Gainers & Losers Of July 19: AEZS, VRTX, AGRX, PTI, INO...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 19, 2017.

GAINERS

1. Aeterna Zentaris Inc. (AEZS)

Gained 129.41% to close Wednesday's (July 19) trading at $2.34.

News: The FDA has accepted the Company's resubmitted New Drug Application seeking approval of Macrilen for the evaluation of growth hormone deficiency in adults.

The regulatory agency's decision on Macrilen is expected on December 30, 2017. Macrilen was issued a Complete Response Letter by the FDA in November 2014.

2. Vertex Pharmaceuticals Inc. (VRTX)

Gained 20.83% to close Wednesday's (July 19) trading at $159.69.

News: The Company reported positive data from phase I and phase II studies of three different triple combination regimens involving its drug candidates VX-440 and VX-152 in people with cystic fibrosis who have one F508del mutation and one minimal function mutation (F508del/Min).

Upcoming event:

Vertex is scheduled to report its second quarter 2017 financial results on Wednesday, July 26, 2017 after the financial markets close.

Near-term catalysts:

-- Submit NDA to the FDA and an MAA to the EMA for Tezacaftor/Ivacaftor combination in people with Cystic Fibrosis ages 12 and older who have two copies of the F508del mutation and people who have one mutation that results in residual CFTR function and one F508del mutation in the third quarter of 2017. -- Data from a phase 1 study of VX-659 in healthy volunteers and people with Cystic Fibrosis in the second half of 2017.

3. Agile Therapeutics Inc. (AGRX)

Gained 18.23% to close Wednesday's trading at $4.93.

News: H.C. Wainwright & Co analysts have initiated coverage on AGRX with Buy recommendation and target price of $10.00.

Recent event:

On June 27, 2017, Agile resubmitted its NDA for Twirla, an investigational low-dose combined hormonal contraceptive patch. Twirla was turned down by the FDA in 2013.

Once the FDA has accepted the submission as a complete response, a decision date that will be based on a six-month review is expected to be announced.

Upcoming event:

The Company is expected to report Q2, 2017 financial results on August 7, 2017.

4. Marinus Pharmaceuticals Inc. (MRNS)

Gained 14.48% to close Wednesday's trading at $1.66.

News: No news

Near-term catalyst:

Top line data from phase II trial of Ganaxolone in children with CDKL5 genetic disorder is awaited. The preliminary data from this trial, which were reported in January of this year, were positive.

5. Akcea Therapeutics Inc. (AKCA)

Gained 10% to close Wednesday's trading at $11.11.

News: The Company announced the closing of its IPO.

The Company's shares made their debut on the NASDAQ Global Select Market on July 14, 2017, at an opening price of $8.13 each.

The gross proceeds from the offering were $143.8 million. In addition, Novartis Pharma AG purchased $50.0 million of Akcea's common stock in a separate private placement concurrent with the completion of Akcea's initial public offering at a price per share equal to the initial public offering price of $8.00 per share.

Pipeline:

The most advanced product candidate in the pipeline is Volanesorsen. The Company reported positive results from a phase III study in patients with familial chylomicronemia syndrome in March of this year.

Volanesorsen is also under a phase III trial for the treatment of familial partial lipodystrophy.

6. Roka Bioscience Inc. (ROKA)

Gained 8.26% to close Wednesday's trading at $2.36.

News: No news

Recent event:

The Company reported first quarter 2017 financial results in May.

Net loss for the first quarter of 2017 was $7.6 million or $1.53 per share compared with a net loss of $8.2 million, or $4.66 per share in the first quarter of 2016.

Revenue for the recent first quarter was $2.0 million compared with $1.6 million for the first quarter of 2016 and $1.9 million for the fourth quarter of 2016. As of March 31, 2017, the Company had cash and cash equivalents and marketable securities of $16.2 million.

LOSERS

1. Neurotrope Inc. (NTRP)

Lost 23.78% to close Wednesday's trading at $5.80.

News: The Company presented clinical results from its recently completed Phase 2 trial of Bryostatin-1 in patients with moderate to severe Alzheimer's disease at the Alzheimer's Association International Conference 2017 in London.

The study evaluated the safety, tolerability and efficacy of Bryostatin-1 in 147 moderate-to-severe AD patients across three treatment arms (20 µg, 40 µg, placebo).

According to the Company, an encouraging therapeutic signal was observed in late stage Alzheimer's disease patients with the 20 µg group, which was maintained across time points with relatively minimal toxicity and good tolerability. The study was not powered for statistical significance.

2. Orexigen Therapeutics Inc. (OREX)

Lost 18.02% to close Wednesday's trading at $2.32.

News: No news

Recent event:

On May 9, 2017, the Company reported financial results for the first quarter ended March 31, 2017.

Orexigen's net loss widened to $69.1 million or $4.67 per share in Q1, 2017 from $22.3 million or $1.54 per share in the year-ago quarter. The first quarter 2017 revenue soared to $19.1 million from $5.0 million in the comparable prior year period.

Near-term catalyst:

The Company is slated to report Q2, 2017 results on August 2, 2017.

3. Proteostasis Therapeutics Inc. (PTI)

Lost 15.07% to close Wednesday's trading at $3.89.

News: No news

Near-term catalysts:

-- Additional data from phase I/II clinical trial of PTI-428 in patients with Cystic Fibrosis are expected to be reported this month. -- Preliminary data from phase I/II clinical trial of PTI-428 in adults diagnosed with CF, who are actively taking Kalydeco are expected during this quarter (3Q, 2017).

4. Inovio Pharmaceuticals, Inc. (INO)

Lost 13.41% to close Wednesday's trading at $6.78.

News: The Company has offered to sell $75.0 million of shares of its common stock in an underwritten public offering.

Inovio expects to grant the underwriters an option to purchase up to an additional $11.25 million of shares of its common stock on the same terms and conditions.

5. CytomX Therapeutics Inc. (CTMX)

Lost 8.85% to close Wednesday's trading at $13.28.

News: No news

Pipeline:

The Company's lead programs are CX-072 for the treatment of cancer and CX-2009 in patients with select advanced solid tumors, both of which are under phase I/II testing.