Associated tags: Psoriatic arthritis, Patient, Uveitis, Disease, Axial spondyloarthritis, Half-life, Clinical trial, HS, SLRN, Pharmaceutical industry, MD, LOS, Hidradenitis suppurativa, Doctor of Philosophy, Inflammation, Webcast, Graves' ophthalmopathy, Safety
Research,
IL-17A,
Strategic planning,
Cell,
Exophthalmos,
Disease,
Infection,
Fungus,
Risk,
Inflammation,
SLRN,
Patient,
Psoriatic arthritis,
Acquisition,
Doctor of Philosophy,
MD,
Quality of life,
CAS,
Senior,
IPR,
Eye,
NeoGenomics,
Graves' ophthalmopathy,
Suicidal ideation,
Behavior,
Hidradenitis suppurativa,
QW,
Drug development,
LOS,
Corporate communication,
Abscess,
Diplopia,
Pharmaceutical industry LOS ANGELES, March 28, 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 reported financial results for the full year ended December 31, 2023 and highlighted recent corporate updates and upcoming milestones.
Key Points:
- R&D Expenses: Research and development expenses were $355.9 million for the full year ended December 31, 2023, as compared to $55.6 million for 2022.
- G&A Expenses: General and administrative expenses were $66.2 million for the full year ended December 31, 2023, as compared to $13.5 million for 2022.
- Net Loss: Net loss for the full year ended December 31, 2023 was $381.6 million, compared to $64.8 million for 2022.
- In December 2023, the Company announced the appointment of Lynn Tetrault to its Board of Directors.
MACR,
Psoriatic arthritis,
1991 World Sportscar Championship,
INC,
Doctor of Philosophy,
LOS,
MD,
SLRN,
ISR,
Rheumatology,
Skin,
Safety,
Joint,
Swedish Health Services,
Enthesitis,
Patient,
Medicine,
HS,
LEI,
Phase,
IL-17A LOS ANGELES, March 11, 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 its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance. Results from the 160 mg weekly (QW) and every other week (Q2W) arms showed improved magnitude of responses on higher hurdle endpoints such as ACR70, PASI100, and Minimal Disease Activity relative to the Phase 2 80 mg Q2W dose. This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.
Key Points:
- (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance.
- This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.
- Izokibep was well-tolerated with a favorable safety profile consistent with previous experience and the IL-17A class, without evidence of the safety liabilities observed with targeting IL-17A&F.
- This reinforces our enthusiasm for developing izokibep as an important potential new medicine for patients.”
Psoriatic arthritis,
INC,
Doctor of Philosophy,
LOS,
MD,
SLRN,
FDA,
Quality of life,
Pain,
Infection,
DLQI,
Suicidal ideation,
Abscess,
Risk,
Behavior,
Safety,
Hidradenitis suppurativa,
Fungus,
Patient,
Medicine,
IL-17A LOS ANGELES, March 11, 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 long-term data from a Phase 2b clinical trial of izokibep in hidradenitis suppurativa (HS). These data demonstrated no evidence of increased safety liability with longer-term treatment and increased duration of therapy was associated with further clinical improvements over time.
Key Points:
- (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced long-term data from a Phase 2b clinical trial of izokibep in hidradenitis suppurativa (HS).
- These data demonstrated no evidence of increased safety liability with longer-term treatment and increased duration of therapy was associated with further clinical improvements over time.
- “The magnitude and depth of responses for signs and symptoms of Hidradenitis Suppurativa in this long-term study are consistent with izokibep’s mechanism of action.
- A confirmatory phase 3 trial of approximately 400 patients is planned to address guidance on size of safety database given the FDA no longer considers moderate-to-severe HS an orphan disease.
Retrieved on:
Monday, November 27, 2023
8-K,
Quality of life,
Conference,
Contract research organization,
Hidradenitis suppurativa,
Arm,
Physician,
SLRN,
Disease,
MD,
Doctor of Philosophy,
Clinical trial,
QW,
Part,
American College,
Patient,
Safety,
Psoriatic arthritis,
Pharmaceutical industry 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”).
Key Points:
- 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”).
- In September 2023, ACELYRIN disclosed top-line results from Part B of its Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe Hidradenitis Suppurativa (“HS trial”).
- The CRO does not conduct any trials on behalf of ACELYRIN beyond the izokibep clinical program.
- ACELYRIN’s team recently identified clinical trial execution errors involving its CRO and one of the vendors engaged by the CRO.
Retrieved on:
Tuesday, November 7, 2023
SLRN,
Research,
American College,
MDA,
Quality of life,
Inflammation,
Doctor of Philosophy,
Hidradenitis suppurativa,
Graves' ophthalmopathy,
GxP,
Disease,
DRS,
LOS,
LEI,
I&I,
Secukinumab,
Shep,
Abscess,
Shepherd (name),
Axial spondyloarthritis,
Amgen,
Webcast,
TED,
Safety,
Patient,
D,
Week,
FRCP,
MD,
MRCP,
Development,
Growth,
Clinical trial,
Internal,
Suicidal ideation,
INC,
Enthesitis,
Psoriatic arthritis,
FDA,
CMC,
Poster,
National Center for Advancing Translational Sciences,
Senior,
Psoriasis,
IL-17A,
Cryptocurrency,
Pharmaceutical industry,
Medical device,
Management LOS ANGELES, Nov. 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 reported financial results for the third quarter ended September 30, 2023 and highlighted additional corporate updates and milestones.
Key Points:
- (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the third quarter ended September 30, 2023 and highlighted additional corporate updates and milestones.
- For the quarter ended September 30, 2023, these expenses include a stock-based compensation expense of $11.7 million.
- Net Loss: Net loss totaled $83.9 million for the third quarter of 2023, or $0.87 per share, compared to $14.4 million or $8.17 per share for the third quarter of 2022.
- ET to review its third quarter 2023 financial results.
SLRN,
Sigma,
External,
Engineering,
Strategic planning,
York Region District School Board,
MD,
CMC,
Federal Aviation Administration,
Doctor of Philosophy,
HBA,
Senior,
Growth,
University,
Business administration,
Amgen,
LOS,
Chairperson,
Benchmarking,
Anderson School,
Hispanics in the United States Naval Academy,
United States Department of the Navy,
INC,
Patient,
Management,
Science,
Mathematics LOS ANGELES, Nov. 06, 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 Patricia Turney as Chief Technical Operations Officer. Reporting to Founder and CEO Shao-Lee Lin, MD, PhD, Ms. Turney will be responsible for overseeing technical operations, CMC regulatory, corporate quality and facilities, and will join the company’s Senior Leadership Team.
Key Points:
- (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 Patricia Turney as Chief Technical Operations Officer.
- Reporting to Founder and CEO Shao-Lee Lin, MD, PhD, Ms. Turney will be responsible for overseeing technical operations, CMC regulatory, corporate quality and facilities, and will join the company’s Senior Leadership Team.
- “I am delighted to welcome Patricia to the ACELYRIN leadership team as we continue to advance our portfolio and grow our manufacturing capabilities and capacity,” said Dr. Lin.
- Earlier in her career at Amgen, she also led R&D strategic operations initiatives for portfolio analysis, benchmarking, training, lean six sigma, and strategic planning.
Retrieved on:
Tuesday, October 31, 2023
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.
Key Points:
- 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 will be available on the Company’s website under “Events” at the following link: https://www.acelyrin.com/events .
- A replay of the webcast will be available on the Company’s website for 90 days.
Secukinumab,
SLRN,
Bachelor,
Royal college,
FRCP,
University,
Senior,
Physician,
Bachelor of Medicine, Bachelor of Surgery,
Psoriasis,
CMO,
Graves' ophthalmopathy,
Psoriatic arthritis,
Hidradenitis suppurativa,
Dermatology,
Patient,
Novartis,
Rheumatology,
Shep,
United Kingdom,
LOS,
MRCP,
University of Zimbabwe,
Pharmaceutical industry,
Medical device,
Medicine,
Development,
MD,
Axial spondyloarthritis LOS ANGELES, Oct. 03, 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 Shephard (Shep) Mpofu, MD, MRCP, FRCP as Senior Vice President of Development. Dr. Mpofu will be responsible for leading clinical development as well as translational sciences and will also join the company’s Senior Leadership Team.
Key Points:
- Dr. Mpofu will be responsible for leading clinical development as well as translational sciences and will also join the company’s Senior Leadership Team.
- “Shep is an internationally recognized immunologist and rheumatologist as well as an esteemed colleague.
- Dr Mpofu is a United Kingdom General Medical Council Board-certified rheumatologist, who previously practiced at several institutions in the United Kingdom (UK) prior to joining industry.
- “I am very excited to join the rapidly growing team at ACELYRIN and strongly believe in the company’s potential to advance transformative medicines for patients,” said Dr. Mpofu.
Retrieved on:
Monday, September 11, 2023
NRI,
Tissue,
SLRN,
Conference call,
Part,
Doctor of Philosophy,
Psoriatic arthritis,
Hidradenitis suppurativa,
Spectrochimica Acta Part B,
MD,
Patient,
Data,
Uveitis,
Independent safety officer,
LOS,
III,
Conference,
Safety,
Interim analysis,
Disease,
Medical imaging,
Pharmaceutical industry,
Vaccine,
HS HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis.
Key Points:
- HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis.
- Response was dose ordered, and safety was consistent with prior izokibep experience and not dose-limiting.
- Izokibep appears to be demonstrating consistent early and high orders of response without safety or tolerability limitation.
- The trial was conducted at 50 sites globally and assessed various efficacy endpoints, including the primary endpoint of HiSCR75 (Hidradenitis Suppurativa Clinical Response) at 16 weeks utilizing a non-responder imputation (NRI) analysis method.
IPO,
Axial spondyloarthritis,
IV,
Spermatogenesis,
Nektar Therapeutics,
Doctor of Philosophy,
Pain,
Graves' ophthalmopathy,
Psoriatic arthritis,
Dermatology,
Teprotumumab,
MD,
Patient,
Randomized controlled trial,
Prurigo nodularis,
DMC,
Disease,
Tissue,
SLRN,
Disability,
Human,
IL-17A,
Data,
Hearing,
Uveitis,
Rheumatology,
Growth,
FDA,
Safety,
D,
Secukinumab,
Neutropenia,
Exercise,
POC,
Eosinophilic esophagitis,
Allergy,
B cell,
AAD,
Webcast,
CFO,
Enthesitis,
LOS,
Research,
Hives,
Therapy,
Inflammation,
Huber loss,
CU,
Data monitoring committee,
TED,
Pharmaceutical industry,
Vaccine,
Management,
Rare-earth element,
HS,
Part,
Hidradenitis suppurativa LOS ANGELES, Aug. 14, 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 reported financial results for the second quarter ended June 30, 2023 and highlighted additional recent corporate updates and milestones.
Key Points:
- LOS ANGELES, Aug. 14, 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 reported financial results for the second quarter ended June 30, 2023 and highlighted additional recent corporate updates and milestones.
- Enrollment of the double-blind, placebo-controlled Part B of the Phase 2b/3 trial evaluating izokibep in HS completed ahead of schedule, accelerating anticipated top-line results into the third quarter 2023.
- Net Loss: Net loss totaled $26.0 million for the second quarter of 2023, compared to $14.5 million for the second quarter of 2022.
- ET to review its second quarter 2023 financial results.
