CDK4

Arvinas Reports First Quarter 2024 Financial Results and Provides Corporate Update

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Mardi, mai 7, 2024
Corporation, Sale, Greyhawk, License, Ribociclib, Palsy, HER2, General counsel, NVS, Food, ARVN, Research, Quantum Leap, Business development, Genentech, Development, Administration, Arm, Prostate cancer, Exercise, CDK7, Senior, Patient, Bayer, EOP, CDK4, Interim, PROTAC, LRRK2, Pharmaceutical industry

NEW HAVEN, Conn., May 07, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the first quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • Announced the resignation of Chief Financial Officer and Treasurer, Sean Cassidy, effective February 29, 2024.
  • Research and Development Expenses: Research and development expenses were $84.3 million for the quarter ended March 31, 2024, as compared with $95.3 million for the quarter ended March 31, 2023.
  • General and Administrative Expenses: General and administrative expenses were $24.3 million for the quarter ended March 31, 2024, as compared with $24.9 million for the quarter ended March 31, 2023.
  • Revenues: Revenues were $25.3 million for the quarter ended March 31, 2024 as compared with $32.5 million for the quarter ended March 31, 2023.

BeiGene Reports First Quarter 2024 Financial Results and Business Updates

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Mercredi, mai 8, 2024
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, FDA, Obinutuzumab, Acalabrutinib, NMPA, Food, Sustainability, European Commission, Progression-free survival, Fulvestrant, MTA, ASCEND, ESCC, Patent, PDUFA, ADC, CLL, Patient, CDK4, Symantec Endpoint Protection, Chronic lymphocytic leukemia, HPK1, Tislelizumab, BLA, Anticipation, EGFR, NSCLC, CDK2, GAAP, Food and Drug Administration, Growth, Lung cancer, Pharmaceutical industry

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.

Key Points: 
  • Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.
  • The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab.
  • Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period.
  • The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

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

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Lundi, avril 29, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, PFS, Brentuximab vedotin, Triple-negative breast cancer, Lung cancer, MBC, ASCO, Lymphoma, PFE, Metastasis, ALK, Breast cancer, Learning, CRS, Food, Colorectal cancer, Abstract, RRMM, Rituximab, ADC, HR, CDK4, De novo, Spacecraft, DLBCL, Tucatinib, Anaplastic lymphoma kinase, Safety, Crizotinib, Pembrolizumab, Survival, EZH2, Pros, Inc., Neoplasm, Progression-free survival, Recurrence, PAL, Biologics license application, HRR, Hodgkin lymphoma, Patient, Society, Cyclin-dependent kinase 4, Cytokine release syndrome, Annual general meeting, APLS, PBC, Lenalidomide, B-cell lymphoma, Pharmaceutical industry

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.

Arvinas Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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Mardi, février 27, 2024
CDK4, ESPP, Research, BCL6, Sale, Exercise, LRRK2, ARVN, CDK7, ATM, HER2, Genentech, European Medicines Agency, Congress, Development, Breast cancer, Pfizer, CBR, ESMO, Everolimus, Greyhawk, ESR1, Oncology, Enrollment, Investment, Insurance, Prostate cancer, PFS, Food, Ribociclib, Bayer, Administration, Patient, Neutropenia, Pharmaceutical industry

NEW HAVEN, Conn., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Median PFS of 11.1 and 11.0 months in patients with ESR1 wild-type and ESR1 mutant tumors, respectively.
  • Announced the appointment of Randy Teel, Ph.D., Arvinas’ current senior vice president of corporate and business development, to the role of interim chief financial officer and treasurer.
  • The Arvinas Board of Directors has launched a formal search process to identify Mr. Cassidy’s permanent replacement.
  • Revenues: Revenue was $78.5 million and $(43.1) million for the year and quarter ended December 31, 2023 as compared with $131.4 million and $38.0 million for the year and quarter ended December 31, 2022.

Arvinas and Pfizer Announce Interim Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) and Plans to Expand Vepdegestrant Development Program

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Mardi, décembre 5, 2023
CBR, Patient, Febrile neutropenia, ESR1, Breast Cancer Research, HER2, Neoplasm, Infection, Breast cancer, Fulvestrant, PFE, Colorectal cancer, Cyclin-dependent kinase 4, Chimera, Neutropenia, Melanoma, Sarah Cannon Research Institute, DNA, Incidence, Research, CDK4, ARVN, Abstract, FIH, Proteolysis, Face, Webcast, CDK, Safety, PFS, Circulating tumor DNA, Pharmaceutical industry

NEW HAVEN, Conn. and NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced clinical data for vepdegestrant (ARV-471), a novel oral PROteolysis TArgeting Chimera (PROTAC®) estrogen receptor (ER) degrader, in combination with palbociclib (IBRANCE®). Interim results from the Phase 1b combination cohort demonstrate encouraging clinical activity in heavily pre-treated patients with a median of four lines of therapy across disease settings with locally advanced or metastatic ER positive/human epidermal growth factor 2 (HER2) negative (ER+/HER2-) breast cancer. These data will be presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • These data will be presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • The results from this trial evaluating vepdegestrant in combination with palbociclib help advance our goals of benefitting patients with ER+/HER2- breast cancer.
  • “Collectively, the data presented this year at SABCS for vepdegestrant, especially in combination with palbociclib, show the potential of this investigational innovative therapeutic option.
  • A conference call and webcast will be held with executives from Arvinas and Pfizer to discuss the data presented at SABCS.

Kinnate Biopharma Inc. Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

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Jeudi, novembre 9, 2023
KNTE, Brain, Research, SAN, Food, MEK, NRAS, Workforce, Investment, Clinical trial, CDK4, Investigational New Drug, Binimetinib, FGFR, Pharmaceutical industry, Cryptocurrency

(Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, today announced financial results for the third quarter of 2023 and recent corporate updates.

Key Points: 
  • (Nasdaq: KNTE) (“Kinnate” or the “Company”), a clinical-stage precision oncology company, today announced financial results for the third quarter of 2023 and recent corporate updates.
  • Third quarter research and development expenses for 2023 were $24.5 million, compared to $23.5 million for the same period in 2022.
  • Third quarter general and administrative expenses for 2023 were $6.6 million, compared to $7.8 million for the same period in 2022.
  • Third quarter net loss for 2023 was $30.7 million, compared to $30.7 million for the same period in 2022.

BeiGene and Ensem Therapeutics Announce Partnership to Advance Differentiated CDK2 Inhibitor

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Mardi, novembre 21, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Kinetic, BGNE, Breast cancer, CDK4, Patient, Doctor of Philosophy, SSE, Drug discovery, Cancer, Partnership, CDK2, Pharmaceutical industry, BeiGene, IND

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and Ensem Therapeutics, Inc. (ENSEM), a biotechnology company focusing on high-value and difficult-to-drug oncology targets, today announced an agreement for BeiGene to acquire an exclusive global license to an Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and Ensem Therapeutics, Inc. (ENSEM), a biotechnology company focusing on high-value and difficult-to-drug oncology targets, today announced an agreement for BeiGene to acquire an exclusive global license to an Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor.
  • “This CDK2 inhibitor from ENSEM complements our internally discovered Phase 1 CDK4 inhibitor, which has the potential to improve upon current CDK4/6 inhibitors in some breast cancer patients, and strengthens our early development pipeline in breast cancer and other solid tumors.
  • “We are pleased to partner with BeiGene on the development of this differentiated CDK2 inhibitor,” said Shengfang Jin, Ph.D., President and Chief Executive Officer at ENSEM.
  • “We believe BeiGene is the right partner to advance our first IND-ready asset due to their wealth of expertise in bringing innovative cancer therapies to patients globally.

Arvinas Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Mardi, novembre 7, 2023
Research, Sale, Arm, Equity method, Bayer, ATM, ESMO, LRRK2, RPF, Enrollment, Greyhawk, Income tax, CTA, Prostate cancer, Exercise, Development, PROTAC, Pfizer, Clinical trial, BCL6, Neuroscience, CDK4, Breast cancer, State Administrative Expenses, ARVN, Genentech, European Society of Gynaecological Oncology, Investment, AR, Patient, Administration, Everolimus, Pharmaceutical industry, Medical imaging, Dietary supplement, Life insurance, IND, Gaius Papirius Carbo Arvina

NEW HAVEN, Conn., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Research and Development Expenses: Research and development expenses were $85.9 million for the quarter ended September 30, 2023, as compared with $77.5 million for the quarter ended September 30, 2022.
  • General and Administrative Expenses: General and administrative expenses were $22.6 million for the quarter ended September 30, 2023, as compared with $20.0 million for the quarter ended September 30, 2022.
  • Revenues: Revenues were $34.6 million for the quarter ended September 30, 2023, as compared with $33.2 million for the quarter ended September 30, 2022.
  • Net Loss: Net loss was $64.0 million for the quarter ended September 30, 2023, as compared with $66.2 million for the quarter ended September 30, 2022.

Kinnate Biopharma Inc. Announces Pipeline Updates, Strategic Reprioritization and Workforce Restructuring

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Lundi, septembre 18, 2023
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(Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.

Key Points: 
  • (Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.
  • Additionally, Kinnate will pause development of KIN-7136 and explore strategic alternatives for exarafenib monotherapy and KIN-3248, as part of the reprioritization plan.
  • We believe that reprioritizing our programs is the most effective approach to unlock the full promise of our innovative therapies.”
    Farzan added, “The reprioritization plan unfortunately impacts our workforce.
  • Kinnate will implement a corporate restructuring by reducing the Company’s workforce by approximately 70%.

Boundless Bio Announces Clinical Trial Collaboration and Supply Agreement with Lilly to Evaluate VERZENIO® (abemaciclib) in Combination with BBI-355 in Patients with CDK4 or CDK6 Amplified Solid Tumors

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Mardi, septembre 19, 2023
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, DNA, CDK6, Bio, Clinical trial, A-DNA, Lilly, Patient, Biology, Eli Lilly and Company, Boundless, CDK4, Breast cancer, Pharmaceutical industry

Boundless Bio , a clinical stage, next-generation precision oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, today announced a clinical trial collaboration and supply agreement with Eli Lilly and Company for supply of their CDK4/6 inhibitor Verzenio® (abemaciclib) for use in combination with BBI-355 in a clinical trial of patients with locally advanced or metastatic solid tumors with oncogene amplifications.

Key Points: 
  • Boundless Bio , a clinical stage, next-generation precision oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, today announced a clinical trial collaboration and supply agreement with Eli Lilly and Company for supply of their CDK4/6 inhibitor Verzenio® (abemaciclib) for use in combination with BBI-355 in a clinical trial of patients with locally advanced or metastatic solid tumors with oncogene amplifications.
  • BBI-355 is an orally administered, novel, selective small molecule inhibitor of CHK1 and represents what Boundless Bio believes is the first ecDNA-directed therapy (ecDTx) in development for oncogene amplified cancers.
  • “We are pleased to enter this supply agreement with Lilly to evaluate the combination of BBI-355 and abemaciclib in patients with ecDNA-driven solid tumors harboring CDK4 or CDK6 amplifications in our ongoing POTENTIATE trial,” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio.
  • “To date, CDK4/6 inhibitors have only been approved in HR+/HER2- breast cancer.