Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) had a great day in the market yesterday as investors awaited the FDA’s decision with regard to Firdapse. While the stock was down in after-hours, it has quickly made it to the green and seems to have plenty of room to climb after the company recently announced that it has received the approval that investors have been waiting for. Today, we’ll talk about:
- The approval;
- what we’re seeing from CPRX stock as a result; and
- what we’ll be watching for ahead.
CPRX Announces FDA Approval
As mentioned above, Catalyst Pharmaceuticals is having a strong start to the trading session this morning, following up on yesterday’s gains. The excitement comes from an FDA approval that was announced about an hour ago.
In a press release, CPRX said that the United States Food and Drug Administration (FDA) has approved Firdapse 10 mg tablets for the treatment of adults with Lambert-Eatorn Myasthenic Sydrome (LEMS). The company said that it is expecting for the treatment to become commercially available in the first quarter of 2019.
LEMS is a rare autoimmune disease. At present, it is believed that the disease affects approximately 1 in 100,000 people in the United States. Unfortunately, the symptoms of the condition can be life-threatening when the weakness of muscles involves respiratory muscles.
In a statement, Patrick J. McEnany, Chairman and CEO at CPRX, had the following to offer:
The FDA’s approval of Firdapse is a potentially transformative milestone in the lives of patients in the U.S. suffering with LEMS, as it now gives adult LEMS patients access to a new first-in-class-therapy… The approval of Firdapse is a crowning achievement for our company and an important step forward in our transition into a premier neurological rare disease company. We continue to prepare for what we hope will be a successful launch based on productive discussions with payers, our efforts in patient identification and our development of a field-based commercial infrastructure. Our Catalyst Pathways™ patient services program is designed to assist patients and physicians with education, clinical diagnostic tools and assistance in navigating the reimbursement landscape.
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 leads to moves in the market. When it comes to Catalyst Pharmaceuticals, the news proved to be overwhelmingly positive. After all, the FDA approval of Firdapse means that the company will be able to start commercializing the treatment, turning it into a revenue generator. Although, the stock was down in after-hours as investors awaited the news, it has quickly made up for declines in the pre-market and is starting to edge into green territory. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:27), CPRX is trading at $3.14 per share after a gain of $0.01 per share or 0.32% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on CPRX. In particular, we’re interested in following the story surrounding the approval of Firdapse and the company’s efforts to commercialize the treatment, generating revenue. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks.
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