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SIEN

Sientra

$9.76

0.945 (10.73%)

16:29
03/20/19
03/20
16:29
03/20/19
16:29

Sientra responds to FDA letter, does not expect matter to impact operations

Sientra announced it has provided an initial response to the FDA related to a post-approval study Warning Letter issued on March 19, 2019 and will provide a comprehensive plan for compliance to FDA within 15 days. The company also issued the following statement: "Sientra takes this matter seriously and will take all necessary steps to address the topic of the Warning Letter issued by the FDA for one of the company's post-approval studies. We are working to fully address the points noted with our study's participant retention, including patient questionnaire completion and additional follow-up office visits. We have employed numerous methods to encourage patient participation and look forward to continuing to work collaboratively with the FDA for a prompt resolution... Sientra looks forward to discussing its plans to achieve compliance at the FDA's General and Plastic Surgery Devices Panel meeting scheduled for March 25-26, 2019." The company noted it believes this matter will not have an adverse impact on its ongoing business or operations.

SIEN Sientra
$9.76

0.945 (10.73%)

03/13/19
SPHN
03/13/19
NO CHANGE
Target $26
SPHN
Overweight
Sientra growth outlook remains effectively on-track, says Stephens
Stephens analyst Chris Cooley reiterated his Overweight rating and $26 price target on Sientra shares following the company's Q4 report, contending that its growth outlook "remains effectively on-track." He still thinks investors should accumulate the shares at "historically trough multiples in med tech" to benefit from the expected acceleration in growth during the second half of 2019, Cooley tells investors in a post-earnings research note.
03/13/19
STFL
03/13/19
NO CHANGE
Target $16
STFL
Buy
Sientra price target lowered to $16 after quarterly results at Stifel
Stifel analyst Jonathan Block lowered his price target lowered to $16 from $19 saying that while Q4 results were largely known, the company provided a tempered first half of 2019 outlook. The analyst notes that Sientra had already preannounced Q4 results in January, but points out that there were a couple of incremental data points on the conference call that may exert some near-term pressure on the stock, including recent headlines surrounding ALCL and textured implants that have pressured the number of Plastic Surgeon breast augmentation consultations in Q1, which may continue into Q2. Nonetheless, Block reiterates a Buy rating on the shares.
03/14/19
WELS
03/14/19
INITIATION
Target $9
WELS
Market Perform
Sientra initiated with a Market Perform at Wells Fargo
Wells Fargo analyst David Maris started coverage of Sientra with a Market Perform rating and a $9 price target. The analyst says he is on the sidelines given the FDA is holding meetings on March 25-26 to discuss breast implant safety and the result could be increased monitoring and warnings, which could have a negative impact on costs and volumes.
03/19/19
WELS
03/19/19
NO CHANGE
Target $9
WELS
Market Perform
Sientra implied costs to gain FDA compliance negligible, says Wells Fargo
Wells Fargo analyst David Maris kept his Market Perform rating and $9 price target on Sientra after the company disclosed an FDA warning letter for failure to comply with the post-approval study requirements for its silicone gel breast implants. The analyst notes that he spoke with the management, and they believe that the FDA is targeting a patient follow-up rate of 65% at the end of 10 years after the study vs. the company's current 61% at year 3. Maris adds that given about 5K patients in the study with $100-$200 implied cost per patient, the required incremental cost to address FDA concerns is "negligible" relative to the company's current operating expenses.

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