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VIVO

Meridian Bioscience

$15.20

-0.6 (-3.80%)

17:31
10/23/17
10/23
17:31
10/23/17
17:31

Meridian Bioscience comments on FDA Warning Letter issued to subsidiary

Meridian Bioscience announced that the FDA has issued a Warning Letter related to matters at its Magellan Diagnostics subsidiary. In its July 27 press release, Meridian indicated that it expected Magellan would receive a Warning Letter based on the observations from the FDA's inspection, which was completed on June 29. Since the issuance of the FDA 483 Inspectional Observations at the conclusion of the inspection, Magellan has initiated prompt and comprehensive quality system remediation activities. Magellan will promptly submit a response to the Warning Letter for the Agency's consideration. Meridian Bioscience and Magellan reiterate their mutual commitment to strengthening Magellan's quality system and ensuring all aspects of the system are in full compliance. Both organizations take this very seriously. Magellan is addressing the observations noted in the Form FDA 483 and the Warning Letter with the highest sense of urgency.

VIVO Meridian Bioscience
$15.20

-0.6 (-3.80%)

05/18/17
ADAM
05/18/17
NO CHANGE
Target $14
ADAM
Hold
Meridian Bioscience warning letter a setback, says Canaccord
Canaccord analyst Mark Massaro noted the FDA issued a warning letter to Meridian Bioscience regarding its Magellan Diagnostics subsidiary, which is 10%-12% of its revenue. The letter warned about the risk of inaccurate test results from certain lead poisoning tests. Massaro said it is difficult to determine what the impact will be on margins until it can resolve both the FDA and CDC concerns, but it is definitely a setback for the company. Massaro maintained his Hold rating and lowered his price target to $14 from $15 on Meridian Bioscience shares.
05/17/17
PIPR
05/17/17
NO CHANGE
PIPR
Underweight
Piper sees 'reputational damage' for Meridian after FDA warning
Piper Jaffray analyst William Quirk expects "reputational damage" to Meridian Bioscience after the FDA issued a warning statement against using the company's Magellan LeadCare test systems citing the possibility of false negatives. It is possible Magellan revenue could fall by as much as 50% as physicians unplug systems, Quirk tells investors in a research note. He keeps an Underweight rating on shares of Meridian.
04/27/17
PIPR
04/27/17
NO CHANGE
PIPR
Underweight
Piper still sees competitive threats to Meridian, keeps at Underweight
Piper Jaffray analyst William Quirk noted that Meridian Bioscience reported better than expected Q2 revenue and earnings, with both Life Science and Diagnostics performance beating his forecast. However, he still sees increased risk of competition and thinks investor nervousness about dividend cuts will weigh on shares and keeps an Underweight rating on Meridian.
04/27/17
RAJA
04/27/17
NO CHANGE
RAJA
Underperform
Raymond James 'struggles' with Meridian Bioscience's valuation
Raymond James analyst Nicholas Jansen reiterated his Underperform rating following the Q2 report that beat low expectations. Jansen continues to believe the portfolio of assets will struggle to grow and said sustainability is a big question mark, keeping him cautious as he "struggles" with valuation.

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