ADMP Waiting To See If 3rd Time Is Charm, FDA Nod For SGYP, Be All Ears For OTIC

(RTTNews) - AbbVie's (ABBV) blockbuster blood cancer drug Imbruvica has been approved by the FDA for yet another indication - this time, for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. This indication is approved under accelerated approval.

The new indication marks the fifth patient population for whom Imbruvica is now approved and broadens the number of patients who may be treated with the medication, AbbVie noted.

Imbruvica is already approved for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström's macroglobulinemia. The drug had global sales of $1.32 billion in the first nine months of 2016.

ABBV closed Thursday's trading at $61.38, down 0.45%.

Adamis Pharmaceuticals Corp.'s (ADMP) resubmitted New Drug Application for its Epinephrine Pre-filled Syringe product candidate for the emergency treatment of anaphylaxis has been accepted for review by the FDA.

Epinephrine Pre-Filled Syringe was turned down by the U.S. regulatory agency in March of 2015 and well as in June 2016.

This is the third time that Epinephrine Pre-Filled Syringe is at the FDA altar. Will third time be the charm? We need to wait and see.

ADMP closed Thursday's trading at $3.05, up 1.67%.

Allergan plc's (AGN) RHOFADE cream has been approved by the FDA for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults.

RHOFADE, generically known as Oxymetazoline Hydrochloride, is the first and only alpha1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults.

AGN closed Thursday's trading at $214.58, down 0.91%.

Novavax Inc. (NVAX) has initiated a phase II safety and immunogenicity trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older).

The trial is designed to enroll up to 300 older adults in the Southern Hemisphere, and top-line results are expected in the third quarter of 2017.

NVAX closed Thursday's trading at $1.37, down 3.52%. In after-hours, the stock was up 1.46% to $1.39.

Otonomy Inc. (OTIC) has initiated patient enrollment in its phase II clinical trial evaluating OTO-104 for the prevention of hearing loss in cancer patients undergoing chemotherapy with platinum-based agents.

The trial is expected to enroll up to 60 subjects at 8-10 leading oncology centers in the United States.

Two phase III clinical trials for OTO-104 in Ménière's disease patients are underway, and results are expected in the second half of 2017.

OTIC closed Thursday's trading at $15.40, down 1.60%.

Shares of Synergy Pharmaceuticals Inc. (SGYP) were up over 5% in extended trading on Thursday, following FDA approval of TRULANCE for the treatment of adults with chronic idiopathic constipation.

The FDA decision on TRULANCE, generically known as plecanatide, was originally scheduled for January 29, 2017.

The approved dosing regimen for TRULANCE is 3 mg taken orally, once daily, with or without food at any time of the day. The drug is expected to be available in the U.S. later this quarter.

SGYP closed Thursday's trading at $6.41, down 1.84%. In after-hours, the stock was up 5.46% to $6.76.

Shire plc's (SHPG) resubmitted New Drug Application for SHP465, a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder, has been accepted for review by the FDA - with a decision expected on or around June 20, 2017.

The NDA for SHP465 was initially submitted by Shire in 2006. It was turned down by the U.S. regulatory agency on May 18, 2007, and the company was asked to conduct additional clinical studies.

SHPG closed Thursday's trading at $164.11, down 1.38%.