Lenalidomide

Knight Therapeutics Reports First Quarter 2024 Results

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Giovedì, Maggio 9, 2024

Inventories: As at March 31, 2024, inventories were at $95,400, an increase of $3,566 or 4%.

Key Points: 
  • Inventories: As at March 31, 2024, inventories were at $95,400, an increase of $3,566 or 4%.
  • Accounts payable and accrued liabilities: As at March 31, 2024, accounts payable and accrued liabilities were $94,711, an increase of $4,094 or 5%.
  • Cash, cash equivalents and marketable securities: As at March 31, 2024, Knight had $181,859 in cash, cash equivalents and marketable securities, an increase of $20,034 or 12% compared to December 31, 2023.
  • Knight will host a conference call and audio webcast to discuss its first quarter ended March 31, 2024, today at 8:30 am ET.

Genmab Announces Financial Results for the First Quarter of 2024

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Giovedì, Maggio 2, 2024

Genmab is maintaining its 2024 financial guidance published on February 14, 2024.

Key Points: 
  • Genmab is maintaining its 2024 financial guidance published on February 14, 2024.
  • We expect to update our guidance no later than in connection with our second quarter 2024 earnings.
  • Genmab will hold a conference call to discuss the results for the first quarter of 2024 today, Thursday, May 2, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT.
  • Actual results or performance may differ materially from any future results or performance expressed or implied by such statements.

Enterome to Present Clinical Data on EO2463 in B-cell Lymphoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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Giovedì, Aprile 25, 2024

PARIS, April 25, 2024 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced that clinical data from the ongoing Phase 1/2 trial of EO2463 in monotherapy and in combination with lenalidomide and/or rituximab in indolent non-Hodgkin lymphoma (NHL) will be presented at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, to take place May 31 - June 4, in Chicago, Illinois.

Key Points: 
  • PARIS, April 25, 2024 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced that clinical data from the ongoing Phase 1/2 trial of EO2463 in monotherapy and in combination with lenalidomide and/or rituximab in indolent non-Hodgkin lymphoma (NHL) will be presented at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, to take place May 31 - June 4, in Chicago, Illinois.
  • SIDNEY (EONHL1-20) is a Phase 1/2 multicenter, open-label, first-in-human study of EO2463 as monotherapy and in combination with lenalidomide and/or rituximab for the treatment of patients with indolent non-Hodgkin lymphoma (NHL).
  • The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL).
  • For more information on the study, refer to Clinicaltrials.gov identifier: NCT04669171.

Starton Therapeutics Announces Enrollment Completion for STAR-LLD Phase 1b Clinical Trial in Multiple Myeloma

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Giovedì, Aprile 25, 2024

PARAMUS, N.J., April 25, 2024 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today the successful completion of enrollment for its STAR-LLD Phase 1b clinical trial in multiple myeloma.

Key Points: 
  • PARAMUS, N.J., April 25, 2024 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today the successful completion of enrollment for its STAR-LLD Phase 1b clinical trial in multiple myeloma.
  • “This milestone marks a significant step forward in our commitment to bringing more advanced therapies to patients.
  • We extend our gratitude to the participants, investigators, and clinical teams whose dedication and collaboration have made this achievement possible significantly ahead of our original timelines,” stated Pedro Lichtinger, Chairman and CEO of Starton Therapeutics.
  • Together, we are not just advancing science; we are transforming lives.”
    Starton previously disclosed preliminary trial findings regarding the safety and efficacy of STAR-LLD for multiple myeloma.

Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting

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Lunedì, Aprile 29, 2024

Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago.
  • “We are excited to participate in our first ASCO Annual Meeting following the creation of Pfizer’s new Oncology organization, where we will highlight our efforts to accelerate breakthrough medicines that help people with cancer live better and longer lives,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer.
  • An oral presentation on extended duration of response from the Phase 3 MOUNTAINEER trial adds to the positive profile of TUKYSA in colorectal cancer.
  • Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting Friday, May 24.

InnoCare Releases 2023 Results and Business Highlights

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Giovedì, Marzo 28, 2024

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

Onco360 Selected as the Preferred National Specialty Pharmacy Partner for XPOVIO® (selinexor)

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Mercoledì, Marzo 13, 2024

Onco360®, the nation’s largest independent Oncology Pharmacy, is now the national specialty pharmacy network partner for Karyopharm’s product XPOVIO® (selinexor), a first-in-class, XPO-1 inhibitor.

Key Points: 
  • Onco360®, the nation’s largest independent Oncology Pharmacy, is now the national specialty pharmacy network partner for Karyopharm’s product XPOVIO® (selinexor), a first-in-class, XPO-1 inhibitor.
  • “Onco360 is excited to expand our partnership with the team at Karyopharm and become the preferred national specialty pharmacy partner for XPOVIO,” said Benito Fernandez, Chief Commercial Officer.
  • Multiple myeloma is an incurable hematological malignancy involving plasma cells.
  • Only 50 percent of patients diagnosed with multiple myeloma survive past five years following initial diagnosis.

Legend Biotech Reports Fourth Quarter and Full Year 2023 Results and Recent Highlights

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Lunedì, Marzo 11, 2024

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its fourth quarter and full year 2023 unaudited financial results and key corporate highlights.

Key Points: 
  • Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its fourth quarter and full year 2023 unaudited financial results and key corporate highlights.
  • Financial Results for Quarter and Year Ended December 31, 2023
    As of December 31, 2023, Legend Biotech had approximately $1.3 billion of cash and cash equivalents, time deposits, and short-term investments.
  • There was no license revenue for the three months ended December 31, 2023, and December 31, 2022.
  • License revenue for the year ended December 31, 2023, was $35.2 million, compared to $50.0 million for the year ended December 31, 2022.

Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS® Regimen in Patients with Relapsed/​Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Retrieved on: 
Martedì, Marzo 12, 2024

Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).

Key Points: 
  • Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).
  • The safety and tolerability of ADCETRIS in the ECHELON-3 trial were consistent with what has been previously presented for patients with relapsed/refractory DLBCL treated with ADCETRIS in clinical trials.
  • “This is the third Phase 3 study in a type of lymphoma to demonstrate an overall survival benefit for an ADCETRIS combination.
  • Pfizer plans to share the ECHELON-3 data with the U.S. Food and Drug Administration (FDA) to potentially support regulatory filing in the U.S.

U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma

Retrieved on: 
Venerdì, Marzo 15, 2024

RARITAN, N.J., March 15, 2024  /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of CARVYKTI® (11 to 0) finding the risk-benefit assessment of CARVYKTI® for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) date of April 5, 2024. 

Key Points: 
  • "We are pleased with the advisory committee's support for CARVYKTI in earlier lines of treatment based on the CARTITUDE-4 data," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • "As a physician and researcher committed to advancing patient care, the potential of CARVYKTI in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma."
  • The ODAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases.
  • The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA.