FDA Panel Snubs JNJ, CHMP Seeks More Data From PBYI, TBPH On Watch, AGRX Slumps

Today’s Daily Dose brings you news about Agile’s stock offering; FDA panel’s thumbs down for arthritis drug Sirukumab; Theravence’s mixed results from its phase IIb study of gastroparesis drug Velusetrag and setback for Puma’s Neratinib in the E.U.

Read on…

Shares of Agile Therapeutics Inc. (AGRX) were down 12% in extended trading on Wednesday, following its proposed public offering of common stock.

The Company intends to grant underwriters a 30-day option to purchase an additional fifteen percent of the shares of common stock offered in the public offering.

Agile’s New Drug Application for Twirla, an investigational low-dose combined hormonal contraceptive patch, is under FDA review – with a decision date set for December 26, 2017.

Twirla was turned down by the FDA in 2013. It remains to be seen if the second time will prove the charm for Twirla?

AGRX closed Wednesday’s trading at $4.57, down 0.65%. In after-hours, the stock was down 12.04% to $4.02.

An FDA panel has recommended against approving Sirukumab for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs.

Sirukumab, whose proposed trade name is Plivensia, is being co-developed by Johnson & Johnson’s Janssen Biotech subsidiary and GlaxoSmithKline plc (GSK).

While the panel voted unanimously in support of the efficacy data, there was uncertainty regarding the safety profile. As a result, the Committee did not support the approval of Sirukumab.

The FDA usually follows the panels’ recommendation, although it is not required to do so. We estimate that the final decision is likely to be announced by September 23, 2017.

JNJ closed Wednesday’s trading at $132.16, down 0.26%.

MiMedx Group Inc. (MDXG) has initiated a phase III study of AmnioFix Injectable in the treatment of Plantar Fasciitis on subjects that have moderate or severe pain due to Plantar Fasciitis with failed treatment for at least one month.

The phase III study is designed to enroll approximately 164 patients, with an estimated enrollment period of 18 months.

MDXG closed Wednesday’s trading at $14.39, down 3.81%.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has asked Puma Biotechnology Inc. (PBYI) to provide additional data analyses related to the safety and efficacy of Neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in patients who have…

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