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GTHX Hits Record High, BVX Q4 Revenue Up 20%, ASNS Catches Eyes

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

1. Proteostasis Therapeutics Inc. (PTI)

Gained 54.11% to close Tuesday's (Mar.13) trading at $6.38.

News: Breakthrough Therapy Designation granted for the Company's drug candidate PTI-428 for the treatment of cystic fibrosis.

Last December, Proteostasis successfully completed its phase II study designed to evaluate the efficacy, safety, and tolerability of 50 mg once-a-day of PTI-428 over a 28-day treatment of CF patients on background Orkambi.

Near-term Catalysts:

-- Preliminary data from a 14-day phase I study of PTI-428 plus Kalydeco is due this quarter (period ending MARCH 2018).
-- The Company plans to initiate a triple combination study of PTI-428, PTI-801 and PTI-808 in the treatment of cystic fibrosis in the first half of this year - with initial results expected in the second half of 2018.

2. Arsanis Inc. (ASNS)

Gained 24.79% to close Tuesday's trading at $22.75.

News: No news

Recent event:

--On November 16, 2017, the Company went public on the NASDAQ Global Market offering its shares at a price of $10 each.

Clinical Trials & Near-term catalysts:

-- The Company's investigational lead product candidate is ASN100, which is currently in a Phase 2 clinical trial for the prevention of S. aureus pneumonia in high-risk, mechanically ventilated patients.
-- Top line safety and efficacy results from the phase II study of ASN100 are expected in the second half of 2018.

3. Bovie Medical Corp. (BVX)

Gained 21.12% to close Tuesday's trading at $2.81.

News: The Company reported financial results for its fourth quarter and full year ended December 31, 2017.

Total revenue for the fourth quarter of 2017 was approximately $11.3 million, up 20% year-over-year.

Net loss attributed to common shareholders for the fourth quarter of 2017 was $0.8 million or $0.03 per share compared to a net loss of $0.5 million or $0.02 per share for the fourth quarter of 2016.

Looking ahead to 2018, the Company expects total revenue in the range of $41.0 million to $42.5 million, representing growth of 5% to 9% year-over-year.

4. Athersys Inc. (ATHX)

Gained 17.95% to close Tuesday's trading at $1.84.

News: The Company is planning to significantly expand its existing development and commercialization collaboration with Healios K.K.

In Japan, Healios is conducting the TREASURE study, evaluating MultiStem therapy for ischemic stroke, and has received a priority review designation under Sakigake from Japan's Pharmaceutical and Medical Devices Agency.

As part of this expansion, Healios is making an approximate $21 million equity investment at $1.76 per share, will deposit $10 million into escrow, and has entered into a letter of intent with Athersys to expand Healios' license to develop MultiStem products for indications to include acute respiratory distress syndrome, trauma in Japan and the use of MultiStem products in conjunction with organ bud technology and certain ophthalmological indications globally.

5. Novus Therapeutics Inc. (NVUS)

Gained 14.38% to close Tuesday's trading at $4.83.

Novus is a development stage specialty pharmaceutical company focused on the development of a novel, drug product for management of otitis media.

News: No news

Pipeline & Near-term Catalysts:

OP-02, a novel drug-device product, being developed as first-in-class treatment option for otitis media, is expected to move into phase I studies this year.

6. Myovant Sciences Ltd. (MYOV)

Gained 13.65% to close Tuesday's trading at $19.23.

News: No news

Clinical Trials & Near-term catalysts:

Myovant's lead product candidate is Relugolix, under phase III development. The Company licensed rights to the drug candidate from Takeda outside Japan and certain other Asian countries.

Relugolix is under five international Phase 3 clinical trials namely:

-- Two phase III trials in women with heavy menstrual bleeding associated with uterine fibroids, dubbed LIBERTY 1 & 2.
-- Two phase III trials in women with endometriosis-associated pain, known as SPIRIT 1 & 2.
-- A phase III trial in men with advanced prostate cancer, dubbed HERO.

MVT-602, for the treatment of female infertility as part of assisted reproduction, is under phase I testing. MVT-602 was also licensed from Takeda.

Completion of enrollment in all the five phase III studies is expected this year, with data anticipated in 2019.
Phase II trials with MVT-602 are planned for this year.

7. Vaxart Inc. (VXRT)

Gained 13.58% to close Tuesday's trading at $6.94.

News: No news

Vaxart's development programs include oral tablet vaccines that are designed to protect against norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), and antiviral drug candidates, including teslexivir (BTA074), an antiviral treatment for condyloma caused by HPV types 6 and 11.

8. G1 Therapeutics Inc. (GTHX)

Gained 8.95% to close Tuesday's trading at $38.73. The stock touched an all-time high of $39.29 in intraday trading.

News: The Company announced the closing of an underwritten public offering of 3.91 million shares of its common stock at a public offering price of $29.50, including 510,000 shares sold pursuant to the full exercise of the underwriters' option.
G1 Therapeutics received approximately $108.4 million in proceeds from the offering.

Pipeline:

The Company has 3 drug candidates in its pipeline namely, Trilaciclib, G1T38 and G1T48.

-- Trilaciclib is under four Phase 2 clinical trials - three studies in patients with small-cell lung cancer (SCLC), and one study in patients with triple-negative breast cancer.
-- G1T38 is under a phase 1b/2a study for the treatment of ER+, HER2- breast cancer.
-- G1T48 in development as monotherapy for ER+, HER2- breast cancer, for which the IND was filed in the fourth quarter of 2017.

Recent event:

On Mar.5, 2018, the Company announced positive topline data from its Phase 2a trial evaluating Trilaciclib in patients undergoing chemotherapy for first-line small cell lung cancer (SCLC).

Near-term Catalysts:

-- Initiate a Phase 1b/2 trial of G1T38 in combination with Tagrisso for the treatment of patients with EGFR mutation-positive NSCLC in the first quarter of 2018.
-- Present preliminary data from the Phase 1b trial of G1T38 plus Faslodex in ER+, HER2- breast cancer patients in the second quarter of 2018.
-- Complete patient enrollment in the Phase 2a trial of Trilaciclib in second-/third-line SCLC and the Phase 2 trial of Trilaciclib in triple-negative breast cancer in the second quarter of 2018.
-- Initiate a Phase 1/2a trial of G1T48 in ER+, HER2- breast cancer patients in the second quarter of 2018.

by RTTNews Staff Writer

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