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RVNC's All Smiles, NVCR Catches Eyes, ACRS Waiting For Xmas Gift, KIDS Growing

Dec05 120517

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

1. Revance Therapeutics Inc. (RVNC)

Gained 33.65% to close Tuesday's (Dec.5) trading at $34.75.

News: The Company's two phase III trials of DaxibotulinumtoxinA for Injection (RT002) for glabellar lines, dubbed SAKURA 1 and SAKURA 2, met the primary composite endpoint of statistically significant improvement against placebo in reducing the severity of glabellar lines, i.e., the frown lines or wrinkles between the brows.

In the SAKURA 1 trial, the percent of RT002-treated patients who had none or mild wrinkles and achieved at least a two-point improvement from baseline on both validated physician and patient assessments at Week 4 was 73.6%. In the SAKURA trial, it was 74%. About 88 percent of RT002-treated patients in SAKURA 1 and 91 percent of RT002 patients in SAKURA 2 said they were very satisfied or satisfied with their treatment experience at that time point.

Near-term catalysts:

-- A long-term safety trial, dubbed SAKURA 3, is underway, and is expected to be completed in the second half of 2018.
-- If all goes well as planned, the Company plans to submit a Biologics License Application for RT002 in the first half of 2019.

2. Mustang Bio Inc. (MBIO)

Gained 10.68% to close Tuesday's trading at $10.67.

News: The Company entered into a license agreement with Harvard University and a research collaboration agreement with Beth Israel Deaconess Medical Center for the development of CRISPR/Cas9-enhanced CAR T therapies for the treatment of cancer.


Mustang Bio is focused on developing CAR T-cell therapies to cure cancer. The Company's lead CAR T therapies are MB-101 for glioblastoma and MB-102 for acute myeloid leukemia, both of which are under phase I development. MB-103 for glioblastoma multiforme; MB-104 for multiple myeloma; MB-105 for prostate, pancreatic, gastric & bladder cancers and MB-106 for B-cell non-Hodgkin Lymphoma are the Company's preclinical CAR T product candidates.

Near-term catalysts:

-- Read out phase I data of MB-101 in glioblastoma and MB-102 in acute myeloid leukemia in early 2018.
-- Initiate a first-in-human phase I study of MB-103 for glioblastoma multiforme in 2018.

3. Depomed Inc. (DEPO)

Gained 9.93% to close Tuesday's trading at $7.86.

News: The Company has granted commercialization rights to its Nucynta opioid franchise to Collegium Pharmaceutical Inc. (COLL), and has decided to move its headquarters and trim its workforce by 40%.

The transaction is expected to close early January 2018, and is anticipated to be immediately accretive to Depomed.

With regard to relocation, Depomed is planning to move from Newark, California sometime in mid-2018 and is currently evaluating potential Midwest and East Coast locations. Depomed expects to save approximately $10 million annually as a result of the headquarters restructuring and relocation.

4. NovoCure Limited (NVCR)

Gained 9.59% to close Tuesday's trading at $20.00.

News: No news

Recent event:

-- On October 26, 2017, the Company reported third quarter financial results.

The net losses for the three months ended September 30, 2017, narrowed to $11.5 million or $0.13 per share on revenue of $50 million. This compared with a net loss of $33.6 million or $0.39 per share and revenue of $21.7 million for the same period in 2016.

The Company derives revenue from Optune, its wearable, portable, FDA-approved Tumor Treating Fields (TTFields) delivery system for the treatment of adult patients with glioblastoma.

Near-term catalysts:

-- Initiate a phase III pivotal trial of TTFields in locally advanced pancreatic cancer this quarter (Q4).
-- Initiate a phase III pivotal trial of TTFields in recurrent ovarian cancer in 2018.
-- Data from phase II pilot trial of TTFields in mesothelioma, dubbed STELLAR, expected in 2018.
-- Data from phase III pivotal trial of TTFields for brain metastases from non-small cell lung cancer, dubbed METIS, expected in 2020.
-- Data from phase III pivotal trial of TTFields for the treatment of advanced non-small cell lung cancer after failing platinum-based therapy expected in 2021.

5. Cellular Biomedicine Group Inc. (CBMG)

Gained 8.42% to close Tuesday's trading at $10.95.

Cellular Biomedicine is a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases.

News: No news


The Company currently has ongoing CAR-T Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL), CALL-1 for adult Acute Lymphoblastic Leukemia (ALL), and a phase I trial in China for AlloJoin (CBMG's "Off-the-Shelf" Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis.

Near-term catalysts:

-- Top line data readout from phase I clinical trials for CARD-1 and CALL-1 Chimeric Antigen Receptor (CAR) T-cell treatment for Diffuse Large B-Cell Lymphoma (DLBCL) and Acute Lymphoblastic Leukemia (ALL) in the first half of 2018.
-- Final data readout from AlloJoin phase I clinical trial for off-the-shelf Knee Osteoarthritis (KOA) therapy in China in the first half of 2018.

6. OrthoPediatrics Corp. (KIDS)

Gained 6.57% to close Tuesday's trading at $19.64.

News: No news

Recent event:

-- On October 12, 2017, the Company went public on the NASDAQ Global Market, offering its shares at a price of $13.00 each.
-- On November 8, 2017, the Company reported third quarter financial results.

Net loss for the third quarter of 2017 was $1.5 million or $1.70 per share compared to a net loss of $0.8 million or $1.38 per share in the year-ago quarter. Total revenue for the recent third quarter was $12.4 million, a 22.1% increase compared to $10.1 million for the same period last year.

7. Aclaris Therapeutics Inc. (ACRS)

Gained 6.29% to close Tuesday's trading at $22.82.

News: No news

Near-term catalyst:

The FDA decision on the Company's New Drug Application for A-101 40% topical solution, proposed for the treatment of seborrheic keratosis, is expected on December 24, 2017.

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