December is off to a complicated start for the biotech sector so far. While VBI Vaccines (NASDAQ:VBIV) has garnered Food and Drug Administration (FDA) approval for a vaccine designed to prevent Hepatitis B, one of its peers hasn’t been so lucky. BeyondSpring Pharmaceuticals (NASDAQ:BYSI) has announced the public health agency has reached the decision not to approve its drug candidate for chemotherapy side-effect neutropenia on the grounds that it believes further study is needed. This develop was not welcome news for the company or shareholders, who have been watching BYSI stock fall all morning.
What’s Happening With BYSI Stock
The early morning breaking of this news sent BYSI stock down in premarket trading by 52%. As soon as markets opened, it continued falling, and although it has remained stagnant within the last hour, the stock has fallen by almost 54% as of this writing. It shows no signs of rebounding
Despite a minimal downtick, BYSI stock had seen no serious declines within the past week. Today’s deep plunge has the company in the red. However, BYSI’s declines for the month are worse, currently just shy of 60%.
Why It Matters
According to a statement issued by the company, the results of the single registrational trial (106 Phase 3) were deemed “not sufficiently robust” to demonstrate the treatment method’s benefit. The agency’s ruling also added that a “second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN (chemotherapy-induced neutropenia) indication,” a central component of the treatment.
The company enjoyed a better summer than fall season in 2021. When BeyondSpring reported positive developments regarding its lung cancer treatment method, this positive outlook sent shares shooting up.
“As a company focused on commercializing immune-oncology cancer therapies, BeyondSpring has a noble aim,” InvestorPlace contributor Chris MacDonald noted. Sadly, today’s events have proven that such a credit isn’t enough to keep shareholders confident when the FDA hands down a negative verdict.
Dr. Lan Huang, BeyondSpring’s co-founder, CEO and chairwoman, remains confident in her company’s work. She states that “selective immunomodulating microtubule-binding agent” Plinabulin has “significant potential to raise the standard of care in CIN” when combined with G-CSF (granulocyte colony-stimulating factor).
What It Means
BeyondSpring is facing what seems to be a difficult road ahead as it prepares for a new year. While the news of the day is far from ideal, the company is clearly focused on moving forward with its mission. Dr. Huang adds that the company remains fully committed to bringing it to cancer patients across the globe and will be meeting with the FDA to discuss the next steps.
A lot will depend on the type of progress that BeyondSpring is able to make within the coming year and how fast it is able to move forward. The FDA has not had any drug candidates submitted to it with Plinabulin’s capabilities. The company still has the chance to be the first in its field to get a drug to market. If it does, it will be very good for BYSI stock.
The company does indeed have a noble aim, and if it continues making progress, it will be easy to root for. BYSI stock is definitely worth watching as 2022 takes shape.
On the date of publication, Samuel O’Brient did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.