Markets

A small biopharma stock soars 198% after the company says it will seek FDA approval following a successful cancer-drug trial

<figure> <img src="https://i.insider.com/610ac935c31de700184a37f8?format=jpeg" alt="Stock photo of doctors analyzing a lung cancer scan." height="1815" width="3630" charset=""> <figcaption> <span class="copyright">BSIP/Universal Images Group via Getty Images</span> </figcaption> </figure><ul class="summary-list"> <li>BeyondSpring surged 197% Wednesday after announcing it is seeking FDA approval for its cancer drug.</li> <li>The company said plinabulin met the primary endpoint of significantly improving the overall survival of patients.</li> <li>Shares of BeyondSpring surged to their highest price since May 2018.</li> <li><a href="https://newsletter.businessinsider.com/join/4np/10-things-opening-bell?utm_source=markets&utm_medium=ingestgest"><strong>Sign up here for our daily newsletter, 10 Things Before the Opening Bell</strong></a><strong>.</strong></li> </ul><p>Shares of BeyondSpring surged 197% on Wednesday after the New York-based biopharmaceutical company announced it is now seeking approval from the US Food and Drug Administration for its cancer-drug trial.</p><p>Shares of the company were trading at their highest level since May 2018. The stock was up 188%, at $27.74 as of 1:32 p.m. ET.</p><p>The company on Wednesday said plinabulin, its lead drug, met the primary endpoint of significantly improving the overall survival of patients during the DUBLIN-3 phase three trial of its lung cancer treatment.</p><p>The study also met secondary endpoints including boosting overall response rate, progression-free survival, and 24-36 months of overall survival rates. </p><p>BeyondSpring also said it plans to seek approval from China's drug regulator.</p><p>Dr. Lan Huang, co-founder, CEO, and chair, <a href="https://www.globenewswire.com/news-release/2021/08/04/2274399/0/en/BeyondSpring-Announces-Positive-Topline-Results-from-its-DUBLIN-3-Registrational-Trial-of-Plinabulin-in-Combination-with-Docetaxel-for-the-Treatment-of-2nd-3rd-Line-Non-Small-Cell-.html">said</a> she will set a pre-non-disclosure agreement meeting with the FDA in 2021 to agree on the contents of their NDA. This, she said, will support a submission in the first half of 2022. </p><p>"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," Huang said.</p><p>Plinabulin is a novel, intravenous-infused, patent-protected drug candidate for non-small cell lung cancer.</p><p>The company's stock last week closed at a record-low.</p><div class="read-original">Read the original article on <a href="https://www.businessinsider.com/beyondspring-bysi-stock-price-soars-198-lung-cancer-fda-approval-2021-8">Business Insider</a></div>
A small biopharma stock soars 198% after the company says it will seek FDA approval following a successful cancer-drug trial