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ANIK Plunges On Disappointing Data, MRNS Initiates Marigold, SSKN On Watch

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Today's Daily Dose brings you news about Alexion's progress in paroxysmal nocturnal hemoglobinuria; Anika's disappointing results of CINGAL in osteoarthritis of the knee; timeline of Kala's submission of New Drug Application for KPI-121 0.25% for the treatment of dry eye disease; Marinus' Marigold study and Pacira's deal with China-based Nuance Biotech.

Read on…

Alexion Pharmaceuticals Inc. (ALXN) has submitted its Biologics License Application to the FDA for approval of ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria.

The submission uses a rare disease priority review voucher, which designates the BLA for an expedited eight-month review by the FDA instead of the standard 12-month review.

The Company is also preparing submissions for the approval of ALXN1210 as a treatment for patients with paroxysmal nocturnal hemoglobinuria in the European Union by mid-year and in Japan in the second half of the year. ALXN1210 has received Orphan Drug Designation (ODD) for the treatment of patients with PNH in the U.S. and EU.

ALXN closed Tuesday's trading at $121.91, up 2.73%.

Shares of Anika Therapeutics Inc. (ANIK) plunged over 20% in extended trading on Tuesday, following disappointing results from its second pivotal phase III trial evaluating CINGAL for the treatment of symptoms associated with osteoarthritis ("OA") of the knee.

According to the Company, the study did not achieve statistical significance at primary endpoint of 26 weeks. The primary endpoint was a comparison of the pain reduction of CINGAL compared with triamcinolone hexacetonide (TH) alone at 26-weeks.

CINGAL has previously been evaluated in a placebo-controlled Phase III clinical trial (13-01) that demonstrated safety and efficacy relative to saline through 26-weeks.

When the two studies are taken into consideration, the Company believes that the two Phase III studies validate the effectiveness of CINGAL for use in patients with knee osteoarthritis.

CINGAL is Anika's third-generation viscosupplement, following the Company's ORTHOVISC and MONOVISC products, to treat pain associated with osteoarthritis of the knee.

ANIK closed Tuesday's trading at $46.12, up 2.33%. In after-hours, the stock was down 20.86% to $36.50.

Kala Pharmaceuticals Inc. (KALA) plans to submit a New Drug Application for KPI-121 0.25% for the treatment of dry eye disease during the second half of 2018.

If approved, KPI-121 0.25% could be the first FDA-approved product for the short-term treatment of dry eye disease.

An additional phase III trial evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease, dubbed STRIDE 3, is expected to be initiated in the third quarter of 2018. Top-line results for STRIDE 3 are anticipated in the fourth quarter of 2019.

KALA closed Tuesday's trading at $13.35, down 2.91%.

Marinus Pharmaceuticals Inc. (MRNS) has initiated a pivotal phase III clinical trial evaluating the use of oral Ganaxolone in children and young adults with CDKL5 Deficiency Disorder.

The trial, dubbed Marigold Study, is designed to enroll approximately 70 patients between the ages of 2 and 21 with a confirmed disease-related CDKL5 gene variant.
The study's primary efficacy endpoint is percent reduction in seizures.

Currently, there are no approved therapies for CDKL5 Deficiency Disorder worldwide. Existing anti-epilepsy medications do not work well in CDD, and at best, any efficacy is short-lived, noted the Company.

MRNS closed Tuesday's trading at $6.96, down 0.43%.

Pacira Pharmaceuticals Inc. (PCRX) has entered into an agreement with China based Nuance Biotech Co. Ltd. to advance the development and commercialization of EXPAREL in China.

EXPAREL is a non-opioid option for achieving long-lasting pain control after surgery via infiltration into the surgical site or administration as an interscalene brachial plexus nerve block.

EXPAREL net product sales were $282.9 million in 2017, a 6% increase over the $265.8 million reported in 2016. Looking ahead to 2018, the Company expects EXPAREL net product sales to be in the range of $300 to $310 million.

PCRX closed Tuesday's trading at $38.05, up 2.28%.

STRATA Skin Sciences (SSKN) has submitted its 510(k) application to the FDA for its Multi-Micro Dose tip accessory for the proprietary XTRAC 308nm excimer laser.

The patent pending Multi-Micro Dose Tip applies multiple high-energy doses at varying levels of energy to the patient's psoriatic plaque. Data have shown that higher doses of the XTRAC treatment achieved PASI-75 clearance in as little as two to four weekly treatments compared to an average of 6.2 treatments in previously published studies, added the Company.

SSKN closed Tuesday's trading at $2.24, up 7.18%.

by RTTNews Staff Writer

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