Beyondspring Inc Stock Price, News & Analysis

BeyondSpring Pharmaceuticals (NASDAQ: BYSI) announced the appointment of Mark Santos to its Board of Directors. Santos, who has over 30 years of experience in the healthcare sector, will support BeyondSpring's transition into an R&D and commercial company. Previously President of ION Solutions, he brings significant expertise in oncology, which is critical as BeyondSpring advances its lead asset, plinabulin, for preventing chemotherapy-induced neutropenia and anti-cancer benefits. Plinabulin is under Priority Review in the U.S. and China, with a PDUFA date of November 30, 2021.

BeyondSpring (NASDAQ: BYSI) has announced the commencement of a Phase 2 study for its lead asset, plinabulin, which is combined with nivolumab and ipilimumab in treating recurrent small-cell lung cancer (SCLC) patients who failed prior therapies. The Phase 1 study showed a promising 43% overall response rate (ORR) with significant tumor reductions and a notable decrease in adverse effects compared to historical data. Conducted by the Big Ten Cancer Research Consortium, the study aims to evaluate the triple combination's efficacy and safety, addressing an urgent medical need in SCLC.

BeyondSpring Pharmaceuticals (BYSI) announced promising preclinical data showcasing the effectiveness of plinabulin against small cell lung cancer (SCLC) at the 2021 AACR-NCI-EORTC conference. Plinabulin demonstrated strong **anti-cancer effects** in 80 patient-derived tumor models, particularly in SCLC with an **IC₇₀ of 35 nM**. The combination of plinabulin with nivolumab and ipilimumab reported a **46% objective response rate** in clinical trials. These findings bolster BeyondSpring’s strategy for developing plinabulin as a key cancer treatment option and highlight its potential in combination therapies.

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.