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CRMD

CorMedix

$9.31

0.16 (1.75%)

08:17
07/09/19
07/09
08:17
07/09/19
08:17

CorMedix says Neutrolin Phase 3 clinical development complete after FDA feedback

CorMedix announced that it has received feedback from the U.S. FDA regarding the submitted statistical analyses of data and additional information requested by the FDA for the primary and secondary efficacy endpoints of the Company's LOCK-IT-100 clinical study. LOCK-IT-100 examined the safety and effectiveness of the investigational new drug Neutrolin as a catheter lock solution compared to heparin for the prevention of catheter-related bloodstream infection in hemodialysis patients. Based on the FDA's feedback, the Company believes it has completed Phase 3 of clinical development for Neutrolin in hemodialysis patients and does not need to conduct another clinical trial at this time. In its feedback, the FDA did not raise any additional questions regarding the analyses provided and indicated that it would conduct a thorough review of all of the clinical data when the clinical study report is submitted for LOCK-IT-100. In FDA's response to the Company's question on whether LOCK-IT-100 is adequate as a single study to support a New Drug Application, the FDA stated that while the data from LOCK-IT-100 and supporting information may be sufficient, it cannot confirm that the data from LOCK-IT-100 are adequate to support an indication for prevention of CRBSI in hemodialysis patients until it has completed its review of the NDA. The Company will continue discussions with the FDA concerning the chemistry, manufacturing and controls data that will be needed to support Neutrolin's NDA. FDA's feedback on the CMC data is an important regulatory requirement prior to the Company requesting a pre-NDA meeting.

CRMD CorMedix
$9.31

0.16 (1.75%)

07/26/18
HCWC
07/26/18
NO CHANGE
Target $3
HCWC
Buy
CorMedix price target raised to $3 from $2 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for CorMedix to $3 saying the Neutrolin interim readout delivered a "home run." The analyst sees a possibility now for Neutrolin to be filed before the end of this year and to be approved in 2019, versus his original assumption that the drug would not enter the U.S. market prior to 2020. Further, the news of the clear efficacy signal in the LOCK-IT-100 study could meaningfully accelerate ex-U.S. sales of the product, the analyst adds. He reiterates a Buy rating on CorMedix.
12/06/18
ROTH
12/06/18
INITIATION
Target $6
ROTH
Buy
CorMedix initiated with a Buy at Roth Capital
Roth Capital analyst Jerry Isaacson started coverage of CorMedix with a Buy rating and $6 price target. The analyst notes that the company is developing Neutrolin for the prevention of catheter-related blood stream infections in patients with central venous catheters, and believes there is a large market opportunity for Neutrolin in multiple patient populations. CorMedix has Fast-Track designation from the FDA and QIDP designation, leading to 10.5 years of market exclusivity, he adds.
12/06/18
12/06/18
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. LG Display (LPL) initiated with a Buy at Citi. 2. Twitter (TWTR) and Alphabet (GOOG, GOOGL) were initiated with a Buy at Guggenheim, while Snap (SNAP) and Facebook (FB) were initiated with a Neutral. 3. Apache (APA) initiated with an Overweight at Stephens. 4. CorMedix (CRMD) initiated with a Buy at Roth Capital. 5. Protagonist Therapeutics (PTGX) initiated with a Buy at Nomura Instinet. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
12/12/18
HCWC
12/12/18
NO CHANGE
Target $3.5
HCWC
Buy
CorMedix price target raised to $3.50 from $3 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for CorMedix to $3.50 and reiterates a Buy rating on the shares. The analyst continues to believe that it is possible that the FDA would agree to an accelerated filing pathway for Neutrolin because of the unmet nature of the medical need with respect to catheter-related bloodstream infections and the power of the previously-reported LOCK-IT-100 interim analysis. CorMedix management have indicated that progress continues to be made towards the finalization of a New Drug Application filing on Neutrolin, Selvaraju tells investors in a research note.

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