- BYSI stock trading volume surges to 20,000% normal…
- Shares nearly triple from Tuesday’s close at the open…
- BeyondSpring seeks FDA approval for cancer treatment…
BeyondSpring Inc. (NASDAQ: BYSI) more than doubled in value on news about the company’s cancer drug.
BYSI stock surged more than 180% early in today’s session and was holding 160% higher at writing.
The rally comes after BeyondSpring announced positive results from a trial using its drug, Plinabulin, in combination with chemotherapy to treat lung cancer.
The company says the results of that trial showed “statistically significant improvement” in overall survival for the combination treatment vs the chemotherapy docetaxel alone.
BeyondSpring Seeks FDA Approval
Editorial credit: grandbrothers / Shutterstock.com
BeyondSpring said it will seek approval from the FDA in the U.S. and the National Medical Products Administration in China for the combination to treat 2nd and 3rd line non-small cell lung cancer (NSCLC).
The company said, “Plinabulin is a first-in-class, selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen-presenting cell (APC) inducer.”
In addition to improving overall survival, BeyondSpring says the combination treatment “met key secondary endpoints, including significantly improving ORR (objective response rate), PFS (progression-free survival), 24 and 36-month overall survival rates, and significant reduction in the incidence of Grade 4 neutropenia.”
The trial, known as DUBLIN-3, “is a randomized, single-blind to patients, active-controlled, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with measurable lung lesion.”
In that trial, “patients were treated on a 21-day cycle with infusion of docetaxel (75 mg/m2 on day 1) and plinabulin (30 mg/m2 on days 1 and 8) vs. docetaxel alone (75 mg/m2, day 1).”
Trevor M. Feinstein, M.D., of the Piedmont Cancer Institute and a principal investigator for DUBLIN-3 said this trial is key for “an area of severe unmet medical needs.”
“In DUBLIN-3, a prolonged survival benefit, characterized by a long-tailed OS curve, was observed with plinabulin that represents an immune-associated anti-cancer benefit,” said Feinstein. “The opportunity that plinabulin offers to these patients is not only to live longer, but also with significantly reduced severe neutropenia, which are both meaningful for these very sick patients.”
Dr. Ramon Mohanlal, Chief Marketing Officer and Executive Vice President of R&D at BeyondSpring said, “The success of the DUBLIN-3 study represents proof-of-concept of plinabulin’s immune-enhancing mechanism of action that is complimentary to that of checkpoint inhibitors, and which is the rationale for it to be combined as triple IO combinations in multiple tumor indications.”
BeyondSpring’s co-founder, CEO, and Chairwoman, Dr. Lan Huang, said, “A pre-NDA meeting will be scheduled with the FDA in 2021 to agree on the contents for our NDA, to support a NSCLC indication NDA submission in the first half of 2022.”
She added, “the strong results from DUBLIN-3 further validate our conviction that plinabulin, as an immune anti-cancer agent, has the potential to be a cornerstone therapy for many solid tumors.”
More About Plinabulin
Plinabulin is BeyondSpring’s “lead asset.”
The company says the drug “triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). “
The drug was previously granted a “breakthrough therapy designation” by the FDA “for the chemotherapy-induced neutropenia (CIN) indication.”
A new drug application is also under priority review at the FDA “seeking approval for use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN).”
That priority review designation accelerates the FDA review time of the drug from 10 months to a goal of six months.
The Prescription Drug User Fee Act (PDUFA) target action date for plinabulin to be approved for CIN is November 30, 2021.
Seven Facts About BYSI Stock
- BeyondSpring was founded in 2010 and is headquartered in New York City.
- It is “a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs.”
- BeyondSpring’s pipeline of drugs “includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.”
- BYSI stock closed at $9.63 per share on Tuesday.
- Shares opened today’s session at $28.10.
- The stock hit a daily high of $28.74 today.
- Trading volume surged to nearly 20,000% normal at more than 37 million shares.
Featured cover image editorial credit: Pavel Kapysh / Shutterstock.com