CorMedix Inc. [NASDAQ: CRMD] traded at a low on 03/01/21, posting a -39.87 loss after which it closed the day’ session at $9.02. The company report on March 1, 2021 that CorMedix Receives Complete Response Letter From FDA for DefenCath™ Catheter Lock Solution.
CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock solution) 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 Additionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.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.
The results of the trading session contributed to over 10761157 shares changing hands. Over the past one week, the price volatility of CorMedix Inc. stands at 15.03% while the volatility over the past one month is 13.69%.
The market cap for CRMD stock reached $304.97 million, with 32.13 million shares outstanding and 31.66 million shares in the current float. Compared to the average trading volume of 867.97K shares, CRMD reached a trading volume of 10761157 in the most recent trading day, which is why market watchdogs consider the stock to be active.
What do top market gurus say about CorMedix Inc. [CRMD]?
Based on careful and fact-backed analyses by Wall Street experts, the current consensus on the target price for CRMD shares is $25.60 per share. Analysis on target price and performance of stocks is usually carefully studied by market experts, and the current Wall Street consensus on CRMD stock is a recommendation set at 2.00. This rating represents a strong Buy recommendation, on the scale from 1 to 5, where 5 would mean strong sell, 4 represents Sell, 3 is Hold, and 2 indicates Buy.
Needham have made an estimate for CorMedix Inc. shares, keeping their opinion on the stock as Buy, with their previous recommendation back on February 17, 2021. While these analysts kept the previous recommendation, JMP Securities raised their target price to Mkt Outperform. The new note on the price target was released on September 29, 2020, representing the official price target for CorMedix Inc. stock. Previously, the target price had yet another raise to $20, while Truist analysts kept a Buy rating on CRMD stock.
The Average True Range (ATR) for CorMedix Inc. is set at 1.85, with the Price to Sales ratio for CRMD stock in the period of the last 12 months amounting to 1524.83. The Price to Book ratio for the last quarter was 7.78, with the Price to Cash per share for the same quarter was set at 1.10.
How has CRMD stock performed recently?
CorMedix Inc. [CRMD] fell into the red zone at the end of the last week, falling into a negative trend and dropping by -47.31. With this latest performance, CRMD shares gained by 3.20% in over the last four-week period, additionally plugging by 91.91% over the last 6 months – not to mention a rise of 73.46% in the past year of trading.
Overbought and oversold stocks can be easily traced with the Relative Strength Index (RSI), where an RSI result of over 70 would be overbought, and any rate below 30 would indicate oversold conditions. An RSI rate of 50 would represent a neutral market momentum. The current RSI for CRMD stock in for the last two-week period is set at 34.66, with the RSI for the last a single of trading hit 25.79, and the three-weeks RSI is set at 40.19 for CorMedix Inc. [CRMD]. The present Moving Average for the last 50 days of trading for this stock 10.76, while it was recorded at 14.56 for the last single week of trading, and 6.92 for the last 200 days.
CorMedix Inc. [CRMD]: Deeper insight into the fundamentals
Operating Margin for any stock indicates how profitable investing would be, and CorMedix Inc. [CRMD] shares currently have an operating margin of -7416.31 and a Gross Margin at -57.63. CorMedix Inc.’s Net Margin is presently recorded at -5801.29.
Return on Total Capital for CRMD is now -121.05, given the latest momentum, and Return on Invested Capital for the company is -94.69. Return on Equity for this stock declined to -114.99, with Return on Assets sitting at -68.04. When it comes to the capital structure of this company, CorMedix Inc. [CRMD] has a Total Debt to Total Equity ratio set at 0.02. Additionally, CRMD Total Debt to Total Capital is recorded at 0.02, with Total Debt to Total Assets ending up at 0.01. Long-Term Debt to Equity for the company is recorded at 0.01, with the Long-Term Debt to Total Capital now at 0.01.
Reflecting on the efficiency of the workforce at the company, CorMedix Inc. [CRMD] managed to generate an average of -$547,769 per employee. Receivables Turnover for the company is 51.79 with a Total Asset Turnover recorded at a value of 0.01.CorMedix Inc.’s liquidity data is similarly interesting compelling, with a Quick Ratio of 8.40 and a Current Ratio set at 8.40.
Earnings analysis for CorMedix Inc. [CRMD]
With the latest financial reports released by the company, CorMedix Inc. posted -0.21/share EPS, while the average EPS was predicted by analysts to be reported at -0.24/share. When compared, the two values demonstrate that the company surpassed the estimates by a Surprise Factor of 12.50%. The progress of the company may be observed through the prism of EPS growth rate, while Wall Street analysts are focusing on predicting the 5-year EPS growth rate for CRMD.
Insider trade positions for CorMedix Inc. [CRMD]
There are presently around $84 million, or 29.10% of CRMD stock, in the hands of institutional investors. The top three institutional holders of CRMD stocks are: BLACKROCK INC. with ownership of 1,995,193, which is approximately 4.661% of the company’s market cap and around 1.40% of the total institutional ownership; ELLIOTT INVESTMENT MANAGEMENT L.P., holding 1,758,374 shares of the stock with an approximate value of $15.86 million in CRMD stocks shares; and VANGUARD GROUP INC, currently with $12.21 million in CRMD stock with ownership of nearly 4.879% of the company’s market capitalization.
Positions in CorMedix Inc. stocks held by institutional investors increased at the end of March and at the time of the March reporting period, where 41 institutional holders increased their position in CorMedix Inc. [NASDAQ:CRMD] by around 1,189,639 shares. Additionally, 20 investors decreased positions by around 259,355 shares, while 22 investors held positions by with 7,821,543 shares. The mentioned changes placed institutional holdings at 9,270,537 shares, according to the latest SEC report filing. CRMD stock had 12 new institutional investments in for a total of 378,266 shares, while 8 institutional investors sold positions of 221,209 shares during the same period.