01.02.2017 05:33:13

Gainers & Losers Of The Day: MNTA, BLCM, VSAR, TENX, DMTX...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of January 31, 2017.

GAINERS

1. Momenta Pharmaceuticals Inc. (MNTA)

Gained 25.17% to close Tuesday's (Jan.31) trading at $18.90.

News: Teva Pharmaceuticals' patents related to multiple sclerosis therapy Copaxone 40 mg/ml has been invalidated by the U.S. Court.

The U.S. District Court has invalidated all 4 patents relating to Copaxone 40 mg/mL based on obviousness. Copaxone 40 mg/ml, which is dosed three-times weekly, is a reformulation of once-daily 20mg/ml Copaxone.

A generic version of Copaxone 20 mg/ ml, developed by Momenta Pharmaceuticals (MNTA) and Sandoz, a division of Novartis (NVS), was approved by the FDA in April 2015, and was launched in the U.S. in June of that year under the name Glatopa.

Momenta is also one of the companies seeking approval of a generic version of Copaxone 40 mg/ml, which is a more affordable dosing regimen. The Abbreviated New Drug Application for a three-times-a-week generic Copaxone 40 mg/ml, submitted by Sandoz, Momenta's development and commercialization partner, is under FDA review.

2. Aeterna Zentaris Inc. (AEZS) (AEZ.TO)

Gained 21.15% to close Tuesday's trading at $3.15.

News: The company has completed its phase III trial of Zoptrex in advanced endometrial cancer.

The pivotal phase III trial, dubbed ZoptEC, which was initiated in 2013, was fully enrolled - with over 500 patients - in June 2015, and the final dosing occurred in January 2016.

A significant number of patients survived more than 18 months since enrollment in the study, according to the company. Top-line results from the study are expected in April 2017.

3. Akari Therapeutics Plc (AKTX)

Gained 17.65% to close Tuesday's trading at $8.00.

News: No news

Near-term catalyst: Akari's lead investigational clinical product is Coversin. A phase II trial of Coversin in Europe in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) without polymorphism is underway, with data expected in the first quarter of 2017.

4. PAVmed Inc. (PAVM)

Extending its rally for the second day, the stock gained 15.99% to close Tuesday's trading at $6.82.

News: No news

Near-term catalyst: The last we heard from PAVmed was the 510(k) premarket notification submission for its first product, the PortIO Intraosseous Infusion System, on December 19, 2016. The company expects receiving FDA clearance and beginning commercialization of the device this year.

5. Neothetics Inc. (NEOT)

Gained 14.29% to close Tuesday's trading at $1.52.

News: No news

Near-term catalyst: A phase II proof of concept trial of LIPO-202 for the reduction of submental subcutaneous fat is underway. Top-line data from this trial are expected in late second quarter 2017.

6. Bellicum Pharmaceuticals Inc. (BLCM)

Gained 12.72% to close Tuesday's trading at $13.38.

News: Rick Fair, who served as head of oncology at Roche/Genentech, has been appointed CEO and President of Bellicum Pharma.

The company's lead product candidate is BPX-501, which is being evaluated in multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.

7. Cynosure Inc. (CYNO)

Gained 12.42% to close Tuesday's trading at $53.40.

News: No news

Last week, there were reports that Cynosure is exploring strategic options, including a possible sale of the company.

Anticipated event: Q4 and full-year 2016 financial results are expected on Feb.7, 2017.

8. Capricor Therapeutics Inc. (CAPR)

Gained 11.93% to close Tuesday's trading at $2.44.

News: No news

Near-term catalyst: Top-line six-month data from its phase I/II trial of CAP-1002 for the treatment of heart disease associated with Duchenne muscular dystrophy, dubbed HOPE, is anticipated early in the second quarter of 2017.

9. Strongbridge Biopharma plc (SBBP)

Gained 11.36% to close Tuesday's trading at $2.45.

News: No news

Near-term catalysts:

-- Launch Keveyis in April 2017. Keveyis was approved by the FDA in August 2015 to treat all forms of Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis. Strongbridge acquired the U.S. rights to Keveyis from a subsidiary of Taro Pharmaceutical Industries Ltd. as recently as December 23, 2016. -- Enrollment in a phase III trial of COR-003 for the treatment of endogenous Cushing's syndrome, dubbed SONICS, is expected to be completed by end of Q2 2017, and top-line data is anticipated in Q1 2018. -- Another phase III trial of COR-003 for the treatment of endogenous Cushing's syndrome, dubbed LOGICS, is planned for initiation - with topline data expected to be reported in Q3 2018.

10. Champions Oncology Inc. (CSBR)

Gained 10.98% to close Tuesday's trading at $4.75. Based on Tuesday's closing price, the stock has gained 30% in the last 6 trading days.

News: No news

Anticipated event: Financial results for Q3 ended January 31, 2017 to be reported on March 13, 2017. In the previous quarter, the company delivered 50% revenue growth. For its fiscal year ending April 2017, the company anticipates revenue in the range of $16 million to $18 million.

11. Ultragenyx Pharmaceutical Inc. (RARE)

Gained 10.63% to close Tuesday's trading at $75.01.

News: No news

Near-term catalysts:

-- Phase II seizure study data of UX007 for Glut1 Deficiency Syndrome expected this quarter (Q1, 2017). -- Data from the phase III study of KRN23 in adult patients with X-Linked Hypophosphatemia anticipated in the first half of 2017. -- Data from phase III study of Ace-ER for GNE Myopathy anticipated in the second half of this year.

12. Versartis Inc. (VSAR)

Gained 10.00% to close Tuesday's trading at $14.30.

News: The company promoted Joshua T. Brumm to Chief Operating Officer and Paul Westberg to Chief Business Officer.

Near-term catalyst: Top-line data from a pediatric phase III trial of Somavaratan in growth hormone deficiency, dubbed VELOCITY, is anticipated in September 2017.

LOSERS

1. Tenax Therapeutics Inc. (TENX)

Lost 76.41% to close Tuesday's trading at $0.46.

News: The phase III trial of Levosimendan for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome failed.

The trial, dubbed LEVO-CTS, did not achieve statistically significant reductions in the dual endpoint of death or use of a mechanical assist device at 30 days, nor in the quad endpoint of death, myocardial infarction, need for dialysis, or use of a mechanical assist device at 30 days.

2. Dimension Therapeutics (DMTX)

Lost 54.12% to close Tuesday's trading at $1.95.

News: Interim top-line results from ongoing phase I/II trial of DTX101 for the treatment of adult patients with moderate/severe to severe hemophilia B announced.

Hemophilia B is a rare genetic bleeding disorder resulting from a deficiency in FIX. Although all patients treated with DTX101 improved from moderate/severe-to-severe to either moderate or mild range in terms of factor levels based on World Federation of Hemophilia, asymptomatic elevations of alanine aminotransferase (ALT) were observed in 5 of 6 patients. One of the patients experienced a grade 4 adverse event due to an elevated ALT. Elevated level of ALT is an indicator of liver damage.

3. Pulmatrix Inc. (PULM)

Lost 18.87% to close Tuesday's trading at $2.15, marking its second consecutive day of losses after announcing a $5 million registered direct offering on January 30, 2017.

News: On Jan.30, 2017, the company announced it will sell an aggregate of approximately 2 million shares of common stock, at a price of $2.50 per share, in the registered direct offering. The closing of this offering is expected to take place on or about February 2, 2017, subject to the satisfaction of customary closing condition.

4. Eyegate Pharmaceuticals Inc. (EYEG)

Lost 14.37% to close Tuesday's trading at $1.53.

Pullback after yesterday's gain of more than 9%. On January 30, 2017, the company reported positive topline results from the first-in-human pilot trial of its EyeGate Ocular Bandage Gel in corneal epithelial defects.

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