Evoke Pharma (EVOK) Stock: Soaring On FDA Exemption

Evoke Pharma Inc (NASDAQ: EVOK)

Evoke Pharma is having an amazing day in today’s trading session. At the open of the market, the stock was trading on impressive gains. Since the open, we’ve seen some movement upward and some movement downward, but all in all, the stock has held onto the profits. Below, we’ll talk about what we’re seeing from EVOK, why the stock is climbing, and what we’ll be watching for ahead.

What We’re Seeing From EVOK

As mentioned above, Evoke Pharma is having an overwhelmingly strong day in the market today. When the trading session started, the stock hit the ground running, already trading on impressive gains. From there, we’ve seen movement in both directions. However, at the end of it all, the stock is holding onto the profits. At the moment (12:06), EVOK is trading at $3.93 per share after a gain of $1.32 per share or 50.57% thus far today.

Why The Stock Is Up

Our partners at Trade Ideas were the first to send the alert that EVOK was making a run for the top. As soon as they did, the CNA Finance team went to work, digging to see what was causing the movement. In this case, it didn’t take much time to dig up the cause of the gains. Ultimately, we’re seeing a reaction to an FDA exemption announced early this morning.

Evoke Pharma announced that the FDA has assessed the company’s gastrointestinal treatment known as Gimoty. After the assessment, the FDA has exempted the late-stage product from a Human Factors Validation study; a requirement before a New Drug Application can be submitted. Because of the fact that the FDA believes that EVOK adequately considered risks associated with the nasal spray, HF Validation is not necessary. As a result, the company intends on filing its NDA for the treatment by the end of the year. In a statement, the company’s CEO, Dave Gonyer, had the following to offer…

We intend to pursue an NDA submission by the end of the year and plan to update our investors in the near term with more specific timelines on these efforts…”

What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will be keeping a close eye on EVOK. In particular, we’re interested in the more precise timelines the company will offer as well as any updates to come surrounding Gimoty nasal spray. Nonetheless, we’ll keep a close eye on the news and continue to bring you the updates as they break!

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