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VTVT Steadying Up, ADVM Advances, AGRX Bouncing Back

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

1. vTv Therapeutics Inc. (VTVT)

Gained 10.47% to close Tuesday's (Jan.16) trading at $6.12.

News: No news

Clinical Trials & Near-term Catalysts:

-- The Company's lead product candidate is Azeliragon, under phase III trial in patients with mild Alzheimer's disease, dubbed STEADFAST.

The STEADFAST trial has 2 parts - Part A and Part B. Part A enrolled patients in the United States and Canada. Part B included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa.

-- Top-line results from Part A of the study are expected to be reported in early 2018 and that from Part B in late 2018.
-- A phase 1b/2 study of TTP399 in adult patients with type 1 diabetes, dubbed simplici-T1, was initiated in November 2017.

2. Adverum Biotechnologies Inc. (ADVM)

Gained 10.13% to close Tuesday's trading at $4.35.

News: No news

Pipeline:

The Company's pipeline includes one clinical compound, ADVM-043 for alpha-1 antitrypsin deficiency, and two pre-clinical compounds ADVM-022 for wet AMD and ADVM-053 for hereditary angioedema.

Clinical Trials & Near-term Catalysts:

-- The first patient in a phase 1/2 clinical trial of ADVM-043 for alpha-1 antitrypsin (A1AT) deficiency, dubbed ADVANCE, was dosed on December 28, 2017. Preliminary data from this study are expected in the second half of 2018.
-- Report 12-month efficacy data for ADVM-022 in wet AMD in non-human primates in the first half of 2018.
-- Submit an IND application to the FDA for ADVM-022 in wet AMD in the second half of 2018.
-- Submit an IND application to the FDA for ADVM-053 in hereditary angioedema in the second half of 2018.

3. Agile Therapeutics Inc. (AGRX)

Gained 6.40% to close Tuesday's trading at $3.49.

News: No news

Recent event:

-- On December 22, 2017, the FDA refused to approve the Company's investigational contraceptive patch Twirla, which sent the stock down 47% to $2.52.

Twirla was rejected by the FDA in 2013 too, and the Company was asked to conduct a new clinical trial and provide additional information on the manufacturing process for the hormonal contraceptive patch.

Al Altomari, chairman and CEO of Agile Therapeutics, said, "We are clearly disappointed, and we are evaluating the FDA's response. We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and discuss a path to approval for Twirla. We will work closely with the FDA to address the points raised in the CRL as quickly as possible."

4. EDAP TMS S.A. (EDAP)

Gained 6.01% to close Tuesday's trading at $2.80.

News: No news

EDAP markets Ablatherm for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. The device is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance from the FDA. Ablatherm Fusion also is FDA cleared.

Another marketed device of the Company is Focal One, an innovative robot-assisted HIFU device, dedicated to focal therapy of prostate cancer. Focal One is CE marked but is not FDA approved.

5. Kala Pharmaceuticals Inc. (KALA)

Gained 5.58% to close Tuesday's trading at $16.47.

News: No news

Recent event:

-- On January 5, 2018, the Company reported top line results from its two phase III clinical trials, dubbed STRIDE 1 and STRIDE 2, evaluating KPI-121 0.25% in patients with dry eye disease.

There was statistically significant improvement in ocular discomfort, the primary symptom endpoint, in STRIDE 1 but not in STRIDE 2. The STRIDE 1 and STRIDE 2 trials achieved statistical significance for the primary sign endpoint of conjunctival hyperemia change.

Near-term Catalysts:

-- The New Drug Application for Inveltys for post surgical pain and inflammation is under FDA review, with a decision expected on August 24, 2018.

6. Collegium Pharmaceutical Inc. (COLL)

Gained 5.54% to close Tuesday's trading at $21.31.

News: No news

Recent events:

-- On January 10, 2018, Collegium gained the right to commercialize Depomed Inc.'s (DEPO) Nucynta franchise. The transaction is expected to be immediately accretive and to significantly increase product revenue for Collegium.
--On November 8, 2017, the Company reported better-than-expected Q3, 2017 financial results.

Net loss for the third quarter of 2017 narrowed to $13.3 million or $0.45 per share on Xtampza ER product revenue of $12.0 million. Analysts polled by Thomson Reuters were expecting a loss of $0.74 per share on revenue of $5.4 million. The Company had incurred a net loss of $26.4 million or $1.13 per share on product revenue of $408,000 in the third quarter of 2016.

-- On November 7, 2017, the FDA approved the Company's supplemental New Drug Application seeking to enhance the label for Xtampza ER by adding comparative OxyContin data and oral human abuse deterrent claim.

Xtampza ER, a twice-daily, oxycodone medication, received its FDA approval in April 2016 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

by RTTNews Staff Writer

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