ADMP On Watch, It's A Thumbs Down For BMRN, No Pain, All Gain For IPCI

(RTTNews) - Adamis Pharmaceuticals Corp.'s (ADMP) 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 - with a decision date set for June 4, 2016.

Anaphylaxis is a serious allergic reaction.

This is Epinephrine's second go-around with the FDA. The NDA for Epinephrine Pre-Filled Syringe submitted under Section 505(b)(2) was issued a complete response letter on March 27, 2015, wherein the FDA had raised concerns about Chemistry, Manufacturing and Controls.

ADMS closed Thursday's trading 7.04% higher at $25.55.

The FDA has rebuffed BioMarin Pharmaceutical Inc.'s (BMRN) investigational drug Kyndrisa for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping saying that the standard of substantial evidence of effectiveness has not been met.

The company is reviewing the Complete Response Letter issued for Kyndrisa and will determine the next course of action regarding the application.

Kyndrisa is still under review in the European Union. The opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use is expected in the first half of 2016.

BMRN touched a new 52-week low of $77.59 on Thursday before closing the day's trading at $84.43, up 0.37%.

Robotic medical device company Hansen Medical Inc. (HNSN) has a couple of catalysts lined up over the coming months.

The company hopes to present the long-awaited interim analysis of ARTISAN IDE Study, a single arm study of its Hansen Sensei System for introducing and positioning RF ablation catheters in subjects with paroxysmal atrial fibrillation, promptly.

The company has also plans to submit the 510k to FDA for a neurological indication for the Magellan Robotic System this quarter.

HNSN slumped to a new low of $1.28 on Thursday before closing the day's trading at $1.44, down 25.58%.

Shares of Intellipharmaceutics International Inc. (IPCI) (I.TO) surged over 15% on Thursday, following successful bioequivalence results for abuse deterrent Rexista Oxycodone XR.

Rexista Oxycodone XR has demonstrated bioequivalence to Oxycontin extended release tablets as manufactured and sold in the United States by Purdue Pharma LP.

Rexista Oxycodone XR is the company's non-generic extended release formulation intended for the management of moderate to severe pain when an around-the-clock analgesic is required.

As the bioequivalence results are positive, the phase III efficacy trials are not required for Rexista Oxycodone XR. The company plans to file an NDA for Rexista Oxycodone XR within the next six months.

IPCI closed Thursday's trading at $2.45, up 15.57%.

Karyopharm Therapeutics Inc. (KPTI) has initiated a new phase 2/3 clinical trial with oral Selinexor in patients with advanced unresectable dedifferentiated liposarcoma.

The trial, dubbed SEAL, will enroll 50 patients in the phase 2 portion - with the potential to increase enrollment in the phase 3 portion following an interim analysis.

Top-line data from the phase 2 portion of the SEAL study are expected in early 2017.

KPTI closed Thursday's trading at $6.84, down 1.44%.