CRMD stock is moving higher after B. Riley FBR analyst Andrew D’Silva initiated coverage of CorMedix with a Buy rating.
B. Riley FBR analyst Andrew D’Silva initiated coverage of CorMedix with a Buy rating and $15 price target. The company’s lead candidate, Neutrolin, has the potential to be the first FDA-approved catheter lock solution, D’Silva tells investors in a research note. With a New Drug Application expected in the first half of 2020, the analyst is modeling a U.S. commercial launch starting in the second half of 2021. He sees CorMedix’s revenue growing to $135.5M in 2023.
Positive responses received from the FDA regarding the Company’s pre-New Drug Application, or pre-NDA, meeting questions relating to the preparation of the NDA. The FDA agreed that Neutrolin is eligible for priority review, setting a review period goal of 6 months rather than the standard review period of 10 months. The FDA also agreed that the Neutrolin NDA submission is eligible for rolling review and that the Company’s proposed submission plan is reasonable. The FDA further agreed that it is appropriate to submit a request for approval of Neutrolin under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD Pathway) at the time of the NDA submission.
The Company completed its interaction with the FDA related to the chemistry, manufacturing and controls (CMC) package that will be required to support Neutrolin’s NDA. The FDA was supportive of Neutrolin’s proposed manufacturing program, including the manufacture of the active pharmaceutical ingredients (APIs), the container closure and testing, and indicated that it will conduct a thorough review of all of the CMC information as well as assess the commercial readiness of the various manufacturing facilities at the time of the NDA filing. No further CMC meetings with the FDA are planned prior to the NDA submission.
The Company believes it is on schedule for NDA submission and potential for approval during the second half of 2020.
Back on October 16, 2019, CorMedix announced that it has completed its interaction with the FDA related to the chemistry, manufacturing and controls package that will be needed to support Neutrolin’s new drug application. The FDA was supportive of Neutrolin’s proposed manufacturing program, including the active pharmaceutical ingredients, the container closure and testing, and indicated that it will conduct a thorough review of all of the CMC information as well as assess the commercial readiness of the various manufacturing facilities at the time of NDA filing. No further CMC meetings with FDA are planned prior to NDA submission. A pre-NDA meeting has now been scheduled and CorMedix is looking forward to discussing with the FDA the filing of the NDA for Neutrolin, including the FDA programs intended to facilitate and expedite review of the application, such as Priority Review designation, rolling submission, and LPAD.
CorMedix is developing the regulatory pathways aimed at additional indications for use in catheters for oncology patients and for patients requiring total parenteral nutrition (TPN). The Company is first focused on securing the indication for use in hemodialysis patients utilizing data from LOCK-IT-100, because it believes this strategy will provide greater opportunity for generating the clinical data needed for additional indications for use.
Khoso Baluch, CorMedix CEO commented, “We are delighted to have completed the CMC and pre-NDA meetings with the FDA. I believe we have entered the home stretch towards our goal of getting Neutrolin approved in the U.S. in the second half of 2020. We are now able to focus our full attention on submitting the new drug application as quickly as possible. Over the next several months, we expect to build manufacturing, marketing and medical affairs capabilities in anticipation of commercial launch either alone or with a partner. This is an exciting time for the Company and for the staff who have worked so hard to get us where we are today.”