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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.
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Annexon, Inc. (Nasdaq: ANNX) outlines global registrational program for ANX007, a first-in-class C1q and classical complement inhibitor, for the treatment of patients with geographic atrophy (GA). The company has gained alignment with the U.S. Food and Drug Administration (FDA) on a Phase 3 registration program that includes using the prevention of ≥15-letter loss of best corrected visual acuity (BCVA) as the primary outcome measure. The program will initiate with ARCHER II, a global sham-controlled trial, and ARROW, a head-to-head trial using SYFOVRE® as an injection comparator, expected to initiate in mid-2024 and late 2024, respectively.
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Annexon, Inc. (ANX) reports successful Phase 1 trial results for ANX1502, a first-in-kind oral, selective small molecule inhibitor targeting the active form of C1s. The drug achieved target serum levels, demonstrated supportive impact on a key biomarker, and was generally well tolerated. The company plans to advance a tablet formulation of ANX1502 into a proof-of-concept study in patients with Cold Agglutinin Disease (CAD) in 2024.
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Annexon, Inc. (Nasdaq: ANNX) announces the granting of inducement awards to three new non-executive employees under the 2022 Employment Inducement Award Plan, with options to purchase 108,000 shares of Annexon common stock. The options have a ten-year term, an exercise price per share of $2.79, and vest over 4 years, subject to continued service through the applicable vesting dates.
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Annexon, a clinical-stage biopharmaceutical company (Nasdaq: ANNX), will have its president and CEO, Douglas Love, participate in a fireside chat during the 6th Annual Evercore ISI HealthCONx Conference on November 29, 2023. The company is developing complement-based medicines for inflammatory-related diseases. A live webcast of the event will be available on the Investors page at www.annexonbio.com, with a replay archived for 30 days.
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Annexon, Inc. (Nasdaq: ANNX) - Prioritizing ANX005 for Guillain-Barré Syndrome (GBS), ANX007 for Geographic Atrophy (GA), and First-in-Kind Complement Small Molecule, ANX1502. Third quarter 2023 financial results reported. ANX005 Phase 3 Pivotal Data in GBS On Track for First Half of 2024. ANX007 Awarded First-Ever PRIME Designation for the Treatment of GA. ANX1502 Phase 1 Data on Track for Q4 2023.
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ANNX: Annexon, Inc. to Participate in Fireside Chat at 2023 Jefferies London Healthcare Conference. Douglas Love, president and CEO, to discuss complement-based medicines for inflammatory-related diseases. Live webcast available on Annexon website.
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Annexon, Inc. has received PRIME designation from the European Medicines Agency (EMA) for its therapeutic candidate ANX007, which showed significant preservation of visual function in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Phase 2 ARCHER trial data demonstrated a durable and dose-dependent impact on visual function, including improved best corrected visual acuity (BCVA). Annexon plans to engage with regulatory authorities to design a global pivotal Phase 3 program for ANX007.
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Annexon, Inc. grants inducement to two new non-executive employees under the 2022 Employment Inducement Award Plan.
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ANX005 granted orphan drug designation by the European Medicines Agency for the treatment of GBS. Target enrollment achieved in Phase 3 pivotal study. Company on track to report pivotal data in the first half of 2024.
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Annexon, Inc. CEO to participate in fireside chat at Cantor Global Healthcare Conference
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FAQ
What is the current stock price of Annexon (ANNX)?
The current stock price of Annexon (ANNX) is $5.23 as of December 20, 2024.
What is the market cap of Annexon (ANNX)?
The market cap of Annexon (ANNX) is approximately 553.2M.
What does Annexon, Inc. specialize in?
Annexon, Inc. specializes in developing novel therapeutics that target complement-mediated neurodegenerative and autoimmune diseases by focusing on the classical complement pathway.
What are Annexon's main product candidates?
Annexon's main product candidates are ANX005 for Guillain-Barré Syndrome (GBS), ANX007 for geographic atrophy (GA) in the eye, and ANX1502 for autoimmune diseases.
What recent achievements has Annexon announced?
Annexon recently announced positive top-line results from its Phase 3 trial of ANX005 in GBS, showcasing significant improvements in clinical outcomes and muscle strength.
What is the financial condition of Annexon?
Annexon maintains a robust balance sheet with approximately $260 million in cash and equivalents, providing a financial runway into mid-2026. They also completed a public offering to raise additional capital.
When are the next key milestones expected for Annexon’s pipeline?
Key milestones are expected in 2024, including the initiation of Phase 3 trials for ANX007 in GA and proof-of-concept data for ANX1502 in autoimmune diseases.
What is the scientific approach of Annexon?
Annexon's scientific approach targets the C1q protein to block the activation of the classical complement pathway, aiming to stop neuroinflammation and its related diseases before they start.
What is the potential impact of ANX007 on GA patients?
ANX007 has shown the potential to preserve retinal structures and vision in patients with geographic atrophy, with Phase 3 trials set to further investigate its efficacy.
How does ANX005 work in treating GBS?
ANX005 works by inhibiting C1q to prevent complement-mediated inflammation, showing significant improvements in muscle strength and nerve damage in GBS patients.
What regulatory designations has ANX005 received?
ANX005 has received Fast Track and Orphan Drug Designations from the FDA and Orphan Drug Designation from the European Medicines Agency.
Where can I find more information about Annexon?
More information about Annexon can be found on their official website, annexonbio.com.
Annexon, Inc.
Nasdaq:ANNX
ANNX Rankings
ANNX Stock Data
553.22M
98.66M
0.5%
106.1%
7.35%
Biotechnology
Pharmaceutical Preparations
United States of America
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