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BeyondSpring Inc. (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies. The company focuses primarily on its lead asset, Plinabulin, a novel cancer therapeutic. Plinabulin is currently in a global Phase 3 trial for non-small-cell lung cancer (NSCLC) and is also being tested in a pivotal global Phase 3 trial for the prevention of docetaxel-induced neutropenia. This compound operates as a tubulin depolymerizing agent and functions through multiple mechanisms of action, including immune system enhancement, tumor cell apoptosis, and vascular disruption.
BeyondSpring is also expanding clinical trials to address additional cancer indications. These include immuno-oncology applications with immune checkpoint inhibitors in NSCLC, central nervous system malignancies such as glioblastoma (GBM), and KRAS-positive mutant cancers.
Recent developments highlight the promising potential of Plinabulin:
- Brain Cancer Research: New preclinical data from the University of Toledo College of Medicine demonstrate Plinabulin's anti-proliferative properties in glioblastoma multiforme (GBM) at therapeutic concentrations. The data confirm Plinabulin's ability to block GBM patient-derived sphere invasion and significantly decrease GBM cell survival and microtubule extension.
- Immunotherapy Advancements: BeyondSpring and MD Anderson presented at the Society for Immunotherapy of Cancer's (SITC) Annual Meeting, showcasing Plinabulin's immunomodulating activity. The Phase 1 clinical study revealed a high disease control rate in patients with various cancers who had progressed on PD-1, PD-L1, and/or CTLA-4 antibodies.
In addition to its focus on cancer therapies, BeyondSpring has a majority-owned subsidiary, SEED Therapeutics, which is advancing Targeted Protein Degradation (TPD) molecular glue technology for innovative drug discovery. SEED has made significant progress, including a collaboration with Eli Lilly for developing oncology assets.
The company continues to advance its programs strategically, with a notable reduction in R&D and G&A expenses in 2023. As of December 31, 2023, BeyondSpring reported $17.9 million in cash and short-term investments, positioning itself well for upcoming milestones in 2024.
BeyondSpring remains committed to improving clinical outcomes for patients with high unmet medical needs through groundbreaking technology and strategic partnerships.
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.
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.
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