Sesen Bio Inc (NASDAQ: SESN) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced the acceptance of an Analytical Comparability Plan by the FDA. Of course, the news excited investors, pushing the stock up. Today, we’ll talk about:
- The plan acceptance;
- what we’re seeing from SESN stock as a result; and
- what we’ll be watching for ahead.
SESN Announces FDA Plan Acceptance
As mentioned above, Sesen Bio is having a great start to the trading session this morning after announcing that the FDA has accepted a key plan. The news was announced via press release early this morning.
In the release, SESN said that it has completed a Type C CMC meeting with the FDA and has reached an agreement with the regulatory body on its Analytical Comparability plan. Importantly, the plan acceptance means that upon final comparability data being provided in the BLA submission, no additional clinical trials will be necessary to estabilish comparability.
The company said that in its Phase 2 and 3 clinical trials, it manufactured Vicinium in its own facility. However, based on an assessment of global demand potential, the company sought a commercial manufacturer that had the capacity and quality to meet the forecast.
This led to an agreement with FUJIFILM Diosynth Biotechnologies U.S.A. The company also said that in April, the first in a series of full-scale, commercial GMP runs was successfully completed with the first run meeting all release specifications.
In a statement, Dr. Thomas Cannell, President and CEO at SESN, had the following to offer:
Because we are changing manufacturing sites, it was important to agree on an approach to establish product comparability, which will be part of the BLA submission for Vicinium.
Gaining FDA agreement with our proposed Analytical Comparability Plan was the primary objective for yesterday’s meeting with the FDA. This is a very positive outcome and brings us one step closer to regulatory approval of Vicinium, and our ability to help save and improve the lives of 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 Sesen Bio, the news proved to be incredibly positive.
After all, with no need for further clinical studies, the company will not need to invest a large sum of money into further research. Moreover, this means that a BLA is on the way relatively soon.
It’s also worth mentionint hat with demand forecast suggesting the need for a large, commercial scale manufacturer, the drug could prove to be a blockbuster. So, it’s not surprising to see that excited investors are pushing the stock on a run 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 (9:51), SESN is trading at $2.09 per share after a gain of $0.34 per share or 19.37% 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 SESN. In particular, we’re interested in following the story surrounding the company’s continued work to Vicinium to market. Nonetheless, we’ll keep an eye on the story and bring the news to you as it breaks!
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