Totality of data observed with subcutaneous lonigutamab in Thyroid Eye Disease (TED) patients demonstrate potential for efficacy in line with standard of care and a more favorable safety profile Conducted positive end of Phase 2 FDA meeting; Phase 3 program expected to be initiated in Q1 2025 Topline Phase 3 data expected in second half of 2026; cash runway expected through mid-2027 Conference call to review unmet need in... Read More

LOS ANGELES, Jan. 02, 2025 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced it will host a virtual investor event on Monday, January 6, 2025 at 4:30 PM ET to provide updated Phase 2 data for subcutaneous lonigutamab further supporting its potential for a best-in-class... Read More

Phase 2b/3 trial of izokibep did not meet primary endpoint; secondary endpoints also did not achieve statistical significance Company continues focus on development of subcutaneous lonigutamab in thyroid eye disease, with initiation of Phase 3 program on schedule for Q1 2025 $562.4 million in cash, cash equivalents, and short-term marketable securities on September 30, 2024 projected to provide runway to mid-2027, including... Read More

Topline data from Phase 2b/3 trial of izokibep as a treatment for non-infectious non-anterior uveitis expected in December 2024 Positive lonigutamab EOP2 FDA interaction completed and initiation of subcutaneous Phase 3 development program in thyroid eye disease (TED) expected in Q1 2025 Cash, cash equivalents, and short-term marketable securities at September 30, 2024 of $562.4 million projected to provide cash runway to... Read More

LOS ANGELES, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced it will host a conference call on Wednesday, November 13, 2024 at 4:30 p.m. ET to discuss its third quarter 2024 financial results and other corporate updates. A live webcast of the conference call... Read More

Experts and advocates to provide important strategic input and clinical expertise as ACELYRIN completes its Phase 2 trial of lonigutamab in TED and prepares to initiate Phase 3 program in first quarter of 2025 LOS ANGELES, Oct. 16, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today... Read More

LOS ANGELES, Sept. 19, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive results from the company’s global Phase 3 clinical trial of izokibep in moderate-to-severe hidradenitis suppurativa (HS) patients will be shared as a late-breaking oral presentation... Read More

Rapid-fire Oral Presentation to Highlight Efficacy, Safety, and Quality of Life Outcomes LOS ANGELES, Sept. 10, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive data from its Phase 1/2 clinical trial of lonigutamab (an anti-insulin-like growth factor 1... Read More

LOS ANGELES, Aug. 22, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that members of its management team will participate in fireside chats and 1x1 meetings at the following investor conferences: Wells Fargo Healthcare Conference 2024 Date: Thursday, September 5,... Read More

Phase 3 trial of izokibep in hidradenitis suppurativa met primary endpoint of HiSCR75 at 12 weeks Company to prioritize development of lonigutamab; dose confirmation ongoing in Phase 2 trial with plans to initiate Phase 3 program in Q1 2025 Cash, cash equivalents, and short-term marketable securities at June 30, 2024 of $635.2 million; projected to extend cash runway to mid-2027 Company to hold webcast and conference call at... Read More

LOS ANGELES, Aug. 06, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced it will host a conference call on Tuesday, August 13, 2024 at 5:00 p.m. ET to discuss its second quarter 2024 financial results and provide a corporate update. A live webcast of the conference call... Read More

LOS ANGELES, June 05, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive results from the company’s global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) will be shared as a late breaking oral presentation at the 2024 European Alliance... Read More

Lonigutamab is the first subcutaneous anti-IGF-1R to demonstrate clinical responses in thyroid eye disease (TED) patients LOS ANGELES, May 29, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive proof-of-concept data from an ongoing Phase 1/2 trial of... Read More

Completed enrollment in izokibep Phase 3 trial in hidradenitis suppurativa and enrollment completion in Phase 2b/3 trial in uveitis expected this month; top line data for both trials now expected by end of third and fourth quarter of 2024, respectively Reported positive proof-of-concept for lonigutamab in thyroid eye disease patients and positive top-line Phase 2b/3 data for izokibep in psoriatic arthritis Cash, cash... Read More

Mina Kim appointed Chief Executive Officer and to Board of Directors ACELYRIN Founder Shao-Lee Lin, M.D., Ph.D., steps down as Chief Executive Officer Shephard (Shep) Mpofu, M.D., MRCP, FRCP named Chief Medical Officer, Gil Labrucherie, the company’s Chief Financial Officer, additionally named Chief Business Officer, and Sanam Pangali named Chief Legal Officer and Head of People LOS ANGELES, May 09, 2024 (GLOBE NEWSWIRE) --... Read More

LOS ANGELES, April 29, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced it will host a conference call on Monday, May 13, 2024 at 4:30 p.m. ET to discuss its first quarter 2024 financial results and provide a corporate update. A live webcast of the conference call will... Read More

Reported positive Phase 1/2 proof-of-concept data for lonigutamab, first subcutaneous anti-IGF-1R to demonstrate clinical responses in thyroid eye disease patients Achieved primary endpoint with high statistical significance in global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis with robust clinical responses also achieved for higher hurdle endpoints Announced differentiated long-term 32-week data from global... Read More

Rapid improvements demonstrated for proptosis, clinical activity scores, and diplopia versus placebo with a favorable safety profile Phase 2b/3 trial to be initiated in the second half of 2024 Conference call to review these data to be held at 8:30 a.m. ET today LOS ANGELES, March 20, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC . (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and... Read More

Dose ordered and robust HiSCRs were rapidly demonstrated with about a third of patients achieving HiSCR100, or resolution of abscesses and nodules, by week 16 and through week 32 Deep and consistent HiSCR responses were observed for placebo patients switching to active treatment Marked reductions in draining tunnels and skin pain also contributed to clinically meaningful improvements in quality of life Potential for... Read More

Study met primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance and is expected to be the first of two registrational trials in psoriatic arthritis Robust clinical responses achieved for the high hurdles of ACR70, PASI100, as well as composite endpoints ACR50/PASI100 and Minimal Disease Activity Favorable safety profile consistent with the IL-17A class and previous izokibep experience LOS... Read More

Highly accomplished leader bringing more than 25 years of investor relations, communications, and operational & strategic finance experience at public healthcare companies LOS ANGELES, Feb. 15, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC . (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced the appointment of Agnes... Read More

LOS ANGELES, Dec. 20, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC . (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced the appointment of Lynn Tetrault to its board of directors. “I am pleased to welcome Lynn to our board of directors as we close our first year as a publicly traded company. Lynn is a highly... Read More

LOS ANGELES, Nov. 27, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (“PsA trial”). Background In September 2023, ACELYRIN... Read More

Portfolio of programs continues to advance with data from both the global Phase 2b/3 trial for izokibep in PsA and proof-of-concept for lonigutamab as a subcutaneous treatment for thyroid eye disease expected in first quarter 2024 Additional PsA Phase 2 long-term data on clinical measures of disease resolution and quality of life to be presented at 2023 Annual Meeting of the American College of Rheumatology Cash, cash... Read More

Expands capacity for multi-asset manufacturing with highly accomplished supply chain, manufacturing and quality control leader bringing more than 25 years of biopharmaceutical experience across R&D, clinical and commercial supply management Joins at a pivotal time as ACELYRIN advances a robust portfolio of programs through late-stage clinical trials LOS ANGELES, Nov. 06, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC . (Nasdaq:... Read More

LOS ANGELES, Oct. 31, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced it will host a conference call on Tuesday, November 7, 2023 at 4:30 p.m. ET to discuss its third quarter 2023 financial results and provide a corporate update. A live webcast of the conference call... Read More

Veteran drug developer and prior CMO from Novartis AG gene therapies brings decades of clinical experience including long tenure as Global Lead for secukinumab, which he advanced from early development through to approvals across multiple indications including Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis and Hidradenitis Suppurativa Strong complement to ACELYRIN’s current team and robust portfolio with multiple... Read More

The primary endpoint of HiSCR75 at week 16 did not meet statistical significance in the Non-Responder Imputation (NRI) primary analysis. HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis. HiSCR response rates of izokibep 160mg weekly (QW) were consistent with Part A open label results, demonstrating early onset of HiSCR100 at week 4, increasing through week 12 to... Read More

LOS ANGELES, Sept. 06, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that Founder and Chief Executive Officer Shao-Lee Lin, MD, PhD will participate in a moderated fireside chat during the Morgan Stanley 21 st Annual Global Healthcare Conference being held September 11-13,... Read More

New data from Part A of Phase 2b/3 trial of izokibep in Hidradenitis Suppurativa demonstrated improvements in number of draining tunnels in two-thirds of patients as early as week 4; the placebo-controlled Part B remains on track for top-line data in the third quarter 2023. Enrollment completed in Phase 2b/3 randomized controlled trial of izokibep in Psoriatic Arthritis; top-line data now accelerated to first quarter 2024... Read More

LOS ANGELES, Aug. 07, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced it will host a conference call on Monday, August 14, 2023 at 4:30 p.m. ET to discuss its second quarter 2023 financial results and provide a corporate update. A live webcast of the conference call... Read More

Accomplished global leader brings 20 years of immunology sales and marketing expertise. ACEYLRIN currently has a robust portfolio including late-stage clinical trials underway supporting multiple potential commercial launches in coming years. LOS ANGELES, July 18, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of... Read More

Initial Public Offering generated gross proceeds of $621 million;net proceeds of $573.7 million Strong cash position of $289.2 million at end of Q1 2023 $862.9 million from IPO net proceeds and existing cash balance on March 31, 2023 expected to fund key milestones across all three clinical programs Accelerated top-line data for P2b/3 randomized controlled study of izokibep in Hidradenitis Suppurativa (HS) from end of year,... Read More