Madrigal Pharmaceuticals shares sharply higher on its liver drug

Madrigal’s MGL-3196 achieves primary endpoint in Phase 2 clinical trial

Madrigal Pharmaceuticals shares sharply higher. See Stockwinners.com
Madrigal Pharmaceuticals NASH drug reports positive results

Madrigal Pharmaceuticals (MDGL) announced positive top-line results from a Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis. In this trial, MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor beta -selective agonist, demonstrated statistically significant results for the primary endpoint, the percent change in hepatic fat versus placebo as measured by MRI-PDFF, a non-invasive imaging test.

Nonalcoholic fatty liver disease (NAFLD) is a condition in which fat builds up in your liver. Nonalcoholic steatohepatitis (NASH) is a type of NAFLD. If you have NASH, you have inflammation and liver cell damage, along with fat in your liver.

Recent published data have shown a high correlation of the reduction of liver fat of 30% or more as measured by MRI-PDFF to improvement in NASH on liver biopsy.

Statistically significant reductions in ALT and AST were observed in MGL-3196 treated patients; greater reductions in ALT and AST, statistically significant relative to placebo, were observed in the prespecified group of 44/78 patients with relatively higher MGL-3196 drug levels.

In drug-treated relative to placebo patients, statistically significant improvements were also seen in multiple secondary endpoints considered to be potentially clinically relevant in patients with NASH including LDL-C, triglycerides, apolipoprotein B, and Lp(a).

MGL-3196 has been well-tolerated with mostly mild AEs, and a few moderate AEs, the numbers of which are balanced between placebo and drug-treatment groups.

There are no adverse effects of MGL-3196 on safety laboratory or vital sign parameters. There have been three serious adverse effects in the study, all considered unrelated to MGL-3196.

The on-going study remains blinded. Safety, efficacy of NASH resolution by biopsy, and repeat MRI-PDFF will be assessed at 36 weeks. Multiple inflammatory and fibrosis serum biomarkers at 12 and 36 weeks are being and will be assessed.

PRICE ACTION

MDGL closed at $43.90. It last traded at $68.20 in pre-market.


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DaVita sold or $4.9 billion

Optum to acquire DaVita Medical Group for approximately $4.9B in cash

 Optum to acquire DaVita Medical Group for approximately $4.9B in cash. See Stockwinners.com
Optum to acquire DaVita Medical Group for approximately $4.9B in cash

Optum, part of UnitedHealth Group (UNH), and DaVita Medical Group, a subsidiary of DaVita (DVA), are combining.

The agreement, entered into on December 5, calls for Optum to acquire DaVita Medical Group for approximately $4.9B in cash.

The transaction is expected to close in 2018 and is subject to regulatory approval and other customary closing conditions.

Following the transaction, DaVita Medical Group will become part of Optum’s OptumCare division, which works with more than 80 health plans to serve millions of consumers annually through 30,000 affiliated physicians and hundreds of care facilities.

DaVita’s medical unit had been a significant drag on the company’s financial performance in recent quarters.

The company said it would use the proceeds from the sale for stock buybacks after the deal closes next year, and to repay debt.

Joe Mello, COO of DaVita Medical Group, will continue in a leadership role in the combined entity, as will the DaVita Medical Group leadership team.

DaVita plans to use the proceeds from the transaction for significant stock repurchases over the one to two years following the closing of the transaction, as well as to repay debt and for general corporate purposes.

DVA closed at $60.93. It last traded at $68.29.


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