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FDA Nod For MRK's Antibiotic; DRRX Awaits Big Day In Dec., Airxpanders Goes Bust

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Today's Daily Dose brings you news about FDA approval of Merck's antibiotic; Durect's upcoming regulatory catalyst; stock offering of Amarin and bankruptcy filing of Airxpanders.

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Shares of Amarin Corporation plc (AMRN) were down 8% in extended trading on Wednesday, following the commencement of an underwritten public offering of $400 million of its American Depositary Shares pursuant to a shelf registration. All of the shares in the proposed offering are to be sold by Amarin.

The Company expects to grant the underwriters a 30-day option to purchase up to an additional $60 million of its American Depositary Shares in connection with the proposed public offering.

A supplemental new drug application for Vascepa seeking cardiovascular risk reduction indication is under priority review by the FDA, with a decision date set for September 28, 2019. It is not known whether an FDA panel will review the Vascepa sNDA before the regulatory agency announces its final decision.

Vascepa is a prescription-only omega-3 fatty acid capsule, used as an adjunct to diet for reducing triglyceride levels in adult patients with severe hypertriglyceridemia.

AMRN closed Wednesday's trading at $21.07, down 3.08%. In after-hours, the stock was down 8.31% to $19.32.

DURECT Corporation's (DRRX) full response to the Complete Response Letter it previously received from FDA related to POSIMIR (bupivacaine extended-release solution) has been accepted by the regulatory agency, and a decision is expected on December 27, 2019.

POSIMIR is DURECT's investigational post-operative pain relief depot product that utilizes the Company's patented SABER technology. POSIMIR is designed to be administered directly into the surgical site to deliver bupivacaine for up to three days after surgery. The drug was issued a Complete Response Letter by the FDA n February 2014.

DRRX closed Wednesday's trading at $0.69, up 0.83%.

The FDA has given market clearance for FX 635 Laser system, developed by privately-held Erchonia Corporation, for chronic low back pain of musculoskeletal origin.

FX 635 Laser system becomes the first and only FDA-market cleared low-level laser treatment option.

Commenting on the approval, Steven Shanks, President of Erchonia stated, "We believe we have demonstrated that the use of non-thermal lasers has proven to be a far better option for treating low back pain than that of opioids or NSAIDS."

In clinical trials that looked at reduction of chronic low back pain with opioids and NSAIDS over 1 year, opioids demonstrated a 30% reduction in pain and NSAIDS proved a 34.5% reduction in pain.

Days after getting FDA clearance for a smooth-shell version of AeroForm device, which is used for post-mastectomy breast reconstruction, AirXpanders Inc. has ceased operations and will not be providing customer service or sales support after Thursday, July 18, 2019.

The medical device company anticipates filing a petition for relief under chapter 7 of Title 11 of the United States Code no later than July 26, 2019.

AeroForm was granted U.S. FDA de novo marketing authorization in 2016, subsequent U.S. market clearance in 2017, first CE mark in Europe in 2012, and is currently licensed for sale in Australia.

The FDA has approved Merck's (MRK) RECARBRIO for the treatment of adults with complicated urinary tract and complicated intra-abdominal bacterial infections where limited or no alternative treatment options are available.

Recarbrio is comprised of three components - Imipenem, a beta-lactam antibiotic; Cilastatin, a DHP-I inhibitor which increases half-life and tissue penetration of Imipenem; and Relebactam, a beta-lactamase inhibitor. The drug is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO.

RECARBRIO is reportedly expected to be launched later this year.

MRK closed Wednesday's trading at $81.92, up 0.40%.

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