Fri, Jan. 2, 12:50 PM
Fri, Jan. 2, 9:28 AM
- MiMedx (NASDAQ:MDXG) is off 11% premarket on light volume in response to its announcement that it has received a subpoena from the Office of Inspector General of the Department of Health and Human Services in connection with a civil investigation into matters related to the company's sales and marketing activities.
- The company plans to cooperate fully with investigators.
Oct. 30, 2014, 9:11 AM
Jul. 29, 2014, 12:47 PM
Jan. 6, 2014, 12:31 PM
- Although "management has done a nice job of shepherding the company through some turbulence ... at almost an $850M valuation, we believe this stock is reflecting an overenthusiastic scenario; and at least on a fundamental basis, we believe it is prudent to move to the sideline," Northland Capital's Suraj Kalia says, regarding shares of MiMedx (MDXG -7.5%).
- MDXG has faced a number of hurdles over the past six months including questions from the FDA about the status (HCT/P) of its products and new rules regarding Medicare coverage for EpiFix.
- MDXG cut to Market Perform from Outperform.
- Price target is $6.
Dec. 12, 2013, 1:30 PM
- MiMedx Group (MDXG +7%) charges ahead after its wound care allograft EpiFix receives coverage from Medicare contractor CGS. The move brings coverage from Medicare Administrative Contractors to six of eight, and 86% of Medicare beneficiaries will now be eligible for coverage for EpiFix products.
- Press release
Dec. 9, 2013, 9:15 AM
Nov. 29, 2013, 10:50 AM
- Shares of MiMedx Group (MDXG +6.1%) are stronger in early trading after the CMS issued final payment rules for HOPPS.
- EpiFix gets a pass-through for 2014 — it retains the current payment methodology (ASP +6%) for one more year.
- Here's CEO Parker Petit commenting on the new two-tier payment system adopted by CMS: "We believe this new ... reimbursement policy will reduce excessive spending and broaden patient access to advanced wound care, which will benefit Medicare recipients. We applaud CMS for making this policy change." (PR)
- Also, Osiris Therapeutics (OSIR +4.5%) looks to have gotten a two-year pass-through for Grafix.
- Meanwhile, SA contributor Jason Napodano doesn't sound optimistic on either MDXG or OSIR. See here and here.
Oct. 21, 2013, 3:57 PM
- Shares of Osiris Therapeutics (OSIR -17%) are having a rough session.
- At the heart of today's weakness is a debate about the status of Grafix and Ovation which, in turn, has roots in an FDA letter sent to MidMedx (MDXG) in August regarding a distinction between HCT/P products and biologic products.
- Around that time, The Street's Adam Feuerstein suggested the issue might end up affecting OSIR.
- This morning, OSIR said that after discussions with the FDA, it was determined that "Grafix will remain on the market as a wound cover for the treatment of acute and chronic wounds. For certain expanded indications ... OSIR has committed to submit a Biologics License Application." (PR)
- Feuerstein promptly published a new piece carrying the headline: "FDA slaps Osiris for misleading medical claims about stem-cell bandage."
- A few hours later, OSIR issued a PR alleging Feuerstein "falsely claimed [that] OSIR was issued a Warning Letter from the FDA [and] falsely stated that OSIR would need to stop marketing Grafix for diabetic foot ulcers." Now, the company says it is "reviewing all of its legal and regulatory options." (PR)
Sep. 5, 2013, 12:45 PM
Sep. 5, 2013, 9:14 AM
Sep. 4, 2013, 4:36 PM
- MiMedx (MDXG) responds to an FDA letter which sent the shares tumbling 36% during the regular session.
- The FDA says the company's Amnion / Chorion Injectable products "are not regulated solely under section 361 of the Public Health Service Act" and in order to market them, the company needs a "valid biologics license." Because "none of the ... products ... are the subject of an approved biologics license application, nor are there INDs in effect for any of these products, [the FDA] has determined that [the company's] actions have violated the Act." (full letter)
- For its part, the company is "surprised" and says an inspector from the FDA advised it that the Center for Biologics Evaluation and Research "had completed its review and had no findings or further questions and, therefore, the  inspection was classified as No Action Indicated." MDXG says a copy of the report establishing NAI is available on its website. (PR)
- MDXG +9% AH.
Aug. 14, 2013, 12:10 PM
- MiMedx (MDXG +1.2%) moves up on some positive comments out of Craig Hallum this morning, saying that it thinks Epifix is better than Osiris Therapeutics (OSIR) Grafix.
- Yesterday, OSIR soared on reports that its stem-cell based biosurgery product Grafix closed three times as many wounds as conventional treatment in a study of patients with a diabetic foot ulcer.
- OSIR is taking a bit of a breather today, currently -12%.
Jul. 15, 2013, 12:45 PM
Jul. 3, 2013, 10:45 AMMiMedx Group (MDXG.PK -5.7%) slips this morning after the company filed a $100.55M shelf registration statement to sell any combination of common and preferred stock, warrants and equity units. In addition, MDXG shareholders may offer for resale up to 7.5M shares of MDXG common stock owned by them under the shelf registration. | Comment!
MDXG vs. ETF Alternatives
Other News & PR