ACHN Gearing Up For PNH Results, VBLT On Track, WAVE Waxing, Not Waning

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of November 16, 2017.

GAINERS

1. Achillion Pharmaceuticals Inc. (ACHN)

Gained 17.49% to close Thursday's (Nov.16) trading at $3.56.

News: Johnson & Johnson Innovation-JJDC Inc., the existing stockholder of Achillion, has priced its public offering of 18.37 million shares of common stock at $2.75 each. The shares constitute all of JJDC's equity position in Achillion.

The offering is expected to close on November 20, 2017.

Near-term catalysts:

-- Updated interim results from a phase II trial of ACH-4471 monotherapy for untreated paroxysmal nocturnal hemoglobinuria (PNH) are expected to be reported before the end of the year. -- Interim results from Group 1 of a phase II, 14-day proof-of-mechanism trial of ACH-4471 in patients with either C3G or IC-MPGN are expected by year-end 2017. -- Initiate a phase I trial evaluating potential extended release formulations of ACH-4471 in healthy volunteers by the end of this year. -- Begin enrollment in a phase II trial evaluating ACH-4471 in PNH patients currently receiving Alexion Pharmaceuticals, Inc's (ALXN) Soliris, and who remain transfusion-dependent during the first half of 2018. -- Begin enrollment in a phase II 12-month open-label trial of ACH-4471 for patients with biopsy-confirmed C3G or IC-MPGN in the first half of 2018. -- Initiate a phase II 6-month randomized, placebo-controlled trial of ACH-4471 in patients with C3G during the first half of 2018.

2. Vascular Biogenics Ltd. (VBLT)

Gained 17.26% to close Thursday's trading at $9.00.

News: No news

Recent event:

-- On November 14, 2017, the Company reported third quarter 2017 financial results.

The comprehensive loss for the quarter ended September 30, 2017, widened to $6.5 million or $0.24 per share from $3.2 million or $0.12 per share in the year-ago quarter. No revenues were reported in the comparable quarters.

Near-term catalysts:

-- Initiate a phase III study of VB-111 in ovarian cancer by year-end 2017. -- Top-line results from phase III study of VB-111 in recurrent glioblastoma, dubbed GLOBE, are expected to be available in the first quarter of 2018.

3. Leap Therapeutics Inc. (LPTX)

Gained 11.67% to close Thursday's trading at $6.70.

News: The Company has announced an $18 million private placement offering with a select group of institutional investors and strategic partners, including HealthCare Ventures and Eli Lilly and Co.

Leap will sell 2.96 million shares of unregistered common stock and warrants to purchase shares of its common stock at a price of $6.085 per unit.

4. WAVE Life Sciences Ltd. (WVE)

Gained 11.24% to close Thursday's trading at $29.70. The stock has gained 30% in the last 5 trading days.

News: No news

Near-term catalysts:

-- Data from a global phase I clinical trial for WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping are expected in Q3, 2018. -- Top line data from PRECISION-HD program, which includes two phase 1b/2a global clinical trials evaluating WVE-120101 and WVE-120102 for patients with Huntington's disease, are anticipated in 1H 2019.

5. Collegium Pharmaceutical Inc. (COLL)

Gained 11.10% to close Thursday's trading at $16.82.

News: No news

Recent events:

--On November 8, 2017, the Company reported better-than-expected Q3, 2017 financial results.

Net loss for the third quarter of 2017 narrowed to $13.3 million or $0.45 per share on Xtampza ER product revenue of $12.0 million. Analysts polled by Thomson Reuters were expecting a loss of $0.74 per share on revenue of $5.4 million.

The Company had incurred a net loss of $26.4 million or $1.13 per share on product revenue of $408,000 in the third quarter of 2016.

-- On November 7, 2017, the FDA approved the Company's supplemental New Drug Application seeking to enhance the label for Xtampza ER.

Xtampza ER, a twice-daily, oxycodone medication, received its FDA approval last April for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Now that the sNDA has been approved, comparative OxyContin data and oral human abuse deterrent claim have been added to the Xtampza ER label.

6. Sierra Oncology Inc. (SRRA)

Gained 10.20% to close Thursday's trading at $2.16.

News: No news

Near-term catalyst:

-- An update on the Company's SRA737 program is expected in February 2018.

SRA737 is under two phase I trials - a phase I trial of SRA737 administered orally in subjects with advanced cancer, and a phase I trial of oral SRA737 given in combination with Gemcitabine plus Cisplatin or Gemcitabine alone in subjects with advanced cancer.

7. Merit Medical Systems Inc. (MMSI)

Gained 9.81% to close Thursday's trading at $40.85.

News: The Company has agreed to purchase certain assets of Becton Dickinson and Co., which the latter is selling in connection with its proposed acquisition of C.R. Bard, Inc., for $100 million.

The assets to be acquired from Becton, Dickinson include Aspira Pleural Effusion Drainage Kits, Aspira Peritoneal Drainage System and soft tissue core needle biopsy products currently sold under the trade names of Achieve Programmable Automatic Biopsy System, Temno Biopsy System and Tru-Cut Biopsy Needles.

Merit expects the acquisition to provide incremental annual revenues in the range of $42-48 million, adjusted gross margins for the subject product lines in the range of 60-70%, and, over a period of six to twelve months, to be accretive by 50-120 basis points to Merit's adjusted gross margins.

The acquisition is expected to provide $0.10-$0.19 in adjusted non-GAAP earnings per share accretion for Merit in fiscal year 2018.

LOSERS

1. Forward Pharma A/S (FWP)

Lost 6.96% to close Thursday's trading at $4.28.

News: No news

2. Cutera Inc. (CUTR)

Lost 6.29% to close Thursday's trading at $42.45.

News: No news

Recent event:

-- On November 7, 2017, the Company reported solid third quarter financial results.

The Company's net income rose to $6.2 million or $0.42 per share on net revenue of $38.2 million in the recent third quarter. The net income was $1.6 million or $0.12 per share and revenue was $30.3 million in the year-ago quarter.

Looking ahead to full year 2017, the Company expects revenue to be at the upper end of its previously announced revenue guidance range of $144 - $147 million, and GAAP earnings per share is expected to be in the range of $0.77 - $0.81.