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XBIO To Report Phase 2 Data This Year, VNRX Abuzz, ATRS To Face FDA In Sep

pharma gainers 081318 lt

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

1. Xenetic Biosciences Inc. (XBIO)

Xenetic Bio is a clinical-stage biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics.

Gained 28.30% to close Monday's (Aug 13) trading at $4.08.

News: No news

Clinical Trials & Near-term Catalysts:

The lead program is XBIO-101, under phase II study for treatment of progesterone resistant endometrial cancer. Preliminary data from this study is expected this year.
A biomarker study with XBIO-101 for triple negative breast cancer is also being planned.

2. Idera Pharmaceuticals Inc. (IDRA)

Idera is a clinical-stage biopharmaceutical company focused on developing novel oligonucleotide therapeutics for oncology and rare diseases. Its lead drug candidate is Tilsotolimod.

Gained 18.24% to close Monday's trading at $7.39.

News: No news

Recent events:

-- On August 3, the Company reported its financial and operational results for the second quarter ended June 30, 2018.
-- On July 30, a one-for-eight reverse stock split of common stock was implemented.

Upcoming event:

The Company is slated to make a presentation at the 2018 Wedbush PacGrow Healthcare Conference on Tuesday, August 14, 2018 at 10:20 a.m. Eastern Time at the Parker Hotel in New York City.

Clinical Trials & Near-term Catalysts:

-- A phase III trial of intratumoral Tilsotolimod in combination with Ipilimumab versus Ipilimumab alone in patients with PD-1 refractory metastatic melanoma, dubbed ILLUMINATE 301, initiated in the first quarter of 2018, is underway.
-- A two-arm Phase 1/2 study of Tilsotolimod in combination with either Yervoy or Keytruda for the treatment of patients with anti-PD-1 refractory metastatic melanoma, dubbed ILLUMINATE-204, is ongoing. Enrollment in the Yervoy combination arm is expected to be completed by year-end 2018.
-- A phase 1b trial of intratumoral Tilsotolimod monotherapy in patients with refractory solid tumors is underway.

The Company also has three investigator sponsored trials namely,

-- A Phase 1/2 open label study of intratumoral Tilsotolimod in combination with intratumoral Yervoy and IV Opdivo in a protocol open to multiple tumor types including non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck and urothelial carcinoma.
-- A phase II study of intratumoral Tilsotolimod in combination with IV Keytruda in patients with NSCLC.
-- A Phase 2 placebo-controlled study of intradermal administration of Tilsotolimod in patients with T3/T4 primary melanoma scheduled to undergo a combined re-excision and sentinel node biopsy (SNB) procedure.

3. VolitionRx Limited (VNRX)

VolitionRx is focused on developing simple, easy to use, cost effective blood tests designed to help diagnose a range of cancers.

Gained 13.02% to close Monday's trading at $1.91.

News: The Company announced encouraging preliminary data from a prospective, multi-centered Proof of Concept Study of 84 men into the utility of Volition's Nu.Q assays to diagnose men with high-grade prostate cancer.

According to the Company, at 88% specificity, the Volition panel of five assays (including PSA) identified 94% of high-grade prostate cancers that require treatment compared to just 33% identified by Prostate-Specific Antigen (PSA) alone.

Cameron Reynolds, CEO at Volition, said, "If these results are validated in larger trials, they will present a potentially significant new market opportunity. Volition's research team is continuing to develop our Nu.Q assays and we aim to launch products in 2019."

4. Bioblast Pharma Ltd. (ORPN)

Bioblast is focused on developing clinically meaningful therapies for patients with rare diseases.

Gained 12.28% to close Monday's trading at $1.28.

News: No news


The Company's lead compound is Trehalose, which is being explored in the indications of oculopharyngeal muscular dystrophy (OPMD) and spinocerebellar ataxia type 3 (SCA3). It is under phase II development in the two indications.

Recent event:

On July 26, the Company announced that it is seeking a commercial partner for Trehalose.

5. Antares Pharma Inc. (ATRS)

Antares is a specialty pharmaceutical company developing self-administered parenteral pharmaceutical products using advanced drug delivery auto injection technology.

Gained 10.54% to close Monday's trading at $3.20.

News: No news

Recent events:

On August 7, the Company reported second quarter financial results.

Net loss was $4.5 million or $0.03 per share on revenue of $14.2 million in the second quarter of 2018. This compares with net loss of $2.8 million or $0.02 per share and revenue of $13.4 million for the comparable period in 2017.

On August 6, the Company inked a deal with Pfizer Inc. (PFE) to develop a combination drug device rescue pen. This rescue pen will utilize the Antares QuickShot auto injector and an undisclosed Pfizer drug.

Near-term Catalyst:

The Company's re-submitted NDA for XYOSTED is under FDA review, with a decision expected on September 29, 2018.

Xyosted (testosterone enanthate) is a self-administered subcutaneous injection formulation of testosterone in development for the treatment of testosterone deficiency (hypogonadism).

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