Latest news with #HER2-overexpressed
Yahoo
24-04-2025
- Business
- Yahoo
Puma Biotechnology to Host Conference Call to Discuss First Quarter 2025 Financial Results
LOS ANGELES, April 24, 2025--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PT/4:30 p.m. ET on Thursday, May 8, 2025, following the release of its first quarter 2025 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 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. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. Further information about Puma Biotechnology may be found at View source version on Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500info@ ir@ David Schull or Olipriya Das, Russo Partners, +1 212 845
Yahoo
03-04-2025
- Business
- Yahoo
Vividion Therapeutics Doses First Patient in Phase I Study of RAS-PI3Kα Inhibitor for Treatment of Advanced Solid Tumors
VVD-159642, Vividion's fourth clinical-stage program stemming from its chemoproteomics discovery platform, is designed to improve patient outcomes by inhibiting RAS-PI3Kα, a key signaling pathway implicated in solid tumor development and progression Preclinical data support clinical trials with a broad patient population, and may deliver increased efficacy in combination with other RAS/MAPK pathway inhibitors Approximately 20 percent of all cancers are driven by mutations of the RAS family of genes1 Vividion continues to advance the chemoproteomics technology platform with goal to unlock disease-causing, yet traditionally undruggable targets with precision small-molecule therapeutics SAN DIEGO & BERLIN, April 03, 2025--(BUSINESS WIRE)--Vividion Therapeutics, Inc. (Vividion) today announced that the first patient has been dosed in a Phase I clinical trial evaluating VVD-159642, an investigational oral inhibitor designed to target RAS-driven cancers. Vividion is a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, utilizing innovative discovery technologies to unlock targets with strong disease-link, yet traditionally undruggable and develop small molecule precision therapeutics for devastating cancers and immune disorders. The new Phase I study (NCT06804824) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of VVD-159642 as a single agent and in combination with either sotorasib or trametinib in patients with advanced solid tumors. "Despite being a major driver in approximately 20% of cancers, the RAS gene has proven exceptionally difficult to target with drugs, largely due to its essential role in the RAS-PI3Kα signaling pathway, which is vital for healthy cell function," said Jenna Goldberg, M.D., Chief Medical Officer of Vividion. "VVD-159642 is designed and being studied to selectively prevent RAS activation of the PI3Kα pathway, thus blocking oncogenic signaling without disrupting normal cellular function. Preclinical studies of VVD-159642 give us confidence in its potential to inhibit tumor growth while avoiding the on-target toxicities that have limited prior attempts to drug this important target. In addition to providing a more tolerable alternative to current therapies, we believe that VVD-159642 has potential to treat a broad patient population, including in both RAS-mutant and HER2-overexpressed tumors, and may deliver increased efficacy in combination with other RAS/MAPK pathway inhibitors." "We're excited to bring our fourth innovative oncology asset into the clinic, which not only represents continued validation of Vividion's covalent-first chemoproteomics platform but also provides a potential new treatment option for patients with RAS-driven cancers," said Aleksandra Rizo M.D., Ph.D., Chief Executive Officer of Vividion. "The team at Vividion is rapidly advancing scientific innovations into clinical development that have the potential to address multiple devastating diseases not reachable by current therapies," said Christian Rommel, Ph.D., Head of Research and Development at Bayer's Pharmaceuticals Division. "The initiation of this clinical trial marks a significant step forward in leveraging Vividion's innovative drug discovery approach to target a highly relevant signaling pathway and bring a potential new treatment option to people suffering from difficult-to-treat cancers." Vividion also has ongoing Phase I trials evaluating an oral KEAP1 activator in solid tumors and oral STAT3 inhibitor in solid and hematologic malignancies. The company is advancing multiple innovative drug discovery programs toward the clinic and has a rich pipeline of opportunities emerging in early discovery in the fields of oncology and immunology. About VividionVividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a clinical stage biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders. The company's platform has enabled it to identify hundreds of previously unknown functional pockets on well-validated protein targets implicated in a wide range of diseases, while simultaneously identifying compounds from its proprietary covalent chemistry library that interact in a highly selective manner with those pockets. The company is leveraging its proprietary chemoproteomic platform to advance a diversified pipeline of highly selective small molecule therapeutics targeting high value, traditionally undruggable targets in oncology and immunology. For more information, please visit About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to Find more information at Follow us on Facebook: aka (2025-0057) Forward-Looking StatementsThis release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Reference: 1. Ian A. Prior et al "The Frequency of RAS Mutations in Cancer". Cancer Res (2020) 80 (14): 2969–2974. Available at: Accessed: March 2025. View source version on Contacts Bayer Global Media Contact:Derin Denham, phone +1 973 610 7324 Email: Contact for media inquiries Bayer U.S.: Elaine Colon, phone +1 732 236 1587 Email: Vividion Media Contact: Laurie Sherman, phone +1 858 630 8246 Email: media@
Yahoo
05-03-2025
- Business
- Yahoo
Puma Biotechnology to Present at Barclays Annual Global Healthcare Conference
LOS ANGELES, March 05, 2025--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder, will provide an overview of Puma at 2:00 p.m. ET on Tuesday, March 11, at Barclays 27th Annual Global Healthcare Conference. The conference will be held at the Loews Miami Beach. A live webcast of the presentation will be available on the Puma Biotechnology website at The presentation will be archived on the website and available for replay for 30 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. Further information about Puma Biotechnology may be found at View source version on Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500info@ ir@ David Schull or Olipriya Das, Russo Partners, +1 212 845 Sign in to access your portfolio
Yahoo
13-02-2025
- Business
- Yahoo
Puma Biotechnology to Host Conference Call to Discuss Fourth Quarter and Full Year 2024 Financial Results
LOS ANGELES, February 13, 2025--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PT/4:30 p.m. ET on Thursday, February 27, 2025, following the release of its fourth quarter and full year 2024 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 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. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. Further information about Puma Biotechnology may be found at View source version on Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500info@ ir@ David Schull or Olipriya Das, Russo Partners, +1 212 845 Sign in to access your portfolio
Yahoo
05-02-2025
- Business
- Yahoo
Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)
LOS ANGELES, February 05, 2025--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on February 4, 2025, the Compensation Committee of Puma's Board of Directors approved the grant of inducement restricted stock unit awards covering 7,250 shares of Puma common stock to two new non-executive employees. The awards were granted under Puma's 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying each award vesting on the first anniversary of the award's vesting commencement date, February 1, 2025, and one-sixth of the shares underlying each award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The awards were granted as an inducement material to the new employees entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4). About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. View source version on Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500info@ ir@ Sign in to access your portfolio
