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PTI Gaining Ground, LENS Looks Brighter, Busy Year Ahead For CNAT

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

1. Presbia PLC (LENS)

Gained 79.54% to close Tuesday's (Dec.19) trading at $4.65. This is the second straight day of gain for the stock.

Product portfolio:

The Company's lead product is Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision. The Presbia Flexivue Microlens is currently approved for sale in 42 countries around the world. It is not approved in the U.S. yet.

News:

On December 14, 2017, the Company announced that it has received an investment proposal of up to $5 million from Orchard Capital Corporation. Actions are also being taken to reduce its cash burn rate by eliminating pre-FDA approval marketing, manufacturing and engineering expenses related to the post-FDA approval U.S. commercial launch of the Presbia Flexivue Microlens.

The Company is also exploring other financing options and plans to finalize the capital raise by mid-February 2018.

Near-term catalyst:

-- The Company is planning to make its final submission to the FDA seeking approval of Presbia Flexivue Microlens before the end of 2017, with approval expected in 2018.

2. Conatus Pharmaceuticals Inc. (CNAT)

Gained 17.12% to close Tuesday's trading at $5.13.

News: No news

Clinical Trials & Near-term Catalysts:

The company's lead compound is Emricasan, a first-in-class, orally active caspase protease inhibitor, that interrupts the progression of liver disease by reducing the activity of enzymes that mediate inflammation and cell death.

Emricasan, being developed in collaboration with Novartis, is under four phase IIb clinical trials namely,

-- A phase IIb trial of Emricasan, in post-orthotopic liver transplant (POLT) recipients, dubbed POLT-HCV-SVR. Top-line results are expected in the second quarter of 2018.
-- A phase IIb trial of Emricasan in reducing hepatic venous pressure gradient in patients with compensated or early decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), and severe portal hypertension, dubbed ENCORE-PH. Top-line results from this trial are expected in the second half of 2018.
-- A phase IIb clinical trial of Emricasan evaluating potential improvements in fibrosis and steatohepatitis in patients with fibrosis caused by NASH, dubbed ENCORE-NF. Top line results are expected in the first half of 2019.
-- A phase IIb clinical trial of Emricasan in NASH cirrhosis patients, dubbed ENCORE-LF. Top-line results are expected in the second half of 2019.

3. Proteostasis Therapeutics Inc. (PTI)

Gained 12.30% to close Tuesday's trading at $5.02.

News: No news

Pipeline:

The Company's drug candidates include PTI-428, PTI-801 and PTI-808 for cystic fibrosis.

Recent events:

-- On December 13, 2017, the Company priced an underwritten public offering of 8 million shares of its common stock at a price of $5.00 each. The offering was supposed to close on December 18, 2017.
-- On December 12, 2017, the Company reported positive study results across all three of its cystic fibrosis pipeline programs. The news sent the stock soaring over 161% to close that day's trading at $6.14.

The reported data included 28-day phase II clinical trial results of PTI-428 in cystic fibrosis patients receiving Vertex Pharmaceuticals' Orkambi as their background therapy; initial data from the first five subjects in an ongoing phase I study of PTI-801 in cystic fibrosis patients on Orkambi background therapy and data from a phase I study of PTI-808 in healthy volunteers.

Near-term catalyst:

-- A 14-day phase II study of PTI-428 in cystic fibrosis patients on Vertex Pharmaceuticals' Kalydeco is ongoing, with preliminary data anticipated in the first quarter of 2018.

4. Fulgent Genetics Inc. (FLGT)

Gained 12.29% to close Tuesday's trading at $4.02.

News: No news

Recent event:

-- On November 6, 2017, the Company reported Q3, 2017 financial results and provided guidance for the fourth quarter.

GAAP loss for the third quarter of 2017 was $1.1 million or $0.06 per share, and non-GAAP loss, which excludes equity-based compensation expenses and equity loss in investee, and uses a corporate tax rate of 36% for the quarter, was $442,000, or $0.02 per share.

Revenue for the recent third quarter was $4.5 million, a decrease of 10% year over year from $5.0 million in the third quarter of 2016.

Looking ahead to the fourth quarter, the Company expects revenue to increase to $5 million.

5. Ardelyx Inc. (ARDX)

Gained 7.63% to close Tuesday's trading at $6.35.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead drug candidate is Tenapanor, which is under phase III testing for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and for the treatment of people with irritable bowel syndrome with constipation (IBS-C).

A long-term safety study of Tenapanor for IBS-C, dubbed T3MPO-3, is on track to conclude by the end of 2017.

File a New Drug Application with the FDA seeking approval of Tenapanor for IBS-C in the second half of 2018.

6. Ovid Therapeutics Inc. (OVID)

Gained 7.21% to close Tuesday's trading at $9.96.

News: The FDA has granted Fast Track designation to OV101 for the treatment of Angelman syndrome.

Angelman syndrome, which requires life-long care, is a rare genetic disorder characterized by developmental delay, lack of speech, seizures, and walking and balance disorders.

Clinical Trials & Near-term catalysts:

OV101, the Company's lead drug candidate, is being developed for the treatment of Angelman syndrome and Fragile X syndrome.

A phase II trial of OV101 in adults with Angelman syndrome, dubbed STARS, a Phase 1 trial of OV101in adolescents with Angelman syndrome or Fragile X syndrome, and a Phase 1b/2a trial of OV935 for the treatment of rare epileptic encephalopathies are underway.

The data from the STARS trial is expected to be available in the second half of 2018.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

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