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TENX Heartened, AXGN Sees 40% Revenue Growth, Mark Your Calendar For REPH

Mar1-up-030118-lt.jpg

The following are some of today's top gainers in the pharma/biotech sector.

1. Tenax Therapeutics Inc. (TENX)

Gained 128.45% to close Thursday's (Mar.1) trading at $10.60.

News: Results of a preclinical study of Levosimendan, published in the journal named Pulmonary Circulation, suggests that chronic administration of the compound improves right heart function.

This is the second study published in recent months by Dr. Hansen and colleagues who have investigated the potential benefits of Levosimendan treatment for right heart failure secondary to pulmonary hypertension.

A phase II trial of Levosimendan for the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) is expected to be initiated in the third quarter of 2018.

Recent event:

-- On February 26, 2018, the Company implemented a 1-for-20 reverse stock split.

2. AxoGen Inc. (AXGN)

Gained 16.27% to close Thursday's trading at $33.95.

News: The Company reported a narrower loss and 49% revenue growth in Q4, 2017.

Adjusted net loss for the fourth quarter of 2017 was $2.5 million or $0.07 per share on revenue of $17.0 million. This compared with an adjusted net loss of $3.2 million or $0.10 per share and revenue of $11.4 million in the fourth quarter of 2016.

Looking ahead, the Company expects that 2018 revenue to grow at least 40% over 2017 revenue of $60.4 million.

3. Xenon Pharmaceuticals Inc (XENE)

Gained 16% to close Thursday's trading at $4.35.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase I first-in-human clinical trial of single ascending doses and multiple ascending doses of XEN1101 in healthy subjects is underway. XEN1101 is a next-generation Kv7 potassium channel opener for the potential treatment of epilepsy. Data from this study are expected mid-year.

-- A Phase 2 proof-of-concept trial evaluating XEN1101's efficacy as a treatment for adult focal seizures is anticipated to begin in the second half of 2018.

-- A phase I clinical trial XEN901, a selective Nav1.6 inhibitor for the treatment of epilepsy in the UK was initiated last month, with a phase I read-out expected in the second half of 2018.

-- A Phase 2 proof-of-concept trial evaluating XEN901's efficacy as a treatment for adult focal seizures is anticipated to begin by year-end.

4. Catabasis Pharmaceuticals Inc. (CATB)

Gained 15.70% to close Thursday's trading at $1.99.

News: No news

Pipeline & Near-term Catalysts:

The lead investigational drug is Edasalonexent for the treatment of Duchenne Muscular Dystrophy (DMD).

-- A single global phase III trial with Edasalonexent in patients with DMD regardless of mutation type is planned for initiation in the first half of 2018 - with top-line results expected in 2020.

Recent event:

-- On February 13, 2018, the Company announced new positive efficacy and safety results from its phase II trial evaluating Edasalonexent in Duchenne Muscular Dystrophy, dubbed MoveDMD.

There was preservation of muscle function and sustained disease-modifying effects in boys with Duchene muscular dystrophy in the MoveDMD trial open-label extension following 48 and 60 weeks of treatment with Edasalonexent, according to the Company.

5. Adamis Pharmaceuticals Corp. (ADMP)

Gained 13.33% to close Thursday's trading at $3.40.

News: No news

Recent events:

-- On February 23, 2018, the Company announced that it is in discussions with two potential partners relating to the commercial launch of its drug Symjepi.

Symjepi 0.3mg is a non-selective alpha and betaadrenergic receptor agonist in a single-dose, pre-filled syringe for use the emergency treatment of allergic reactions (Type I) including anaphylaxis. It received FDA approval last June.

Regulatory Catalyst:

The supplemental New Drug Application for its low dose Symjepi product candidate (Symjepi 0.15mg) for the emergency treatment of anaphylaxis is under FDA review - with a decision expected on September 3, 2018.

6. Orexigen Therapeutics Inc. (OREX)

Gained 11.32% to close Thursday's trading at $1.18.

News: A SEC filing dated Feb.28, 2018 reveals the departure of Directors or Certain Officers, election of Directors, and appointment of certain officers.

According to the filing, Jason Keyes resigned as Executive Vice President and Chief Financial Officer of the Company, effective from February 23, 2018.

On February 27, 2018, the Company appointed Monica Forbes as Vice President and acting Chief Financial Officer to serve as the Company's principal financial officer, and appointed Stephen Moglia, the Company's current Vice President and Chief Accounting Officer, to serve as the Company's principal accounting officer, with each appointment effective as of February 24, 2018.

Recent event:

On Nov.13, 2017, the Company reported financial results for the third quarter ended September 30, 2017.

The net loss for Q3, 2017 was $20.8 million or $1.35 per share on total revenue of $18.90 million. This compared with a net income of $40.96 million or $1.12 per share and total revenue of $7 million in the year-ago quarter.

The net income in Q3, 2016 included a non-cash settlement gain of $80.2 million.

Near-term Catalyst:

-- The Company is slated to report Q4, 2017 financial results in the last week of MARCH.

7. Recro Pharma Inc. (REPH)

Gained 10.88% to close Thursday's trading at $9.99.

News: No news

Near-term Catalyst:

-- The NDA for IV Meloxicam, proposed for the management of moderate to severe pain is under FDA review - with a decision expected on May 26, 2018.

by RTTNews Staff Writer

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