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ACELYRIN, INC. (Nasdaq: SLRN) is a Los Angeles area-based late-stage clinical biopharmaceutical company with additional operations in the San Francisco Bay area. The company is focused on providing patients with life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN is at the forefront of innovative treatments in the field of immunology, with a strong pipeline of late-stage clinical programs designed to address significant unmet medical needs.
Core Business: ACELYRIN’s primary focus is on developing transformative therapies in the fields of immunology and inflammation. The company’s lead product candidates include izokibep and lonigutamab. Izokibep is a next-generation inhibitor of IL-17A with a robust potential for tissue penetration and extended half-life. It is being evaluated in multiple late-stage trials targeting moderate-to-severe hidradenitis suppurativa (HS), psoriatic arthritis (PsA), and uveitis. Lonigutamab is a subcutaneously delivered monoclonal antibody targeting the IGF-1 receptor, aimed at treating thyroid eye disease (TED).
Recent Achievements: In March 2024, ACELYRIN announced long-term data from a Phase 2b clinical trial of izokibep in hidradenitis suppurativa, demonstrating significant clinical improvements over time. Additionally, ACELYRIN disclosed positive results from its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis, which met the primary endpoint of ACR50 with high statistical significance. These results underscore izokibep’s potential as a differentiated treatment option for multiple immunologic conditions.
Current Projects: The company is currently advancing izokibep through Phase 3 trials for hidradenitis suppurativa and psoriatic arthritis. Long-term efficacy results from these trials continue to show promising improvements in quality of life for patients. ACELYRIN is also progressing through a Phase 1/2 trial of lonigutamab for thyroid eye disease, demonstrating rapid clinical benefits and a favorable safety profile.
Financial Condition: As of December 31, 2023, ACELYRIN reported cash, cash equivalents, and short-term marketable securities totaling $721.3 million, which is expected to fund operations into 2026. This financial stability allows ACELYRIN to continue advancing its clinical programs through key developmental milestones.
Partnerships and Collaborations: ACELYRIN leverages strategic collaborations with contract research organizations (CROs) and other vendors to conduct its clinical trials. Despite recent challenges with trial execution errors by its CRO, ACELYRIN remains committed to ensuring quality control and transparency in its clinical development processes.
For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X.
ACELYRIN, INC. (Nasdaq: SLRN) has formed a scientific and patient advisory board comprising leading experts and advocates in thyroid eye disease (TED). This board will provide strategic input, clinical expertise, and patient perspectives as ACELYRIN prepares to advance lonigutamab, a subcutaneously delivered IgG1 monoclonal antibody targeting the anti-insulin-like growth factor 1 (IGF-1) receptor, into Phase 3 clinical development for TED in the first quarter of 2025.
The advisory board includes renowned scientific advisors and a patient advocate, each bringing distinct expertise in TED. ACELYRIN aims to leverage their collective insights to execute its goal of delivering a potentially best-in-class subcutaneous anti-IGF-1R treatment for TED patients.
ACELYRIN, INC. (Nasdaq: SLRN) announced positive results from its global Phase 3 clinical trial of izokibep in moderate-to-severe hidradenitis suppurativa (HS) patients. The results will be presented at the 2024 European Academy of Dermatology and Venereology in Amsterdam. The trial demonstrated statistically significant and clinically meaningful responses across multiple efficacy endpoints, particularly in higher order responses like HiSCR90 and HiSCR100, by 12 weeks. Dr. Shephard Mpofu, Chief Medical Officer of ACELYRIN, believes these data could support a path to regulatory approval for izokibep as a treatment for HS.
ACELYRIN, INC. (Nasdaq: SLRN) announced positive data from its Phase 1/2 clinical trial of lonigutamab for thyroid eye disease (TED) will be presented at the 42nd Annual Meeting of the European Society of Ophthalmic Plastic and Reconstructive Surgery. The presentation, titled 'Preliminary Safety, Efficacy, and Quality of Life Outcomes of Subcutaneous Lonigutamab from a Phase 1/2 Proof of Concept Study in Patients with Thyroid Eye Disease,' will take place on September 14, 2024, in Rotterdam, Netherlands.
Dr. Jwu Jin Khong will deliver the rapid-fire oral presentation. ACELYRIN's Chief Medical Officer, Dr. Shephard Mpofu, highlighted the potential of lonigutamab to improve clinical outcomes through rapid suppression of IGF-1 receptor signaling, achieving robust responses with low drug exposures. The company believes the data supports the potential for subcutaneously-delivered lonigutamab to provide deep and durable responses with convenient, self-administered dosing.
ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focusing on immunology, has announced its participation in three upcoming investor conferences in September 2024. The company's management team will engage in fireside chats and one-on-one meetings at the following events:
- Wells Fargo Healthcare Conference in Boston on September 5
- Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 6
- H.C. Wainwright 26th Annual Global Investment Conference in New York on September 9
Live webcasts of the fireside chats will be available on ACELYRIN's website, with replays accessible for 30 days after each event.
ACELYRIN, INC. (Nasdaq: SLRN) announced positive Phase 3 data for izokibep in Hidradenitis Suppurativa, meeting the primary endpoint of HiSCR75 at 12 weeks. The company is refocusing its strategy to prioritize lonigutamab development for thyroid eye disease, with plans to initiate a Phase 3 program in Q1 2025. ACELYRIN reported $635.2 million in cash and equivalents as of June 30, 2024, projecting a cash runway extension to mid-2027.
Key financial highlights for Q2 2024 include R&D expenses of $76.4 million and G&A expenses of $16.6 million. The company reported a net loss of $85.7 million for the quarter. ACELYRIN is implementing a 33% workforce reduction as part of its strategic shift and pipeline reprioritization.
ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company specializing in immunology, has announced its upcoming second quarter 2024 financial results and corporate update. The company will host a conference call on Tuesday, August 13, 2024, at 5:00 p.m. ET to discuss these matters. Investors and interested parties can access a live webcast of the conference call through the company's website under the Events & Presentations section. For those unable to attend the live event, a replay of the webcast will be available on ACELYRIN's website for 90 days following the call, providing ample opportunity for stakeholders to review the information presented.
ACELYRIN (Nasdaq: SLRN) has announced positive 16-week results from its global Phase 2b/3 trial of izokibep, a novel IL-17A inhibitor, in treating psoriatic arthritis (PsA).
The findings will be presented at the 2024 European Alliance of Associations for Rheumatology Congress in Vienna, Austria. The trial, which is double-blind, placebo-controlled, and multicenter, demonstrates the efficacy and safety of izokibep in patients with active PsA.
The presentation, titled 'Efficacy and Safety of Izokibep in Patients with Active Psoriatic Arthritis: Week 16 Results,' will be delivered by Dr. Philip Mease on June 15, 2024, at 9:30 am CEST.
ACELYRIN announced that positive proof-of-concept data from its Phase 1/2 trial of lonigutamab, a subcutaneous anti-IGF-1R antibody, will be presented at the Endocrine Society's Annual Meeting (ENDO 2024) in Boston. Lonigutamab is designed to treat thyroid eye disease (TED). The presentation, led by Dr. Shoaib Ugradar, will take place on June 3, 2024, from 2:00pm to 2:15pm ET. This announcement is significant as lonigutamab is the first subcutaneous treatment to show clinical responses in TED patients, utilizing the only FDA-approved mechanism for the disease.
ACELYRIN, INC. provided a business update, highlighting milestones such as completing enrollment in Phase 3 trials and reporting positive data for lonigutamab and izokibep. The company aims to accelerate the development of transformative medicines while maintaining financial stability. Changes in the leadership team were also announced.
ACELRYIN, INC. announced a leadership transition with Mina Kim appointed as the new CEO and board member, replacing founder Shao-Lee Lin, who stepped down. The company focuses on developing transformative medicines in immunology and has seen early positive data in clinical trials. Shep Mpofu becomes the Chief Medical Officer, Gil Labrucherie takes on the role of Chief Business Officer, in addition to being the CFO, and Sanam Pangali is named Chief Legal Officer and Head of People.
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