Welcome to our dedicated page for Eledon Pharmaceuticals news (Ticker: ELDN), a resource for investors and traders seeking the latest updates and insights on Eledon Pharmaceuticals stock.
Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN) is a clinical-stage biotechnology company dedicated to developing immune-modulating therapies for life-threatening conditions. The company's main focus lies in targeting the CD40L pathway, aiming to provide novel treatments for organ and cellular transplantation, autoimmune diseases, and neurodegenerative conditions.
At the core of Eledon's research is tegoprubart, a humanized IgG1 anti-CD40L antibody. Tegoprubart shows high affinity for CD40 Ligand (CD40L), a crucial biological target involved in generating pro-inflammatory responses in autoimmune diseases, transplant rejection, and neuroinflammation. The CD40/CD40L pathway is essential in both adaptive and innate immune responses, making it a prime target for non-lymphocyte depleting therapeutic interventions.
In 2023, Eledon achieved significant milestones, including presenting initial clinical evidence of tegoprubart's potential to prevent organ rejection while maintaining robust kidney function and a favorable safety profile. The company also played a pivotal role in the second-ever genetically modified heart transplant from a pig to a human, using tegoprubart as a key immunosuppressive component.
Looking forward to 2024, Eledon is committed to advancing its clinical programs. Key initiatives include ongoing development in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). The firm has several pivotal studies underway, including a Phase 1b trial for kidney transplantation, a long-term safety and efficacy extension study, and the Phase 2 BESTOW trial comparing tegoprubart to tacrolimus in kidney transplant patients.
Financially, Eledon reported a net loss of $40.3 million for 2023, slightly improved compared to the previous year's $88.0 million, which included a significant non-cash goodwill impairment charge. The firm's research and development expenses increased to $30.3 million, underscoring its commitment to advancing its clinical pipeline.
Eledon Pharmaceuticals is headquartered in Irvine, California, and continually seeks to build on its deep historical knowledge of anti-CD40L biology to develop groundbreaking therapies. For more information, visit www.eledon.com.
Eledon Pharmaceuticals (NASDAQ: ELDN) reported Q3 2024 financial results and business updates. Key highlights include completed enrollment of Phase 2 BESTOW trial in kidney transplantation, positive initial data from type 1 diabetes islet transplantation trial, and an $85 million oversubscribed offering. The company reported Q3 net income of $77.0 million ($1.05 per share), primarily due to a non-cash gain of $96.4 million. R&D expenses increased to $16.5 million from $7.9 million year-over-year. Cash position stands at $78.2 million, with an additional $79.5 million from October offering, expected to fund operations through end of 2026.
Eledon Pharmaceuticals (Nasdaq: ELDN) has announced its participation in the Guggenheim Securities Inaugural Healthcare Innovation Conference. CEO David-Alexandre C. Gros, M.D., will engage in a fireside chat on Wednesday, November 13, 2024, at 1:30 p.m. ET (10:30 a.m. PT). The presentation will be available via webcast, with advance registration required. A replay of the session will be accessible on the company's investor relations website following the live event.
Eledon Pharmaceuticals announced the pricing of an $85 million underwritten offering, consisting of 18,356,173 shares of common stock at $3.65 per share and pre-funded warrants for 4,931,507 shares at $3.649 with a $0.001 exercise price. The offering, expected to close around October 30, 2024, includes participation from notable investors like BVF Partners LP, RA Capital Management, and others. The proceeds will be used to advance Eledon's pipeline and for working capital. Leerink Partners is acting as sole book-running manager, with Noble Capital Markets as financial advisor.
Eledon Pharmaceuticals (NASDAQ: ELDN) reported positive initial data from a trial using tegoprubart for islet transplantation in Type 1 diabetes patients. Two out of three subjects achieved insulin independence and maintained normal glucose levels after treatment. The first two subjects showed three to five times higher islet engraftment compared to standard tacrolimus-based treatment. The first patient achieved insulin independence two weeks after a second transplant, while the second patient stopped insulin support four weeks post-transplant. The third subject reduced insulin use by over 60% three days after the procedure. The treatment was generally well tolerated with no unexpected adverse events.
Eledon Pharmaceuticals (NASDAQ: ELDN) has announced its participation in the upcoming Cantor Global Healthcare Conference. The company's CEO, David-Alexandre C. Gros, M.D., will engage in a fireside chat on Wednesday, September 18, 2024, at 8:35 a.m. ET.
Interested parties can register in advance for the webcast of the fireside chat. For those unable to attend live, a replay of the webcast will be made available on the company's website in the Events section following the session. This presentation at a major healthcare conference provides an opportunity for Eledon to showcase its developments and engage with industry professionals and investors.
Eledon Pharmaceuticals (NASDAQ: ELDN) has announced the early completion of enrollment for its Phase 2 BESTOW clinical trial, evaluating tegoprubart for preventing organ rejection in kidney transplant patients. The trial reached its target of 120 participants four months ahead of schedule, reflecting strong interest in innovative therapies. This multicenter, two-arm study compares tegoprubart to tacrolimus, with the primary objective of assessing graft function at 12 months post-transplant. Top-line results are now expected in Q4 2025.
The accelerated enrollment builds on promising results from Eledon's ongoing Phase 1b trial presented at the American Transplant Congress in June 2024. Tegoprubart aims to provide a safer alternative to calcineurin inhibitors, which often cause side effects. Eledon is conducting multiple trials to establish tegoprubart as a new standard in immunosuppression therapy for organ transplant patients.
Eledon Pharmaceuticals (Nasdaq: ELDN) reported key developments for Q2 2024. The company has enrolled 80 participants in its Phase 2 BESTOW trial, comparing tegoprubart to tacrolimus for kidney transplant rejection prevention. At the American Transplant Congress, Eledon presented updated data from 13 participants in its Phase 1b trial, showing tegoprubart's safety and efficacy. The company completed an oversubscribed $50 million private placement, extending its cash runway through December 2025.
Eledon anticipates completing BESTOW trial enrollment by end of 2024 and reporting updated interim data from Phase 1b studies by mid-2025. The company is restating financial statements due to warrant reclassification but assures this is non-cash and won't impact operations or cash position. Eledon ended Q2 with $83.6 million in cash and cash equivalents.
Eledon Pharmaceuticals (NASDAQ: ELDN) has reached a significant milestone in its Phase 2 BESTOW trial, enrolling 80 participants, which represents two-thirds of the projected recruitment for evaluating tegoprubart in preventing kidney transplant rejection. The multicenter study, comparing tegoprubart to tacrolimus, aims to enroll approximately 120 participants across the United States, Europe, and Latin America. The trial's primary objective is to assess graft function at 12 months post-transplant using estimated glomerular filtration rate (eGFR). Eledon's CEO, David-Alexandre C. Gros, M.D., expressed gratitude for the high level of interest and emphasized the urgency for innovative solutions in transplant rejection prevention. The company remains on track to complete enrollment by the end of the year.
Eledon Pharmaceuticals (Nasdaq: ELDN) will be participating in the Leerink Partners Therapeutics Forum focused on Inflammation & Immunology (I&I) and Metabolism. The event is scheduled for July 9, 2024, in Boston, MA. During the forum, Eledon's management team will engage in one-on-one meetings with investors and industry professionals. This participation highlights Eledon's active role in the field of therapeutics and its ongoing efforts to engage with key stakeholders.
Eledon Pharmaceuticals presented updated data from its ongoing Phase 1b trial of tegoprubart for preventing organ rejection in kidney transplant patients at the American Transplant Congress.
The study involved 13 participants and demonstrated a consistent mean eGFR of 70.5 mL/min/1.73m² at all reported time points post-transplant. Notably, two participants had mean eGFRs above 90 mL/min/1.73m² at 12 months post-transplant.
Tegoprubart was generally well tolerated, with no cases of hyperglycemia, new onset diabetes, or tremor, commonly seen with current calcineurin inhibitor-based treatments. Three participants discontinued the study due to adverse effects, including hair loss, viral infection, and rejection.
Eledon is also running a Phase 2 BESTOW trial with expected enrollment completion by year-end 2024.
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