Fostamatinib

Knight Therapeutics Announces Regulatory Submission of Fostamatinib in Brazil

Retrieved on:

Wednesday, February 21, 2024

ANVISA, Fostamatinib, TSX, ITP, GUD, SYK, Therapy, Thrombocytopenia, Patient, Knight, Pharmaceutical industry

MONTREAL, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda., has submitted a marketing authorization application to ANVISA, the Brazilian health regulatory agency, for fostamatinib for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

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MONTREAL, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda., has submitted a marketing authorization application to ANVISA, the Brazilian health regulatory agency, for fostamatinib for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Knight has previously submitted marketing authorization applications for fostamatinib in Colombia and Mexico.
“This submission of fostamatinib demonstrates Knight’s continued execution of our strategy of leveraging our solid platform and expertise to bring innovative therapies for important unmet healthcare needs in Latin America,” said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.
On May 24, 2022, Knight announced that it entered into an agreement with Rigel Pharmaceuticals, Inc. for the exclusive rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America.
Fostamatinib is commercially available in the United States under the brand name TAVALISSE® and in Europe under the brand name TAVLESSE® for the treatment of adult chronic ITP.

Celcuity Appoints Eldon Mayer as Chief Commercial Officer

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Tuesday, February 20, 2024

ALZA, Mallinckrodt, Schering-Plough, Gedatolisib, Progeria, Marketing, Strategic planning, CELC, Organization, Fostamatinib, Pharmaceutical industry

MINNEAPOLIS, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Eldon Mayer as Chief Commercial Officer.

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MINNEAPOLIS, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Eldon Mayer as Chief Commercial Officer.
Mr. Mayer joins Celcuity with over 30 years of biopharmaceutical commercial experience in companies ranging from early-stage biotechs to full scale pharmaceutical companies across many therapeutic areas, including oncology.
Prior to Eiger, he was Executive Vice President and Chief Commercial Officer of Rigel Pharmaceuticals where he built and led the commercial organization and launched Tavalisse® (fostamatinib disodium hexahydrate) for chronic immune thrombocytopenia.
“I am excited to join Celcuity and work alongside driven, collaborative colleagues during this pivotal time for the company,” said Eldon Mayer.

Knight Therapeutics Reports Third Quarter 2023 Results

Retrieved on:

Thursday, November 9, 2023

Gross margin: For the quarter ended September 30, 2023, gross margin, as a percentage of revenues, was 49% compared to 42% in Q3-22.

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Gross margin: For the quarter ended September 30, 2023, gross margin, as a percentage of revenues, was 49% compared to 42% in Q3-22.
Selling and marketing (“S&M”): For the quarter ended September 30, 2023, S&M expenses were $11,924, a decrease of $1,532 or 11%, compared to the same period in prior year.
General and administrative (“G&A”): For the quarter ended September 30, 2023, G&A expenses were $11,080, an increase of $664 or 6%, compared to the same period in prior year.
For the quarter ended September 30, 2023, interest income was $3,055, an increase of $593 or 24%, compared to the same period in prior year.

Rigel Announces Poster Presentations at the 65th American Society of Hematology Annual Meeting and Exposition

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Thursday, November 2, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 2, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the upcoming presentation of four posters highlighting data from their commercial and clinical-stage hematology-oncology portfolio at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually.

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"We are also excited by the compelling data in patients with mIDH1 MDS and look forward to evaluating this potential opportunity further.
On top of the olutasidenib data, we are delighted to share other updates and data across our development portfolio, demonstrating our presence in the hematology-oncology space."
These results support the use of fostamatinib as a second-line treatment in patients with primary ITP.
To learn more about Rigel Pharmaceuticals and their clinical and commercial hematology/oncology portfolio visit Booth #2805 during ASH 2023.

Rigel Announces Presentation at the Upcoming IDWeek 2023

Retrieved on:

Wednesday, October 11, 2023

SOUTH SAN FRANCISCO, Calif., Oct. 11, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced an upcoming oral presentation highlighting data from the FOCUS Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients without respiratory failure who have certain high-risk prognostic factors at IDWeek 2023 being held October 11-15, 2023, in Boston, MA and provided an update on the ACTIV-4 Host Tissue trial of fostamatinib in hospitalized patients with COVID-19.

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SOUTH SAN FRANCISCO, Calif., Oct. 11, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced an upcoming oral presentation highlighting data from the FOCUS Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients without respiratory failure who have certain high-risk prognostic factors at IDWeek 2023 being held October 11-15, 2023, in Boston, MA and provided an update on the ACTIV-4 Host Tissue trial of fostamatinib in hospitalized patients with COVID-19.
However, our focus remains on our hematology-oncology commercial and clinical portfolio," said Raul Rodriguez, Rigel's president and CEO.
Patients were randomly assigned 1:1 to receive fostamatinib (150 mg BID administered orally) or placebo for 14 days.
A significantly higher proportion of patients who received fostamatinib were discharged from the hospital by Day 15 compared to placebo (p=0.0029).

Global SYK Inhibitors Market & Clinical Trials Outlook to 2028: by Company, Country, Indication and Phase - ResearchAndMarkets.com

Retrieved on:

Monday, February 27, 2023

One such novel target that is emerging to have some possible promising potential for drug development in several disorders including cancers is SYK.

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One such novel target that is emerging to have some possible promising potential for drug development in several disorders including cancers is SYK.
Spleen tyrosine kinase (SYK) is a cytoplasmic non-receptor kinase that is known to have oncogenic properties and has been extensively investigated.
Its therapeutic potential has been noticed by pharmaceutical companies and drugs against SYK have started their initial clinical trial phases.
This emerging target has resulted in several pharmaceutical industries trying to develop novel therapies and testing them under clinical trials.

Worldwide SYK Inhibitors Industry to 2028: Dosage, Patent, Price & Sales Insights on Fostamatinib

Retrieved on:

Friday, February 24, 2023

This report contains a thorough analysis of the recent trend and shifts towards SYK inhibitors and provides detailed information about the possible opportunities that have opened up since the introduction of SYK inhibitors in the market.

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This report contains a thorough analysis of the recent trend and shifts towards SYK inhibitors and provides detailed information about the possible opportunities that have opened up since the introduction of SYK inhibitors in the market.
One such novel target that is emerging to have some possible promising potential for drug development in several disorders including cancers is SYK.
Spleen tyrosine kinase (SYK) is a cytoplasmic non-receptor kinase that is known to have oncogenic properties and has been extensively investigated.
Its therapeutic potential has been noticed by pharmaceutical companies and drugs against SYK have started their initial clinical trial phases.

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

Retrieved on:

Tuesday, September 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.

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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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Tuesday, July 26, 2022

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

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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

Retrieved on:

Wednesday, June 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).

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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.