Waiha

Annexon Highlights Strategic Focus to Advance Four Flagship Complement Programs through Late-Stage Development and Progress Across Three Therapeutic Franchises

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Domenica, Gennaio 8, 2023

BRISBANE, Calif., Jan. 08, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today reported progress across its broad portfolio of complement therapies and outlined its focus on four flagship programs to support its advancement to a late-stage biopharmaceutical company developing first-in-class treatments for complement-mediated diseases of the body, brain and eye.

Key Points: 
  • Annexon has prioritized resources and execution of late-stage development of its four flagship programs: Guillain-Barré syndrome (GBS), Huntington’s disease (HD), geographic atrophy (GA) and its first-in-kind oral small molecule, ANX1502.
  • Our mission is to free the body, brain and eye from diseases driven by the classical complement cascade,” said Douglas Love, president and CEO of Annexon.
  • Following an assessment of the market opportunity in wAIHA and a range of additional autoimmune indications, Annexon has determined not to advance development in wAIHA.
  • A replay of the webcast will be archived on the Annexon website for 30 days following the presentation.

HUTCHMED Initiates a Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China

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Lunedì, Ottobre 10, 2022

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Oct. 10, 2022 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase II/III trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Oct. 10, 2022 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase II/III trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China.
  • The Phase II stage of the study is to evaluate the safety and preliminary efficacy of sovleplenib in adult patients with wAIHA.
  • If results of the Phase II stage are positive, the Phase III stage will be initiated to confirm such efficacy and safety.
  • Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase, also known as Syk.

Rigel to Present at the H.C. Wainwright 24th Annual Global Investment Conference

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Martedì, Settembre 6, 2022

SOUTH SAN FRANCISCO, Calif., Sept. 6, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that Dean Schorno, the company's chief financial officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference at 2:00 p.m.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Sept. 6, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that Dean Schorno, the company's chief financial officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference at 2:00 p.m.
  • To access the live and subsequently archived webcast, go to the Investor Relations section of the company's website at www.rigel.com .
  • Rigel in-licensed olutasidenib from Forma with exclusive, worldwide rights to develop, manufacture, and commercialize the investigational agent.
  • Rigel conducted a Phase 3 clinical trial( NCT03764618 ) evaluating fostamatinibfor the treatment of warm autoimmune hemolytic anemia (wAIHA)1.

Rigel Announces Conference Call and Webcast to Report Second Quarter 2022 Financial Results and Business Update

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Martedì, Luglio 26, 2022

SOUTH SAN FRANCISCO, Calif., July 26, 2022 /PRNewswire/ -- Rigel Pharmaceuticals,Inc.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., July 26, 2022 /PRNewswire/ -- Rigel Pharmaceuticals,Inc.
  • (Nasdaq: RIGL) today announced that it will report its second quarter 2022 financial results after market close on Tuesday, August 2, 2022.Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.
  • In addition, Rigel has product candidates in development with partners BerGenBioASA and Daiichi Sankyo.
  • 1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

Rigel Announces Top-line Results from FORWARD Phase 3 Clinical Trial of Fostamatinib in Patients with Warm Autoimmune Hemolytic Anemia

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Mercoledì, Giugno 8, 2022

SOUTH SAN FRANCISCO, Calif., June 8, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced top-line efficacy and safety data from the FORWARD Phase 3 clinical trial, a global, multi-center, randomized, double-blind, placebo-controlled trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA). The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. In a post-hoc regional analysis of U.S., Canadian, Australian, and Western European trial sites, patients treated with fostamatinib had a favorable durable hemoglobin response compared to placebo, whereas in the Eastern European trial sites patients did not. Rigel plans to continue analyzing the data to understand the geographical differences in patient disease characteristics and outcomes and discuss these findings with the U.S. Food and Drug Administration (FDA).

Key Points: 
  • On behalf of the entire Rigel team, we are grateful to the patients, their caregivers, and the healthcare professionals who participated in the trial."
  • Of the 90 patients that completed the FORWARD Phase 3 study, 71 (79%) enrolled in the open-label extension study.
  • Fostamatinib is currently being evaluated in a Phase 3 randomized, double-blind, placebo-controlled clinical study in 90 patients with wAIHA who have failed at least one prior treatment.
  • Fostamatinib is currently being studied in a Phase 3 clinical trial( NCT03764618 )for the treatment of warm autoimmune hemolytic anemia (wAIHA)2; a Phase 3 clinical trial( NCT04629703 )for the treatment of hospitalizedhigh-riskpatients withCOVID-192; and an NIH/NHLBI-sponsored Phase 3 clinical trial (ACTIV-4 Host Tissue Trial, NCT04924660 ) for the treatment of COVID-19 in hospitalized patients.

Knight Therapeutics Enters into Exclusive License and Supply Agreements with Rigel Pharmaceuticals to Commercialize Fostamatinib in Latin America

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Martedì, Maggio 24, 2022

MONTREAL, May 24, 2022 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD), a pan-American (ex-USA) specialty pharmaceutical company, today announced that it has entered into exclusive license and supply agreements with Rigel Pharmaceuticals granting Knight the rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America.

Key Points: 
  • MONTREAL, May 24, 2022 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD), a pan-American (ex-USA) specialty pharmaceutical company, today announced that it has entered into exclusive license and supply agreements with Rigel Pharmaceuticals granting Knight the rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America.
  • In return, Knight receives exclusive rights to fostamatinib in all potential indications, including chronic ITP, wAIHA, and COVID-19 in Latin America.
  • We are excited to be working with Rigel to provide access to an innovative, first-in-class treatment option to patients across Latin America with chronic ITP.
  • TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.
    Investor Contact for Knight Therapeutics Inc.:

Annexon Biosciences Highlights Portfolio Progress and Key Anticipated Milestones, and Reports First Quarter 2022 Financial Results

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Lunedì, Maggio 9, 2022

BRISBANE, Calif., May 09, 2022 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced progress across its broad pipeline of product candidates and reported first quarter 2022 financial results.

Key Points: 
  • I am very proud of the strong execution by the Annexon team in advancing our classical complement platform across multiple indications driven by aberrant complement activity.
  • Research and development (R&D) expenses: R&D expenses were $27.0 million for the quarter ended March 31, 2022, compared to $20.7 million for the quarter ended March 31, 2021.
  • General and administrative (G&A) expenses: G&A expenses were $8.4 million for the quarter ended March 31, 2022, compared to $5.5 million for the quarter ended March 31, 2021.
  • Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late- stage clinical trials, with clinical data anticipated throughout 2022 and 2023.

Rigel Announces Conference Call and Webcast to Report First Quarter 2022 Financial Results and Business Update

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Martedì, Aprile 26, 2022

SOUTH SAN FRANCISCO, Calif., April 26, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will report its first quarter 2022 financial results after market close on Tuesday, May 3, 2022. Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.

Key Points: 
  • (Nasdaq: RIGL) today announced that it will report its first quarter 2022 financial results after market close on Tuesday, May 3, 2022.Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.
  • Her research interests include immune thrombocytopenia (ITP), wAIHA, cancer-associated thrombosis, and paroxysmal nocturnal hemoglobinuria.
  • The FDA has granted fostamatinib Orphan Drug and Fast Track designations for the treatment of patients with wAIHA.
  • 1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

Annexon Biosciences Announces Program Highlights and Reports Fourth Quarter and Full Year 2021 Financial Results

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Martedì, Marzo 1, 2022

BRISBANE, Calif., March 01, 2022 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders, today announced recent highlights and reported fourth quarter and full year 2021 financial results.

Key Points: 
  • This is an exciting time for Annexon, and I am confident in our potential to deliver game-changing medicines to patients in need.
  • Annexon anticipates reporting data from all patients treated, including data from the three-month follow-up period, in the second quarter of 2022.
  • In addition, Annexon reported preclinical data supporting the potential role of the complement pathway in warm autoimmune hemolytic anemia (wAIHA).
  • Annexon continues to expect that its current cash position is sufficient to fund its operating plans into the first quarter of 2024.

Rigel Announces Conference Call and Webcast to Report Fourth Quarter and Year End 2021 Financial Results and Business Update

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Martedì, Febbraio 22, 2022

(Nasdaq:RIGL) today announced that it will report its fourth quarter and year end 2021 financial results after market close on Tuesday, March 1, 2022.Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.

Key Points: 
  • (Nasdaq:RIGL) today announced that it will report its fourth quarter and year end 2021 financial results after market close on Tuesday, March 1, 2022.Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give an update on the business.
  • Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to developing and commercializing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer, and rare immune diseases.
  • In addition, Rigel has product candidates in development with partners BerGenBio ASA and Daiichi Sankyo.
  • 1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.