Biopharma firm CorMedix (NYSE American: CRMD) has seen its shares skyrocket more than 500% in the last 12 months as investors are pinning their hopes on the positive LOCK trial results. Investors would be interested to know from the management how the ongoing discussions with the FDA regarding the phase 3 trial results and future course of action.
CorMedix is planning to report its fourth-quarter results tomorrow after the bell. The micro-cap firm is expected to narrow its loss per share to $0.08 compared to $0.15 loss reported last year. Revenue is forecasted to improve to $240,000 over $90,000 in the prior year period. Last quarter, the biopharma firm reported a loss of $0.11 per share, which failed to meet street consensus.
The biopharma firm has been focusing on developing and bringing products to market for treating patients with infection and inflammation. CorMedix currently is focusing on launching its flagship drug Neutrolin in the US. It’s worth noting that the drug has already got approved in the European region and is already sold in the European Union and the Middle East for various indications.
Shareholders would be interested in knowing how the approval process in the US is coming along. Recently, CorMedix has completed Phase 3 trials for Neutrolin and is currently discussing with the Food and Drug Administration (FDA) for the future course of action.
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Neutrolin protects patients who are using catheter from bloodstream-related infections while undergoing dialysis for the treatment of end-stage renal diseases. The ongoing trial is called the Catheter Lock Solution Investigational Trial or LOCK-IT-100, which is going to be a game changer for the micro-cap firm if it gets the nod from the FDA.
CorMedix estimates the annual demand for catheter lock solutions for hemodialysis patients in the US to be between 30 million to 40 million vials. Neutrolin would get 10 years of market exclusivity post the approval, which would be the ideal target for the firm.
Last month, the company updated about the meeting with the FDA on the Phase 3 trial results. Since the biopharma firm has only submitted preliminary data earlier, it needs to send the full data for the regulator’s analysis.
CorMedix plans to send the data to the regulator within the next few months. However, the company didn’t update much on the progress it had during the meeting for filing a new drug application (NDA). The most important update investors would be looking for tomorrow will be relating to the progress of the NDA filing.
It’s worth noting that normally the US FDA requires firms to conduct two clinical trials to understand the safety and efficacy of the product before giving its nod for marketing. Hence, investors are skeptical whether the drug regulator would give the go-ahead for Neutrolin considering it has completed only one trial.
From the company’s point of view, the earlier it hits the market, it would be better for the firm to report profits on a sustainable basis. Any delay in product launch means CorMedix needs to arrange for funding to run the operations without any friction and investors need to wait for maybe a year or two for the firm to deliver results, hoping the drug gets approved.