Shares of Ocular Therapeutix ( OCUL -5.38% ) gained 21.6% last month, according to data provided by S&P Global Market Intelligence. The eye drug specialist reported second-quarter and first-half 2018 results. Considering it only has one commercialized product on the market, it doesn't have much to show on its income statements, but investors were comforted to know that the business exited June 2018 with nearly $57 million in cash and cash equivalents.
That could come in handy. Ocular Therapeutix announced that its new drug application (NDA) resubmission for Dextenza, a treatment for postoperative inflammation and pain, was accepted by the U.S. Food and Drug Administration at the end of June. The drug candidate has a PDUFA date of December 28, which is when the regulatory body will rule on the product's future.
Ocular Therapeutix has seen its market valuation double since the beginning of the year, as investors grow more excited about the company's potential to become a bona fide commercial-stage operation. Receiving marketing approval for Dextenza would be the biggest win yet for the company on that front, although there are two other drug candidates currently in phase 3 trials.
That said, the eye specialist is still valued at less than $300 million, which hints that Mr. Market still isn't very enthusiastic about the company's prospects. That could change as the PDUFA date approaches, but investors shouldn't get too carried away just yet. With a net loss of $27.5 million in the first half of 2018, failing to receive marketing approval or to successfully commercialize Dextenza could hurt investors betting on a positive outcome at the end of the year.