Puma Biotechnology

Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Retrieved on: 
Wednesday, March 20, 2024
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This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.

Key Points: 
  • This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.
  • Puma plans to initiate this trial in the second half of 2024.
  • Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial.
  • We look forward to the initiation of the ALISCA-Breast1 trial in the second half of 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

Vaxart, Inc. Appoints Steven Lo as President, Chief Executive Officer, and Director

Retrieved on: 
Wednesday, March 6, 2024
Therapy, SAN, AstraZeneca, Biotechnology, University, Puma Biotechnology, Drug development, Endocrinology, Genentech, Roche, Kaiser Permanente, Management

SOUTH SAN FRANCISCO, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) (the “Company” or “Vaxart”) today announced that it has appointed Steven Lo as President and Chief Executive Officer and a member of the Board of Directors, effective as of March 18, 2024. Mr. Lo is a highly experienced biopharma executive with over 25 years of experience in the healthcare, biotechnology, and pharmaceutical industries, including over 12 years of C-level experience in publicly traded biotech companies. Michael J. Finney, Ph.D. will step down as interim Chief Executive Officer and will continue to serve as Chair of the Board of Directors.

Key Points: 
  • Michael J. Finney, Ph.D. will step down as interim Chief Executive Officer and will continue to serve as Chair of the Board of Directors.
  • Lo.
  • Lo was most recently with Valitor, Inc., a private biotech company, serving as its Chief Executive Officer and a member of the board of directors since 2022.
  • Lo was the President, Chief Executive Officer, and member of the board of directors of Zosano Pharma Corporation, a clinical-stage biopharmaceutical company.

Puma Biotechnology to Host Conference Call to Discuss Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 15, 2024
Research, FDA, Clinical Trials, Practice Management, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, EST, Puma Biotechnology, Conference

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 29, 2024, following the release of its fourth quarter and full year 2023 financial results.

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 29, 2024, following the release of its fourth quarter and full year 2023 financial results.
  • The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international).
  • Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https://www.pumabiotechnology.com .
  • A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

Zymeworks Announces Appointment of Dr. Alessandra Cesano to its Board of Directors

Retrieved on: 
Thursday, February 8, 2024
Standard of care, Immunotherapy, Amgen, Prostate cancer, Research, SITC, Society, Patient, ESSA, FDA, Publication, Biomarker, Doctor of Philosophy, NanoString Technologies, Therapy, Drug development, Biogen, Journal, University, Puma Biotechnology

Dr. Cesano succeeds Dr. Kenneth Hillan, who will step down effective today after a successful 7-year tenure as a director of Zymeworks.

Key Points: 
  • Dr. Cesano succeeds Dr. Kenneth Hillan, who will step down effective today after a successful 7-year tenure as a director of Zymeworks.
  • “Zymeworks is honored to welcome Dr. Cesano to our board of directors,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks.
  • She joins three other new directors appointed in 2023: Mr. Derek Miller, Mr. Carlos Campoy, and Dr. Nancy Davidson.”
    “The Zymeworks board of directors is sincerely grateful to Dr. Hillan for his dedicated service and significant contributions to the board.
  • Dr. Cesano was also appointed to serve as a member of the research and development committee and nominating and corporate governance committee of the board of directors.

Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Paclitaxel, Tamoxifen, CDK, Food, Letrozole, Carcinoma, Fulvestrant, Progression-free survival, Doctor of Pharmacy, Breast cancer, Patient, Anastrozole, PFS, BID, FDA, Puma Biotechnology, DOR, DCR, ORR, PUMA, Phase, Biomarker, Cancer, Pharmaceutical industry, Birth control

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).
  • The Company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers.
  • “There continues to be a need for new drugs for the treatment of metastatic HER2-negative, hormone receptor-positive breast cancer,” said Alvin Wong, PharmD, Chief Scientific Officer of Puma Biotechnology.
  • “The clinical trials of alisertib to date in HER2-negative, hormone receptor-positive metastatic breast cancer have demonstrated alisertib’s potential clinical benefit in this patient population, and we look forward to initiating the PUMA-ALI-1201 trial in 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

Puma Biotechnology to Host Conference Call to Discuss Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, October 19, 2023
Biotechnology, Practice Management, FDA, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, Conference, Puma Biotechnology, EDT, Puma, Fine chemical, Internet service provider

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, November 2, 2023, following the release of its third quarter 2023 financial results.

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, November 2, 2023, following the release of its third quarter 2023 financial results.
  • The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international).
  • Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https://www.pumabiotechnology.com .
  • A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

Puma Biotechnology Announces Presentation of Findings from a Phase I/II Study of Alisertib and Pembrolizumab for Rb-Deficient Head and Neck Squamous Cell Carcinomas at the 2023 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting

Retrieved on: 
Saturday, October 14, 2023
Biotechnology, Practice Management, FDA, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, Aurora, HIV disease progression rates, Alisertib, Biomarker, Division, Rb, Plasma, Pembrolizumab, AACR, CD56, MD Anderson Cancer Center, HNSCC, Apoptosis, DNA, Cancer, Mitosis, Membrane protein, Aurora kinase A, AURKA, University, Patient, Preclinical development, Therapy, Doctor of Philosophy, CD8, Puma Biotechnology, Retinoblastoma protein, Immunotherapy, Phase, Immunogenic cell death, Carcinoma, Thyroid, HPV, PFS, Infection, Head, Adenosine, Puma, CPS, Cytokine, Nature, Progression-free survival, Conference, Poster, Pharmaceutical industry, Vaccine, Aurora kinase

Alisertib is an adenosine triphosphate–competitive, reversible inhibitor of Aurora Kinase A (AURKA) that results in disruption of mitosis.

Key Points: 
  • Alisertib is an adenosine triphosphate–competitive, reversible inhibitor of Aurora Kinase A (AURKA) that results in disruption of mitosis.
  • A synthetic lethal relationship between AURKA and Rb1 has been implicated preclinically, and alisertib has been shown to induce immunogenic cell death in HPV+ cancer cells.
  • Based on these findings, the 40 mg dose level was selected for the Phase II portion of the study.
  • The prospect of biomarker-defined populations who may benefit most from alisertib treatment continues to be an area of great interest.”

Susan G. Komen® Hosts 2023 San Diego MORE THAN PINK Walk

Retrieved on: 
Tuesday, October 10, 2023
Family, Research, Breast cancer, Global Payments, Caregiver, CBS, Disease, THAN, Petco, Puma Biotechnology, Amanda, Friends, SAN, Survivor, Walking, Collins Aerospace, Volunteering, CBS 8, Patient, Birth control, Balboa Park

SAN DIEGO, Oct. 10, 2023 /PRNewswire/ -- Susan G. Komen®, the world's leading breast cancer organization, will be hosting the 2023 San Diego MORE THAN PINK Walk on Sunday, November 5 at Balboa Park.

Key Points: 
  • SAN DIEGO, Oct. 10, 2023 /PRNewswire/ -- Susan G. Komen® , the world's leading breast cancer organization, will be hosting the 2023 San Diego MORE THAN PINK Walk on Sunday, November 5 at Balboa Park.
  • "We are excited to have the community join us this year at the MORE THAN PINK Walk to make a difference in our fight against breast cancer in our community," said Leia Brune, executive director for Susan G. Komen.
  • Breast cancer survivors and those living with metastatic disease, caregivers, family members and loved ones will come together in Balboa Park starting at 6:30 a.m.
  • Walk participants will include breast cancer survivors, metastatic breast cancer thrivers, co-survivors, volunteers, community partners and supporters of Susan G. Komen.

Susan G. Komen® Hosts Annual 2023 Los Angeles MORE THAN PINK Walk

Retrieved on: 
Friday, September 29, 2023
Survivor, Puma Biotechnology, Friends, Breast cancer, Research, THAN, IHeartRadio, Bank of America, KABC, Patient, Daiichi Sankyo, CBD, Walking, Bank, Exposition Park, Family, Capital Group Companies, Caregiver, Disease, Birth control, Walgreens

LOS ANGELES, Sept. 29, 2023 /PRNewswire/ -- Susan G. Komen®, the world's leading breast cancer organization, will be hosting the annual 2023 Los Angeles MORE THAN PINK Walk on Sunday, October 29, 2023. The annual Walk will be held for the first time at Exposition Park.  

Key Points: 
  • LOS ANGELES, Sept. 29, 2023 /PRNewswire/ -- Susan G. Komen® , the world's leading breast cancer organization, will be hosting the annual 2023 Los Angeles MORE THAN PINK Walk on Sunday, October 29, 2023.
  • The annual Walk will be held for the first time at Exposition Park.
  • "We are excited to have the community join us this year at the MORE THAN PINK Walk to make a difference in our fight against breast cancer in our community," said Yolanda Van Dyke, Executive Director for Los Angeles Susan G. Komen.
  • Walk participants will include breast cancer survivors, metastatic breast cancer thrivers, co-survivors and supporters of Susan G. Komen.

enGene Appoints Richard Bryce, MBChB, MRCGP, MFPM, as Chief Medical Officer

Retrieved on: 
Thursday, September 7, 2023
Puma Biotechnology, Bachelor, Royal college, Biotechnology, University, Therapy, RCOG, Engen Botswana Limited, Bachelor of Medicine, Bachelor of Surgery, Membership of the Royal College of Physicians of Ireland, MRCGP, RCP, Carfilzomib, DDX, Royal Navy, Onyx Pharmaceuticals, EMA, LEGEND, Science, Patient, Liposarcoma, Chief medical informatics officer, Commander of the Navy (Sri Lanka), Growth, FDA, Puma, Pharmaceutical industry, EU, NMIBC, Medicine

"We are thrilled to have Dr. Bryce join enGene during a pivotal period in our growth as we advance our Phase 1/2 registrational LEGEND study for EG-70 in NMIBC," said Jason Hanson, CEO of enGene.

Key Points: 
  • "We are thrilled to have Dr. Bryce join enGene during a pivotal period in our growth as we advance our Phase 1/2 registrational LEGEND study for EG-70 in NMIBC," said Jason Hanson, CEO of enGene.
  • Before joining enGene, Dr. Bryce was most recently Chief Medical Officer at Rain Oncology, a late-stage company developing precision oncology therapeutics, where he built a clinical development team and oversaw multiple clinical studies, including a global Phase 3 registrational study in dedifferentiated liposarcoma.
  • Prior to that, he was Chief Medical & Scientific Officer at Puma Biotechnology, where he led the development strategy for neratinib.
  • He also served as a Surgeon Lieutenant Commander in the Royal Navy.