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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 in patients treated with MGL-3196 compared with placebo at Week 12.

The safety and efficacy of NASH resolution will be assessed at 36 weeks too, and will be reported.

MGL-3196 is also being explored as a potential treatment for heterozygous familial hypercholesterolemia (HeFH), and a phase II trial in this indication is ongoing. Top-line results from this study are expected in early 2018.

Madrigal Pharma began trading on the NASDAQ on July 22, 2016, following its reverse merger with Synta Pharmaceuticals Corp.

MDGL touched a new high of $101 on Wednesday, before closing the day's trading at $87.18, up 88.29%.

Moleculin Biotech Inc. (MBRX) has received $2 million in private grant funding related to recently announced Investigational New Drug clearance for a physician-sponsored Phase I trial of WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma.

MBRX closed Wednesday's trading at $1.89, down 9.13%.

Odonate Therapeutics Inc. has priced its IPO at $24.00 per share. The shares are expected to begin trading on the NASDAQ Global Select Market on December 7, 2017 under the ticker symbol "ODT." The offering is expected to close on December 11, 2017, subject to customary closing conditions.

Gross proceeds from the offering are estimated to be approximately $150 million.

The Company's lead drug candidate is Tesetaxel, a novel chemotherapy agent that belongs to a class of drugs known as taxanes.

Tesetaxel is under a phase III study in patients with locally advanced or metastatic breast cancer, known as CONTESSA.

Shares of Vistagen Therapeutics Inc. (VTGN) were up nearly 94% on Wednesday, following receipt of a patent, issued by the U.S. Patent and Trademark Office, covering certain methods of production for AV-101.

AV-101 is in phase II development, initially as a new generation oral antidepressant drug candidate for major depressive disorder, or MDD.

A small phase II monotherapy study of AV-101 in MDD, being fully funded by the NIMH, is underway.

VistaGen is preparing to launch a 180-patient phase II study of AV-101 as an adjunctive treatment for adult MDD patients with an inadequate response to standard, FDA-approved antidepressants in the first quarter of 2018. The trial is expected to complete at the end of 2018.

VTGN closed Wednesday's trading at $1.80, up 93.55%.

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