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. reports developments tied to its clinical-stage oncology pipeline, led by Plinabulin, an immune-modulating cancer therapy studied in non-small cell lung cancer and other indications. Recurring updates cover DUBLIN-3 data analyses, Plinabulin combinations with docetaxel, checkpoint inhibitors and antibody-drug conjugates, and presentations at oncology and immuno-oncology medical meetings.
Company news also includes periodic financial results, annual-report announcements, capital and corporate updates, and disclosures related to BeyondSpring’s equity interest in SEED Therapeutics and molecular glue degrader programs. These updates connect the company’s research activity, clinical-development strategy and financing actions with its public-company reporting cycle.
BeyondSpring (NASDAQ: BYSI) announced three poster presentations at the ESMO 2021 Congress highlighting the benefits of plinabulin combined with G-CSF for preventing chemotherapy-induced neutropenia (CIN). The combination is currently under regulatory review in the U.S. and China, with a PDUFA date of November 30, 2021. The presentations will be available starting September 16, 2021. Plinabulin, a promising treatment for CIN and a Phase 3 candidate for non-small cell lung cancer, has also received Breakthrough Designation from the FDA in both countries.
BeyondSpring, a biopharmaceutical company focused on innovative cancer therapies, will present at the Morgan Stanley 19th Annual Global Healthcare Conference on September 14, 2021, at 11:45 AM ET during a fireside chat. Additionally, it will participate in R.W. Baird’s 2021 Global Healthcare Conference on September 15, 2021, at 4:55 PM ET, with a presentation format. 1x1 meetings are available from September 9-15, 2021. The company is advancing plinabulin, a leading drug candidate, for various cancer treatments and prevention of chemotherapy-induced neutropenia.
BeyondSpring Inc. (NASDAQ: BYSI) will host a conference call on September 10, 2021, at 8:00 AM ET to discuss financial results for Q2 2021 and recent corporate updates. Notably, BeyondSpring's lead asset, plinabulin, is progressing in clinical trials, aiming for approval to prevent chemotherapy-induced neutropenia. The company has received Priority Review and breakthrough designation in the U.S. and China, with a PDUFA date set for November 30, 2021. The conference can be accessed via phone or webcast, with an archived replay available on its website.
BeyondSpring (NASDAQ: BYSI) announced significant findings from its DUBLIN-3 Phase 3 trial of plinabulin, showing improved survival rates for NSCLC patients. Compared to docetaxel alone, the combination with plinabulin demonstrated enhanced overall survival, overall response rate, and progression-free survival, alongside a reduction in severe neutropenia incidents. The findings will be presented at the ESMO Congress on September 20, 2021. BeyondSpring plans to submit an NDA in the U.S. and China for plinabulin, furthering its regulatory journey for treating NSCLC and preventing chemotherapy-induced neutropenia.
BeyondSpring's subsidiary, Wanchunbulin, has formed a partnership with Hengrui Pharmaceuticals for the exclusive rights to commercialize and co-develop plinabulin in Greater China. The agreement includes milestone payments of up to 1.3 billion RMB (approx. $200 million), consisting of an upfront payment of 200 million RMB (about $30 million) and regulatory sales milestones. Hengrui will also make an equity investment of 100 million RMB (around $15 million) into Wanchunbulin. This collaboration focuses on the potential of plinabulin in treating chemotherapy-induced neutropenia and non-small cell lung cancer.
BeyondSpring (NASDAQ: BYSI) announced that CEO Dr. Lan Huang has been named one of the PharmaVOICE 100 most inspiring people in life sciences. This recognition highlights her leadership in developing plinabulin, a key oncology drug under FDA Priority Review for chemotherapy-induced neutropenia, with a PDUFA date set for November 30, 2021. Positive results from the DUBLIN-3 Phase 3 study showed improved survival rates for non-small cell lung cancer patients, supporting plans for a second NDA submission next year, potentially expanding plinabulin's indications.
BeyondSpring announced positive topline results from the DUBLIN-3 trial, demonstrating that plinabulin combined with docetaxel significantly improves overall survival (mean OS, p = 0.03) for NSCLC patients compared to docetaxel alone. Key secondary endpoints also showed significant improvements in overall response rate, progression-free survival, and reduced incidence of Grade 4 neutropenia. The company intends to seek U.S. FDA and China NMPA approval based on these results, with full data set to be presented at an upcoming conference.
BeyondSpring (NASDAQ: BYSI) appointed Brendan Delaney to its Board of Directors, effective immediately. Delaney brings over 25 years of experience in commercial oncology drug launches, which is crucial as BeyondSpring's lead asset, plinabulin, is under FDA Priority Review for preventing chemotherapy-induced neutropenia, with a PDUFA date set for November 30, 2021. His expertise is expected to aid in the commercial launch planning, contingent on regulatory approval.
BeyondSpring announced its participation in the virtual William Blair Biotech Focus Conference on July 14-15, 2021. The company, focused on innovative cancer therapies, will be available for one-on-one meetings during the event. Their lead asset, plinabulin, is under review for preventing chemotherapy-induced neutropenia, with a PDUFA date of November 30, 2021, in the U.S. BeyondSpring’s pipeline includes pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, utilizing a targeted protein degradation discovery platform.
BeyondSpring announced an R&D Day on June 25, 2021, to discuss its immune agent Plinabulin for cancer treatment, particularly in non-small cell lung cancer. Key Opinion Leaders Steven Lin, M.D., and Trevor Feinstein, M.D., will present insights on the current treatment landscape. Topics include Plinabulin's FDA priority review for chemotherapy-induced neutropenia and ongoing pivotal studies. The company aims to address unmet medical needs in cancer therapy, with Plinabulin being central to their strategy, also exploring combinations with checkpoint inhibitors.