Core Viewpoint - Disc Medicine, Inc. has announced an upsized underwritten offering of common stock and pre-funded warrants, aiming to raise approximately $225 million to support its clinical development and commercialization efforts for hematologic diseases [1][2]. Group 1: Offering Details - Disc is selling 2,619,049 shares of common stock at $84.00 per share and pre-funded warrants to purchase 59,523 shares at $83.9999 each, with gross proceeds expected to be around $225 million [1]. - The Selling Stockholder, AI DMI LLC, is selling 297,619 shares, expecting to raise approximately $25 million [1]. - Underwriters have a 30-day option to purchase an additional 446,428 shares at the public offering price [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for the commercialization of bitopertin for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), funding research and clinical development of current or additional product candidates, and for general corporate purposes [2]. Group 3: Underwriters - Jefferies, Leerink Partners, Morgan Stanley, and Cantor are acting as joint book-running managers for the offering, while Wedbush PacGrow and H.C. Wainwright & Co. are co-managers [3]. Group 4: Regulatory Information - The offering is made pursuant to an automatic shelf registration statement filed with the SEC, and a final prospectus supplement will be available on the SEC's website [4].

Core Insights - Disc Medicine, Inc. is focused on advancing its pipeline for serious hematologic diseases, with key developments in Erythropoietic Protoporphyria (EPP) and myeloproliferative neoplasms, including myelofibrosis (MF) and polycythemia vera (PV) [1][2] Pipeline and Development Progress - The company is accelerating the development of bitopertin for EPP, having submitted a New Drug Application (NDA) for accelerated approval and received the FDA's Commissioner's National Priority Voucher (CNPV) to expedite the review process to 1-2 months [5][6] - Initial data from the Phase 2 RALLY-MF trial of DISC-0974 in anemia of MF is expected by the end of 2025, with topline data anticipated in 2026 [3][6] - DISC-3405 is being developed for PV, with data expected in 2026, and plans to initiate a Phase 2 trial for DISC-0974 in anemia of inflammatory bowel disease in 2026 [3][11] Financial Position - As of the end of Q3 2025, the company reported a strong financial position with approximately $616 million in cash, cash equivalents, and marketable securities, supporting its ongoing development efforts [5][6] Strategic Objectives - The company aims to drive enrollment in the ongoing APOLLO confirmatory trial of bitopertin in EPP to support potential approval in the US and other territories [6] - Plans include advancing DISC-0974 into late-stage clinical development for anemia of MF and exploring the role of hepcidin in additional indications [6][11]

Market Overview - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 200 points, closing up 0.48% at 46,172.36, while NASDAQ rose 0.18% to 22,605.82, and S&P 500 gained 0.29% to 6,648.25 [1] - In the commodities market, oil prices increased by 0.1% to $57.48, while gold decreased by 1% to $4,262.00, silver fell by 4.6% to $50.820, and copper dropped by 0.5% to $4.9735 [5] Company Performance - SLB (NYSE:SLB) reported third-quarter 2025 results that exceeded expectations, with revenue of $8.93 billion, a 4% sequential increase but a 3% year-over-year decline, narrowly beating Wall Street's estimate. Adjusted EPS was 69 cents, surpassing the 66 cents estimate, although it was down 7% sequentially and 22% year-over-year [2] - Rani Therapeutics Holdings Inc (NASDAQ:RANI) saw a significant share price increase of 316% to $1.96 following a collaboration agreement with Chugai Pharmaceutical and an oversubscribed private placement of $60.3 million [6] - Artiva Biotherapeutics Inc (NASDAQ:ARTV) shares surged 105% to $5.68 after receiving Fast Track Designation from the FDA for AlloNK, with Wedbush raising its price target from $18 to $23 [6] - Disc Medicine, Inc. (NASDAQ:IRON) shares rose by 23% to $91.82 after receiving a National Priority Voucher from the FDA, with Wedbush maintaining an Outperform rating and raising the price target from $90 to $110 [6] - UTime Ltd (NASDAQ:WTO) shares fell by 33% to $0.090 due to the pricing of a $25 million registered direct offering [6] - Standard Lithium Ltd. (NYSE:SLI) shares decreased by 25% to $4.0631 following the announcement of a previously announced underwritten public offering [6] - Omeros Corporation (NASDAQ:OMER) shares dropped 17% to $8.18 after publishing a peer-reviewed manuscript regarding survival outcomes in patients treated with narsoplimab [6] International Markets - European shares declined, with the eurozone's STOXX 600 falling 0.95%, Spain's IBEX 35 Index down 0.29%, London's FTSE 100 down 0.86%, Germany's DAX 40 declining 1.82%, and France's CAC 40 slipping [6] - Asian markets closed mostly lower, with Japan's Nikkei 225 down 1.44%, Hong Kong's Hang Seng index down 2.48%, China's Shanghai Composite down 1.95%, while India's BSE Sensex rose by 0.58% [8]

Core Insights - U.S. stocks experienced a mostly positive session, with the Dow Jones index increasing by over 150 points on Friday [1] Company Highlights - Revolution Medicines Inc (NASDAQ:RVMD) saw a significant share price increase of 11.2%, reaching $55.25, after the FDA granted a non-transferrable voucher for its drug daraxonrasib under the National Priority Voucher pilot program [1] - Disc Medicine Inc (NASDAQ:IRON) shares surged by 25.7% to $93.50 following the receipt of a Commissioner's National Priority Voucher from the FDA for bitopertin [4] - Liberty Energy Inc (NYSE:LBRT) reported a 23.4% increase in share price to $14.73 after announcing third-quarter results [4] - Solana Co (NASDAQ:HSDT) shares rose by 19.5% to $12.08 [4] - Sealsq Corp (NASDAQ:LAES) experienced a 14.4% increase, reaching $7.28 [4] - Rekor Systems Inc (NASDAQ:REKR) shares gained 13.3% to $2.94 [4] - Praxis Precision Medicines Inc (NASDAQ:PRAX) saw a 12.5% increase to $183.00 after announcing a $525 million public offering [4] - Sify Technologies Ltd (NYSE:SIFY) shares rose by 11.8% to $13.15 [4] - Kenvue Inc (NYSE:KVUE) increased by 8.4% to $15.30 [4] - Propetro Holding Corp (NYSE:PUMP) surged by 7.6% to $5.52 [4] - Owens & Minor Inc (NYSE:OMI) shares gained 6.7% to $4.90 [4] - American Express Co (NYSE:AXP) reported a 6% increase in share price to $342.57, surpassing analyst estimates for revenue and adjusted earnings per share [4] - AppFolio Inc (NASDAQ:APPF) shares increased by 4.7% to $233.90, with an upgrade from Keybanc analyst Jason Celino from Sector Weight to Overweight and a new price target of $285 [4]

Disc is seeking accelerated approval of bitopertin for patients aged 12 years and older with EPPThe CNPV program is designed to reduce the drug application review process to 1-2 months WATERTOWN, Mass., Oct. 16, 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 that it received a Commissioner’s National ...

Disc is seeking accelerated approval and priority review of its NDA submissionFDA decision to accept and file the NDA for review occurs within 60 days of submission WATERTOWN, Mass., Sept. 30, 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 submission of a New Drug Application (NDA) to the U.S. Fo ...

Financial Data and Key Metrics Changes - The company is preparing to file its New Drug Application (NDA) for bitopertin in October, with a potential PDUFA date between June and October of the following year, marking a significant milestone for the company [4][5] - The company reported a P-value of less than 0.001 for the reduction in protoporphyrin-9 (PP9), indicating a clinically meaningful reduction in patients with erythropoietic protoporphyria [9][10] Business Line Data and Key Metrics Changes - The lead program, bitopertin, is in the accelerated approval pathway with the FDA, focusing on rare diseases related to red blood cell biology [4][5] - The second program is expected to present data on anemia of myelofibrosis and anemia of chronic kidney disease at upcoming conferences [5][6] Market Data and Key Metrics Changes - The company identified approximately 14,000 diagnosed patients in the U.S. for the target disease, with enrollment in trials not being a problem due to strong patient advocacy [18][23] - The company plans to leverage claims data to identify and validate physicians treating these patients, enhancing their market access strategy [23][24] Company Strategy and Development Direction - The company is focused on increasing disease awareness and ensuring that patients and physicians are informed about available therapies, as historically there have been no options for these patients [22][23] - The company aims to build a self-sustaining entity driven by revenues from bitopertin, with plans to explore additional indications within their iron modulation programs [60][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for bitopertin, citing positive interactions with the FDA regarding the use of PP9 as a surrogate endpoint [10][11] - The management highlighted the importance of continuous engagement with healthcare providers to ensure that patients receive appropriate care and treatment options [26][30] Other Important Information - The company has a strong financial position with $650 million on the balance sheet, which is expected to fund operations into 2028 [60] - The company has orphan protection for bitopertin, providing seven years of exclusivity in the U.S. plus potential pediatric extensions [36] Q&A Session Summary Question: Can you recap the interactions with the FDA regarding the accelerated approval path for bitopertin? - Management detailed a series of meetings with the FDA that led to the decision to pursue an accelerated approval pathway, emphasizing the strong rationale for using PP9 as a surrogate endpoint [10][11] Question: What are the key differences between the Apollo and Aurora trials? - Management explained that the Apollo trial will focus on measuring the time patients can spend in light, which is a clinically meaningful endpoint, alongside the reduction in PP9 levels [18][19] Question: How does the company plan to address the patient population for bitopertin? - Management discussed the importance of identifying engaged patients who regularly seek healthcare, estimating about 6,000 such patients, while also planning to reach out to the remaining diagnosed but less engaged patients [26][27] Question: What is the expected market opportunity for the company's anemia treatments? - Management indicated that there is a significant unmet need for anemia treatments in myelofibrosis, with an estimated market of about 22,000 patients, and potential pricing similar to existing therapies [42][44] Question: How does the company view its capital position and future financing needs? - Management expressed confidence in their capital position, indicating that they are well-funded to support ongoing trials and commercial preparations without immediate need for additional equity financing [60][61]

Financial Data and Key Metrics Changes - The company is preparing to file its New Drug Application (NDA) for bitopertin in October, with a potential PDUFA date between June and October of the following year, marking a significant milestone for the company [4][5] - The company reported a strong reduction in protoporphyrin-9 (PP9) levels with a P-value of less than 0.001, indicating clinically meaningful results from its phase 2 studies [9][10] Business Line Data and Key Metrics Changes - The lead program, bitopertin, is focused on treating erythropoietic protoporphyria, with the company ramping up efforts for its launch [4][5] - The second program is expected to present data on anemia of myelofibrosis and anemia of chronic kidney disease at upcoming conferences [5][6] Market Data and Key Metrics Changes - The company identified approximately 14,000 diagnosed patients in the U.S. for its lead indication, with enrollment in trials not being a problem due to strong patient advocacy [19][24] - The company plans to target the European and Japanese markets, with the genetic prevalence in Japan estimated to be four times higher than in the U.S. [39] Company Strategy and Development Direction - The company is focused on raising disease awareness and ensuring that patients and physicians are informed about available therapies, which is crucial given the historical lack of treatment options [23][24] - The company aims to build a self-sustaining entity driven by revenues from bitopertin to support its broader heme portfolio and explore larger indications [62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for bitopertin, highlighting positive interactions with the FDA regarding the accelerated approval process [11][12] - The company is well-funded with $650 million on the balance sheet, providing a runway into 2028 to support ongoing trials and commercial preparations [62] Other Important Information - The company has orphan protection for bitopertin, which provides seven years of exclusivity in the U.S., along with method-of-use patents extending until 2042 [37] - The safety profile of bitopertin shows that dizziness occurs in over 50% of patients initially but resolves over time, indicating a manageable side effect [35] Q&A Session Summary Question: Can you recap the interactions with the FDA regarding the accelerated approval path for bitopertin? - The company had a series of meetings with the FDA, which were responsive to the rationale for using PP9 as a surrogate endpoint, leading to the decision to submit an NDA this fall [11][12] Question: What are the key differences between the Apollo and Aurora trials? - Apollo will focus on measuring the time patients can spend in light as a co-primary endpoint, while Aurora primarily assessed the reduction in PP9 levels [18][20] Question: How does the company plan to address the patient population for bitopertin? - The company segments the patient population based on engagement with healthcare providers, identifying about 6,000 engaged patients who regularly seek care [27][28] Question: What is the expected market opportunity for the anemia treatment in myelofibrosis? - The company estimates a market of about 22,000 patients for anemia in myelofibrosis, with potential pricing similar to other anemia treatments in related indications [45] Question: How does the company view its capital position and runway? - The company is well-funded and expects its current capital to support its operations and trials through 2028, aiming to become self-sustaining through revenues from bitopertin [62]

Financial Data and Key Metrics Changes - The company is preparing to file its New Drug Application (NDA) for bitopertin in October, with a potential PDUFA date between June and October of the following year, marking a significant milestone for the company [4][5][11] - The company reported a strong reduction in protoporphyrin-9 (PP9) levels with a P-value of less than 0.001, indicating clinically meaningful results from its phase 2 studies [9][10] Business Line Data and Key Metrics Changes - The lead program, bitopertin, is focused on treating erythropoietic protoporphyria, with plans for an accelerated approval pathway [4][5] - The second program is expected to present data on anemia of myelofibrosis and anemia of chronic kidney disease at upcoming conferences [5][6] Market Data and Key Metrics Changes - The company identified approximately 14,000 diagnosed patients in the U.S. for its lead indication, with expectations for rapid enrollment in clinical trials [19] - The market for bitopertin is expected to be significant, with pricing comparisons to existing therapies like Scenesse, which is priced at $300,000 to $350,000 per year [36] Company Strategy and Development Direction - The company is focused on increasing disease awareness and ensuring that healthcare providers are informed about available therapies for rare diseases [23][24] - The company plans to leverage claims data to identify and engage with physicians who treat diagnosed patients, enhancing its commercial strategy [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for bitopertin, citing positive interactions with the FDA regarding the use of PP9 as a surrogate endpoint [11][12] - The company is well-funded with $650 million on its balance sheet, providing a runway into 2028 to support ongoing trials and commercial preparations [62] Other Important Information - The company has orphan drug designation for bitopertin, providing seven years of market exclusivity in the U.S. [37] - The company is also exploring additional indications for its iron modulation programs, indicating a broad pipeline strategy [62] Q&A Session Summary Question: Can you recap the interactions with the FDA regarding the accelerated approval path for bitopertin? - Management detailed a series of meetings with the FDA that confirmed the rationale for an accelerated approval pathway based on phase 2 data and the use of PP9 as a surrogate endpoint [11][12] Question: What are the key differences between the Apollo and Aurora trials? - The Apollo trial will focus on measuring the time patients can spend in light as a co-primary endpoint, alongside the reduction of PP9 levels [19][20] Question: How does the company plan to address the patient population for bitopertin? - The company plans to segment the patient population based on engagement with healthcare providers, identifying approximately 6,000 engaged patients and 8,000 less engaged patients [27][28] Question: What is the expected pricing strategy for bitopertin? - The company anticipates pricing in line with existing therapies for rare diseases, potentially around $300,000 to $350,000 per year [36] Question: How does the company view the competitive landscape for its anemia treatments? - Management highlighted the significant unmet need in treating anemia in myelofibrosis, positioning their drug as the only one currently in development for this indication [43][44]

Core Viewpoint - Disc Medicine, Inc. received positive feedback from the FDA regarding its planned New Drug Application (NDA) submission for bitopertin, aimed at treating Erythropoietic Protoporphyria (EPP) [1][2] Group 1: NDA Submission Details - The pre-NDA meeting confirmed alignment with the FDA on the timing and content of the NDA submission, which is scheduled for October 2025 [2] - The NDA will be submitted under the FDA's accelerated approval pathway based on existing data [2] Group 2: About Bitopertin - Bitopertin is an investigational, orally administered inhibitor of glycine transporter 1 (GlyT1), designed to modulate heme biosynthesis [3] - It has potential as a first disease-modifying therapy for various hematologic diseases, including EPP [3] - Bitopertin has undergone multiple clinical trials, including the Phase 2 BEACON trial and the Phase 2 AURORA trial [3] Group 3: About Erythropoietic Protoporphyria (EPP) - EPP is a rare and potentially life-threatening disease caused by mutations affecting heme biosynthesis, leading to the accumulation of protoporphyrin IX (PPIX) [5] - Symptoms include severe pain and complications such as gallstones and liver damage, with current treatment options being limited [5] - There is currently only one FDA-approved therapy for EPP, Scenesse® (afamelanotide) [5] Group 4: About Disc Medicine - Disc Medicine is focused on discovering and developing novel treatments for serious hematologic diseases, targeting heme biosynthesis and iron homeostasis [6] - The company aims to build a portfolio of innovative therapeutic candidates to address a wide spectrum of hematologic diseases [6]