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TXMD Awaits Big Day Next Week, TEVA Faces FDA In Sep., ESPR On Watch

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Today's Daily Dose brings you news about Anika's accelerated share repurchase program; Esperion's phase III study results of bempedoic acid in patients with hypercholesterolemia; TherapeuticsMD and Teva's near-term catalysts.

Read on…

Anika Therapeutics Inc. (ANIK) will be entering into an accelerated share repurchase program with Morgan Stanley & Co. LLC to repurchase $30 million of its outstanding common stock.

The Company expects that the accelerated share repurchase program will commence in late May and that it will be completed in the fourth quarter of 2018.

ANIK closed Wednesday's trading at $39.50, up 1.41%.

Esperion's (ESPR) third pivotal phase III study of bempedoic acid 180 mg versus placebo added to background lipid-modifying therapy in patients with hypercholesterolemia who are considered statin intolerant has also met the primary endpoint.

The 24-week study achieved LDL-C lowering totaling 26 percent in patients on bempedoic acid who remained on treatment at both week 12 and week 24.

The study met its primary endpoint with LDL-C lowering of 23 percent at 12 weeks in the intent to treat (ITT) analysis compared with placebo which had a decrease of one percent. Patients treated with bempedoic acid also achieved a significantly greater reduction of 25 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, compared with placebo which had an increase of three percent, noted the Company.

That said, investors were not impressed with the results this time too as the serious adverse events were higher in the bempedoic acid arm (6.0 percent) compared to 3.6 percent in the placebo arm. However, according to the study investigator, none of the serious adverse events were deemed to be related to bempedoic acid.

A pivotal study evaluating the bempedoic acid/ezetimibe combination pill (053 Study) in 350 patients with ASCVD, or at high risk for ASCVD, on maximally-tolerated statin therapy is underway, with top-line results expected in August 2018.

Another pivotal study evaluating bempedoic acid in 3,000 patients with ASCVD on maximally-tolerated statin therapy is ongoing, with top-line results expected in September 2018.

The Company plans to submit NDAs to the FDA for bempedoic acid and the bempedoic acid /ezetimibe combination pill for LDL-C-lowering indications no later than the first quarter of 2019. Additionally, Esperion plans to submit Marketing Authorization Applications to the European Medicines Agency no later than the second quarter of 2019.

ESPR closed Wednesday's trading at $38.32, down 3.57%.

TransEnterix Inc. (TRXC) has entered into a debt financing agreement with Hercules Capital Inc. to secure up to $40.0 million in term loans.

The funding of the first $20 million tranche occurred on May 23, 2018, and the Company will be eligible to draw on the second tranche of $10 million upon achievement of certain Senhance System revenue-related milestones for its 2018 fiscal year, and a third tranche of $10 million upon achievement of designated trailing six months GAAP net revenue from Senhance sales.

The Senhance System is currently cleared for use in the U.S. for laparoscopic colorectal and laparoscopic gynecologic surgery, accounting for approximately 1.5 million procedures in the U.S. annually.

In January of 2018, the Company sought FDA's permission to expand the indications for use of the Senhance System to include laparoscopic inguinal hernia and gallbladder surgery. If the FDA clears the Company's request, the additional indications are expected to bring the Senhance System's total addressable procedures in the U.S. to approximately 3 million.

TRXC closed Wednesday's trading at $2.92, down 4.89%.

TherapeuticsMD Inc. (TXMD) is yet to hear from the FDA regarding the approval of TX-004HR, the Company's investigational applicator-free estradiol vaginal softgel capsule. The FDA's decision date is May 29, 2018.

The Company is seeking approval of TX-004HR for the treatment of moderate-to-severe vaginal pain during sexual activity (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

TXMD closed Wednesday's trading at $5.95, up 1.71%.

Theratechnologies Inc. (TH.TO) has reached a pricing agreement with the AIDS Drug Assistance Program Crisis Task Force, opening access to Trogarzo injection and EGRIFTA to low income, underinsured and uninsured Americans in all 50 states and the territories.

Trogarzo represents a critical new treatment advance as the first HIV therapy with a new mechanism of action approved in 10 years and proven efficacy in difficult-to-treat patients with multi-drug resistant HIV-1.

EGRIFTA is a growth hormone-releasing factor analog and is the only FDA-approved treatment indicated for the reduction of excess abdominal fat in HIV infected patients with lipodystrophy, according to the Company.

TH.TO closed Wednesday's trading at $13.84, up 2.52%.

The FDA decision on Teva Pharmaceutical Industries Ltd.'s (TEVA) Fremanezumab, an investigational therapy for the preventive treatment of migraine, which was initially set for mid-June, is now expected on September 16, 2018.

Celltrion, the Company's only source for API (active pharmaceutical ingredient) production for Fremanezumab was issued a warning letter for its facility in Incheon, South Korea, by the FDA in January.

With Celltrion addressing the issues addressed in the warning letter, the FDA has finalized the decision date now.

Will Fremanezumab be greenlighted by the FDA like Amgen's Aimovig, the first drug designed to prevent migraines? Aimovig was approved as recently as May 17, 2018.

TEVA closed Wednesday's trading at $21.15, up 0.71%.

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