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 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.
BeyondSpring announced significant advancements regarding its lead drug, plinabulin, including a New Drug Application (NDA) filed with the FDA for priority review aimed at preventing chemotherapy-induced neutropenia (CIN). The FDA set a PDUFA date of November 30, 2021. Recent presentations revealed favorable PROTECTIVE-2 Phase 3 data, indicating plinabulin combined with G-CSF offers better outcomes than pegfilgrastim alone. The company also initiated clinical trials on plinabulin with checkpoint inhibitors for resistant tumors, showcasing promising Phase 1 data.
BeyondSpring Inc. (NASDAQ: BYSI) will host a conference call on June 16, 2021, at 8:30 AM ET to discuss its Q1 2021 financial results and recent corporate updates. Investors can access the call by dialing 877-451-6152 (U.S.) or 201-389-0879 (International), using conference ID 13720525. A live webcast will be available on the company’s website, and an archived replay will be accessible for 90 days. BeyondSpring focuses on developing immuno-oncology therapies, with its lead asset, plinabulin, undergoing Priority Review for chemotherapy-induced neutropenia and being tested for anti-cancer benefits.
BeyondSpring, a biopharmaceutical firm, showcased data from the PROTECTIVE-1 Phase 3 clinical trial of plinabulin at the ASCO Annual Meeting. Plinabulin demonstrated a non-inferior effectiveness against chemotherapy-induced neutropenia (CIN) compared to pegfilgrastim, with benefits including reduced febrile neutropenia and lower bone pain. The drug, which targets CIN prevention, received FDA's Priority Review for its NDA submission in the U.S. and China, with a PDUFA action date set for November 30, 2021. The study results highlighted plinabulin's fast action and potential market impact, especially amid rising CIN-related hospitalizations.
BeyondSpring Inc. (NASDAQ: BYSI) announced a late-breaking poster presentation regarding plinabulin, demonstrating its efficacy in preventing chemotherapy-induced neutropenia (CIN) in combination with pegfilgrastim.
The Phase 3 PROTECTIVE-2 study showed significant improvements in immune profiles and CIN prevention compared to pegfilgrastim alone. The U.S. FDA accepted the New Drug Application with Priority Review, setting a PDUFA action date of November 30, 2021. With 110,000 annual hospitalizations due to CIN in the U.S., plinabulin is positioned to address this critical medical need, expanding its market potential significantly.
BeyondSpring announced positive results from the PROTECTIVE-2 Phase 3 clinical trial of plinabulin combined with pegfilgrastim for preventing chemotherapy-induced neutropenia (CIN). The combination therapy demonstrated a 50% reduction in both the incidence and duration of febrile neutropenia (FN) compared to pegfilgrastim alone, with 3.6% incidence versus 6.3%. Additionally, it decreased hospitalization duration significantly to 3.75 days from 7.14 days. The data supports the combination's effectiveness in improving quality of life and has led to NDA submissions in the U.S. and China.
BeyondSpring (NASDAQ: BYSI) announced the dosing of the first patient in a Phase 1b/2 trial studying plinabulin in combination with PD-1/PD-L1 inhibitors and radiation therapy for advanced cancers, including non-small cell lung cancer (NSCLC). This triple therapy could address resistance to immunotherapy, a significant unmet medical need. The study, led by Dr. Vivek Subbiah at MD Anderson Cancer Center, aims to evaluate safety and tolerability in patients who have progressed on prior treatments. Plinabulin has shown promise in overcoming resistance, with a notable 43% response rate in previous studies.
BeyondSpring announced that the FDA has accepted its New Drug Application (NDA) for plinabulin in combination with G-CSF for preventing chemotherapy-induced neutropenia (CIN), granting it Priority Review with a target action date of November 30, 2021. This combination aims to improve CIN prevention, addressing a significant medical need that affects up to 467,500 cancer patients annually. The NDA submission included pivotal Phase 3 data showing notable benefits over existing treatments, such as a 31.5% rate of preventing grade 4 neutropenia. The combination also demonstrated a reduction in severe adverse events and improved patient quality of life.
BeyondSpring is scheduled to present at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 9:00 am ET. Interested parties can access the presentation through a live webcast. BeyondSpring focuses on developing innovative cancer therapies, with their lead asset, plinabulin, aimed at preventing chemotherapy-induced neutropenia and enhancing cancer treatment outcomes. A replay of the presentation will be available post-event on their investor relations page.
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