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 Pharmaceuticals reported positive results from its DUBLIN-3 Phase 3 trial for plinabulin combined with docetaxel in treating 2nd/3rd line NSCLC. The combination achieved a statistically significant improvement in overall survival (OS) and other key endpoints compared to docetaxel alone. Notably, the mean OS was 15.08 months for the combination versus 12.77 months for docetaxel (p=0.0332). BeyondSpring plans to seek FDA and China NMPA approval, with an NDA filing expected in the first half of 2022. Results will be presented at the ESMO Congress and discussed in a conference call today.
BeyondSpring Pharmaceuticals announced promising data on plinabulin for chemotherapy-induced neutropenia (CIN) at the ESMO 2021 Congress. The drug, combined with G-CSF, is under regulatory review in the U.S. with a PDUFA date of November 30, 2021. Key presentations highlighted significant reductions in Grade 4 neutropenia and improvements in patient quality of life. The data stems from a meta-analysis involving over 7000 patients, reinforcing plinabulin's potential as a leading treatment for CIN. Acknowledging its first-in-class status, BeyondSpring continues to pursue global approval.
BeyondSpring reported its Q2 2021 financial results, showing strong advancements in its cancer therapy, plinabulin, particularly in treating non-small cell lung cancer (NSCLC). Key data from the DUBLIN-3 study highlighted significant overall survival improvements when plinabulin was combined with docetaxel versus docetaxel alone. The company has partnered with Hengrui for plinabulin's commercial launch in Greater China. However, net loss has increased to $19.3 million, with cash reserves at $76.3 million, indicating a need for ongoing funding as developmental costs rise.
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.
