Beyondspring Inc Stock Price, News & Analysis

BeyondSpring has submitted a New Drug Application (NDA) to the FDA and China NMPA for plinabulin in combination with G-CSF to prevent chemotherapy-induced neutropenia (CIN). This innovative approach addresses a significant unmet medical need, as CIN represents a major complication in cancer treatment. The PROTECTIVE-2 Phase 3 study showed that plinabulin plus G-CSF improved grade 4 neutropenia prevention from 13.6% to 31.5%. The NDA is supported by data from five trials involving over 1,200 patients, indicating potential to enhance patient care and outcomes in oncology.

BeyondSpring (BYSI) announced a KOL webinar on March 18, 2021, focusing on Plinabulin, its lead asset aimed at preventing chemotherapy-induced neutropenia (CIN). Experts Douglas Blayney and Jeffrey Vacirca will present, detailing the unmet medical needs in CIN prevention. The update includes recent progression in Plinabulin's clinical trials, with positive topline data from the PROTECTIVE-2 Phase 3 trial. Currently, Plinabulin is also in the DUBLIN-3 trial for non-small cell lung cancer, with results expected in H2 2021, highlighting its potential dual functionality in oncology.

BeyondSpring, a biopharmaceutical company focused on innovative cancer therapies, announced CEO Dr. Lan Huang's virtual presentation at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 7:30 a.m. ET. The company will also hold one-on-one meetings during the LifeSci Advisors Corporate Access Event from January 7-13, 2021. BeyondSpring's lead asset, plinabulin, is in Phase 3 trials for non-small cell lung cancer and is recognized by the U.S. FDA as a Breakthrough Therapy for preventing chemotherapy-induced neutropenia.

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.