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VCEL Shines On Q4 Results, CLSD's PEACHTREE Blooms, SBPH Waiting To ACHIEVE

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

1. Vericel Corp. (VCEL)

Gained 41.92% to close Monday's (Mar.5) trading at $11.85.

News: The Company reported stellar Q4 financial results.

Net income for the fourth quarter of 2017 was $0.3 million or $0.01 per share on total net revenue of $23.4 million. This compared with a net loss of $6.2 million or $0.34 per share, and total net revenue of $16.5 million in the fourth quarter of 2016.

Excluding license revenue, net revenue in the fourth quarter of 2017 was $22.2 million, up 34% over the comparable year-ago quarter.

Analysts polled by Thomson Reuters were expecting the Company to incur a loss of $0.07 per share on revenue of $18.76 million in the recent fourth quarter.

Looking ahead, the Company expects total net product revenues for the full year 2018, excluding additional license revenue, to be in the range of $73 million to $78 million compared to total net product revenue, excluding license revenue, of $62.8 million in 2017.

2. GTx Inc. (GTXI)

Gained 38.31% to close Monday's trading at $23.25.

News: The Company announced new data from a phase II proof-of-concept clinical trial of Enobosarm administered orally in postmenopausal women with stress urinary incontinence (SUI), including magnetic resonance imaging (MRI) results from patients' pelvic floor muscle.

MRI results show increases in pelvic floor muscle and urethral muscle diameter supporting Enobosarm's mechanism of action. New data in a subset of women also suggests a positive treatment effect of Enobosarm for urge incontinence (UI) suggesting a possible treatment effect for women with mixed incontinence.

Near-term Catalyst:

-- A phase II clinical trial of Enobosarm in postmenopausal women with stress urinary incontinence, dubbed ASTRID, is underway. Top-line results from this study are expected in the second half of 2018.

3. Clearside BioMedical Inc. (CLSD)

Gained 32.10% to close Monday's trading at $10.33.

News: The Company announced positive topline results from its pivotal phase III trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis.

In the trial, dubbed PEACHTREE, 96 patients were randomized to the treatment arm to receive two 4.0 mg doses of suprachoroidal CLS-TA 12 weeks apart, and 64 patients were randomized to undergo sham procedures at the same 12-week interval.

According to the trial results, 47% of patients who received suprachoroidal CLS-TA every 12 weeks gained at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16% of patients who underwent a sham procedure.

4. Infinity Pharmaceuticals Inc. (INFI)

Gained 31.40% to close Monday's trading at $2.72.

News: No news

The Company has a couple of events to watch out for this year related to its Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in advanced solid tumors.

The Phase1/1b monotherapy expansion component of the study is fully enrolled, and the combination dose escalation component of the study has been completed.

Near-term Catalysts:

-- Report data from the monotherapy expansion component of the study in the second quarter of 2018.
-- Report data from the combination dose-escalation component of the study in the second quarter of 2018.
-- Report initial data from the combination expansion component of the study in the second quarter of 2018.
-- Report additional data from the combination expansion component, with more mature clinical and translational data, including insights from paired tumor biopsies, in the second half of 2018.

5. Marinus Pharmaceuticals Inc. (MRNS)

Gained 17.45% to close Monday's trading at $5.25.

News: No news

Pipeline & Near-term Catalysts:

The Company's lead drug candidate is Ganaxolone, being developed in three different formulations namely IV, capsule and liquid. Ganaxolone in oral formulation has completed phase II testing successfully in the indication of CDKL5 disorder.

CDKL5 disorder is a serious and rare genetic disorder that is caused by a mutation of the cyclin-dependent kinase-like 5 (CDKL5) gene, located on the X chromosome. This disorder mostly affects girls, and is characterized by early-onset, difficult-to-control seizures and severe neuro-developmental impairment.

-- Ganaxolone in intravenous (IV) formulation is under a phase II trial in women diagnosed with severe Postpartum Depression, dubbed Magnolia Study. Data from this study is expected in early 2018.
-- A phase II study of Oral Ganaxolone in women with moderate Postpartum Depression, dubbed Amaryllis trial, is also underway. Data from this study is expected in 2018.

6. Odonate Therapeutics Inc. (ODT)

Gained 13.93% to close Monday's trading at $31.00.

News: A SEC filing made on MAR.2, 2018 reveals that Tang Kevin, the Chairman and CEO of the Company, acquired 14,050 shares at an average price of $27.46 each.

Recent events:

-- The Company went public on the NASDAQ Global Select Market on December 7, 2017, offering its shares at a price of $24.00 each.
-- On January 2, 2018, Jefferies initiated coverage on Odonate with a Buy rating and a price target of $40.
-- The Company announced financial results for the three and twelve months ended December 31, 2017, on Feb.14, 2018.

As of December 31, 2017, Odonate had $198.1 million in cash.

Clinical Trial:

-- A phase III study of Tesetaxel in patients with locally advanced or metastatic breast cancer, dubbed CONTESSA, was initiated on December 28, 2017.

7. Athersys Inc. (ATHX)

Gained 11.76% to close Monday's trading at $1.52.

The Company is developing MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas.

News: No news

Clinical trial:

-- A pivotal trial in Japan evaluating MultiStem cell therapy treatment of patients who have suffered an ischemic stroke, dubbed TREASURE, is ongoing.

Near-term Catalyst:

-- The Company will release its year-end 2017 financial results at approximately 4:00 PM Eastern Time on Tuesday, March 13, 2018.

8. Catalyst Biosciences Inc. (CBIO)

Gained 11.73% to close Monday's trading at $30.77.

News: The Company announced the calling of remaining warrants and conversion of remaining series A preferred shares issued on April 12, 2017.

With more than $135 million in cash, the Company said it is in a strong financial position.

Near-term Catalysts:

-- Announce interim data from an open-label phase 2 part of the Phase 2/3 program of Marzeptacog alfa (activated) (MarzAA), subcutaneous efficacy trial in individuals with hemophilia A or B with inhibitors to evaluate the ability of MarzAA to minimize, spontaneous bleeding episodes in July 2018.
-- Announce additional data from the Factor IX CB2679d Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B in the second quarter of 2018.
Initiate a Phase 2b trial of CB 2679d in individuals with severe hemophilia B in the third quarter of 2018.

9. Vaxart Inc. (VXRT)

Gained 11.72% to close Monday's trading at $5.53.

News: The Company presented clinical data from two Phase 1 studies of its norovirus oral tablet vaccine on MARCH 3, 2018 at the International Congress on Infectious Diseases.

The orla norovirus vaccine was well-tolerated (with no dose limiting toxicities), and generated immune responses to norovirus VP1, without a corresponding increase in anti-Ad5 neutralizing antibody responses, according to the Company.

Pipeline:

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.

10. Spring Bank Pharmaceuticals Inc. (SBPH)

Gained 11.72% to close Monday's trading at $5.53.

News: The Company strengthens Board of Directors with the addition of a prominent biopharma R&D veteran Timothy Clackson.

Pipeline:

The Company's lead product candidate is Inarigivir, also known as SB 9200, under Phase 2a trial, for the treatment of HBV, dubbed ACHIEVE.

Near-term Catalysts:

-- Report top-line results from the third monotherapy cohort (100mg) of the ACHIEVE trial in mid-2018
-- Report top-line results from the fourth monotherapy cohort (200mg) of the ACHIEVE trial in late 2018
-- Initiate Part B of the ACHIEVE trial in mid-2018 to evaluate the co-administration of Inarigivir (100mg) with Gilead's Viread.

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