revenues for Q3 reached $133 million, a year-over-year increase of 47.1%, exceeding the Zacks Consensus Estimate of $132 million, driven by strong sales of Livmarli and bile acid products [2][8] Financial Performance - Livmarli's net product sales were $92 million in Q3, reflecting a 56% increase year over year, with U.S. sales at $64 million and international sales at $28 million [6][8] - Net product sales of bile acid products, including Cholbam and Ctexli, totaled $40.8 million in Q3, marking a 31% year-over-year increase [9] - Research and development expenses rose by 35.6% year over year to $43 million, while selling, general, and administrative expenses increased by 22.6% to $61.9 million [9] Guidance and Outlook - The company tightened its 2025 revenue guidance to a range of $500-$510 million, up from the previous range of $490-$510 million, with the Zacks Consensus Estimate currently at $508.9 million [11] Product Developments - Livmarli is approved for treating cholestatic pruritus in patients with Alagille syndrome and certain patients with progressive familial intrahepatic cholestasis [3] - A new tablet formulation of Livmarli was launched in the U.S. in June 2025, aimed at providing convenience for older patients [4] - Mirum acquired Travere Therapeutics' bile acid products in August 2023, enhancing its portfolio with Cholbam and Ctexli [4] Pipeline Updates - Mirum is conducting a phase III EXPAND study for Livmarli in rare cholestatic conditions, with enrollment expected to complete in 2026 [12] - The lead pipeline candidate, volixibat, is under evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis [12][13] - A phase II study on the newly in-licensed PDE4D inhibitor, MRM-3379, for Fragile X syndrome has been initiated [13] Market Performance - Mirum's shares have increased by 71.7% year to date, significantly outperforming the industry average rise of 10.9% [5]

Core Insights - Mirum Pharmaceuticals' lead product, Livmarli, is the primary revenue driver for the company, significantly contributing to its top-line growth [1][3][13] Product Overview - Livmarli is an orally administered ileal bile acid transporter (IBAT) inhibitor approved for treating cholestatic pruritus in patients with Alagille syndrome (ALGS) and certain patients with progressive familial intrahepatic cholestasis (PFIC) [2] - A new tablet formulation of Livmarli was approved by the FDA earlier this year, enhancing convenience for older patients [3] Financial Performance - In the first half of 2025, Livmarli's net product sales reached $161.4 million, reflecting a 79.1% year-over-year increase [3] - Mirum has raised its revenue guidance for 2025 to a range of $490-$510 million, up from the previous estimate of $435-$450 million, due to strong sales performance [6][13] Market Dynamics - Mirum's acquisition of Travere Therapeutics' bile acid products in 2023 has diversified its revenue stream, adding Cholbam capsules and Ctexli tablets to its portfolio [5] - Competition is intensifying in the market, particularly from Albireo AB's Bylvay, which directly competes with Livmarli [8] Pipeline Developments - Mirum's lead pipeline candidate, volixibat, is currently undergoing evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis [9] Valuation and Stock Performance - Year-to-date, Mirum's shares have increased by 74.6%, outperforming the industry average of 7.4% [14] - The company's shares are trading at a premium, with a price/book ratio of 14.21 compared to the industry average of 3.35 [15] - The Zacks Consensus Estimate for 2025 loss per share has improved from 84 cents to 69 cents, with 2026 estimates shifting from a loss of 13 cents to earnings of 3 cents [16]

Core Insights - CorMedix (CRMD) and Mirum Pharmaceuticals (MIRM) are focusing on treatments for underserved medical conditions, creating niches in areas often overlooked by larger pharmaceutical companies [1] CorMedix (CRMD) - CorMedix's lead product, DefenCath, is the first FDA-approved antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in adult patients undergoing chronic hemodialysis [2] - DefenCath generated $78.8 million in net revenues in the first half of 2025, prompting CorMedix to raise its full-year revenue guidance for 2025 [6] - The company plans to expand DefenCath's label into total parenteral nutrition to increase its customer base [7] - CorMedix acquired Melinta Therapeutics for $300 million, adding seven marketed therapies and diversifying its revenue streams [8] - The acquisition of Melinta is a strategic move to mitigate competition in the CRBSI market from established players like Pfizer and Amphastar [10] - The Zacks Consensus Estimate for CorMedix's 2025 sales and EPS indicates a year-over-year increase of approximately 411% and 607%, respectively [19] Mirum Pharmaceuticals (MIRM) - Mirum's lead product, Livmarli, is approved for treating cholestatic pruritus in patients with Alagille syndrome and has generated $161.4 million in net product sales in the first half of 2025, reflecting a 79.1% year-over-year increase [3][14] - Livmarli's sales momentum is expected to continue, supported by a new tablet formulation launched in June 2025 [13] - MIRM's revenue is heavily reliant on Livmarli, making it vulnerable to regulatory setbacks and competitive pressures, particularly from Albireo's Bylvay [18][29] - Mirum's strategic acquisition of Travere Therapeutics' bile acid products has diversified its revenue stream, generating $78 million in the first half of 2025 [17] - The Zacks Consensus Estimate for Mirum's 2025 sales implies a year-over-year increase of around 51%, with a projected 61% narrowing of loss per share [19] Comparative Analysis - Year-to-date, CRMD shares have gained 39.1%, while MIRM shares have increased by 78.7%, compared to a 3.5% return for the industry [24] - MIRM's shares trade at a higher price/book (P/B) ratio of 14.35 compared to CRMD's 3.47, indicating a more expensive valuation [25] - CorMedix is viewed as a stronger investment option due to its expanding product portfolio and growth trajectory, while Mirum's reliance on Livmarli poses risks [27][31]

Summary of Mirum Pharmaceuticals FY Conference Call Company Overview - **Company**: Mirum Pharmaceuticals (NasdaqGM:MIRM) - **Industry**: Biopharmaceuticals focused on rare diseases - **Products**: Three commercialized small molecule drugs: LIVMARLI, CHOLBAM, and CHENODAL [1][2] Financial Performance - **Revenue Guidance**: Management raised revenue guidance for 2025 to a range of $490 million to $510 million, reflecting robust revenue gains in the first half of 2025 compared to 2024 [1][2] - **Cash Flow**: The company is operating cash flow positive and has a strong balance sheet [2] Product Details LIVMARLI - **Indications**: Approved for Alagille syndrome and PFIC (Progressive Familial Intrahepatic Cholestasis) [3] - **Market Growth**: The PFIC indication has shown unexpected growth, particularly in adult populations, leading to increased patient identification [4][5] - **Clinical Profile**: LIVMARLI has a differentiated clinical profile, showing benefits in pruritus, growth, and bilirubin improvements [4] CHENODAL - **Indication**: Approved for CTX (Cerebrotendinous Xanthomatosis) with seven years of orphan exclusivity [3] CHOLBAM - **Indication**: Approved for bile acid synthesis disorders [3] International Expansion - **Partnerships**: Strong performance from international business, particularly in Japan with partner Takeda, who received approvals for Alagille and PFIC [6] Clinical Pipeline EXPAND Trial - **Objective**: Expanding the label of LIVMARLI to include additional settings of cholestatic pruritus, targeting at least 500 pediatric patients in the U.S. [7][8] VISTA Study - **Indication**: Evaluating volixibat for PSC (Primary Sclerosing Cholangitis) with an expected top-line readout in Q2 of the following year [9][10] - **Market Size**: Approximately 30,000 patients in the U.S., with a significant unmet need for effective treatments [9][10] AVANTAGE Study - **Indication**: Evaluating volixibat for PBC (Primary Biliary Cholangitis) with positive interim data showing significant improvements in pruritus and fatigue [17][18] MRM-3379 - **Indication**: Targeting Fragile X syndrome, a genetic mutation leading to autism spectrum disorder, with a market opportunity of around 25,000 patients in the U.S. [22][23] - **Phase 2 Study**: Expected to start in Q4 of the current year, focusing on different age groups [25] Competitive Landscape - **Volixibat Positioning**: Positioned as a first-line treatment option for pruritus in PBC, differentiating from existing therapies that primarily target second-line settings [20][21] Future Outlook - **Clinical and Commercial Catalysts**: Continued growth of all three medicines, initiation of Phase 2 in Fragile X, and upcoming data readouts for PSC and PBC expected in 2026 [27] - **Portfolio Expansion**: The company is actively looking for opportunities in the rare disease space, focusing on adding value and ensuring alignment with current capabilities [28][29]

Core Insights - Mirum Pharmaceuticals reported a narrower loss of $0.12 per share for Q2 2025, compared to a loss of $0.52 per share in the same quarter last year, and better than the Zacks Consensus Estimate of a loss of $0.31 per share [1][8] - Revenues for Q2 2025 reached $127.8 million, reflecting a year-over-year increase of 64.1%, surpassing the Zacks Consensus Estimate of $108 million, driven by strong sales of Livmarli and newly acquired bile acid products [2][8] - The company raised its revenue guidance for 2025 to a range of $490 million to $510 million, up from the previous estimate of $435 million to $450 million, due to the strong performance of Livmarli [10] Financial Performance - Livmarli's net product sales were $88.2 million in Q2 2025, marking an 87% increase year-over-year, with U.S. sales at $57 million and ex-U.S. sales at $31.2 million [7][8] - Net product sales from bile acid products, including Cholbam and Ctexli, totaled $39.6 million in Q2 2025, reflecting a 30% year-over-year increase [7] - Research and development expenses rose by nearly 41% year-over-year to $46.1 million, while selling, general, and administrative expenses increased by approximately 28.7% to $63.3 million [9] Recent Developments - Mirum is conducting a phase III EXPAND study for Livmarli to treat pruritus in rare cholestatic conditions, with enrollment expected to complete in 2026 [11] - The FDA approved a new tablet formulation of Livmarli, launched in the U.S. in June 2025, aimed at improving convenience for older patients [11] - The lead pipeline candidate, volixibat, is under evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis, with top-line data expected in Q2 2026 [12] Stock Performance - Mirum's shares increased by 8.6% in after-hours trading on August 6, 2025, following the better-than-expected results and raised revenue guidance [4] - Year-to-date, Mirum's stock has risen by 29.1%, significantly outperforming the industry average increase of 0.2% [6]