Core Viewpoint - Disc Medicine, Inc. has initiated an underwritten offering of $200 million in common stock, with an additional option for underwriters to purchase up to $30 million more, aimed at funding research and clinical development for hematologic diseases [1][2]. Group 1: Offering Details - The offering consists of $200 million in common stock and pre-funded warrants for certain investors [1]. - Underwriters have a 30-day option to purchase an additional $30 million in shares at the public offering price [1]. - The offering is subject to market conditions and there is no assurance regarding its completion or terms [1]. Group 2: Use of Proceeds - Net proceeds from the offering will be used for research and clinical development of product candidates, including bitopertin for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) [2]. - Funds will also support working capital and other general corporate purposes [2]. Group 3: Company Overview - Disc Medicine is a clinical-stage biopharmaceutical company focused on developing treatments for serious hematologic diseases [5]. - The company aims to create innovative therapeutic candidates targeting red blood cell biology, specifically heme biosynthesis and iron homeostasis [5].

Core Viewpoint - Disc Medicine, Inc. received positive feedback from the FDA regarding the APOLLO post-marketing confirmatory trial for bitopertin in Erythropoietic Protoporphyria (EPP), marking progress towards potential accelerated approval and eventual full approval of the therapy [1][2][5] Group 1: FDA Interaction and Trial Plans - The FDA interaction is seen as a significant step towards providing a life-altering therapy for EPP patients, with plans to submit a New Drug Application (NDA) in the second half of 2025 [2][5] - The APOLLO trial is set to begin by mid-2025, with sites planned in the US, Canada, Europe, and Australia, and is expected to be well underway by the time of potential accelerated approval [3][5] - The Type C meeting clarified the design of the APOLLO trial, aligning on co-primary endpoints including average monthly time in light without pain and percent change in whole-blood metal-free protoporphyrin IX (PPIX) after six months of treatment [5][6] Group 2: Bitopertin Overview - Bitopertin is an investigational, orally administered inhibitor of glycine transporter 1 (GlyT1), aimed at modulating heme biosynthesis and potentially serving as the first disease-modifying therapy for hematologic diseases [4][8] - The drug has undergone multiple clinical trials, including the Phase 2 BEACON and AURORA trials, focusing on its efficacy in treating EPP [4][5] Group 3: Erythropoietic Protoporphyria (EPP) Context - EPP is a rare and debilitating disease caused by mutations affecting heme biosynthesis, leading to severe reactions to sunlight and significant impacts on patients' quality of life [8][9] - Current treatment options are limited, with only one FDA-approved therapy available, highlighting the need for new therapeutic options like bitopertin [8][9]

Core Viewpoint - Disc Medicine, Inc. is preparing to discuss feedback from the FDA regarding its investigational drug bitopertin for treating erythropoietic protoporphyria (EPP) in a conference call scheduled for January 21, 2025 [1]. Company Overview - Disc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for serious hematologic diseases, aiming to create first-in-class therapeutic candidates targeting heme biosynthesis and iron homeostasis [6]. Product Information - Bitopertin is an investigational, orally administered inhibitor of glycine transporter 1 (GlyT1), designed to modulate heme biosynthesis and support erythropoiesis [3]. - The drug is being developed as a potential treatment for various hematologic diseases, including EPP, and has undergone multiple clinical trials, including the Phase 2 BEACON trial and the Phase 2 AURORA trial [3][4]. Disease Context - Erythropoietic protoporphyria (EPP) is a rare and debilitating disease caused by mutations affecting heme biosynthesis, leading to severe reactions to sunlight and potential liver complications [5]. - Current treatment options are limited, with only one FDA-approved therapy available, highlighting the significant unmet medical need in this area [5].

WATERTOWN, Mass., Jan. 17, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the grant of an inducement equity award to a new employee, effective January 16, 2025. The inducement award is comprised of (i) an option to purchase 35,000 shares of Disc's common stock, at an exercise price equal to the closi ...

In Q1 2025, the Company will discuss the plans for NDA submission under a potential accelerated approval path for bitopertin in erythropoietic protoporphyria (EPP), following a Type C meeting with FDA on confirmatory study designInitial data from an ongoing phase 2 study of DISC-0974 (anti-hemojuvelin antibody) in anemia of myelofibrosis (MF) expected H2 2025 Data from higher doses and multiple dose cohorts of a phase 1b study of DISC-0974 in anemia of chronic kidney disease (CKD) expected H2 2025Initiation ...

Facility significantly increases future financial and operational flexibilityUp to $200M available, with $30 million drawn at close and additional $80 million available at Disc’s sole discretion through second-half 2026Funding can support development across the portfolio, including the recently announced potential accelerated approval pathway for bitopertin in EPP WATERTOWN, Mass., Nov. 08, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the ...

WATERTOWN, Mass., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today presented positive additional data from an ongoing Phase 1b study of DISC-0974 in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and anemia, including results from the 40 mg and 60 mg single ascending dose (SAD) co ...

Core Insights - Disc Medicine, Inc. is set to present clinical data on DISC-0974 at the 2024 ASN Kidney Week, focusing on its Phase 1b study in patients with non-dialysis dependent chronic kidney disease and anemia [1][2] - The study aims to evaluate safety and changes in hepcidin, iron levels, and hematologic parameters [1][2] Presentation Details - The presentation will include data from the 40mg and 60mg dose cohorts, covering safety, pharmacokinetics, and effects on hepcidin and anemia [2][3] - The abstract for the presentation is available on the ASN Kidney Week conference website [2] Company Overview - Disc Medicine is a clinical-stage biopharmaceutical company dedicated to developing novel treatments for serious hematologic diseases, focusing on red blood cell biology and iron homeostasis [4]

Core Insights - Disc Medicine, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for serious hematologic diseases [3] - The company will participate in four upcoming investor conferences in September 2024 [1] Conference Participation - The company will present at the 2024 Wells Fargo Securities Healthcare Conference on September 6th at 10:15 a.m. ET [1] - The Morgan Stanley 22nd Annual Global Healthcare Conference will also feature the company on September 6th at 1:05 p.m. ET [1] - The H.C. Wainwright 26th Annual Global Investment Conference is scheduled for September 11th at 9:30 a.m. ET [1] - The 2024 Cantor Global Healthcare Conference will take place on September 19th at 8:00 a.m. ET [1] Webcast Information - A live webcast of the fireside chats will be available on the company's investor relations website, with an archived replay accessible after the events [2]

Company Overview - MoneyThumb is a leader in automated document evaluation and fraud detection solutions, founded in 2014, and specializes in underwriting automation software that enhances workflows for funders, lenders, and accountants by converting and analyzing PDF financial documents in seconds [3][6] - The company has developed an AI file tampering detection tool that identifies fraudulent activity quickly, providing lenders with a robust defense against risk and loan losses [3][6] Acquisition Details - MoneyThumb has been acquired by Iron Creek Partners LLC, a private investment firm focused on software, data, communications, and business services industries, with the transaction closing on August 19, 2024 [1][4] - The acquisition is expected to provide growth capital to meet MoneyThumb's strong industry demand, which has resulted in 100% year-over-year growth [1][4] Leadership Changes - Ryan Campbell, who has been with MoneyThumb since 2017, has been appointed as the new CEO and will join the investor group, while founder Ralph Mayer will transition to an advisory role and retain his board seat [2] Strategic Goals - The acquisition is seen as a milestone for MoneyThumb, with plans to accelerate growth and continue delivering exceptional software solutions to help lenders manage risk and provide capital to small businesses more efficiently [4] - Iron Creek Partners aims to leverage its sector experience and relationships to support MoneyThumb's growth and broaden its product suite [4][7]