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Gilead Strengthens Inflammation Portfolio With Ouro Medicines Deal
ZACKS· 2026-03-24 20:07
Core Insights - Gilead Sciences (GILD) has agreed to acquire Ouro Medicines for $1.675 billion upfront, with potential additional milestone payments of up to $500 million, to enhance its portfolio in innovative therapies for autoimmune diseases [1][2][9] - The acquisition includes OM336, a bispecific T-cell engager that shows promise in treating severe autoimmune conditions, and is expected to enter registrational studies by 2027 [4][9] - Gilead is also in advanced discussions with Galapagos (GLPG) for a strategic collaboration to co-develop OM336, sharing development costs and royalties [6][7][8] Acquisition Details - The acquisition price is set at $1.675 billion upfront, with an additional $500 million contingent on achieving certain milestones [2][9] - The deal is subject to regulatory approvals and customary closing conditions [2] Product Insights - OM336 is currently under an active investigational new drug (IND) application in the United States and has shown promising early phase I/II data in treating autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP) [3][4] - The drug has received Fast Track and Orphan Drug designations in the U.S. for AIHA and ITP, indicating its potential significance in the market [4] Strategic Collaboration - Gilead plans to collaborate with Galapagos, where Galapagos would fund 50% of the upfront and milestone payments and take on the majority of Ouro's operating assets [6][7] - Both companies will share development costs equally after the start of registrational studies, while Gilead retains exclusive global commercialization rights, excluding Greater China [7][8] Market Positioning - Gilead aims to diversify its revenue base and strengthen its oncology franchise, having seen a 28.1% increase in shares over the past year compared to the industry growth of 9.4% [10] - The acquisition of Ouro Medicines aligns with Gilead's strategy to expand into next-generation immunology treatments, particularly T-cell engager platforms [3][10]
Eledon Pharmaceuticals to Participate in Leerink Partners 2026 Global Healthcare Conference
Globenewswire· 2026-03-04 21:05
Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [3] - The lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, which has broad therapeutic potential [3] - Eledon is conducting preclinical and clinical studies in areas such as kidney allograft transplantation, xenotransplantation, islet cell transplantation, and amyotrophic lateral sclerosis (ALS) [3] Upcoming Events - David-Alexandre C. Gros, M.D., CEO, and Steven Perrin, Ph.D., President and CSO, will participate in a fireside chat at the Leerink Partners 2026 Global Healthcare Conference on March 11, 2026, at 1:40 p.m. ET [1] - A webcast replay of the session will be available on the company's website under Events [2]
Eledon Pharmaceuticals to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-05 21:10
Core Viewpoint - Eledon Pharmaceuticals is actively participating in the biotech sector, showcasing its leadership through a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026, highlighting its commitment to advancing immune-modulating therapies [1]. Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [3]. - The company's lead investigational product is tegoprubart, an anti-CD40L antibody that targets the CD40 Ligand, which has significant therapeutic potential [3]. - Eledon is conducting preclinical and clinical studies in various areas, including kidney allograft transplantation, xenotransplantation, islet cell transplantation, and amyotrophic lateral sclerosis (ALS) [3]. - The company is headquartered in Irvine, California, and more information can be found on its website [3].
Eledon Pharmaceuticals Presents Long-Term Phase 1b Data for Tegoprubart in Kidney Transplant Patients at the American Society of Transplant Surgeons Winter Symposium
Globenewswire· 2026-01-23 12:00
Core Insights - Eledon Pharmaceuticals announced positive 24-month follow-up data from a Phase 1b trial of tegoprubart in kidney transplantation, showing an increase in mean estimated glomerular filtration rate (eGFR) from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months [1][2] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions, with its lead product being tegoprubart, an anti-CD40L antibody [3] - The company aims to leverage its expertise in anti-CD40 Ligand biology to conduct studies in various transplantation fields, including kidney allograft transplantation and amyotrophic lateral sclerosis (ALS) [3]
Eledon Pharmaceuticals to Participate in the 37th Annual Piper Sandler Healthcare Conference
Globenewswire· 2025-12-01 12:00
Core Viewpoint - Eledon Pharmaceuticals is actively participating in the healthcare sector by presenting at the Piper Sandler Healthcare Conference, highlighting its commitment to engaging with investors and stakeholders [1]. Group 1: Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [2]. - The company's lead investigational product is tegoprubart, an anti-CD40L antibody that targets the CD40 Ligand, which has significant therapeutic potential [2]. - Eledon is conducting preclinical and clinical studies in areas such as kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2]. Group 2: Upcoming Events - David-Alexandre C. Gros, M.D., the CEO of Eledon, will participate in a fireside chat at the 37th Annual Piper Sandler Healthcare Conference on December 4, 2025, at 8:50 a.m. ET [1]. - A webcast replay of the fireside chat will be available on the company's website following the live session [1].
Eledon Pharmaceuticals Announces Recent Business Highlights and Third Quarter 2025 Financial Results
Globenewswire· 2025-11-14 22:00
Core Insights - Eledon Pharmaceuticals reported favorable results from the Phase 2 BESTOW trial for tegoprubart, indicating a potential new standard for kidney transplant rejection prevention [1][2] - The company strengthened its financial position with a $57.5 million financing to support its transplantation programs [1][2] Business Highlights - The Phase 2 BESTOW trial demonstrated tegoprubart's efficacy and safety, significantly reducing toxicities associated with tacrolimus [2][7] - Eledon plans to advance tegoprubart into Phase 3 development after discussions with regulators regarding study design and data requirements [7] - The company aims to address unmet needs in transplant medicine, including kidney and islet cell transplantation, as well as xenotransplantation [2] Financial Results - As of September 30, 2025, Eledon's cash, cash equivalents, and short-term investments totaled $93.4 million, down from $140.2 million at the end of 2024 [5] - Research and development expenses for Q3 2025 were $15.0 million, a decrease from $16.5 million in Q3 2024 [5] - General and administrative expenses were $4.1 million in Q3 2025, slightly up from $4.0 million in Q3 2024 [6] - The net loss for Q3 2025 was $17.5 million, compared to a net income of $77.0 million in Q3 2024, which included a non-cash gain related to warrant liabilities [8][15] Upcoming Milestones - In Q4 2025, Eledon plans to enroll the final three patients in a clinical study evaluating tegoprubart for islet cell transplantation [7] - In 2026, the company expects to receive FDA guidance on the Phase 3 trial design for kidney transplantation and initiate the trial [7] - Long-term data from the Phase 1 and Phase 2 BESTOW studies will be reported in 2026, along with data from the islet cell transplantation study [7]
Eledon Pharmaceuticals Announces Pricing of $50 Million Underwritten Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-11-12 12:56
Core Points - Eledon Pharmaceuticals announced a public offering of 15,152,485 shares of common stock at a price of $1.65 per share, along with pre-funded warrants for an additional 15,151,515 shares at $1.649 each, aiming for gross proceeds of approximately $50 million [1][2] - The offering is expected to close on or about November 13, 2025, subject to customary closing conditions [1] - The net proceeds will be used to support clinical development of product candidates and advance pipeline programs, as well as for general corporate purposes [2] Offering Details - The offering is made under a registration statement on Form S-3, previously filed with the SEC [3] - A preliminary prospectus supplement was filed with the SEC on November 12, 2025, with a final prospectus supplement to follow [3] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [5] - The lead product candidate is tegoprubart, an anti-CD40L antibody targeting CD40 Ligand, which has potential applications in kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [5]
Eledon Pharmaceuticals Announces Proposed Underwritten Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-11-11 22:26
Core Viewpoint - Eledon Pharmaceuticals has initiated an underwritten public offering of its common stock and pre-funded warrants, with the intention to use the proceeds for clinical development and general corporate purposes [1][2]. Group 1: Offering Details - The offering includes common stock and pre-funded warrants, with a 30-day option for underwriters to purchase an additional 15% of the total shares sold [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or terms [1]. Group 2: Use of Proceeds - Eledon plans to utilize the net proceeds from the offering to support the clinical development of its product candidates and advance its pipeline programs, along with general corporate purposes [2]. Group 3: Company Background - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions, with its lead product being tegoprubart, an anti-CD40L antibody [5]. - The company is conducting studies in areas such as kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [5].
Eledon Pharmaceuticals to Present Results from Phase 2 BESTOW Trial of Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology Kidney Week 2025 Annual Meeting
Globenewswire· 2025-10-17 11:00
Core Insights - Eledon Pharmaceuticals will present topline results from the Phase 2 BESTOW trial for tegoprubart at the American Society of Nephrology's Kidney Week 2025 Annual Meeting [1][2] - The oral presentation is scheduled for November 6, 2025, focusing on the efficacy and safety of tegoprubart in preventing rejection in kidney transplantation [2] - A conference call to discuss the trial results will be held on November 7, 2025, at 8:00 a.m. ET [3] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company developing immune-modulating therapies for life-threatening conditions [4] - The lead investigational product, tegoprubart, is an anti-CD40L antibody targeting CD40 Ligand, which has significant therapeutic potential [4] - The company is conducting studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [4]
Eledon Pharmaceuticals to Present at the 18th Congress of the International Xenotransplantation Association
Globenewswire· 2025-09-24 20:05
Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [2] - The company's lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, which has broad therapeutic potential [2] - Eledon is conducting preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2] Upcoming Event - Steve Perrin, Ph.D., President and Chief Scientific Officer of Eledon, will participate in a plenary session at the 18 Congress of the International Xenotransplantation Association (IXA) from September 30–October 3, 2025, in Geneva, Switzerland [1] - The plenary session will focus on immunosuppression, immune monitoring, and anti-CD154 pathway blockade, with a specific lecture titled "201.2 Anti-CD154 Pathway Blockade" scheduled for October 1, 2025, from 10:30 a.m. to 12:00 p.m. CET [1]