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XBIO Explodes Over 100%, ZFGN Abuzz, NTRA Grabs Investors' Attention

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

1. Xenetic Biosciences Inc. (XBIO)

Gained 103.90% to close Monday's (June 25) trading at $5.75.

News: No news

Clinical Trials & Near-term Catalysts:

A phase II clinical study of XBIO-101 for the treatment of progesterone resistant endometrial cancer is underway. Interim data from this trial is expected to be announced before the end of 2018.

The Company has an agreement with Baxalta Inc., Baxalta US Inc., and Baxalta GmbH - the wholly-owned subsidiaries of Shire plc (SHPG) - related to its PolyXen technology.

PolyXen technology is Xenetic's proprietary drug development platform.

2. Innovate Biopharmaceuticals Inc. (INNT)

Gained 39.48% to close Monday's trading at $18.76.

News: As part of the 2018 Russell indexes reconstitution, the Company has been added as a member of the broad-market Russell 3000, 2000 and Microcap Indexes, effective today.

Pipeline:

The lead drug candidate is Larazotide acetate (INN-202), which has successfully completed its phase 2b efficacy clinical trial for celiac disease. Also in the pipeline are INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase II trials this year, and INN-329, entering phase III trial for Magnetic Resonance Cholangiopancreatography (MRCP).

Near-term Catalyst:

Phase III registration clinical trials of Larazotide acetate for celiac disease are expected to begin later in 2018.

3. Zafgen Inc. (ZFGN)

Gained 26.80% to close Monday's trading at $8.99.

News: The Company, on Saturday, announced positive full results from its phase II clinical trial of ZGN-1061 in patients with type 2 diabetes.

There was a statistically significant reduction in A1C with ZGN-1061 0.9 mg versus placebo at Week 8 and Week 12. The compound also demonstrated a favorable safety and tolerability profile, with no treatment-related serious adverse events or CV safety signals.

Additionally, the Company reported supportive nonclinical data for ZGN-1061, including data on combination treatment with ZGN-1061 and liraglutide, and data on treatment with ZGN-1061 in nonalcoholic steatohepatitis (NASH).

The nonclinical data on treatment with both ZGN-1061 and liraglutide suggest that this combination therapy may yield additive improvement in glycemic control and weight loss.

In a NASH model, ZGN-1061 markedly reduced liver weight, NAS score and markers of liver damage (ALT and AST), added the Company.

4. Natera Inc. (NTRA)

Gained 18.23% to close Monday's trading at $19.00.

News: Analysts at Canaccord Genuity have raised their price target on the Company's stock to $20 from $19.

Natera develops and commercializes non-invasive methods for analyzing DNA.

Recent events:

-- On May 8, 2018, the Company reported financial results for the first quarter ended March 31, 2018.

Net loss for the first quarter of 2018 was $32.9 million or $0.61 per share compared to net loss of $33.5 million or $0.65 per share for the same period in 2017. Total revenues in the recent first quarter were $62.3 million compared to $49.4 million for the first quarter of 2017, an increase of 26%.

Looking ahead, the Company anticipates 2018 total revenue to be in the range of $250 million to $275 million. The total revenue in 2017 was $210.9 million.

-- On June 21, 2018, the Company announced a new kidney transplant rejection biomarker and study results in collaboration with the University of California, San Francisco.

According to the study results, Natera's dd-cfDNA assay demonstrated 92% sensitivity in detecting acute rejection, identifying 48 out of 52 affected cases based on a cutoff of 1% dd-cfDNA. This sensitivity compares favorably against competition, which reported only 59% sensitivity in a 2017 study, according to the Company.

5. XTL Biopharmaceuticals Ltd. (XTLB)

Gained 18.18% to close Monday's trading at $2.08.

News: No news

6. Valeritas Holdings Inc. (VLRX)

Gained 13.38% to close Monday's trading at $1.61.

Valeritas is a medical technology company and maker of V-Go Wearable Insulin Delivery device. V-Go received FDA clearance in December 2010 and CE Mark in July 2011.

News: The Company announced positive results from its ENABLE Study.

According to the study results, the patients who switched from insulin pens and syringes to V-Go significantly improved blood glucose while lowering insulin dose.

7. Akari Therapeutics Plc (AKTX)

Gained 10% to close Monday's trading at $2.20.

News: No news

Pipeline:

The Company's lead drug candidate is Coversin, which has successfully completed a Phase II trial for patients with Paroxysmal Nocturnal Hemoglobinuria. A phase II trial of Coversin in patients with Atypical Hemolytic Uremic Syndrome is underway. Two Phase II clinical trials of Coversin in the inflammatory-mediated eye disorder Atopic Keratoconjunctivitis and in the skin inflammatory disease Bullous Pemphigoid are also planned.

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