FDA Nod For EDAP, AGRX Issues Pink Slips, APHB Turns Heads, MNKD Breathes Easy

(RTTNews) - Today's Daily Dose brings you an update on Agile's corporate business, news on promising results of AmpliPhi's investigational bacteriophage therapeutic AB-SA01; BioMarin's receipt of milestone payments related to breast cancer drug candidate Talazoparib; FDA clearance of EDAP's Focal One device; MannKind's successful completion of a Phase 1 study of Treprostinil Technosphere (TreT) for Pulmonary Arterial Hypertension, and regulatory approval for expanded use of Roche's Rituxan in the U.S.

Read on…

Agile Therapeutics Inc. (AGRX) is reducing its workforce by approximately 30% and cutting down other planned expenses.

The Company has also submitted a formal dispute resolution request (FDRR) with the FDA for Twirla (AG200-15), an investigational low-dose, non-daily, combination hormonal contraceptive patch.

On December 22, 2017, the FDA refused to approve Twirla, which sent the Company's stock down 47% to $2.52.

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.

AGRX closed Thursday's trading at $0.59, down 1.74%. In after-hours, the stock was up 1.34% to $0.60.

AmpliPhi Biosciences Corp. (APHB) will be making a presentation on June 8, 2018 describing the use of an intravenously administered investigational bacteriophage therapeutic AB-SA01, being developed by the Company, to treat critically ill patients suffering from severe S. aureus infections.

Three patients suffering from endovascular infection and one patient who had severe vertebral osteomyelitis with epidural abscess were treated with AB-SA01.

According to the study results, AB-SA01 was well-tolerated. Bacterial elimination was demonstrated in three out of four patients, and no treatment related adverse outcomes were reported.

APHB closed Thursday's trading at $1.19, up 3.91%. In after-hours, the stock was up 14.64% to $1.37.

BioMarin Pharmaceutical Inc. (BMRN) has received $20 million in milestone payments from Pfizer Inc. (PFE) related to the FDA acceptance and European Medicines Agency (EMA) acceptance of Talazoparib filing.

Talazoparib is being developed for metastatic breast cancer patients with an inherited BRCA Mutation.

The milestone payments are part of an agreement, which BioMarin made with Medivation, Inc. In August 2015, Medivation acquired Talazoparib rights from BioMarin by paying $410 million upfront. BioMarin is entitled to receive up to an additional $160 million (in aggregate) upon the achievement of regulatory and sales-based milestones as well as mid-single digit royalties for Talazoparib.

The FDA is expected to announce its decision on Talazoparib in December 2018.

BMRN closed Thursday's trading at $91.01, down 1.33%.

Shares of EDAP TMS SA (EDAP) soared more than 39% in extended trading on Thursday, following FDA clearance of the Company's Focal One device for the ablation of prostate tissue.

The Focal One high intensity focused ultrasound (HIFU) device is the first medical apparatus designed specifically for focal treatment of the prostate. It combines the three essential components to efficiently perform a focal treatment: (i) state-of-the-art imaging to localize tumors with the use of magnetic resonance imaging (MRI) combined with real-time ultrasound, (ii) utmost precision of HIFU treatment focused on identified targeted cancer areas only and (iii) immediate feedback on treatment efficacy utilizing Contrast-Enhanced Ultrasound Imaging, according to the Company.

The device was granted CE Mark (European regulatory approval) in June 2013.

EDAP closed Thursday's trading at $2.21, down 2.21%. In after-hours, the stock was up 39.37% to $3.08.

Ironwood Pharmaceuticals Inc.'s (IRWD) Olinciguat has been granted Orphan Drug Designation by the FDA for the treatment of patients with sickle cell disease.

Olinciguat is an orally administered soluble guanylate cyclase (sGC) stimulator.

A phase II trial of Olinciguat for the potential treatment of sickle cell disease, dubbed STRONG-SCD, is underway. The trial is designed to enroll approximately 80 patients.

IRWD closed Thursday's trading at $17.32, down 3.02%.

MannKind Corp. (MNKD) has successfully completed a Phase 1 clinical study of Treprostinil Technosphere (TreT) for Pulmonary Arterial Hypertension, achieving the primary endpoint of safety and tolerability.

TreT is proposed as a drug-device combination product for the treatment of patients with pulmonary arterial hypertension (PAH), utilizing a small, portable, breath-powered inhaler that is intended to simplify drug dosing.

The Company is preparing the next phase of development to evaluate the safety and tolerability of TreT in patients with PAH.

TreT is expected to be subjected to the 505(b)(2) regulatory pathway.

MNKD closed Thursday's trading at $2.04, up 2%.

Nymox Pharmaceutical Corp. (NYMX) has reached manufacturing scale-up milestones for its lead compound Fexapotide Triflutate (FT).

Fexapotide triflutate is an injectable pro-apoptotic agent in development for the treatment of benign prostatic hyperplasia. A New Drug Application for Fexapotide Triflutate is expected to be filed later this year.

NYMX closed Thursday's trading at $3.68, up 4.25%.

The FDA has approved Roche Group's (RHHBY.OB) Supplemental Biologics License Application for the use of Rituxan for the treatment of pemphigus vulgaris, a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

Rituxan is already approved for the treatment of moderate to severe active rheumatoid arthritis in adults, Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis.

According to the Company, Rituxan is the first biologic therapy approved by the FDA for pemphigus vulgaris and the first major advancement in the treatment of the disease in more than 60 years.

The drug raked in global sales of $7.54 billion last year.

RHHBY.OB closed Thursday's trading at $26.60, down 0.04%.