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NMRD Turning Heads, EVFM Awaits Contraceptive Gel Data, SLDB Making Solid Gains

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

1. Nemaura Medical Inc. (NMRD)

Gained 30% to close Wednesday's (Sep.12) trading at $2.86.

News: The Company reported positive data from an interim analysis of the first of a number of planned studies in support of a submission to the FDA for approval of its SugarBEAT product.

SugarBEAT is a non-invasive affordable and flexible Continuous Glucose Monitor for use by persons with diabetes and pre-diabetics. The completion of the U.S. study evaluating SugarBEAT and FDA submission is expected in Q1 2019.

The product is expected to be launched in the UK in the coming months.

2. XBiotech Inc. (XBIT)

Gained 26.62% to close Wednesday's trading at $2.92.

News: The Company announced the appointment of Peter Libby, MD to its Scientific Advisory Board (SAB).

Dr. Libby will work with XBiotech to help further develop its clinical and research programs including studies evaluating Bermekimab's potential in improving patient outcomes by reducing risk of heart attack or strokes.

Clinical Trials & Near-term Catalysts:

-- A phase II clinical trial evaluating MABp1 (Bermekimab) in patients with moderate to severe Atopic Dermatitis is underway.
-- A phase II clinical study evaluating Bermekimab in patients with moderate to severe Hidradenitis Suppurativa is underway.
-- A physician-sponsored clinical research study being conducted to examine the safety of Bermekimab in combination with Onivyde and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients suffering from cachexia is ongoing. Clinical results from this study are expected to be reported later in 2018.

3. PLx Pharma Inc. (PLXP)

Gained 24.10% to close Wednesday's trading at $5.15.

News: No news

PLx is a late-stage specialty pharmaceutical company focused on commercializing two patent-protected products, Vazalore 325 mg and Vazalore 81 mg (referred to together as "Vazalore").

Vazalore 325 mg is NDA-approved by the FDA for over the counter distribution and is the first-ever FDA-approved liquid-filled aspirin capsule. The Company is focused on manufacturing, scale-up and label finalization for Vazalore 325 mg aspirin dosage form and preparing an sNDA for Vazalore 81 mg maintenance dose form.

Near-term Catalyst:

The Company will make a presentation at the Janney Healthcare Conference on September 18.

4. Evofem Biosciences Inc. (EVFM)

Gained 16.67% to close Wednesday's trading at $4.06.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Amphora, a non-hormonal, surfactant-free bioadhesive vaginal gel.

A phase III clinical trial of Amphora for the prevention of pregnancy and a phase IIb/III clinical trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women are underway.

Data from the phase III clinical trial of Amphora for the prevention of pregnancy are now expected in late 2018, ahead of its earlier guidance of Q1, 2019. If all goes well as planned, the Company will resubmit Amphora NDA for contraception in the first half of 2019. A Complete Response Letter was issued by the FDA on April 28, 2016.

5. Solid Biosciences Inc. (SLDB)

Gained 16.65% to close Wednesday's trading at $50.65.

News: No news

Near-term Catalysts:

The preclinical activities related to the Company's anti-LTBP4 monoclonal antibody program intended to reduce fibrosis and inflammation in the muscle are expected to be initiated by year-end 2018.

The initial data from a pre-specified interim analysis of IGNITE DMD, the Company's Phase I/II clinical trial of its lead product candidate SGT-001 for the treatment of Duchenne muscular dystrophy (DMD), are expected in the second half of 2019.

6. Galapagos NV (GLPG)

Gained 16.52% to close Wednesday's trading at $119.71. The stock touched an all-time high of $122.28 in intraday trading.

News: Gilead Sciences Inc. (GILD) and Galapagos' phase III study of Filgotinib in adults with moderately-to-severely active rheumatoid arthritis achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 12.

The trial, dubbed FINCH 2, evaluated Filgotinib 100 mg and 200 mg doses, and both the doses achieved the primary end points and all key secondary efficacy endpoints, including low disease activity and clinical remission.

7. TapImmune Inc. (TPIV)

Gained 15.59% to close Wednesday's trading at $9.49.

News: No news

Near-term Catalyst:

The Company is scheduled to make a presentation on September 18 at the 2018 Janney Montgomery Scott Healthcare Conference.

by RTTNews Staff Writer

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