Cellectar Biosciences Inc (NASDAQ: CLRB) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that it has been granted Fast Track Designation by the FDA, exciting investors and sending the stock for the top. Today, we’ll talk about:
- The Fast Track Designation;
- what we’re seeing from CLRB stock as a result; and
- what we’ll be watching for ahead.
CLRB Announces Fast Track Designation
As mentioned above, Cellectar Biosciences is having a great start to the trading session this morning after announcing Fast Track Designation news. The news was issued via press release early in the premarket.
In the release, CLRB said that the United States Food and Drug Administration granted Fast Track Designation for CLR 131 in the fourth line or later relapse/refractory multiple myeloma. CLR 131 is the company’s small-molecule radiotherapeutic phospholipid drug conjugate.
The treatment is designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. At the moment, CLR 131 is being evaluated in the company’s ongoing Clover-1 Phase 2 clinical study in patients with relapsed or refractory multiple myeloma and other select B-Cell lymphomas.
In a statement, James Caruso, President and CEO at CLRB, had the following to offer:
Fast Track Designation furthers our efforts to expeditiously develop CLR 131 as a new, innovative therapy for patients with relapse/refractory multiple myeloma. Patients with third line or later relapsed/refractory multiple myeloma have a poor prognosis and low rates of survival as a result of limited effective treatment options.
Based on data in the initial patient cohort from our ongoing CLOVER-1 trial where patients showed a 30% response rate after receiving a single 25.0 mCi/m2 dose as a seventh line of therapy on average, we are optimistic that CLR 131 has the potential to provide a meaningful treatment option for these patients.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Cellectar Biosciences, the news proved to be overwhelmingly positive.
After all, Fast Track Designation means that the company will have more frequent communications with the FDA as it continues to develop the treatment. Moreover, the Designation means that the road to potential approval has been shortened.
So, it’s not surprising to see that excited investors are pushing the stock for the top. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:59), CLRB is trading at $2.48 per share after a gain of $0.24 per share or 10.71% 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 CLRB. In particular, we’re interested in following the continued development of CLR 131 as the treatment is showing some serious promise. Nonetheless, we’ll keep an eye on the news and bring it to you as it breaks!
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