ADMP Snubbed Again, OCUL, DNAI Skid On Trial Data, AGN Gets FDA Nod. SRPT Abuzz

(RTTNews) - Shares of Adamis Pharmaceuticals Corp. (ADMP) cratered over 53% on Monday, following the receipt of a Complete Response Letter again for the company's Epinephrine Pre-Filled Syringe proposed for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction.

The company's Epinephrine Pre-Filled Syringe was turned down by the FDA last March too.

ADMP closed Monday's trading at $4.09, down 53.84%.

Shares of Alexion Pharmaceuticals Inc. (ALXN) dropped over 10% in extended trading on Monday, following failure of the company's phase III trial of Soliris in patients with refractory generalized myasthenia gravis.

Soliris is already approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis, and for the treatment of patients with atypical hemolytic uremic syndrome.

In the phase III study, dubbed REGAIN, the primary efficacy endpoint of change from baseline in Myasthenia Gravis-Activities of Daily Living Profile total score, a patient-reported assessment, at week 26, did not reach statistical significance.

Soliris net product sales in 2015 were $2.590 billion compared to $2.146 billion in 2014. Looking ahead to 2016, the company expects the drug to generate sales of $2.835 billion to $2.875 billion.

ALXN closed Monday's trading at $154.99, up 0.71%. In after hours, the stock was down 10.52% to $138.69.

Arch Therapeutics Inc. (ARTH.OB) had completed patient enrollment in its first clinical study to assess the safety and performance of AC5 Surgical Hemostatic Device in humans.

AC5 Surgical Hemostatic Device is being designed to achieve hemostasis in surgical procedures. Results from the study are expected later this summer.

ARTH.OB closed Monday's trading at $0.41, up 2.50%.

Allergan plc (AGN) has received FDA approval for BYVALSON for the treatment of hypertension to lower blood pressure.

BYVALSON is a fixed-dose combination of Nebivolol and Valsartan, two FDA approved, once daily, blood pressure lowering agents with different mechanisms of action. The company expects BYVALSON to be available in the second half of this year.

AGN closed Monday's trading at $247.21, up 0.10%.

Shares of Ocular Therapeutix Inc. (OCUL) fell over 42% on Monday as the company's second phase III trial of DEXTENZA for the treatment of allergic conjunctivitis failed to achieve the primary endpoint.

DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular depot and designed for drug release to the ocular surface for up to 30 days.

In the trial, although ocular itching was seen to be numerically lower (more favorable) in the DEXTENZA treatment group compared to the placebo group, the difference did not reach statistical significance.

OCUL closed Monday's trading at $6.81, down 42.53%.

Shares of ProNAi Therapeutics Inc. (DNAI) plunged more than 67% on Monday, following disappointing interim results from the company's phase II trial of PNT2258 for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

According to the company, although modest efficacy was observed in the trial, dubbed Wolverine, the results are not robust enough to justify continued development of PNT2258 in diffuse large B-cell lymphoma.

ProNAi has decided to suspend development of PNT2258 pending further review of data in order to determine next steps.

DNAI closed Monday's trading at $2.07, down 67.55%.

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi's (SNY) one-year phase III study, known as LIBERTY AD CHRONOS, evaluating investigational Dupilumab in moderate-to-severe atopic dermatitis adult patients has met its primary and key secondary endpoints.

In the study, Dupilumab with topical corticosteroids significantly improved measures of overall disease severity at 16 and 52 weeks, when compared to placebo with topical corticosteroids.

REGN closed Monday's trading at $403.89, up 0.78%.

Genentech, a member of the Roche Group (RHHBY.OB) announced positive results from its phase III study, which evaluated Actemra in people with giant cell arteritis.

The study, dubbed GiACTA, met its primary and key secondary endpoints, showing Actemra, initially combined with a six-month steroid regimen, more effectively sustained remission through one year compared to a six or 12-month steroid-only regimen in newly diagnosed and relapsing people with giant cell arteritis.

Actemra is already approved for the treatment of moderate to severe rheumatoid arthritis in adults, and the treatment of active systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis in patients two years of age and older.

RHHBY.OB closed Monday's trading at $33.40, up 1.01%.

Shares of Sarepta Therapeutics Inc. (SRPT) were up more than 25% in after hours on Monday after the FDA request for dystrophin data from biopsies already obtained from an ongoing confirmatory study reignited hopes that the company's Duchenne Muscular Dystrophy drug candidate Eteplirsen stand a chance of getting approved.

The company plans to submit data from thirteen patient biopsy samples, at baseline and Week 48, to the FDA over the coming weeks to facilitate a prompt decision on the NDA by the Agency.

As you may know, the FDA on May 25, 2016 announced that it will not be able to complete the review of Sarepta's Eteplirsen NDA by the decision date of May 26, 2016, sending the company's shares soaring by over 26% that day.

SRPT closed Monday's trading at $16.05, up 3.08%. In after hours, the stock was up 25.79% to $20.19.