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AQB Reaps A Bounty, CLSN Ends Dual Listing, MNK Opens Wallet, OMER On Watch


Today's Daily Dose brings you news Celsion's decision to end dual listing; MiMedx's progress with AmnioFix Injectable; AquaBounty's improving Q2 financial results; tentative approval from FDA for Perrigo's generic version of rosacea treatment Mirvaso and Mallinckrodt's acquisition of privately-held InfaCare.

Read on...

Shares of AquaBounty Technologies Inc. (AQB) were up more than 13% on Friday, following its Q2, 2017 financial results.

The second quarter marked two milestone events for AquaBounty - the purchase of its first commercial farm site for the production of its eco-friendly AquAdvantage Salmon in the United States, and the very first sales of AquAdvantage Salmon.

Net loss for the recent second quarter was relatively flat at $2.1 million compared to the corresponding period of the previous year. On a per share basis, the net loss for Q2, 2017 narrowed to $0.24 from $0.39 in the year-ago period.

The Company recognized $53 thousand of revenue on sales of AquAdvantage Salmon fillets in Q2, 2017 compared to nil revenue in the year-ago quarter.

AQB closed Friday's trading at $7.58, up 13.47%.

Celsion Corp. (CLSN) is delisting its shares from the Tel Aviv Stock Exchange in order to be subject to one set of listing regulations instead of two; to allow greater flexibility to execute its business and financing strategy, and to reduce cost of operations.

The Company's shares were approved for trading on the Tel Aviv Stock Exchange on November 12, 2015.

However, Celsion shares will continue to trade on the NASDAQ Capital Market.

CLSN closed Friday's trading at $1.55, down 2.52%.

Mallinckrodt plc (MNK) has agreed to acquire privately-held InfaCare Pharmaceutical Corp. for an upfront payment of $80 million, with additional payments of up to $345 million dependent on regulatory and sales milestones.

InfaCare's proprietary therapy Stannsoporfin is in late-stage development for the treatment of newborns at risk of developing severe jaundice.

The rolling NDA submission of Stannsoporfin is underway under FDA's Fast Track status. If approved, Stannsoporfin is expected to become the first and only pharmacologic option or therapeutic option for treatment of neonates at risk for developing severe jaundice, in the U.S.

Mallinckrodt expects the acquisition to be dilutive to adjusted diluted earnings per share by $0.15 to $0.20 for 2017 and modestly higher in 2018.

The transaction is expected to close in the second half of 2017.

MNK closed Friday's trading at $41.02, down 1.44%.

MiMedx Group Inc. (MDXG) has sought FDA's permission to initiate a phase III trial of AmnioFix Injectable in the treatment of Achilles tendonitis.

The trial will enroll approximately 158 study patients with moderate to severe pain due to Achilles Tendonitis with failed conservative treatment for at least one month. Enrollment in the Achilles tendonitis study is expected to commence in the next few months.

A phase III study of AmnioFix Injectable in the treatment of Plantar Fasciitis on subjects that have moderate or severe pain due to Plantar Fasciitis with failed treatment for at least one month was initiated very recently.

The phase III Plantar Fasciitis study is designed to enroll approximately 164 patients, with an estimated enrollment period of 18 months.

MDXG closed Friday's trading at $14.68, down 0.14%.

Omeros Corp.'s (OMER) OMS721 has received orphan drug designation from the FDA for the treatment of Immunoglobulin A (IgA) nephropathy.

IgA nephropathy is the most common primary glomerulopathy globally, with an estimated 120,000 to 180,000 cases in the U.S. alone, and accounts for up to 10 percent of all dialysis patients.

Omeros plans to begin enrolling patients in its phase III registration trial of OMS721 in IgA nephropathy later this year.

A phase III program of OMS721 for the treatment of atypical hemolytic uremic syndrome (aHUS) is also underway.

A third phase III program for OMS721 is also on the cards this year, and that is for stem cell transplant-associated thrombotic microangiopathy.

OMER closed Friday's trading at $21.92, up 6.93%.

Perrigo Co. plc (PRGO) has received tentative approval from the FDA for the generic version of Mirvaso topical gel 0.33% for the treatment of rosacea.

Mirvaso is marketed by Galderma, and is protected by six patents owned by Nestle Skin Health S.A. The last of the six patents is said to expire in March 2031, according to the FDA.

Perrigo filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Mirvaso last July. The following month - in August of 2016 - Galderma and Nestle Skin Health filed a patent infringement suit over the proposed Mirvaso generic.

However, this litigation with Galderma Laboratories and Nestle Skin Health for generic Mirvaso has been settled, according to Perrigo.

PRGO closed Friday's trading at $67.43, down 1.29%.

by RTTNews Staff Writer

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