Workflow
Disc Medicine(IRON)
icon
Search documents
Disc Medicine Appoints Lisa Amaya Price, MBA as Chief Human Resources Officer
Globenewswire· 2026-01-12 21:30
Core Viewpoint - Disc Medicine, Inc. has appointed Lisa Amaya Price as Chief Human Resources Officer to support the company's growth and commercialization efforts in the biopharmaceutical sector [1][2]. Group 1: Appointment and Role - Lisa Amaya Price brings over 25 years of experience in human resources and organizational leadership from various commercial-stage companies [1][2]. - The company aims to build a strong, scalable organization by attracting and retaining exceptional talent, with Ms. Amaya Price playing a central role in this initiative [2]. Group 2: Ms. Amaya Price's Background - Prior to joining Disc Medicine, Ms. Amaya Price served as SVP and Chief HR Officer at Deciphera, where she led the integration into ONO Pharmaceuticals [2]. - She has held senior HR leadership positions at LGC Group, Scholar Rock, and Takeda Pharmaceuticals, where she was involved in organizational design and talent selection [2]. Group 3: Inducement Equity Award - On January 12, 2026, Disc granted Ms. Amaya Price an inducement equity award consisting of an option to purchase 37,500 shares, a restricted stock unit award for 25,000 shares, and a supplemental restricted stock unit award for 4,000 shares [3]. - The vesting schedule for the awards includes 25% vesting on January 12, 2027, with the remainder vesting in monthly installments, and the RSU awards vesting in equal installments over four years [3]. Group 4: Company Overview - Disc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for serious hematologic diseases, targeting fundamental biological pathways related to red blood cell biology [4].
Disc Medicine(IRON) - 2025 Q4 - Annual Results
2026-01-12 13:37
Financial Position - As of December 31, 2025, the preliminary unaudited cash, cash equivalents, and marketable securities of Disc Medicine, Inc. were approximately $791 million[6] - The estimate of cash and marketable securities is preliminary and subject to change upon completion of the year-end financial close process[7] - The independent registered public accounting firm has not audited or reviewed the preliminary results, indicating no assurance on the figures provided[7] - The company has no intention or obligation to update the preliminary estimate of its cash and marketable securities[7] - Additional information will be required for a complete understanding of the company's financial position and results of operations as of December 31, 2025[7] Business Objectives and Events - The company announced its recent achievements and key business objectives for 2026 on January 12, 2026[9] - Disc Medicine, Inc. will participate in the 44th Annual J.P. Morgan Healthcare Conference starting January 12, 2026, with a presentation scheduled for January 14, 2026[10] - The press release detailing the financial results and business objectives is attached as Exhibit 99.1[9] - The presentation materials for the conference are attached as Exhibit 99.2[10] Company Classification - The company is classified as an emerging growth company under the Securities Act[5]
Disc Medicine Highlights Recent Achievements and Key Business Objectives and Milestones for 2026
Globenewswire· 2026-01-12 13:30
Core Insights - Disc Medicine, Inc. is focused on developing novel treatments for serious hematologic diseases and has made significant progress in its pipeline and strategic priorities for 2026 [1][2] Summary of Key Achievements During 2025 - Bitopertin received the Commissioner's National Priority Review Voucher (CNPV) and the NDA was submitted under the accelerated approval pathway, which is currently under FDA review [5][6] - Positive initial Phase 2 data from the RALLY-MF study of DISC-0974 in anemia of myelofibrosis was reported, showing robust hematologic activity [6] - The company strengthened its balance sheet through two equity offerings, resulting in cash, cash equivalents, and marketable securities totaling $791 million as of December 31, 2025, providing financial runway into 2029 [6] Key Business Objectives and Milestones for 2026 - The company plans to launch bitopertin for EPP in the US, pending FDA approval, and continue enrollment in the global APOLLO confirmatory study with topline data expected by early 2027 [5][6] - Multiple Phase 2 updates for DISC-0974 and DISC-3405 are anticipated, including important regulatory interactions and expansion into new indications [2][5] - An End of Phase 2 meeting with the FDA regarding DISC-0974 in MF anemia is scheduled for H2 2026, along with updated data from ongoing Phase 2 studies for DISC-0974 and DISC-3405 expected in H2 2026 [5][11]
What Investors Should Know About a $511K Disc Medicine Insider Sale and a 26% Stock Run
Yahoo Finance· 2026-01-11 21:12
Company Overview - Disc Medicine, Inc. is a clinical-stage biotechnology company focused on innovative treatments for hematologic diseases, leveraging expertise in red blood cell biology, particularly in heme biosynthesis and iron homeostasis [5]. Transaction Details - The recent transaction involved the exercise and immediate sale of 6,500 shares by Rahul Khara, the chief legal officer, valued at approximately $511,472, occurring at a weighted average price of $78.69 per share [2][3]. - This sale represented 14.68% of Khara's direct holdings, reducing his ownership from 44,293 to 37,793 shares [4]. Market Context - Over the trailing year, Disc Medicine shares delivered a 26.6% return, outperforming the S&P 500's 18% gain, indicating that investors are pricing in progress in the company's pipeline [2][7]. - The transaction was part of a pre-scheduled Rule 10b5-1 plan, indicating it was an administrative move rather than a discretionary sale, which suggests confidence in the company's future [6][8]. Financial Position - As of the end of the third quarter, the company had approximately $616 million in cash, cash equivalents, and marketable securities, bolstered by a public offering in October that extended its cash runway into 2029 [6]. - Research and development spending increased significantly year over year as the company advanced multiple programs, including preparations for the potential launch of bitopertin following its NDA submission [6]. Future Outlook - The long-term investment thesis remains intact despite the insider sale, with key variables being regulatory execution and clinical data delivery expected over the next 12 to 24 months [8].
Disc Medicine to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-07 13:30
Core Insights - Disc Medicine, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for serious hematologic diseases [3] - The company will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026 [1] - A live webcast of the presentation will be available on the company's investor relations website [2] Company Overview - Disc Medicine is dedicated to discovering and commercializing novel treatments targeting red blood cell biology, specifically heme biosynthesis and iron homeostasis [3] - The company aims to build a portfolio of innovative, potentially first-in-class therapeutic candidates for a wide spectrum of hematologic diseases [3]
Disc Medicine: RALLY-MF Data Validates Pipeline Optionality
Seeking Alpha· 2026-01-05 10:37
Core Viewpoint - The bullish outlook for Disc Medicine (IRON) is attributed to its strategic positioning that alleviates the common cash constraints faced by research-stage biotech companies, allowing it to focus on promising candidates [1] Group 1: Company Analysis - Disc Medicine has structured itself to overcome the typical financial challenges that hinder research-stage biotech firms, which often have innovative candidates but lack sufficient funding [1] - The company is positioned in a high-growth sector, indicating potential for exponential expansion and substantial returns through innovation [1] Group 2: Investment Strategy - The investment approach emphasizes a combination of fundamental analysis and future trend prediction, focusing on disruptive technologies and forward-thinking enterprises [1]
Leering Partners Lifts Disc Medicine, Inc. (IRON) Following EPP Drug NDA Application
Yahoo Finance· 2025-12-11 12:44
Core Insights - Disc Medicine Inc. is recognized as a promising biotech stock by Wall Street analysts, with price target increases from multiple firms following positive developments in its drug pipeline [1][2][3] Group 1: Price Target Increases - Leerink Partners raised the price target for Disc Medicine Inc. to $115 from $110, maintaining an Outperform rating [1][2] - Raymond James also increased its price target to $117 from $108, reiterating a Strong Buy rating [3] Group 2: Drug Development and Clinical Trials - The price target hikes are attributed to the acceptance of the New Drug Application for bitopertin, an oral GlyT-1 inhibitor for erythropoietic protoporphyria (EPP) by the FDA [2] - The company reported topline interim data from the Phase 2 RALLY-MF trial in patients with myelofibrosis anemia, which has bolstered confidence in the drug's prospects [2][3] - Revenue forecasts for the company have been raised significantly to approximately $748 million from $359 million, reflecting optimism about the success of its candidate drug DISC-0974 in myelofibrosis [2] Group 3: Company Overview - Disc Medicine, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for serious hematologic diseases by targeting red blood cell biology, specifically heme production and iron balance [4]
Disc Medicine, Inc. (IRON) Discusses ASH Conference Data Updates and Portfolio Progress Including Anemia and Iron Restriction Programs Transcript
Seeking Alpha· 2025-12-07 19:33
Core Points - The conference call is hosted by John Quisel, the CEO of the company, indicating a focus on management and strategic discussions [1] Group 1 - The call is part of a management conference, suggesting an emphasis on operational updates and future direction [1] - The recording of the conference indicates that the information shared may be significant for stakeholders and investors [1]
Disc Medicine (NasdaqGM:IRON) Update / Briefing Transcript
2025-12-07 13:32
Summary of Disc Medicine Management Call - December 07, 2025 Company Overview - **Company**: Disc Medicine (NasdaqGM:IRON) - **Focus**: Development of therapies for hematologic diseases, particularly myelofibrosis (MF) and related anemias Key Updates on Products and Trials Bitopertin - **Status**: NDA accepted for review by the FDA for accelerated approval for erythropoietic protoporphyria (EPP) with a potential launch by the end of January 2026 [3][6][8] - **Review Process**: Engaged in a rigorous review process with the FDA, characterized by increased communication and collaboration [6][41] - **Commercialization**: Accelerated efforts for launch readiness, including drug supply expected by the end of January 2026 [7][8] DISC-0974 - **Indication**: Treatment for anemia of myelofibrosis (MF) - **Trial Updates**: Phase II RALLI-MF study shows significant decreases in hepcidin, leading to improved hemoglobin levels and reduced transfusion burden [4][10][12] - **Response Rates**: - Non-transfusion-dependent (NTD) group: 63% overall response, 50% major response - Transfusion-dependent (TD) low group: 71% overall response, with consistent results across different JAK inhibitors [12][14] - **Safety Profile**: Well tolerated with no treatment-related serious adverse events reported [14] DISC-3405 - **Mechanism**: Increases endogenous hepcidin production to limit iron availability, targeting conditions like polycythemia vera and sickle cell disease [21][22] - **Trial Initiation**: Phase II trials for polycythemia vera and sickle cell disease initiated, with initial data expected in 2026 [26][27] Market Opportunity - **Anemia of MF**: Affects approximately 22,000 patients in the U.S., representing a significant unmet need [17][18] - **Potential for Blockbuster Status**: DISC-0974 is positioned to address this unmet need effectively, with high response rates and the ability to work alongside existing therapies [19][18] Future Plans - **Regulatory Engagement**: Plans for an end-of-phase II meeting with the FDA for DISC-0974 to align on registrational trial design [19] - **Expansion of Trials**: Plans to initiate a phase II study in anemia of inflammatory bowel disease (IBD) and explore other anemias of inflammation [19][55] Financial and Operational Updates - **Funding**: Completed two follow-on offerings, providing a runway into 2029 without relying on revenue from bitopertin [29] - **Sales Force Preparation**: Hiring 24 sales representatives in anticipation of bitopertin's launch [90] Additional Insights - **Patient Experience**: Anecdotal reports indicate patients feel significantly better on DISC-0974, with improvements in fatigue and overall well-being [70] - **Combination Therapy Potential**: Ongoing discussions about potential combination studies with other agents to enhance efficacy [49][50] Conclusion Disc Medicine is making significant strides in the development of therapies for hematologic conditions, with promising data from ongoing trials and a clear path toward commercialization of its lead products. The company is well-positioned to address significant unmet needs in the market, particularly in the treatment of anemia associated with myelofibrosis.
Disc Medicine (NasdaqGM:IRON) Update / Briefing Transcript
2025-12-07 13:30
Summary of DISC Medicine Management Conference Call Company Overview - **Company**: DISC Medicine (NasdaqGM:IRON) - **Focus**: Development of therapies for anemia and related conditions, particularly in myelofibrosis (MF) and other hematological disorders Key Industry and Company Updates Bitopertin - **NDA Status**: The New Drug Application (NDA) for bitopertin has been accepted for review by the FDA, with a potential approval decision expected by the end of January 2026 [6][12][73] - **Commercialization Readiness**: The company is accelerating its commercialization efforts, with plans to hire 24 sales representatives across the U.S. [7][158] - **Regulatory Engagement**: The FDA is providing increased engagement and communication during the review process, which is part of the Commissioner's National Priority Voucher Program [11][73] DISC-0974 - **Rally MF Trial**: Initial data from the phase 2 Rally MF study shows significant decreases in hepcidin, leading to improved iron mobilization and clinically meaningful benefits in anemia measures such as hemoglobin levels and fatigue [8][22][27] - **Response Rates**: The overall response rate in the non-transfusion dependent (NTD) group is 63%, while the transfusion dependent low (TDLO) group shows a 50% major response rate [22][23] - **Market Opportunity**: Anemia of MF affects approximately 22,000 patients in the U.S., presenting a significant market opportunity for DISC-0974, which has shown high response rates and durability [35][37] DISC-3405 - **Mechanism of Action**: DISC-3405 aims to increase endogenous hepcidin production to limit iron availability, targeting conditions like polycythemia vera and sickle cell disease [43][45] - **Trial Updates**: The phase 2 trial for polycythemia vera has been expanded due to rapid enrollment, and initial data is expected in 2026 [9][48] Core Insights and Arguments - **Efficacy Across Background Therapies**: DISC-0974 shows consistent efficacy regardless of concomitant JAK inhibitors, indicating its potential as a versatile treatment option [26][70] - **Safety Profile**: The safety profile of DISC-0974 is consistent with background adverse events typical for the MF population, with no treatment-related serious adverse events reported [27] - **Future Development Plans**: The company plans to initiate a phase 2 study in anemia of inflammatory bowel disease (IBD) and is exploring the potential of a long-acting version of DISC-0974 [41][90] Additional Important Points - **Patient Experience**: Anecdotal reports suggest patients are experiencing significant improvements in quality of life and reduced fatigue while on DISC-0974 [118] - **Regulatory Landscape**: The acceptance of bitopertin's NDA under the accelerated approval pathway is a significant milestone, potentially paving the way for future therapies [73] - **Market Dynamics**: The company is positioning itself to address a serious unmet need in the anemia market, particularly for MF patients who currently have limited treatment options [40][41] This summary encapsulates the critical updates and insights from the DISC Medicine management conference call, highlighting the company's strategic direction and the potential impact of its therapies in the hematology space.