Catalyst Pharmaceuticals reported a net loss for the second quarter of 2015, but also said it expects to submit a new medication for Federal Drug Administration approval in the fourth quarter of this year.
The Coral Gables-based biopharmaceutical firm lost $4.6 million in the quarter that ended June 30, compared to a loss of $3.2 million in the second quarter of 2014. The company has no revenues because it does not yet have products on the market.
Catalyst plans to submit the drug for FDA approval in the fourth quarter of 2015. Firdapse is designed to treat Lambert-Eaton Myasthenic Syndrome, or LEMS — a rare and sometimes fatal autoimmune neuromuscular disease that affects about 3,000 people in the U.S., according to the company.
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Catalyst said it expects to win approval for the drug next year, and some financial analysts are excited about its possibilities. Doctors have also spoken positively about the drug. But an FDA denial could spell big trouble for the publicly traded firm and mean that it spent millions of dollars in vain.
The company’s stock price has fallen about 9 percent to $4.03 since earnings were announced Aug. 10.