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25.04.2017 05:10:46

Gainers & Losers Of Apr.24: PZRX, BCR, IMNP, ACHN, AKTX...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of April 24, 2017.

GAINERS

1. PhaseRx (PZRX)

Gained 54.03% to close Monday's (Apr.24) trading at $1.91.

News: The European Medicines Agency has granted the Company's investigational drug PRX-OTC orphan drug status for the treatment of ornithine transcarbamylase deficiency.

PRX-OTC, which is the most-advanced drug candidate in the Company's pipeline, is under IND-enabling stage.

*Ornithine transcarbamylase deficiency is an inherited disorder that causes ammonia to accumulate in the blood. (*Source: Genetics Home Reference).

2. C. R. Bard Inc. (BCR)

Gained 19.50% to close Monday's trading at $302.41.

News: C. R. Bard is all set to be acquired by Becton, Dickinson & Co. (BDX) for $317.00 per share in cash and stock, for a total consideration of $24 billion.

As per the terms of the deal, Bard common shareholders will be entitled to receive roughly $222.93 in cash and 0.5077 shares of BD stock per Bard share or a total of value of $317.00 per Bard common share based on BD's closing price on April 21, 2017. At closing, Bard shareholders will own approximately 15 percent of the combined company.

The transaction is subject to regulatory and Bard shareholder approvals and customary closing conditions, and is expected to close in the fall of 2017.

3. Chiasma Inc (CHMA)

Gained 10.34% to close Monday's trading at $1.60.

News: No news

Chiasma's lead product candidate is Mycapssa. The NDA for Mycapssa capsules for the maintenance treatment of adult patients with acromegaly was turned down by the FDA last April. The company needs to conduct another clinical trial before Mycapssa could be approved.

A phase III clinical trial to investigate the non-inferiority of Mycapssa to once-a-month injectable somatostatin analogs, dubbed MPOWERED, is underway. The results of this study are expected to support the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).

LOSERS

1. Immune Pharmaceuticals Inc. (IMNP)

Lost 20.96% to close Monday's trading at $2.79.

News: The Company has announced a major corporate restructuring.

As part of the restructuring, the Company's oncology business Cytovia Inc. could be spun-off into a separate, stand-alone company independent from Immune, which will be lead by Daniel Teper.

In connection with the restructuring, Daniel Teper has resigned as CEO of Immune, effective immediately.

2. ContraVir Pharmaceuticals Inc. (CTRV)

Lost 16.31% to close Monday's trading at $1.18. In after-hours, the stock fell another 22.88% to $0.91.

News: The Company announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock and warrants to purchase shares of its common stock.

3. Akari Therapeutics Plc (AKTX)

Lost 14.68% to close Monday's trading at $17.49.

News: The Company reported positive interim data from an ongoing phase II trial of Coversin in paroxysmal nocturnal hemoglobinuria (PNH).

However, despite the positive results, the stock fell on profit-taking, particularly given the fact that it has gained more than 215% over the last 1 month.

The Company is planning to initiate its phase III program in PNH in the fourth quarter of 2017 and anticipates initial phase III data in the first quarter of 2019.

Akari noted that Coversin has demonstrated positive results in a preclinical model of atypical hemolytic uremic syndrome (aHUS). A phase II trial of Coversin in aHUS is expected to be initiated this quarter - with results anticipated in the second quarter of next year.

The Company is also planning to initiate phase II trials of Coversin in patients with bullous pemphigoid who are refractory to oral steroids as well in mucous membrane pemphigoid in the first quarter of next year and anticipates data from these trials in the fourth quarter of 2018.

4. Achillion Pharmaceuticals Inc. (ACHN)

Lost 11.81% to close Monday's trading at $3.21.

News: The Company updated results from its phase II study of JNJ-4178 to treat HCV in treatment naïve subjects across a range of HCV genotypes and stages of liver disease, dubbed '604 Study'.

JNJ-4178 is a combination of three direct acting antivirals namely, FDA-approved Olysio (simeprevir), developed by Janssen and Medivir, and Achillion's experimental drug Odalasvir along with AL-335, a nucleotide-based HCV polymerase inhibitor.

Janssen is responsible for the global clinical development of JNJ-4178.

According to the trial results, the triple combination of simeprevir, odalasvir and AL-335 has the ability to shorten treatment duration, offer high efficacy and be generally well tolerated in those whose disease is caused by hepatitis C virus (HCV) genotype 1 (GT1), one of the most prevalent causes of hepatitis C globally.

JNJ-4178 achieved 100% SVR24 for treatment durations of both 6 and 8 weeks in treatment naïve patients with HCV genotype 1 infection without cirrhosis.

In HCV genotype 3 patients without cirrhosis, JNJ-4178 achieved an SVR12 of 77% following 12 weeks of therapy, and is not anticipated to advance to the next phase of testing.

The '604 Study' is ongoing and will assess the triple combination JNJ-4178 in patients with compensated cirrhosis.

A phase IIb study of JNJ-4178 in treatment-naïve and treatment-experienced, non-cirrhotic patients chronically infected with HCV genotype 1,2,4,5 and 6, dubbed OMEGA-1, is underway.

5. XOMA Corp. (XOMA)

Lost 8.02% to close Monday's trading at $7.11.

News: The Company reported positive phase II proof-of-concept results for X213 in physiological hyperprolactinemia.

Hyperprolactinemia is a condition characterized by excess prolactin. In pregnant women, excess prolactin secretion occurs to enhance breast development and to induce lactation postpartum.

In the proof-of-concept study, X213, when given as a single 700mg intravenous infusion during the first day post-partum, was effective in suppressing milk secretion, as well as *breast engorgement and pain in 100 percent of the treated women.

(*Breast engorgement is the overfilling of breasts with milk leading to swollen, hard and painful breasts - Source: PubMed Health).

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