07.04.2017 07:16:40
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ACHN Awaits PNH Data, Avita Gears Up For PMA Filing, SSKN Effects Reverse Split
(RTTNews) - Achillion Pharmaceuticals Inc. (ACHN) has initiated dosing in a phase II study of ACH-4471 in patients with paroxysmal nocturnal hemoglobinuria.
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, inherited disorder in which red blood cells break apart prematurely. (Source: NORD)
The primary objective of the study is to assess the change-from-baseline in serum lactate dehydrogenase (LDH) levels, a sensitive biomarker for intravascular hemolysis, during 28 days of dosing.
Interim results from the phase II study in PNH are anticipated during this quarter (Q2, 2017).
ACHN closed Thursday's trading at $3.85, up 1.32%.
The FDA has approved a further increase in the number of patients who can be treated in the United States with Avita Medical Ltd.'s (AVMXY.OB) ReCell regenerative medical device under a compassionate use protocol.
ReCell is an innovative treatment that can be used in conjunction with conventional procedures for the healing of burns, and in reconstructive surgery.
The increased compassionate use of ReCell now allows up to 68 patients to be treated at 18 U.S. burns centers.
Avita plans to submit its Pre-Market Approval application for its ReCell device to the FDA in mid-2017, with an anticipated approval in the second calendar quarter of 2018.
ReCell is cleared by regulatory authorities in Australia and China.
AVMXY.OB closed Thursday's trading at $1.58, up 1.28%.
Bioblast Pharma Ltd. (ORPN) has cancelled its previously announced underwritten public offering of its securities due to adverse market conditions.
The Company had cash of $9.9 million at year-end 2016.
The Company's lead compound is Trehalose, which is being explored in the indications of oculopharyngeal muscular dystrophy (OPMD) and spinocerebellar ataxia type 3 (SCA3).
A phase IIb placebo-controlled OPMD trial is expected to be initiated in Q2 2017 - with data readout anticipated in 2018.
ORPN closed Thursday's trading at $0.60, up 4.84%.
In order to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market, STRATA Skin Sciences Inc. (SSKN) has implemented a 1-for-5 reverse stock split.
At the opening of trading on April 7, 2017, STRATA's common stock will begin trading on a split-adjusted basis.
Following the reverse split, the number of shares of STRATA's common stock outstanding will decrease from approximately 10.9 million pre-split shares to approximately 2.2 million post-split shares.
SSKN closed Thursday's trading at $0.52, down 8.80%.
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