BeyondSpring Inc. Ordinary Shares - BYSI STOCK NEWS

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.

BeyondSpring announced positive preliminary results from a Phase 1 trial of plinabulin combined with nivolumab and ipilimumab for treating small cell lung cancer (SCLC). The study showed a favorable 46% objective response rate (ORR) among 13 evaluable patients with resistant tumors. The combination also re-sensitized tumors previously treated with PD-1/PD-L1 inhibitors, achieving a 43% ORR.

The trial highlighted the treatment's safety with no Grade 4 events reported, and only 12.5% experiencing Grade 3/4 immune-related adverse events (IR-AEs), signaling potential for further development.