DXR Soars On Big Volume, RXII Gets Attention, Busy Q2 Awaits SNDX

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

1. Daxor Corp. (DXR)

Gained 56% to close Wednesday's (Mar.14) trading at $7.80.

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

News: New data from the Company's study shows that patient care individualized by its Precision Blood Volume Analysis (BVA) reduces heart failure readmissions by 56% and mortality by over 80%.

2. RXi Pharmaceuticals Corp. (RXII)

Gained 42.19% to close Wednesday's trading at $4.55.

News: No news

Clinical Trials & Near-term Catalysts:

-- The lead compound is RXI-109, which successfully completed a phase II trial for dermal scarring last December.

RXI-109 is also being tested in a phase 1/2 study in an ophthalmology indication namely in patients with advanced, wet age-related macular degeneration and associated retinal scarring. Readouts from this trial are expected this month.

-- Also in the pipeline are Samcyprone, which is being evaluated in a phase IIa clinical trial in subjects with at least one cutaneous, plantar or periungual wart, and RXI-231, a cosmetic ingredient in a proprietary gel formulation designed to aid in the reduction of pigmentation to improve skin appearance.

The Company expects to share full read-outs from the Phase 2a clinical trial of Samcyprone for the treatment of cutaneous warts in Q1-Q2 2018 time period.

3. Syndax Pharmaceuticals Inc. (SNDX)

Gained 28.36% to close Wednesday's trading at $13.58.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase III registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, is underway. Enrollment in this trial is expected to be complete in the third quarter of 2018. -- Full data from the NSCLC and melanoma cohorts of the ENCORE 601 trial is expected to be reported in the second quarter of 2018. Initial data from the melanoma and non-small cell lung cancer (NSCLC) cohorts of ENCORE 601 trial were presented last November.

The ENCORE 601 is an open-label, Phase 1b/2 clinical trial consisting of 4 cohorts - patients with non-small cell lung cancer (NSCLC) who have not previously received a PD-1 antagonist (cohort 1); patients with NSCLC who have progressed on a PD-1 antagonist (cohort 2); patients with advanced melanoma who have progressed on a PD-1 antagonist (cohort 3); and microsatellite stable colorectal cancer who have not previously been treated with a PD-1 antagonist (cohort 4).

-- Full Phase 2 data from the PD-(L)1 refractory non-small cell lung cancer (NSCLC) cohort of ENCORE 601 are expected in the second quarter of 2018. -- Enrollment in the first stage of the ENCORE 601 cohort of patients with microsatellite stable colorectal cancer (MSS-CRC) is complete. The Company expects to share initial data, as well as a decision on whether to advance this cohort to the second stage of the trial, in the second quarter of 2018. -- ENCORE 602, the Phase 1b/2 clinical trial evaluating the combination of entinostat plus Genentech's TECENTRIQ in patients with triple negative breast cancer, is expected to complete enrollment of the Phase 2 portion in the second quarter of 2018. Top line results from this trial are anticipated in the second half of 2018. -- ENCORE 603, the Phase 1b/2 clinical trial evaluating entinostat in combination with Pfizer/Merck KGaA's BAVENCIO in patients with ovarian cancer, continues to enroll patients into the Phase 2 portion and is on track to complete enrollment in the second quarter of 2018. Top line results are expected in the first half of 2019. -- A phase 1 multiple ascending dose (MAD) clinical trial of SNDX-6352 in patients with solid tumors is ongoing. The Company anticipates presenting data from this trial and disclosing a Phase 2 strategy in the second half of 2018.

4. Novus Therapeutics Inc. (NVUS)

Gained 29.83% to close Wednesday's trading at $6.05.

Novus is a development stage specialty pharmaceutical company focused on the development of a novel, drug product for management of otitis media.

News: No news

Pipeline & Near-term Catalysts:

-- OP-02, a novel drug-device product, being developed as first-in-class treatment option for otitis media, is expected to move into phase I studies this year.

5. Xtant Medical Holdings Inc. (XTNT)

Gained 22.21% to close Wednesday's trading at $8.20.

The Company is focused on developing regenerative medicine products and medical devices for domestic and international markets.

News: No news

Recent event:

-- On February 15, 2018, the Company announced that it has regained compliance with the NYSE American listing standards, with a positive stockholders' equity of approximately $47.4 million on a pro forma basis.

Upcoming event:

The Company is yet to report fourth quarter 2017 financial results.

6. Corindus Vascular Robotics Inc. (CVRS)

Gained 21.32% to close Wednesday's trading at $1.65.

The Company is a developer of precision vascular robotics.

News: No news

Recent events:

-- On March 5, 2018, the Company received FDA clearance for the first automated robotic movement designed for the CorPath GRX platform. -- On February 20, 2018, the Company received FDA clearance for use of its CorPath GRX System in peripheral vascular interventions. -- On January 23, 2018, the Company reported preliminary revenue results for the fourth quarter and year ended December 31, 2017.

Preliminary and unaudited revenue for fourth quarter 2017 is expected to be between $4.0 million and $4.2 million. Preliminary and unaudited revenue for full year 2017 is expected to be between $9.5 million and $9.7 million.

7. AquaBounty Technologies Inc. (AQB)

Gained 16% to close Wednesday's trading at $2.90.

News: No news

Recent event:

-- On March 8, 2018, the Company reported financial results for the year ended December 31, 2017.

2017 was a very successful year - with the Company making the first sales of AquAdvantage Salmon, selling five tons of fillets in Canada.

Net loss for the year ended December 31, 2017, was $9.26 million or $1.06 per share compared to a net loss of $8.47 million or $1.60 per share in 2016. Product revenue in 2017 was $53 thousand compared to nil revenue the year before.

8. Avenue Therapeutics Inc. (ATXI)

Gained 13.54% to close Wednesday's trading at $5.45.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase III safety trial of IV tramadol 50 mg for the management of moderate to moderately severe pain, initiated last December, is ongoing. -- A phase III trial of IV tramadol in patients following bunionectomy surgery is underway, with top-line data expected in the second quarter of 2018. -- A second phase III trial of IV tramadol in patients following abdominoplasty surgery is planned for initiation in the third quarter of 2018.

9. Mersana Therapeutics Inc. (MRSN)

Gained 13.14% to close Wednesday's trading at $16.70.

News: No news

Pipeline:

-- XMT-1522, a Dolaflexin ADC targeting HER2-expressing breast cancer, non-small cell lung cancer (NSCLC) and gastric cancer, in phase I testing. -- XMT-1536, a first-in-class Dolaflexin ADC targeting NaPi2b, a clinically validated ADC target broadly expressed in epithelial ovarian cancer and non-squamous NSCLC, as well as a number of other tumor types, also in phase I development.

10. Apellis Pharmaceuticals Inc. (APLS)

Gained 12.63% to close Wednesday's trading at $25.23.

News: No news

Recent event:

The Company debuted on the NASDAQ Global Select Market on November 9, 2017, offering its shares at a price of $14.00 each.

Clinical Trials & Near-term Catalysts:

-- APL-2 has been successfully studied in a phase II clinical trial (FILLY) in patients with geographic atrophy associated with age-related macular degeneration. -- A phase III program of APL-2 for the treatment of patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) is planned to begin in the second half of 2018. -- APL-2 is also under two phase Ib trials in paroxysmal nocturnal hemoglobinuria - one as monotherapy and the other as add-on to Soliris.

11. Cellectis S.A. (CLLS)

Gained 11.18% to close Wednesday's trading at $35.19.

News: No news

Clinical Trials & Near-term Catalysts:

The Company has two product candidates in clinical testing - UCART19 & UCART123.

UCART19 is under two phase I trials in acute lymphoblastic leukemia, dubbed CALM and PALL.

Intermediary data from first dose cohort of phase I trial of UCART19 were presented at ASH in December 2017. The data showed an 83% complete remission rate across the adult and pediatric patient populations at day 28 post CAR T-cell infusion. Additional results from the two phase I clinical trials with UCART19 will be presented on March 21, 2018.

UCART123 is under two phase I trials - one in acute myeloid leukemia (AML) and the other in blastic plasmacytoid dendritic cell neoplasm (BPDCN).