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5 days ago
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Annexon Biosciences to Present at the Jefferies Global Healthcare Conference
BRISBANE, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced that Douglas Love, president and chief executive officer, will present at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025 at 8:10 a.m. EST. A live webcast of the event can be accessed under the 'Events & Presentations' section on the Investors page at A replay of the webcast will be archived on the Annexon website for 30 days following the presentation. About AnnexonAnnexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement's potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon's mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit Investor Contact:Joyce AllaireLifeSci Advisorsjallaire@ Media Contact:Sheryl SeapyReal Chemistry949-903-4750sseapy@ in to access your portfolio
Yahoo
19-05-2025
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Annexon Showcases Tanruprubart Data Demonstrating Improved Clinical Outcomes in Guillain-Barré Syndrome (GBS) at 2025 Peripheral Nerve Society (PNS) Annual Meeting
First Oral Presentation of the Tanruprubart Real-World Evidence (RWE) Study by International Guillain-Barré Syndrome Outcomes Study (IGOS) Researchers Highlights Benefits over Current Standard of Care in Matched Patient Populations Poster Presentations on New Pivotal Phase 3 Analyses Underscore Tanruprubart's Rapid and Sustained Treatment Effect and Improvement in Quality of Life Compared to Placebo BRISBANE, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today presented oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005) at the 2025 Peripheral Nerve Society (PNS) Annual Meeting being held May 17-20, 2025 in Edinburgh, UK. GBS is a neuromuscular emergency and rare autoimmune disease that affects at least 150,000 people worldwide each year, with no FDA-approved therapies. In its acute phase, GBS rapidly progresses toward severe weakness that can lead to sudden and complete paralysis, often requiring intensive care and mechanical ventilation. Tanruprubart is a first-in-kind monoclonal antibody designed to block C1q, the initiating molecule of the classical complement cascade, with a single infusion to halt ongoing neuroinflammation and nerve damage in the early phase of GBS to improve and expedite overall recovery. 'These compelling clinical results presented at PNS depict how a rapid gain in muscle strength can lead to a better state of health with a single infusion of tanruprubart in a real world setting,' said Henk-André Kroon, M.D., senior vice president of Translational Medicine at Annexon. 'Currently, outcomes for GBS patients around the world remain poor, and we are grateful to our collaborators at IGOS for conducting this prespecified analysis showing the significant improvement with tanruprubart compared to standard of care. As the potential first targeted immunotherapy in GBS, we are eager to move tanruprubart forward for patients in need, with the aim of transforming the global treatment landscape for GBS.' RWE Findings Demonstrate Benefits with Tanruprubart over Current Standard of Care in Matched Patient Populations Results of the pivotal Phase 3 trial are reinforced by a RWE study that matched tanruprubart-treated patients from the pivotal Phase 3 trial with patients predominantly from western countries included in the IGOS registry who were treated with current standard of care, intravenous immunoglobulin (IVIg) or plasma exchange (PE). In the RWE study, tanruprubart showed a rapid increase in muscle function resulting in a sustained and more complete recovery compared to IVIg or PE: By Week 1, patients treated with tanruprubart showed approximately a ten-point improvement in muscle strength over patients treated with IVIg or PE, a clinically meaningful benefit as measured by Medical Research Council (MRC) sumscore and an indicator for future recovery potential Patients treated with tanruprubart were approximately three times more likely to be in a better state of health than patients on IVIg or PE on the GBS-Disability Scale (GBS-DS) at Weeks 4, 8, and 26 New Pivotal Phase 3 Trial Analyses Reinforce the Rapid and Sustained Clinical Benefits of a Single Dose of Tanruprubart Tanruprubart 30 mg/kg halted inflammation and nerve damage resulting in clinical benefits as early as Week 1, including rapid improvements in muscle strength, mobility, balance, and coordination that were maintained through Week 26 Tanruprubart-treated patients rapidly regained the ability to move independently, do personal tasks, and return to a range of routine daily living activities Tanruprubart demonstrated a greater degree of efficacy amongst patients with disease characteristics more commonly observed in western countries, supporting the potential of tanruprubart to benefit patients worldwide Presentations are available on the publications page of the company's website. About Tanruprubart (formerly ANX005) Annexon's lead investigational therapy, tanruprubart, is a first-of-its kind selective, targeted and rapid-acting agent designed to reduce inflammation and nerve damage by stopping C1q activity in the peripheral and central nervous systems. In GBS, tanruprubart is designed to seek out C1q and prevent its binding to targets on peripheral nerves. Tanruprubart is administered intravenously and has been observed to act almost immediately in blocking C1q function. The aim of an effective treatment in GBS is to rapidly stop the autoimmune damage on nerve cells, allowing patients to regain muscle strength sooner and to regain independence and return to pre-illness activities. Tanruprubart has received both Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration as well as orphan drug designation from the European Medicines Agency for the treatment of GBS. About Guillain-Barré Syndrome (GBS)GBS is a rare neuromuscular emergency resulting from an acute autoantibody and classical complement-mediated attack on peripheral nerves that generally occurs post-infection in otherwise healthy persons. It is an acute, rapidly progressive disease with a narrow timeframe for therapeutic intervention. GBS results in the hospitalization of more than 22,000 people annually in the U.S. and Europe. In its acute phase, the peripheral nerve damage progresses rapidly, causing sudden and complete neuromuscular paralysis that can lead to significant morbidity, disability and mortality. Currently, there are no approved treatments for GBS in the U.S. The long-term disease burden associated with GBS has led to a multi-billion-dollar annual economic cost to the U.S. healthcare system alone. More information about the impact of GBS is available at About AnnexonAnnexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement's potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon's mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'contemplate,' 'continue,' 'could,' 'design,' 'due,' 'estimate,' 'expect,' 'goal,' 'intend,' 'may,' 'objective,' 'plan,' 'positioned,' 'potential,' 'predict,' 'seek,' 'should,' 'target,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the ability of tanruprubart to block C1q activity in the peripheral and central nervous systems with a single infusion; the potential therapeutic benefit of tanruprubart, if approved, compared to IVIg/plasma exchange or existing therapies; the clinical and regulatory status of tanruprubart; the planned presentation of RWE at upcoming conferences; the ability to translate the results of the RWE study to a broad population of GBS patients; the impacts of the new education campaign (Move GBS Forward™); the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company's portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company's history of net operating losses; the company's ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company's product candidates; the effects of public health crises on the company's clinical programs and business operations; the company's ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company's product candidates; the company's reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company's ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled 'Risk Factors' contained in the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company's other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce AllaireLifeSci Advisorsjallaire@ Media Contact: Sheryl SeapyReal Chemistry949-903-4750sseapy@
Yahoo
18-05-2025
- Business
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Annexon Announces Presentations on the Clinical Advancement of Tanruprubart as the First Potential Targeted Therapy for Guillain-Barré Syndrome (GBS) at the 2025 PNS Meeting
First Oral Presentation by the International Guillain-Barré Syndrome Outcomes Study (IGOS) of the Real-World Evidence (RWE) Results Showing Improved Outcomes with Tanruprubart (formerly ANX005) Compared to Current Standards of Care in Matched Patient Populations New Analyses of Phase 3 Trial Highlight Tanruprubart's Early and Durable Treatment Effect and Improvement in Quality of Life in Patients with GBS BRISBANE, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005) at the 2025 Peripheral Nerve Society (PNS) Annual Meeting at the Edinburgh International Conference Centre being held May 17-20, 2025 in Edinburgh, UK. GBS is a neuromuscular emergency and rare autoimmune disease with no FDA-approved therapies that is characterized by rapidly progressing and severe weakness that can lead to complete paralysis, often requiring intensive care and mechanical ventilation. Tanruprubart is a first-in-kind monoclonal antibody designed to block C1q, the initiating molecule of the classical complement cascade, with a single infusion to halt ongoing neuroinflammation and nerve damage in the acute phase of GBS to improve and expedite overall recovery. Oral Presentation 'Comparative Effectiveness in IGOS: ANX005 Versus Intravenous Immunoglobulin or Plasma Exchange for Guillain-Barré Syndrome' IGOS Presenter: Eveline Wiegers, M.D., Ph.D. Date/Time: Monday, May 19, from 3:55 pm to 4:10 pm British Summer Time (BST) Poster Presentations 'Linking Early Complement Inhibition to Long-Term Outcomes in GBS: Objective Measures Support Tanruprubart (ANX005) Efficacy' Presenter: Glenn Morrison, Ph.D. Date/Time: Sunday May 18, from 2:30 pm to 3:20 pm BST 'Tanruprubart (ANX005) Improves Health-related Quality of Life in Patients with Guillain-Barré Syndrome Compared to Placebo' Presenter: Glenn Morrison, Ph.D. Date/Time: Monday, May 19, from 2:10 pm to 3:10 pm BST. Poster also selected as a flash oral presentation from 5:30 pm to 5:35 pm BST. 'Efficacy of Tanruprubart (ANX005) for Treatment of Guillain-Barré Syndrome in a Broad Spectrum of Patients' Presenter: Henk-André Kroon, M.D. Date/Time: Monday May 19, from 2:10 pm to 3:10 pm BST About Tanruprubart (formerly ANX005)Annexon's lead investigational therapy, tanruprubart, is a first-of-its kind selective, targeted and rapid-acting agent designed to reduce inflammation and nerve damage by stopping C1q activity in the peripheral and central nervous systems. In GBS, tanruprubart is designed to seek out C1q and prevent its binding to targets on peripheral nerves. Tanruprubart is administered intravenously and has been observed to act almost immediately in blocking C1q function. The aim of an effective treatment in GBS is to rapidly stop the autoimmune damage on nerve cells, allowing patients to regain muscle strength sooner and to regain independence and return to pre-illness activities. Tanruprubart has received both Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration as well as orphan drug designation from the European Medicines Agency for the treatment of GBS. About Guillain-Barré Syndrome (GBS)GBS is a rare neuromuscular emergency resulting from an acute autoantibody and classical complement-mediated attack on peripheral nerves that generally occurs post-infection in otherwise healthy persons. It is an acute, rapidly progressive disease with a narrow timeframe for therapeutic intervention. GBS results in the hospitalization of more than 22,000 people annually in the U.S. and Europe. The peripheral nerve damage progresses rapidly, causing acute neuromuscular paralysis that can lead to significant morbidity, disability and mortality. Currently, there are no approved treatments for GBS in the U.S. The long-term disease burden associated with GBS has led to a multi-billion-dollar annual economic cost to the U.S. healthcare system alone. More information about the impact of GBS is available at About AnnexonAnnexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement's potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon's mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'design,' 'due,' 'estimate,' 'expect,' 'goal,' 'intend,' 'may,' 'objective,' 'plan,' 'positioned,' 'potential,' 'predict,' 'seek,' 'should,' 'suggest,' 'target,' 'on track,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, the ability of tanruprubart (formerly ANX005) to stop C1q activity in the peripheral and central nervous systems; the clinical and regulatory status of ANX005; and the potential therapeutic benefit of ANX005; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company's portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company's history of net operating losses; the company's ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company's product candidates; the effects of public health crises on the company's clinical programs and business operations; the company's ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company's product candidates; the company's reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company's ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled 'Risk Factors' contained in the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company's other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact:Joyce AllaireLifeSci Advisors, LLCjallaire@ Media Contact:Sheryl SeapyReal Chemistry949-903-4750sseapy@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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16-05-2025
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Annexon Reports Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(c)(4)
BRISBANE, Calif., May 16, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced that it has granted inducement to two new non-executive employees under the terms of the 2022 Employment Inducement Award Plan. The equity awards were approved on May 14, 2025, in accordance with Nasdaq Listing Rule 5635(c)(4). In the aggregate, the new non-executive employees received options to purchase 214,000 shares of Annexon common stock. The options carry a ten-year term and an exercise price per share equal to $1.81, which was the closing price of Annexon's common stock on May 15, 2025, the date of grant, and vest over 4 years, with 25% of the shares underlying the options vesting on the first anniversary of the grant date and an additional 1/48th of the shares vesting monthly thereafter, subject to continued service through the applicable vesting dates. About Annexon Annexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement's potent inflammatory pathway that when misdirected can lead to tissue damage and loss in a host of diseases. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade before it starts. Our pipeline spans three diverse therapeutic areas – autoimmunity, neurodegeneration and ophthalmology – and includes targeted investigational drug candidates designed to address the unmet needs of nearly 10 million people worldwide. Annexon's mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit Investor Contact: Joyce AllaireLifeSci Advisorsjallaire@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-04-2025
- Health
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Annexon's Investigational Drug Shows Rapid Recovery And Durable Benefit In Rare Neurological Disorder
Annexon, Inc. (NASDAQ:ANNX) on Tuesday presented data for its late-stage targeted therapy, tanruprubart (formerly ANX005), for Guillain-Barré Syndrome (GBS). GBS is a neuromuscular emergency affecting at least 150,000 people worldwide yearly. The rare autoimmune disease is characterized by rapidly progressing and severe weakness that can lead to complete paralysis, often requiring intensive care and mechanical ventilation. Tanruprubart is a first-in-kind monoclonal antibody designed to block C1q, the initiating molecule of the classical complement cascade. In the Phase 3 pivotal trial of 241 patients, tanruprubart met the primary endpoint with consistent outcomes and rapid, more complete functional recovery versus placebo across multiple time points and clinical efficacy measures. Also Read: The primary endpoint, GBS-Disability Scale (DS), showed that after a single infusion of tanruprubart at 30 mg/kg dose, patients had a statistically significant 2.4-fold higher likelihood of being in a better state of health than placebo at Week 8 (p=0.0058). Highlights from the oral presentation include: New efficacy findings consistently demonstrated rapid recovery and durable benefits of tanruprubart across muscle strength, mobility, and disability measures: At Week 1, treated patients rapidly gained motor function and were 14-fold more likely to perform the Timed Up and Go (TUG) test, a standardized measure of mobility, balance and lower limb capacity. At Week 1, treated patients rapidly gained motor ability and showed more than a 2-point improvement on the Overall Neuropathy Limitation Scale (ONLS), a tool used to assess limitations in everyday activities of the upper and lower limbs New efficacy findings at Week 26 also demonstrated that the benefit of tanruprubart was durable, with twice the number of treated patients having no limitations on the ONLS compared to placebo. Treatment with tanruprubart enabled patients to walk independently and be off ventilation (for those requiring it) approximately a month earlier. Patients treated with tanruprubart also spent approximately a week less time in intensive care Tanruprubart was well tolerated, with no new safety signals or off-target effects. Price Action: ANNX stock is down 5.52% at $1.45 at the last check on Wednesday. Read Next:Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Annexon's Investigational Drug Shows Rapid Recovery And Durable Benefit In Rare Neurological Disorder originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
