Aptose Biosciences (APTO) Stock: FDA Lifts Clinical Hold


Aptose Biosciences Inc APTO Stock NewsAptose Biosciences Inc (NASDAQ: APTO) is headed up early on in the trading session this morning, and for good reason. The company announced that the FDA has lifted a clinical hold, allowing the company to move forward with trials. Of course, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:

  • The lifted clinical hold;
  • what we’re seeing from the stock as a result; and
  • what we’ll be watching for ahead.

APTO Announces Lifted Clinical Hold

As mentioned above, Aptos Biosciences is having an incredibly strong start to the trading session this morning after announcing a lifted clinical hold. In a press release issued early this morning, the company announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold surrounding APTO-253. APTO-253 is the company’s investigational drug for hematologic cancers.

To date, APTO-253 is the only known clinical-stage molecule that has the potential to directly inhibit expression of the MYC oncogene. This is significant as the MYC oncogene is a causitive factor when it comes to many malignancies, including acute myeloid leukemia. In the release, APTO said taht the Phae 1b clinical trial is expected to take place in up to 15 clinical centers. The company also said that the screening and dosing will resume as soon as practical for patients with relapsed or refractory AML or with high risk myelodysplastic syndromes.

Previously, the Phase 1b clinical trial was placed on a clinical hold as the result of an event that occurred at a clinical site with the infusion procedure. APTO said that after an investigation, it was deemed that the event was the result of chemistry and manufacturing based issues. therefore, the company incorporated a Chemistry, Manufacturing and Control (CMC) amendment to the Investigational New Drug (IND), allowing for the continuation of the trial. In a statement, William G. Rice, Ph.D, President and CEO at APTO, had the following to offer:

We are eager to return APTO-253 back into the clinic… Our understanding of this molecule has evolved dramatically, and we are excited to deliver a MYC gene expression inhibitor to patients with debilitating hematologic malignancies.

What We’re Seeing From The Stock 

One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of Aptose Biosciences, the news proved to be overwhelmingly positive. After all, with the clinical hold lifted, the company can now continue to assess the candidate. Of course, that news led to excitement among investors who are sending the stock screaming for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:35), APTO is trading at $3.96 per share after a gain of $01.8 per share or 4.81% thus far today.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on APTO. In particular, we’re interested in following the story surrounding the company’s continued work to bring APTO-253 to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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