Welcome to our dedicated page for Beyondspring news (Ticker: BYSI), a resource for investors and traders seeking the latest updates and insights on Beyondspring stock.
BeyondSpring Inc (NASDAQ: BYSI) is a clinical-stage biopharmaceutical leader advancing innovative cancer therapies through its Plinabulin pipeline and target protein degradation research. This page serves as the definitive source for verified company updates, providing investors and researchers with essential insights into therapeutic developments and strategic initiatives.
Access timely announcements spanning clinical trial progress, regulatory milestones, and partnership agreements. Our curated collection includes press releases on Plinabulin's multifaceted mechanism of action, updates from global Phase 3 studies, and innovations from the SEED Therapeutics collaboration. Each update is vetted for accuracy to support informed decision-making.
Bookmark this resource for structured access to BeyondSpring's scientific advancements in immuno-oncology and protein degradation technology. Regular updates ensure you maintain current awareness of the company's progress in addressing unmet needs in NSCLC and other oncology indications.
BeyondSpring (NASDAQ: BYSI) announced that CEO Dr. Lan Huang will virtually present at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 7:30 a.m. ET. The leadership team will also be available for one-on-one meetings during the LifeSci Advisors Corporate Access Event on January 7-8 and 11-13, 2021. BeyondSpring focuses on developing innovative cancer therapies, including plinabulin, which received Breakthrough Therapy designation from the U.S. FDA. More details can be found in the Events and Presentations section of the BeyondSpring website.
BeyondSpring (NASDAQ: BYSI) announced the appointment of Dr. Jeffrey Vacirca to its Board of Directors, aiming to strengthen its oncology expertise as it seeks commercial approval for plinabulin. This follows promising Phase 3 data from the PROTECTIVE-2 study, which evaluates the drug's efficacy in preventing chemotherapy-induced neutropenia. Dr. Vacirca brings extensive experience as CEO of New York Cancer & Blood Specialists and is well-regarded in the oncology community, expected to enhance collaboration and strategic direction for BeyondSpring.
BeyondSpring (NASDAQ: BYSI) recently announced positive results from its Phase 3 PROTECTIVE-2 Study, showcasing that the combination of plinabulin and pegfilgrastim significantly reduces the incidence of profound neutropenia by 53% compared to pegfilgrastim alone (21.6% vs. 46.4%, p=0.0001). Additionally, the combination therapy leads to a 41% reduction in the odds of febrile neutropenia. These findings were presented at the 2020 San Antonio Breast Cancer Symposium. The company aims to submit a New Drug Application in Q1 2021, following Breakthrough Therapy Designation by the FDA.
BeyondSpring (NASDAQ: BYSI) announced its participation in two significant upcoming events: the 62nd American Society of Hematology (ASH) Annual Meeting (December 5-8, 2020) and the San Antonio Breast Cancer Symposium (SABCS) (December 8-11, 2020). Notably, the company will present findings from the PROTECTIVE-2 Trial, focusing on the Plinabulin and Pegfilgrastim combination's efficacy in preventing chemotherapy-induced neutropenia in breast cancer patients. Presentations will include a poster at ASH on December 5 and three posters at SABCS starting December 9, 2020, featuring research by Dr. Douglas W. Blayney from Stanford University.
BeyondSpring Inc. (NASDAQ: BYSI), a biopharmaceutical company focused on immuno-oncology therapies, will present a corporate overview at the Evercore ISI HealthCONx Conference on December 2, 2020. Dr. Lan Huang, Co-founder and CEO, will participate in a fireside chat at 9:15 am ET. Investors can access a live webcast and replay on BeyondSpring's website under the Investors section. The company's lead asset, plinabulin, is in a Phase 3 trial for non-small cell lung cancer and has received Breakthrough Therapy designation from the U.S. FDA for preventing chemotherapy-induced neutropenia.
BeyondSpring announced a public offering of 7,500,000 ordinary shares priced at $10.00 each, aiming to raise approximately $75 million. The offering is set to close on November 23, 2020, pending customary conditions. Proceeds will support the commercialization of plinabulin and further clinical development. The underwriters also hold a 30-day option for an additional 1,125,000 shares. The offering is conducted under the existing shelf registration with the SEC, effective from November 12, 2020.
BeyondSpring has launched an underwritten public offering of $75 million of its ordinary shares, with the potential to grant underwriters an additional $11.25 million. The proceeds are designated for the commercialization of Plinabulin, ongoing clinical development, and general corporate purposes. The offering is managed by BofA Securities, Jefferies, and Evercore ISI, with terms subject to market conditions. This offering follows the Company's effective shelf registration statement filed with the SEC on November 3, 2020.
BeyondSpring reported its Q3 2020 financial results and operational updates, highlighting a pivotal Phase 3 study for plinabulin showing superior outcomes in preventing chemotherapy-induced neutropenia compared to pegfilgrastim alone. The company plans to file a New Drug Application for plinabulin in the U.S. by early 2021.
Financially, R&D expenses rose to $8.6 million, while G&A expenses increased to $6.7 million, leading to a net loss of $14.5 million. BeyondSpring has $30.9 million in cash and believes it can sustain ongoing clinical trials and NDA preparations.
BeyondSpring (NASDAQ: BYSI) announced positive topline data from its PROTECTIVE-2 Phase 3 study, demonstrating that plinabulin combined with pegfilgrastim significantly prevents Grade 4 neutropenia in chemotherapy patients (31.5% vs. 13.6%, p=0.0015). The combination also achieved significant secondary endpoints, impacting duration of severe neutropenia and absolute neutrophil count. With Breakthrough Therapy designations from the U.S. FDA and China NMPA, BeyondSpring is preparing for NDA submission in Q1 2021. The study included 221 patients and provides promising insights for addressing chemotherapy-induced neutropenia in up to 440,000 U.S. patients annually.
BeyondSpring, a biopharmaceutical company trading on NASDAQ under the symbol BYSI, will present a corporate overview at the Jefferies London Healthcare Conference on November 17, 2020, at 2:55 pm Eastern Time. The event will highlight the company's innovative immuno-oncology therapies aimed at patients with high unmet medical needs. Plinabulin, their lead immune asset, is undergoing Phase 3 trials for chemotherapy-induced neutropenia and non-small cell lung cancer. The presentation can be accessed via a live webcast and archived on their official website.
