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Annexon, Inc. (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company that focuses on developing novel therapeutics aimed at treating complement-mediated neurodegenerative and autoimmune diseases. The company's unique scientific approach targets C1q, the initiating molecule of the classical complement pathway, to halt the inflammatory cascade before it starts, providing significant potential benefits across a range of diseases affecting the body, brain, and eye.
Annexon’s primary product candidates include:
- ANX005: A monoclonal antibody designed to block C1q, currently in pivotal Phase 3 trials for Guillain-Barré Syndrome (GBS) and showing promising results in reducing muscle strength loss and nerve damage.
- ANX007: An antigen-binding fragment aimed at treating geographic atrophy (GA) in the eye, demonstrating notable protection against vision loss and retinal damage in Phase 2 trials.
- ANX1502: An oral small molecule inhibitor targeting autoimmune diseases, expected to generate proof-of-concept data in the second half of 2024.
In recent developments, Annexon announced positive top-line results from their Phase 3 trial of ANX005 in GBS, showing significant improvements in clinical outcomes and muscle strength. This trial marks a major milestone as ANX005 could become the first targeted treatment for GBS in the U.S. The company also showcased ANX007's potential in preserving retinal structures and vision in GA patients, with Phase 3 trials set to commence in 2024.
Financially, Annexon maintains a robust balance sheet with approximately $260 million in cash and equivalents, providing a runway into mid-2026. The company recently completed a public offering to raise additional capital, further strengthening its financial position to advance its clinical programs.
Annexon continues to advance its pipeline rigorously, with multiple upcoming milestones that have the potential to generate substantial value for patients and shareholders alike.
Annexon, Inc. (Nasdaq: ANNX) announced its participation in the Bank of America Securities 2021 Virtual Healthcare Conference on May 12, 2021, at 11:45 am EDT. Douglas Love, President & CEO, will present live at the event. Investors can access the live webcast through the ‘Events & Presentations’ section on Annexon's website, and a replay will be available for 30 days post-event. The company is focused on developing novel therapies for classical complement-mediated autoimmune and neurodegenerative disorders, utilizing a biomarker-driven strategy to enhance treatment efficacy.
Annexon, Inc. reported strong progress in its clinical pipeline during Q4 and full-year 2020. Their lead candidate, ANX005, showed positive results in a DDI study for Guillain-Barré Syndrome, with full C1q target engagement and improved patient outcomes. The company has a robust cash position of $351.2 million. However, R&D expenses surged to $49.3 million, and net losses increased to $63.4 million for the full year, up from $37.2 million in 2019.
Annexon (Nasdaq: ANNX) has initiated patient dosing in its Phase 2 ARCHER clinical trial to evaluate ANX007 for treating Geographic Atrophy (GA), a leading cause of blindness. Currently lacking approved treatments, GA affects over five million people globally. ANX007 aims to inhibit the classical complement pathway, potentially halting immune responses that damage retinal cells. The multicenter trial will assess the therapy's efficacy and safety in patients with GA, following promising Phase 1 results showing full C1q inhibition and good tolerance.
Annexon appoints Thomas G. Wiggans as Chairman
On February 8, 2021, Annexon (Nasdaq: ANNX) announced the appointment of Thomas G. Wiggans as its new Chairman. This change follows the retirement of William Young and Carol Gallagher from the board. The company also welcomed Dr. William H. Carson to the board, who has extensive experience in CNS disorders from his previous role as president and CEO at Otsuka Pharmaceutical. Both appointments aim to enhance Annexon's strategic direction as it advances its clinical-stage C1q inhibitors.
Annexon, Inc. (Nasdaq: ANNX) presented at the J.P. Morgan 39th Annual Healthcare Conference, highlighting its achievements and 2021 milestones. The company initiated multiple clinical trials in 2020, including Phase 2/3 trials for ANX005 in Guillain-Barre Syndrome and Huntington’s Disease. Annexon secured $262.7 million from an IPO and is focused on complement-mediated disorders. Key 2021 goals include new clinical trials and data releases for its investigational monoclonal antibodies. CEO Douglas Love emphasized a strong capital position and leadership for future growth.
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical firm focused on autoimmune and neurodegenerative disorders, announced a corporate update presentation at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 4:30 PM ET. The event will be accessible via a live webcast on their Investors page, with a replay available for 30 days post-event. Annexon is developing innovative therapies based on its technology targeting classical complement-mediated disorders, employing a biomarker-driven strategy to enhance patient identification and treatment response evaluation.
Annexon, Inc. (Nasdaq: ANNX) has initiated patient dosing in a Phase 2/3 clinical study evaluating ANX005, a monoclonal antibody targeting Guillain-Barré Syndrome (GBS), a severe autoimmune disorder. With no approved treatments currently available in the U.S., ANX005 has been granted Fast Track and Orphan Drug designations. The trial aims to assess ANX005's efficacy in improving patient disability. Previous trials show promising results with significant biomarker reductions. The company continues to explore additional applications for ANX005 in complement-mediated autoimmune diseases.
Annexon reported third quarter 2020 results on November 16, showcasing a cash balance of $370.7 million as of September 30, 2020, bolstered by a successful IPO. The company has initiated a Phase 2 trial for ANX005 in Huntington’s Disease and completed enrollment in a Phase 1b trial for Guillain-Barré Syndrome (GBS). R&D expenses increased to $11.8 million and net loss widened to $15.6 million. The company is well-capitalized to advance several crucial clinical trials targeting complement-mediated diseases.
Annexon has initiated a Phase 2 study for its monoclonal antibody ANX005, targeting Huntington's Disease (HD). The trial aims to dose 24 patients and assess safety, tolerability, and biomarkers related to neurodegeneration. ANX005 works by inhibiting C1q, a protein implicated in synapse loss and neuroinflammation. The company, focused on complement-mediated disorders, anticipates initial trial results in H2 2021. It has previously received fast track and orphan drug designations for ANX005 in Guillain-Barré Syndrome.
Annexon has reported its second quarter 2020 financial results, highlighting a completed $263 million IPO in July and a private financing round in June that raised $96.8 million. The company is set to initiate four new clinical trials by year-end, including trials for ANX005 in expanded indications. As of June 30, 2020, cash and cash equivalents reached $124.8 million, a significant increase from $43.9 million at the end of 2019. However, net loss for the quarter amounted to $12.5 million, higher than the previous year's loss of $9.7 million.