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Disc Medicine Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Newsfilter· 2025-02-27 13:00
Core Insights - Disc Medicine, Inc. reported significant progress in 2024, particularly with the potential accelerated approval for bitopertin based on Phase 2 results in erythropoietic protoporphyria (EPP) patients [2][5] - The company plans to initiate the APOLLO trial in mid-2025 and submit a New Drug Application (NDA) in the second half of 2025 [2][5] - Positive clinical data was reported across the company's portfolio, including for DISC-0974 in anemias of myelofibrosis (MF) and non-dialysis-dependent chronic kidney disease (NDD-CKD) [2][5] Recent Highlights and Anticipated Milestones - Bitopertin is positioned for NDA submission in EPP through an accelerated approval pathway, with the APOLLO trial set to begin by mid-2025 [5][6] - Positive updates from Phase 1b trials of DISC-0974 in MF and NDD-CKD were presented, with initial data from ongoing studies expected in H2 2025 [5][6] - The company also plans to initiate a Phase 2 study for DISC-3405 in polycythemia vera (PV) in H1 2025 [5][6] Financial Overview - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $489.9 million, an increase from $360.4 million in 2023 [10][19] - Research and development expenses rose to $96.7 million in 2024 from $69.3 million in 2023, reflecting advancements in clinical studies and increased headcount [10][17] - The net loss for 2024 was $109.4 million, compared to $76.4 million in 2023, primarily due to higher operating costs [10][18]
Disc Medicine, Inc. (IRON) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now
ZACKS· 2025-02-12 15:55
Core Viewpoint - Disc Medicine, Inc. (IRON) has shown a downtrend recently, losing 6.5% over the past four weeks, but a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with reduced selling pressure, suggesting a bullish outlook for the stock [2][4]. - A hammer pattern forms when there is a small difference between opening and closing prices, with a long lower wick, indicating that the stock found support after hitting a new low during a downtrend [3][4]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [4]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for IRON, which is a bullish indicator, as it typically leads to price appreciation [6]. - Over the last 30 days, the consensus EPS estimate for the current year has increased by 2.6%, indicating that analysts expect better earnings than previously predicted [7]. - IRON currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically outperform the market [8].
Disc Medicine Announces Pricing of $225.5 Million Upsized Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-01-23 02:35
Core Viewpoint - Disc Medicine, Inc. has announced an upsized underwritten offering of common stock and pre-funded warrants, aiming to raise approximately $225.5 million to fund research and clinical development of its product candidates and for general corporate purposes [1][2]. Group 1: Offering Details - Disc is selling 3,918,182 shares of common stock at an offering price of $55.00 per share and pre-funded warrants to purchase 181,818 shares at $54.9999 each [1]. - The total gross proceeds from the offering are expected to be around $225.5 million, before deducting underwriting discounts and commissions [1]. - Underwriters have a 30-day option to purchase up to an additional $33.825 million of shares at the public offering price [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund research and clinical development of current or additional product candidates, support commercialization of bitopertin for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), and for working capital and other general corporate purposes [2]. Group 3: Underwriters - Jefferies, Leerink Partners, Stifel, and Cantor are acting as joint book-running managers for the offering, while BMO Capital Markets, LifeSci Capital, Wedbush PacGrow, and H.C. Wainwright & Co. are co-managers [3]. Group 4: Company Overview - Disc Medicine is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel treatments for serious hematologic diseases, targeting fundamental biological pathways of red blood cell biology [6].
Disc Medicine Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
Newsfilter· 2025-01-21 21:01
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].
Disc Medicine Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-01-21 21:01
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].
Disc Medicine Announces Successful Type C Meeting with FDA for Bitopertin in Erythropoietic Protoporphyria (EPP) and Shares Plans for NDA Submission
Globenewswire· 2025-01-21 12:45
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]
Disc Medicine to Host Conference Call on Type C Meeting for Bitopertin in Erythropoietic Protoporphyria (EPP)
Newsfilter· 2025-01-21 00:00
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].
Disc Medicine Reports Inducement Grant under Nasdaq Listing Rule 5635(C)(4)
Newsfilter· 2025-01-17 21:00
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 ...
Disc Medicine Highlights Recent Achievements Across Hematology Portfolio and Key Business Objectives and Milestones for 2025
Globenewswire· 2025-01-10 14:00
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 ...
Disc Medicine Secures $200 Million in Non-Dilutive Debt Financing from Hercules Capital, Inc.
GlobeNewswire News Room· 2024-11-08 13:30
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 ...