FDA Calendar

Tuesday, June 9, 2015

Random Catalyst $APRI, $LPCN $SGYP

Some random upcoming catalyst for 6/9

$APRI

Generate safety and proof-of-concept data from the RayVa Phase 2a clinical trial in patients with Raynaud's phenomenon secondary to scleroderma in order to make a go/no go decision, subject to guidance received from our Data Monitoring Committee (DMC) expected in June 2015

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$LPCN

Pivotal Phase 3 clinical study evaluating efficacy and safety of LPCN 1021, its Oral Testosterone product for hypogonadal men with low testosterone.Expected to announce top-line results from the 52 week safety assessment portion of the SOAR clinical study by mid-year, as well as file the New Drug Application ("NDA") with the U.S. Food and Drug Administration in the second half of this year.

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$SGYP

Completed enrollment in both phase 3 clinical trials with plecanatide for chronic idiopathic constipation (CIC) - pivotal data readouts expected in 2Q and 3Q 2015

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