It’s Raining FDA Approvals, SMMT Opens Wallet, AGRX Snubbed Yet Again

Today’s Daily Dose brings you news about approval of the first and only over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness; approval of MRK/PFE’s Type 2 diabetes drugs; delay in FDA’s action on Portola’s Biologics License Application for AndexXa; Summit’s acquisition of a next generation targeted antimicrobials company; an update on Ocular’s Dextenza and Agile’s disappointment over hormonal contraceptive patch Twirla.

Read on…

Shares of Agile Therapeutics Inc. (AGRX) plunged over 47% on Friday after the Company’s investigational low-dose combined hormonal contraceptive patch Twirla was turned down by the FDA yet again.

In its Complete Response Letter, the FDA has raised concerns of deficiencies relating to quality adhesion test methods, deficiencies in a facility of the Company’s third-party manufacturer, Corium International Inc. (CORI), for Twirla, and the in vivo adhesion properties of Twirla and their potential relationship to the SECURE phase 3 clinical trial results.

Twirla was rejected by the FDA in 2013 too, and the Company was asked to conduct a new clinical trial and provide additional information on the manufacturing process for the hormonal contraceptive patch.

Al Altomari, chairman and CEO of Agile Therapeutics, said, “We are clearly disappointed, and we are evaluating the FDA’s response. We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and discuss a path to approval for Twirla. We will work closely with the FDA to address the points raised in the CRL as quickly as possible.”

AGRX touched a new low of $1.93 on Friday before closing the day’s trading at $2.52, down 47.06%.

The FDA decision date on BioMarin Pharmaceutical Inc.’s (BMRN) Pegvaliase Biologics License Application has now been extended by three months to May 28, 2018.

Pegvaliase is a PEGylated recombinant phenylalanine ammonia lyase enzyme product, proposed to reduce blood…

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