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Mark Your Calendar For May 15, DXR Makes A Comeback, OBSV Abuzz, CVM On Watch


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(RTTNews.com) - The following are some of today's top gainers in the pharma/biotech sector.

1. Axovant Sciences Ltd. (AXON)

Gained 26.13% to close Monday's (May 7) trading at $1.40.

News: No news

Recent events:

-- On February 12, 2018, the Company announced changes to management team and Board of Directors.

The Company's CEO David Hung, President and COO Marion McCourt, and directors Kate Falberg, Tony Vernon, and Patrick Machado have resigned. Pavan Cheruvu has been appointed CEO, while Roger Jeffs, former President and co-CEO of United Therapeutics, and George Bickerstaff, former CFO of Novartis Pharma, have joined the Axovant board of directors.

-- On January 8, 2018, the Company announced that its phase II study of Intepirdine in patients with dementia with Lewy bodies, dubbed HEADWAY, and a pilot phase II study of Intepirdine in patients with dementia and gait impairment did not meet the trial goals. The news sent the stock down as much as 57% to $2.30 that day.

2. Xenetic Biosciences Inc. (XBIO)

Gained 24.31% to close Monday's trading at $2.25.

News: No news

Clinical Trials & Near-term Catalysts:

A phase II clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of 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.

3. Bioblast Pharma Ltd. (ORPN)

Gained 24.31% to close Monday's trading at $2.25.

News: No news

Pipeline:

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.

Recent event:

-- On November 2, 2017, while reporting third quarter 2017 financial results, the Company revealed that it has engaged JSB-Partners, a global life sciences advisor, to assist in executing its business development objectives that include selecting potential development and commercial partners for its investigational product Trehalose as well as exploring merger opportunities. The Company is devoting substantially all of its resources to this effort.

4. Evolus Inc. (EOLS)

Gained 20.19% to close Monday's trading at $8.75.

News: The Company announced the appointment of David Moatazedi as its President and Chief Executive Officer.

Pipeline:

The lead product candidate is DWP-450, an injectable 900 kDa purified botulinum toxin type A complex.

Recent event:

-- On February 8, 2018, the Company went public on the Nasdaq Global Market, offering its shares at a price of $12.00 each.

Near-term Catalysts:

The Company's BLA for DWP-450 for the treatment of moderate to severe glabellar lines, also known as "frown lines," between the eyebrows, is under FDA review, with a decision expected on May 15, 2018.

Evolus relies solely on Daewoong Pharmaceutical plant in South Korea to manufacture DWP-450. The FDA conducted a cGMP and pre-approval inspection of Daewoong's manufacturing facility in South Korea related to the BLA for DWP-450 from November 8 to November 17, 2017. The regulatory agency issued an FDA Form 483 with ten inspectional observations to Daewoong to take corrective actions. Daewoong timely responded to the FDA. However, if the FDA is not satisfied with the response, the decision on DWP-450 is likely to be delayed.

In the European Union and Canada, the decision on DWP-450 is expected by the second half of 2018, and in Canada.

5. CEL-SCI Corp. (CVM)

Gained 17.09% to close Monday's trading at $2.74.

News: No news

Clinical Trial & Near-term Catalyst:

-- The phase III head and neck cancer study for lead investigational immunotherapy Multikine is fully enrolled.

The Company is following the study subjects for outcomes and will be able to analyze all of the data for safety and efficacy when 298 deaths have occurred in the two main comparator arms of the study and the corresponding data have been recorded in the study database.

The primary efficacy endpoint of the study is a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone.

6. CohBar Inc. (CWBR)

Gained 14.36% to close Monday's trading at $6.29.

News: No news

Clinical Trials & Near-term Catalyst:

The lead drug candidate is CB4211, for nonalcoholic steatohepatitis (NASH) and obesity. The Company plans to initiate the Phase 1a/1b clinical trial in mid-2018, with an activity readout expected in early 2019.

Recent event:

-- On December 15, 2017, CohBar's common stock was uplisted to the NASDAQ Capital Market from the OTCQX Best Marketplace.

7. ObsEva SA (OBSV)

Gained 13.39% to close Monday's trading at $11.52.

News: No news

Near-term Catalysts:

-- The Company expects 12 week results from its phase 2b clinical trial of OBE2109 for the treatment of endometriosis, dubbed EDELWEISS, in mid-2018. -- Results of live birth rates and 28-day neonatal safety from the phase III clinical trial of Nolasiban in IVF, dubbed IMPLANT2, are anticipated in the fourth quarter of 2018. -- Initial efficacy results from a phase 2a clinical trial of OBE022 in pre-term labor, known as PROLONG, are anticipated in late 2018. -- 24-week primary endpoint data from two phase III trials of OBE2109 in Uterine fibroids, dubbed PRIMROSE 1 and 2, are expected in the second half of 2019.

8. Tetraphase Pharmaceuticals Inc. (TTPH)

Gained 12.69% to close Monday's trading at $3.64.

News: No news

Near-term Catalysts:

-- The NDA for IV Eravacycline in complicated intra-abdominal infections (cIAI) is under FDA review, with a decision expected on August 28, 2018. -- IV Eravacycline for the treatment of patients with cIAI is also under review by the European Medicines Agency. -- Complete phase 1 MAD studies for TP-271, for the treatment of respiratory diseases, and TP-6076, for the treatment of serious and life-threatening bacterial infections, in the second half of 2018. The phase I multiple-ascending dose studies are being conducted in healthy volunteers.

9. Daxor Corp. (DXR)

Gained 11.76% to close Monday's trading at $6.84.

News: No news

The Company manufactures and markets FDA-cleared BVA-100 blood volume analyzer, which is used in conjunction with a single-use diagnostic kit.

Recent news:

-- On Mar.14, 2018, the Company announced new data from its study showing that patient care individualized by its Precision Blood Volume Analysis (BVA) reduces heart failure readmissions by 56% and mortality by over 80%. The stock rose as much as 62% that day to touch $8.10 in intraday trading. The following day, the stock gained another 177% to touch an intraday high of $21.66 on Mar.15, 2018. DXR has given back most of its gain since then.


Read the original article on RTTNews (http://www.rttnews.com/2891900/mark-your-calendar-for-may-15-dxr-makes-a-comeback-obsv-abuzz-cvm-on-watch.aspx)


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