News – USA – CLSN Stock: Rockets in the Fast Lane – CNA Finance


Celsion Corporation (NASDAQ: CLSN) shot up in the air in pre-market hours this morning, and for good reason The company announced it had been approved by the U.S. Food and Drug Administration (FDA) has received the Fast Track Designation This is what happens:

As noted above, Celsion Corporation is flying to market this morning after FDA Fast Track Designation was announced The company said it has received the designation for GEN-1, a DNA-Mediated Interleukin-12 (IL-12) -Immunotherapy

GEN-1 is currently being developed in Phase 2 trials as a potential option for the treatment of advanced ovarian cancer. The treatment was developed with TheraPlas, the company’s proprietary platform for synthetic, non-viral nanoparticle delivery systems

In the press release, CLSN reminded investors that Fast Track Designation is designed to facilitate development and expedite regulatory review of drugs for the treatment of conditions with significant unmet medical needs. In addition, the company set the criteria for the designation, including :

Given these criteria and the fact that the company received the Fast Track award, CLSN is clearly doing promising work with its GEN-1 candidate

In a statement, Michael H Tardugno, Chairman, President and CEO of CLSN, had the following to offer:

The fast-track designation is an important step in the development of GEN-1 for advanced ovarian cancer Assuming the encouraging data we are generating in early clinical trials persist, this designation supports an accelerated path towards Market readiness

Fast Track enables more frequent communication with the FDA to discuss development plans and clinical trial design. If the criteria are met, Fast Track named drugs may be subject to ongoing review In doing so, the sponsor of the drug can separately submit sections of their new drug submission to the FDA.They are also entitled to expedited approval and priority review, under which drugs for serious medical conditions that meet an unmet medical need can be approved based on a replacement endpoint We are optimistic that GEN-1 will make a change for women with advanced ovarian cancer who have limited treatment options

Not only has the news released today been overwhelmingly positive, it is also clear that the shorts are being pushed out of the stocks of Celsion Corporation ahead of today’s pre-market session, more than 20% of its stock was sold short which is a pretty strong one short interest

However, when stocks with heavily short positions trend upward, those who sell the stock lose money as a result, they try to buy stocks to cover their positions, resulting in significant volume and price gains that seem to be the case today Fall, and with a public free float of around 60 million shares, demand could well exceed supply, resulting in profits well above what we’ve already seen in the pre-market

If You Are Considering Buying CLSN Stock You Must Be Prepared To Take Risks After All, Risk Free Investment Doesn’t Exist When it comes to Celsion, some of the most important risks to consider are:

There’s no question that investing in Celsion or any other stock involves risk. Nevertheless, CLSN stock looks pretty attractive right now

The fast-track designation will accelerate the development and regulatory review of GEN-1 If all goes well, treatment can become a blockbuster and take a decent stake in a multi-billion dollar annual industry Sure, there are risks, but the potential rewards that could come with CLSN stocks are hard to see. p>

Celsion Corporation, Fast Track, Ovarian Cancer, NASDAQ: CLSN, Food and Drug Administration, Stock, Nasdaq

News – USA – CLSN Stock: Rockets On Fast Track Designation – CNA Finance