|Over a week ago|
JMP 'confident' CorMedix has clear CRL resolution path with FDA » 13:3804/1404/14/21
After CorMedix announced…
After CorMedix announced that it has met with the FDA to discuss proposed resolutions for the deficiencies identified in the Complete Response Letter for the New Drug Application for DefenCath, JMP Securities analyst Jason Butler said he is "confident that there is a clear resolution plan agreed upon with the FDA" and he is looking for updates in coming weeks to clarify how soon the NDA can be resubmitted. The analyst, who adds that he is "encouraged" that there remains the potential for a document review, or virtual inspection, reiterates his Outperform rating and $23 price target on CorMedix shares.
CorMedix meets with FDA on DefenCath catheter lock solution NDA » 09:1404/1404/14/21
CorMedix announced that…
CorMedix announced that it has met with the US Food and Drug Administration to discuss proposed resolutions for the deficiencies identified in the Complete Response Letter to CorMedix and the Post-Application Action Letter received by the third-party manufacturer from FDA for the New Drug Application for DefenCath. Representatives from both CorMedix and the CMO participated in the meeting with FDA to ensure that there is alignment on addressing the Agency's concerns. There is now an agreed upon protocol for the manual extraction study identified in the CRL that FDA is requiring as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials. As anticipated previously, CorMedix expects to be able to complete this requirement in the next several weeks. Addressing FDA's concerns regarding the qualification of the filling operation may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath. CorMedix and the CMO are currently evaluating available data to determine if additional process qualification will be needed with subsequent validation to address these issues. The FDA stated that the review timeline would be determined when the NDA resubmission is received and that it expected all corrections to facility deficiencies to be complete at the time of resubmission so that all corrective actions may be verified during an on-site evaluation in the next review cycle, if the FDA determines it will do an onsite evaluation. CorMedix and the CMO continue to work closely to ensure that the identified deficiencies are resolved prior to resubmission of the DefenCath NDA. CorMedix will provide updates on the timeline as resolution of the deficiencies proceeds.
CorMedix price target lowered to $27 from $30 at Truist » 09:0703/3103/31/21
Truist analyst Joon Lee…
Truist analyst Joon Lee lowered the firm's price target on CorMedix to $27 from $30 but keeps a Buy rating on the shares after its Q4 results. The analyst states that his enthusiasm for Defencath remains unchanged in spite of the cash overhang and regulatory uncertainty, but the management reiterated plans to meet with the FDA in mid-April. Joon Lee adds that if a site visit is required, he estimates at least another 12 months of delay due to travel restrictions and backlogs.
CorMedix reports Q4 EPS (19c), consensus (22c) » 16:4203/3003/30/21
Reports Q4 revenue…
Reports Q4 revenue $55,713, consensus $50K. Khoso Baluch, CorMedix CEO commented, "While we were disappointed that the DefenCath NDA was not approved at its PDUFA date, we remain confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce catheter related blood stream infections in patients receiving hemodialysis via central venous catheters. We believe we have the right team and resources to accomplish this as we advance DefenCath closer to regulatory approval." Total cash on hand and short-term investments as of December 31 amounted to $46.3M, excluding restricted cash of $0.2M. The Company believes that, based on the Company's cash resources at year end plus the $41.5M in net proceeds from ATM issuances since the beginning of 2021, it has sufficient resources to fund operations at least into the second half of 2022.
|Over a month ago|
CorMedix extends contract of head of clinical operations Liz Masson-Hurlburt » 08:4603/1103/11/21
CorMedix announced that…
CorMedix announced that it has entered into a new three-year Employment Agreement with Liz Masson-Hurlburt, currently Executive Vice President and Head of Clinical Operations. The new agreement terminates in March 2024, and may be extended annually thereafter upon mutual agreement. Ms. Masson-Hurlburt joined CorMedix in March 2018 and was instrumental in bringing the LOCK-IT-100 clinical study to a successful completion.
CorMedix to hold a conference call » 08:1303/0903/09/21
Management holds a…
Management holds a regulatory update for DefenCath on a conference call to be held on March 9 at 8:30 am. Webcast Link
CorMedix price target lowered to $13.50 from $25 at B. Riley Securities » 08:3203/0203/02/21
B. Riley Securities…
B. Riley Securities analyst Andrew D'Silva lowered the firm's price target on CorMedix to $13.50 from $25 and reiterates a Buy rating on the shares after the company received a Complete Reponse Letter for Defencath for catheter-related bloodstream infections in end-stage renal disease patients receiving hemodialysis with a central venous catheter. The CRL appears to be tied to manufacturing issues versus anything related to Defencath's safety and efficacy, but the FDA is yet to specify the particular issue, D'Silva tells investors in a research note.
CorMedix trading resumes 09:0003/0103/01/21
CorMedix receives CRL from FDA for DefenCath Catheter Lock Solution » 08:3903/0103/01/21
CorMedix announced that…
CorMedix announced that the US Food and Drug Administration cannot approve the New Drug Application for DefenCath in its present form. FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility. FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns. When we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution. Additionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications. CorMedix expects to be able to complete this requirement expeditiously. Satisfactory resolution of these issues is required for approval of the DefenCath NDA by a pre-approval inspection and/or adequate manufacturing facility responses addressing these concerns. If an inspection is required, the FDA is currently facing a backlog due to the pandemic and are actively working to define an approach for scheduling outstanding inspections once safe travel may resume. CorMedix will request a meeting with the FDA, which we estimate will occur by mid-April, to obtain agreement with the Agency on our proposed plan for resolution of the issues at our third-party manufacturing facility. FDA did not request additional clinical data, and did not identify any deficiencies related to the data submitted on the efficacy or safety of DefenCath from LOCK-IT-100. In draft labeling discussed with FDA, the Agency added that the initial approval will be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter. This is consistent with our request for approval pursuant to the Limited Population Pathway for Antibacterial and Antifungal Drugs , which provides for a streamlined clinical development program involving fewer clinical trials. The LPAD pathway is intended to encourage the development of safe and effective products that address unmet medical needs of patients with serious bacterial and fungal infections. DefenCath received designations as Fast Track and Qualified Infectious Disease Product, and the NDA received priority review. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. CorMedix ended the 4th quarter of 2020 with pro forma cash, cash equivalents and short-term investments of approximately $87.8 million, including capital raised though ATM issuance, which the company estimates is sufficient to fund operations at least into second half of 2022.
CorMedix trading halted, news pending 08:2503/0103/01/21