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ANTH Awaits RESULT In Mar., HAIR Grows, NITE Shines, TRXC On Must-watch List

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

1. Anthera Pharmaceuticals Inc. (ANTH)

Gained 43.79% to close Wednesday's (Feb.21) trading at $2.43.

News: No news

Clinical Trial & Near-term Catalyst:

A phase III study of Sollpura for the treatment of Exocrine Pancreatic Insufficiency, dubbed RESULT, is underway.

-- Top line data from RESULT is expected to be reported later this quarter.

If approved, Sollpura has the potential to be the first oral, non-porcine pancreatic enzyme replacement therapy.

2. Restoration Robotics Inc. (HAIR)

Gained 35.61% to close Wednesday's trading at $6.36.

News: No news

Restoration Robotics is a medical device company developing and commercializing the ARTAS Robotic Hair Restoration System.

We had alerted our premium subscribers to this stock on January 29, 2018, when it was trading around $4.79.

3. Nightstar Therapeutics plc (NITE)

Gained 18.44% to close Wednesday's trading at $12.78.

News: No news

Recent event:

-- On September 28, 2017, the Company made its debut on The NASDAQ Global Select Market, offering its American Depositary Shares at a price of $14.00 per ADS.

Nightstar is a clinical-stage gene therapy company developing treatments for rare inherited retinal diseases.

Pipeline & Near-term Catalysts:

-- The lead product candidate is NSR-REP1 for choroideremia, which is expected to enter phase III development in the first half of 2018.
-- NSR-RPGR for the treatment of patients with X-linked retinitis pigmentosa, is under phase I/II clinical trial. Preliminary data from this trial is expected in the second half of this year.
-- NSR-BEST1 is in preclinical development for the treatment of Best vitelliform macular dystrophy, or Best disease. Initiation of a phase I/II clinical trial of NSR-BEST1 is expected in 2019.

4. Fate Therapeutics Inc. (FATE)

Gained 15.49% to close Wednesday's trading at $10.59.

News: No news

Clinical Trials & Near-term Catalysts:

-- FATE-NK100, under phase I study, for refractory / relapsed AML, dubbed VOYAGE
-- FATE-NK100, under phase I study, for recurrent ovarian cancer, dubbed APOLLO
-- FATE-NK100, under phase I study, for advanced solid tumors, dubbed DIMENSION
-- ProTmune, for the prevention of graft-versus-host disease, under a phase II clinical trial.

5. Voyager Therapeutics Inc. (VYGR)

Gained 15.47% to close Wednesday's trading at $27.32.

News: This is the second straight day of gain for the stock after the Company inked an Alzheimer's deal.

On February 20, 2018, the Company entered into a global strategic collaboration with AbbVie (ABBV) to develop potential new treatments for Alzheimer's disease, sending the stock up 22.21% to close at $23.66.

6. Avenue Therapeutics Inc. (ATXI)

Gained 13.77% to close Wednesday's trading at $5.04. This is the second straight day of gain for the stock.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase III trial of IV tramadol 50 mg in the management of postoperative pain following surgery was initiated last month.
-- A phase III trial of IV tramadol in patients following bunionectomy surgery is underway, with top-line data expected in the second quarter of 2018.
-- A second phase III trial of IV tramadol in patients following abdominoplasty surgery is planned for initiation in the third quarter of 2018.

7. BeiGene Ltd. (BGNE)

Gained 10.51% to close Wednesday's trading at $149.92. The stock touched an all-time high of $150.97 in intra-day trading.

News: No news

Pipeline:

The Company's pipeline includes BGB-3111 (Zanubrutinib), BGB-A317 (Tislelizumab) and BGB-290 (Pamiparib).

Clinical Trials:

A pivotal phase II trial in China of BGB-3111 in relapsed/refractory mantle cell lymphoma; a global phase III trial comparing BGB-3111 to bendamustine and rituximab in treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma patients; a global pivotal phase II trial of BGB-3111 in combination with GAZYVA in relapsed or refractory follicular lymphoma patients; and a pivotal phase II trial in China of BGB-3111 in Waldenström's macroglobulinemia are underway.

BGB-A317 is under a global phase III clinical trial in patients with previously untreated advanced hepatocellular carcinoma; phase II trial in China in relapsed/refractory classical Hodgkin's lymphoma; a global phase 1a/1b trial in advanced tumors; phase III trial in China as a second- or third-line treatment for patients with advanced lung cancer; pivotal phase II trial in China in previously treated, PD-L1-positive, locally advanced or metastatic urothelial cancer; phase II trial in China in combination with chemotherapy as a first-line treatment for patients with advanced lung cancer; and a phase II trial in China in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic esophageal, gastric, or gastroesophageal junction carcinoma.

BGB-290 is under a global phase I trial in combination with temozolomide in locally advanced or metastatic solid tumors, and under a global Phase 1b/2 trial in combination with radiation therapy and/or temozolomide in glioblastoma.

Expected 2018 Catalysts:

-- Present updated phase I monotherapy or combination data of BGB-3111 at a medical conference.
-- Present China pivotal trial data of BGB-3111.
-- Initiate head-to-head phase III trial of BGB-3111 versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia.
-- NDA submission of BGB-3111 in China.
-- NDA submission of BGB-A317 in China.
-- Initiate global pivotal trial of BGB-A317.

8. TransEnterix Inc. (TRXC)

Gained 10.07% to close Wednesday's trading at $1.64.

TransEnterix is a medical device company. It is focused on the commercialization of Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery.
News: The Company made a presentation at RBC Capital Markets 2018 Global Healthcare Conference today (Feb.21, 2018).

The Senhance System is currently cleared for use in the U.S. for laparoscopic colorectal surgery and laparoscopic gynecologic surgery. The Company has sought FDA clearance for the Senhance System to include laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery in the indicated list of covered procedures.

The Company expects to achieve FDA clearance for the expanded indications by mid-year 2018.

Upcoming event:

-- The Company is slated to release fourth quarter and fiscal year 2017 financial and operating results after the market closes on Tuesday, March 6, 2018.

9. TG Therapeutics Inc. (TGTX)

Gained 9.92% to close Wednesday's trading at $13.85.

News: The Company announced the publication of results from the phase I first-in-human study of single agent Umbralisib (TGR-1202) in patients with relapsed or refractory b-cell malignancies, including patients with Chronic Lymphocytic Leukemia (CLL) and various forms of lymphoma. The study demonstrated a favorable safety profile for Umbralisib.

Umbralisib is currently under pivotal trials, dubbed UNITY-CLL and UNITY-NHL.

Also in the pipeline is Ublituximab, under phase III development, for high-risk Chronic Lymphocytic Leukemia, and multiple sclerosis.

Near-term Catalyst:

Top-line data on the Overall Response Rate endpoint from the UNITY-CLL trial is expected in the second quarter of 2018.

10. NeoGenomics Inc. (NEO)

Gained 9.78% to close Wednesday's trading at $8.08.

News: The Company reported better-than expected Q4 financial results.

On an adjusted basis, the net income for the fourth quarter of 2017 was $4.36 million or $0.05 per share on revenue of $67.8 million. This compared with an adjusted net income of $4.42 million or $0.05 per share and revenue of $60.49 million in the year-ago quarter.

Analysts polled by Thomson Reuters expected the Company to earn $0.04 per share on revenue of $66.25 million for the fourth quarter of 2017.

Looking ahead to 2018, the Company expects adjusted EPS to range between $0.15 and $0.20, and revenue to be in the range of $260 to $272 million. Analysts are expecting EPS of $0.21 and revenue of $281.06 million for the year. The adjusted EPS was $0.13 and revenue was $258.6 million in 2017.

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