Welcome to our dedicated page for BeyondSpring Ordinary Shares news (Ticker: BYSI), a resource for investors and traders seeking the latest updates and insights on BeyondSpring Ordinary Shares stock.
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 Inc. (NASDAQ: BYSI) announced the formation of a Partnership Advisory Committee to enhance business development efforts for its lead asset, Plinabulin. This committee comprises senior executives from major pharmaceutical companies, including Mukul Agarwal from Forty Seven and Dr. Daniel Zabrowski from Roche. The committee's goal is to facilitate successful partnerships as BeyondSpring approaches the filing of its New Drug Application (NDA) for Plinabulin, which recently received Breakthrough Therapy Designation from the FDA and NMPA for preventing chemotherapy-induced neutropenia.
BeyondSpring (NASDAQ: BYSI) announced promising new clinical data for its lead candidate, Plinabulin, effective in preventing chemotherapy-induced neutropenia (CIN) during the COVID-19 pandemic. Presented at the ESMO Virtual Congress, Plinabulin showed comparable efficacy to Pegfilgrastim (Peg) in preventing severe neutropenia, while offering additional benefits such as reduced bone pain and improved platelet counts. The company has initiated an Expanded Access Program to facilitate access to Plinabulin for clinicians and patients in need during this crisis.
BeyondSpring (NASDAQ: BYSI) recently announced the appointment of Elizabeth Czerepak as Chief Financial Officer, effective immediately. This change comes as the company has received two Breakthrough Therapy Designations for Plinabulin in treating chemotherapy-induced neutropenia in the U.S. and China. BeyondSpring aims to enhance patient care and capitalize on the growing CIN market, valued at over $7 billion annually. Simultaneously, Seed Therapeutics appointed Edward Liu as CFO, strengthening leadership as the firm transitions to commercialization.
BeyondSpring (NASDAQ: BYSI) announced a corporate overview presentation scheduled for September 14, 2020, at the H.C. Wainwright 22nd Annual Global Investment Virtual Conference. The live webcast will be accessible on BeyondSpring's website under the Investors section. The company focuses on developing immuno-oncology therapies to address high unmet medical needs. Its lead asset, Plinabulin, is in Phase 3 trials for chemotherapy-induced neutropenia and non-small cell lung cancer treatment. BeyondSpring also boasts a diverse pipeline, including pre-clinical assets and a novel drug discovery platform.
BeyondSpring has announced that Plinabulin received Breakthrough Therapy Designation from both the FDA and China's CDE for the prevention of Chemotherapy-Induced Neutropenia (CIN). This designation is based on promising results from the PROTECTIVE-2 Phase 3 study, indicating significant advancements in CIN treatment, where Plinabulin showed a substantial improvement in preventing severe neutropenia compared to G-CSF agents. The company plans to submit an NDA to the FDA by the end of 2020, following the full data report from the study.
BeyondSpring reported positive interim results from the PROTECTIVE-2 Phase 3 trial demonstrating that Plinabulin combined with Neulasta significantly reduces the rate of Grade 4 neutropenia. The trial's enrollment of 221 patients has been completed, and results will be finalized in Q4 2020. The company expects to submit an NDA to the FDA for Plinabulin's CIN indication by the end of 2020. Financially, R&D expenses rose to $11 million for Q2 2020, resulting in a net loss of $12.8 million.
BeyondSpring (NASDAQ: BYSI) will report its Q2 2020 financial results and host a conference call on September 3, 2020, at 8 a.m. ET. The call can be accessed at 1-877-451-6152 (U.S.) or 1-201-389-0879 (international) with conference ID: 13709037. BeyondSpring focuses on developing innovative cancer therapies, with its lead asset Plinabulin currently in two Phase 3 trials for chemotherapy-induced neutropenia and non-small cell lung cancer. The company also has three pre-clinical immuno-oncology assets and a unique drug discovery platform.
BeyondSpring (NASDAQ: BYSI) has appointed Dr. Ravindra Majeti, Chief of Hematology at Stanford University, to its Board of Directors. Dr. Majeti co-founded Forty Seven, Inc., which was acquired by Gilead for $4.9 billion. His expertise in hematological cancers is expected to enhance the development of BeyondSpring's leading asset, Plinabulin, currently undergoing Phase 3 trials for chemotherapy-induced neutropenia and non-small cell lung cancer. The leadership change is anticipated to bolster the company's innovation and clinical outcomes.
BeyondSpring (NASDAQ: BYSI) has initiated an Expanded Access Program (EAP) for its late-stage asset, Plinabulin, aimed at preventing chemotherapy-induced neutropenia (CIN) in cancer patients during the COVID-19 pandemic. The first patient was enrolled on July 28, 2020, at Redlands Community Hospital, where the combination of Plinabulin and Pegfilgrastim effectively avoided Grade 4 neutropenia in the second cycle of chemotherapy. This program responds to updated NCCN guidelines to maximize protection for cancer patients while conserving healthcare resources.
BeyondSpring, a biopharmaceutical company focusing on innovative cancer therapies, announced the pricing of a public offering of 1,930,000 ordinary shares at $13.00 each, alongside a private placement of 384,615 shares to Decheng Capital. The total gross proceeds are projected to be approximately $30.1 million. Funds will support the commercialization of Plinabulin and further clinical development. The public offering is set to close on June 23, 2020, while the private placement is expected on July 2, 2020.
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