Axial spondyloarthritis

Summary of opinion: Bimzelx, 21/03/2024 Positive

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Wednesday, April 3, 2024
Civil service commission, Psoriatic arthritis, Hidradenitis suppurativa, Methotrexate, Psoriasis, MRI, Magnetic resonance imaging, Inflammation, Committee, Nonsteroidal anti-inflammatory drug, Disease-modifying antirheumatic drug, HS, Medication package insert, C-reactive protein, Ankylosing spondylitis, European Commission, Marketing, CHMP, CRP, Axial spondyloarthritis

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.
  • The marketing authorisation holder for this medicinal product is UCB Pharma S.A.
  • The CHMP adopted a new indication for the treatment of hidradenitis suppurativa.
  • Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
    Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

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Friday, January 5, 2024
Marketing, INN, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Blood, Safety, Heart failure, Rheumatoid arthritis, Patient, Medical Subject Headings, Pediatrics, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Methotrexate, TNF, Axial, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Frankincense

Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Date of authorisation: 12/11/2021, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

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Tuesday, January 2, 2024
Marketing, INN, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Blood, Safety, Heart failure, Rheumatoid arthritis, Patient, Medical Subject Headings, Pediatrics, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Methotrexate, TNF, Axial, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Frankincense

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

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Tuesday, January 2, 2024
Marketing, MRI, INN, Contraindication, AZA, Axial spondyloarthritis, Rash, Tissue, ACR20, Heart, Cancer, Inflammation, Red, Disease-modifying antirheumatic drug, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, Adolescence, ATC, Joint, Crohn's disease, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Ageing, Nonsteroidal anti-inflammatory drug, Blood, Safety, Heart failure, CRP, Rheumatoid arthritis, Patient, Medical Subject Headings, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Select, Methotrexate, Azathioprine, TNF, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Child, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, MRI, INN, Risk, Contraindication, AZA, Axial spondyloarthritis, Tissue, Heart, Cancer, Inflammation, Red, Disease-modifying antirheumatic drug, Ankylosing spondylitis, Infection, Back pain, Anatomy, Ulcer, IIA, Skin, Hidradenitis suppurativa, Tuberculosis, Bone marrow, ATC, Joint, Crohn's disease, Hidradenitis, Pain, Psoriatic arthritis, Bleeding, Disease, Nose, Ageing, Blood, Safety, Heart failure, CRP, Rheumatoid arthritis, Patient, Medical Subject Headings, Immune system, Ulcerative colitis, International, HS, Lupus, Arthritis, Language, Mouth, Laboratory, Scar, Child, Select, Medicine, Methotrexate, Azathioprine, TNF, Headache, Swelling, Stevens–Johnson syndrome, European Medicines Agency, Spine, Abscess, Rash, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 15, Status: Authorised

ACELYRIN, INC. Reports Third Quarter 2023 Financial Results and Recent Highlights

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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.

ACELYRIN, INC. Scales for Continued Late-Stage Growth with The Appointment of Dr. Shephard Mpofu as Senior Vice President of Development

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Tuesday, October 3, 2023
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.

SLRN Alert: Monsey Law Firm of Wohl & Fruchter LLP Investigating Acelyrin, Inc. for Potential Securities Law Violations

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Thursday, September 14, 2023
SLRN, Axial spondyloarthritis, Abscess, Part, Wohl, Psoriatic arthritis, Hidradenitis suppurativa, Patient, Uveitis, News, Pharmaceutical industry, HS

MONSEY, New York, Sept. 14, 2023 (GLOBE NEWSWIRE) -- The law firm of Wohl & Fruchter LLP is investigating whether Acelyrin, Inc. (Nasdaq: SLRN) (“Acelyrin”) violated federal securities laws in connection with its prior public statements concerning the potential of its lead drug candidate, izokibep.

Key Points: 
  • MONSEY, New York, Sept. 14, 2023 (GLOBE NEWSWIRE) -- The law firm of Wohl & Fruchter LLP is investigating whether Acelyrin, Inc. (Nasdaq: SLRN) (“Acelyrin”) violated federal securities laws in connection with its prior public statements concerning the potential of its lead drug candidate, izokibep.
  • Active ongoing trials with izokibep include Part B of a Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe HS.
  • HiSCR50 represents a 50% improvement in abscesses and inflammatory nodules without worsening in either of these individually or worsening in tunnelling.
  • On September 13, 20203 Acelyrin’s stock price fell another $2.09 to close at $10.71.

ACELYRIN, INC. Reports Second Quarter 2023 Financial Results and Recent Highlights

Retrieved on: 
Monday, August 14, 2023
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.

Galapagos announces first quarter 2023 financial results

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Thursday, May 4, 2023
Linda, Galapagos NV, CD, CET, CD19, Chronic lymphocytic leukemia, PRAC, Baltic, Annual general meeting, Dermatomyositis, Patient, RT, Rheumatoid arthritis, CLL, Filgotinib, DM, Annual, Research, European Commission, Growth, IND, LTE, Safety, Exercise, Civil service commission, CRS, Medicine, SLE, Ulcerative colitis, UC, TYK2, Symantec Endpoint Protection, CFO, ICAN, Lupus, RA, JAK, NHL, ET, Euronext, Glen Burnie, Maryland, Pharmaceutical industry, Nursing, Management, Axial spondyloarthritis, Galápagos Islands, Central Europe, Romainville

Progress with immunology and oncology pipeline:

Key Points: 
  • Progress with immunology and oncology pipeline:
    Clinical sites opened to start patient recruitment in Phase 2 GALARISSO study with TYK2 inhibitor product candidate, GLPG3667, in dermatomyositis (DM)
    Further expanding CAR-T point-of-care network in Europe, with IND filing in the US expected before year-end
    First quarter 2023 financial highlights:
    Webcast presentation tomorrow, 5 May 2023, at 14:00 CET / 8:00 am ET, www.glpg.com
    Mechelen, Belgium; 4 May 2023, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced its first quarter 2023 financial results, a year-to-date business update and its outlook for the remainder of 2023.
  • Within our pipeline, we presented encouraging initial Phase 1/2 results with GLPG5201, our CD19 CAR-T candidate in chronic lymphocytic leukemia.
  • In the first quarter of this year, Jyseleca® achieved €26.7 million in net sales in rheumatoid arthritis (RA) and ulcerative colitis (UC).
  • We continue to gain further insights into the market dynamics for the JAK class and we intend to revisit our 2023 net sales guidance at the next financial update in August.