Form 8-K Neos Therapeutics, Inc. For: Nov 10

Go back to Form 8-K Neos Therapeutics, Inc. For: Nov 10

Neos Therapeutics (NEOS) Posts Wider-than-Expected Q3 Loss

November 11, 2015 7:50 AM EST

Neos Therapeutics (NASDAQ: NEOS) reported Q3 EPS of ($0.77), $0.19 worse than the analyst estimate of ($0.58). Revenue for the quarter came in at $221 thousand versus the consensus estimate of $800 thousand.

For earnings history and earnings-related data on Neos Therapeutics (NEOS) click here.

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Neos Therapeutics (NEOS) Receives FDA Complete Response Letter for Cotempla XR-ODT NDA

November 11, 2015 7:49 AM EST

Neos Therapeutics (Nasdaq: NEOS) announced that the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Cotempla XR-ODT (Methylphenidate Extended Release Orally Disintegrating) 10mg, 20mg, and 30mg tablets. Neos Therapeutics also announced financial results for the third quarter ended September 30, 2015.

Complete Response Letter from the FDA for Cotempla XR-ODT

As the Company previously disclosed, the Company was informed on October 16, 2015 that the FDA had identified unspecified deficiencies that preclude discussion of labeling and postmarketing... More