MDGL Crossed $100 Mark, INSY Awaits FDA Decision In July, ODT IPO Today

Today’s Daily Dose brings you news about Edwards’ recent acquisition; FDA decision date for Insys’ NDA; Madrigal’s NASH trial results; private grant funding for Moleculin’s brain tumor drug candidate and Vistagen’s patent for MDD drug candidate.

Read on…

Edwards Lifesciences Corp. (EW) has acquired privately held medical technology company Harpoon Medical Inc., in continuation of a structured upfront investment made in 2015.

At closing of the deal on December 1, 2017, Edwards paid $100 million in cash for Harpoon. In addition, there is the potential for up to $150 million in pre-specified milestone-driven payments over the next 10 years.

Harpoon Medical is developing a minimally-invasive, beating-heart, mitral valve repair device for patients with *mitral regurgitation. (Leakage of blood backward through the mitral valve each time the left ventricle contracts. Source: American Heart Association).

The HARPOON device is not approved anywhere yet. It is expected to receive CE Mark approval in Europe soon.

EW closed Wednesday’s trading at $113.36, up 0.25%.

INSYS Therapeutics Inc.’s (INSY) New Drug Application for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain has been accepted for filing by the FDA – with a decision date set for July 28, 2018.

Since October, the Company’s share price has lost 47% of its value, and there are reasons to it.

The Company’s founder and majority owner, John N. Kapoor, was arrested in October for allegedly bribing doctors and pharmacists to prescribe “Subsys”, a Fentanyl spray, intended for cancer patients experiencing breakthrough pain. That month, he also stepped down from his seat on the Board of Directors of INSYS. Another director Patrick P. Fourteau also relinquished his post in October.

In the recent third quarter, net revenue was $30.7 million compared to $57.8 million for the third quarter of 2016. The Company blamed the results to a decline in SUBSYS prescription volumes due to ongoing softness in overall demand.

INSY closed Wednesday’s trading at $5.24, down 2.42%. In after-hours, the stock was up 0.16% to $5.25.

Shares of Madrigal Pharmaceuticals Inc. (MDGL) jumped as much as 118% on Wednesday, following positive top-line results from its ongoing phase II clinical trial of MGL-3196 in patients with biopsy-proven non-alcoholic steatohepatitis (NASH).

The trial met the primary end point of statistically significant improvement in the relative decrease in liver fat…

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