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NASH Data Drives MDGL To The Moon, VKTX Turns Head, FDA Nod For KTOV


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

1. Madrigal Pharmaceuticals Inc. (MDGL)

Gained 144.96% to close Thursday's (May 31) trading at $265.61.

News: The Company announced positive top-line, 36-week results from a phase II of MGL-3196 in patients with biopsy-proven non-alcoholic steatohepatitis (NASH).

Last December, the Company reported that there was statistically significant improvement in the relative decrease in liver fat in patients with NASH treated with MGL-3196 compared with placebo, at 12-weeks, the primary end point in the phase II proof-of-concept trial.

According to the updated results, at Week-36, MGL-3196 treated patients with more than or equal to 30% fat reduction at Week 12 demonstrated a higher percentage of NAS (NAFLD activity score) reduction and NASH resolution. There was also a sustained, highly statistically significant reduction in liver fat compared with placebo.

The Company looks forward to advancing MGL-3196 in a phase III clinical trial in patients with NASH.

2. Viking Therapeutics Inc. (VKTX)

Gained 101.01% to close Thursday's trading at $9.99.

News: Viking is also developing a drug for the treatment of NASH. The positive results from a phase II study of Madrigal's investigational drug for NASH seems to have had a positive rub off impact on shares of Viking.

Clinical Trials & Near-term Catalyst:

-- A phase II clinical trial of VK2809 in non-alcoholic fatty liver disease (NAFLD) and elevated LDL cholesterol is ongoing - with results expected to be announced in the second half of 2018.
-- Partnering discussions underway for VK5211 following positive Phase 2 trial results in patients recovering from hip fracture.
-- Proof of concept phase I study of VK2809 in glycogen storage disease (GSD) Ia is expected to begin this quarter. GSD Ia is a rare genetic disease that results in an excess accumulation of glycogen and lipids in the liver, potentially leading to hepatic steatosis, hepatic adenomas, and hepatocellular carcinoma.
-- IND-enabling work for VK0214 in X-ALD is progressing. The Company plans to file an IND to conduct a proof-of-concept study of VK0214 in 2019.

3. Kitov Pharma Ltd (KTOV)

Gained 40.93% to close Thursday's trading at $3.03.

News: The FDA has approved the Company's drug Consensi, previously known as KIT-302, to simultaneously treat pain caused by osteoarthritis, as well as hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain.

Consensi is comprised of two FDA approved drugs, Celebrex, a COX-2 inhibitor, for the treatment of pain caused by osteoarthritis, and Norvasc, a calcium channel blocker for lowering blood pressure.

Commenting on the approval, Isaac Israel, Kitov's CEO, said, "Over 50 million Americans suffer from osteoarthritis. About 1 of 3 U.S. adults or about 75 million people have high blood pressure*, known as the "silent killer" due to the absence of noticeable symptoms. As a result, patients' adherence to the hypertension treatment regimen is low. We believe that Consensi as a single pill combination treatment for osteoarthritis and hypertension presents a unique value proposition of potentially increasing treatment adherence".

4. Sesen Bio Inc. (SESN)

Gained 26.11% to close Thursday's trading at $2.27.

News: The Company has offered to sell 22.22 million shares of its common stock to the public at a price of $1.80 per share. The underwriters have a 30-day option to purchase up to an additional 3.33 million shares of common stock.

The offering is expected to close on or about June 4, 2018.

Recent event:

On May 21, 2018, the Company reported encouraging three-month data from its ongoing phase III trial of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG), dubbed VISTA.

According to the Company, VISTA, achieved 42% complete response rate at 3 months in carcinoma in situ patients. Among patients with papillary disease without CIS, treatment with Vicinium demonstrated a 68 percent recurrence-free rate at three months.

However, with investors worrying about the four treatment-related serious adverse events that were reported in the trial, including acute kidney injury or renal failure and cholestatic hepatitis, the stock slid 23%.

The Company expects to present 12-month data of the VISTA trial by mid-2019.

5. Curis Inc. (CRIS)

Gained 21.93% to close Thursday's trading at $2.78.

News: The FDA has granted Fast Track designation for the Company's investigational drug Fimepinostat (formerly CUDC-907), being developed for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Fimepinostat has completed phase II testing, and the Company expects to re-initiate enrollment this year as part of a pivotal study.

6. Precision Therapeutics Inc. (AIPT)

Gained 17.12% to close Thursday's trading at $1.30.

News: No news

Recent event:

On May 15, 2018, the Company announced financial results for the three months ended March 31, 2018.

Net loss available to common shareholders for the recent first quarter was $1.8 million or $0.15 per share compared with a net loss available to common shareholders of $1.3 million or $0.21 per share in the year-ago quarter.

Revenue for the first quarter of 2018 rose to $411,593 from $175,166 in the year-ago quarter.

The Company sold 16 STREAMWAY Systems in the first three months of 2018, compared with three STREAMWAY Systems in Q1 2017, bringing the total number of STREAMWAY Systems sold to 123.

7. LivaNova PLC (LIVN)

Gained 13.33% to close Thursday's trading at $94.05.

News: The U.S. Centers for Medicare & Medicaid Services is reconsidering its National Coverage Determination for the Company's Vagus Nerve Stimulation Therapy System for Treatment-Resistant Depression.

The Vagus Nerve Stimulation Therapy System has been a Medicare non-covered indication for more than a decade. A change in the Medicare coverage status of VNS Therapy for TRD that ensures adequate patient access to this important therapy would be a positive outcome for patients and physicians, according to the Company.

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