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) generates a steady flow of news centered on the clinical and regulatory progress of its lead asset, Plinabulin, and on its corporate and financing activities. As a clinical-stage biopharmaceutical company focused on cancer, BeyondSpring’s updates often highlight new data from phase 2 and phase 3 trials in non-small cell lung cancer (NSCLC) and other tumor types, as well as mechanistic findings related to Plinabulin’s dendritic cell maturation and immune-modulating properties.
News releases frequently cover results from major oncology conferences and journals. Examples include presentations at the American Society of Clinical Oncology (ASCO), the IASLC/ASCO North America Conference on Lung Cancer (NACLC), the Society for Immunotherapy of Cancer (SITC), Immuno-Oncology 360°, and ESMO Asia, along with peer-reviewed publications in outlets such as Lancet Respiratory Medicine and Med (Cell Press). These communications describe outcomes from the DUBLIN‑3 phase 3 trial, the 303 and 302 phase 2 studies, and basket trials combining Plinabulin with checkpoint inhibitors, chemotherapy, and radiation.
Investors following BYSI news can also expect regular financial updates, including quarterly results, cash position, and operating expense trends, as well as 10‑K filing announcements. Corporate news items address equity financings, such as registered offerings of ordinary shares, and strategic transactions involving BeyondSpring’s equity stake in SEED Therapeutics, a targeted protein degradation company co-founded by BeyondSpring.
For market participants tracking oncology pipelines, the BYSI news stream provides insight into Plinabulin’s clinical performance, safety profile, biomarker research, and planned registrational strategies, including the company’s intention to advance confirmatory trials like DUBLIN‑4. Bookmarking the news page allows readers to monitor how new data, conference presentations, and SEC-referenced announcements may influence the development trajectory of Plinabulin and BeyondSpring’s broader strategy.
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.
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.
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