Actionable news
0
All posts from Actionable news
Actionable news in FLXN: FLEXION THERAPEUTICS Inc,

Flexion Therapeutics Reports Third Quarter 2016 Financial Results

Successfully completed the transfer of the Zilretta manufacturing technology to Patheon - on track for NDA submission in December

Met primary endpoint in clinical trial evaluating Zilretta in Type 2 diabetes patients with knee osteoarthritis

Conference call scheduled for today at 4:30 p.m. ET

BURLINGTON, Mass., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the third quarter ended September 30, 2016.

"Through recent executive hires and further expansion of our commercial and sales teams, we are laying the groundwork to realize our commercialization goals for our investigational therapy, Zilretta™ (also referred to as FX006), in 2017," said Michael Clayman
, M.D., President and Chief Executive Officer of Flexion. "We are looking forward to the upcoming podium presentation of Phase 3 data evaluating Zilretta in patients with osteoarthritis of the knee at the American Association of Knee and Hip Surgeons (AAHKS) meeting on November 11th and remain on track to submit a new drug application (NDA) for Zilretta to the U.S. Food and Drug Administration in December."

Third-Quarter Financial Results

The company reported a net loss of $17.8 million for the third quarter of 2016, compared to a net loss of $11.1 million for the third quarter of 2015.

Research and development expenses increased to $9.0 million in the third quarter of 2016, compared to $7.8 million for the same period in 2015, due to an increase in personnel and other employee-related costs for additional headcount and stock based compensation.

General and administrative expenses increased to $8.4 million in the third quarter of 2016, as compared to $3.2 million for the same period in 2015, due primarily to additional costs associated with building a commercial infrastructure to effectively support the potential commercialization of Zilretta.

As of September 30, 2016, the company had $161.5 million in cash, cash equivalents, and marketable securities compared to $118.6 million as of December 31, 2015.

Third Quarter Highlights and Recent News:

  • Met primary endpoint in clinical trial evaluating Zilretta in Type 2 diabetes patients with knee osteoarthritis; results demonstrated a markedly lower rise in blood glucose in patients receiving a Zilretta injection compared to patients receiving an immediate-release triamcinolone acetonide (TCA) injection; difference was statistically significant (p<0.05, 2-sided) and clinically relevant.



  • Successfully completed the transfer of the Zilretta manufacturing technology to Patheon marking an important milestone that enables NDA submission in December.



  • Hired several senior level executives in preparation of an anticipated Zilretta commercial launch in 2017, including:



    • Carolyn Beaty Scimemi, Esq.
      Chief Compliance Officer
    • Mark Fraga
      , Vice President, Marketing
    • John Magee
      , Vice President of...

More