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

(RTTNews) - 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 previously been treated with Herceptin-based adjuvant therapy.

The Company has time until December 22, 2017 to provide the details.

The CHMP is expected to issue an opinion regarding the Marketing Authorisation Application for Neratinib in the first quarter of 2018.

Neratinib was approved by the FDA last month for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX.

PBYI closed Wednesday's trading at $89.20, down 0.83%.

Theravance Biopharma Inc. (TBPH) has reported mixed results from its phase IIb study of investigational drug Velusetrag (TD-5108) for the treatment of patients with diabetic and idiopathic gastroparesis.

In the study, 5 mg dose of Velusetrag demonstrated statistically significant improvements in gastroparesis symptoms and gastric emptying compared to placebo. But patients in the 15 and 30 mg Velusetrag study arms did not demonstrate nominally statistically significant improvements in gastroparesis symptoms versus placebo. The Company attributed this to an increased frequency in gastrointestinal side effects at these doses that may have been caused by rapid emptying of the stomach.

The findings from the study demonstrate that a 5 mg dose was sufficient to ameliorate the symptoms of gastroparesis, noted Theravance.

TBPH closed Wednesday's trading at $32.05, up 0.38%.