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FDA Snubs Allergan, GNMX Gets Attention, Another Month, Another Suitor For CBPO


Today's Daily Dose brings you news about the upcoming clinical trial catalyst of Aevi Genomic; the Complete Response Letter issued for Allergan's Ulipristal acetate; China Biologic's new suitor, and Rexahn Pharma's deal with Merck.

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Aevi Genomic Medicine Inc. (GNMX) has raised a capital of $4.9 million to accelerate Part B of its ASCEND trial.

ASCEND is a phase II study evaluating AEVI-001 as a potential treatment for a sub-population of Attention Deficit Hyperactivity Disorder (ADHD) patients with genetic mutations that disrupt the mGluR network. The trial consists of 2 parts - A and B.

Part A includes subjects determined to have one of eight specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity. Part B will assess subjects who do not have copy number variants in any of the specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity.

The Company currently anticipates top-line data for Parts A and B of the ASCEND trial during the fourth quarter of 2018.

GNMX closed Tuesday's trading at $1.25, up 12.61%.

The FDA has turned down Allergan plc's (AGN) New Drug Application for Ulipristal acetate for the treatment of abnormal uterine bleeding in women with uterine fibroids.

But the drug is approved in Europe and Canada. In Europe, Ulipristal acetate is marketed under the trade name Esmya by Gedeon Richter. In Canada, the drug is available under the trade name Fibristal, and marketed by Allergan.

Esmya and Fibristal are currently approved for the pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

AGN closed Tuesday's trading at $191.11, up 0.19%.

China Biologic Products Holdings Inc. (CBPO), which has been in crosshairs of takeover since June of this year, has received another acquisition proposal from a Consortium - this time, at an offer price of US$118 per share in cash.

The Consortium consisting of Feng Tai Global Limited, a company beneficially owned by David (Xiaoying) Gao, the former Chairman and CEO of the Company, GL Sandrose Investment L.P., World Investments Limited and CDH Utopia Limited has made the offer to acquire all of the outstanding shares of the Company not already owned by the Consortium.

In June of this year, CITIC Capital Holdings Limited, an alternative investment management and advisory company, had offered to acquire all outstanding shares of China Biologic Products not already owned for US$110 in cash per Ordinary Share.

CBPO closed Tuesday's trading at $101.72, up 1.72%.

Myriad Genetics Inc. (MYGN) has reported improved net income and higher revenue for its fiscal fourth-quarter, and issued its fiscal year and first-quarter 2019 financial guidance.

For the recent fiscal fourth quarter, net income was $13.1 million, with adjusted EPS of $0.38 on total revenue of $200.9 million. This compared with a net income of $12.3 million, with an adjusted EPS of 0.39 on total revenue of $199.6 million in the year-ago same quarter.

Looking ahead to the fiscal first quarter 2019, adjusted EPS is forecast at $0.28-$0.30 range, and total revenue is expected to be in the range of $200-$202 million.

For fiscal year 2019, adjusted EPS is forecast at $1.70-$1.75 range and total revenue in the range of $880-$890 million. In fiscal 2018, the adjusted EPS was $1.20, and total revenue was $772.6 million.

MYGN closed Tuesday's trading at $42.84, up 2.19%.

Onconova Therapeutics Inc.'s (ONTX) commercial partner, Pint Pharma GmbH, will assist in expanding its phase III INSPIRE trial to Argentina, Chile, and Brazil in preparation for future studies of oral Rigosertib.

INSPIRE is a phase III multi-center, randomized controlled study evaluating intravenous form of Rigosertib patients with higher-risk Myelodysplastic Syndromes (MDS) after failure of hypomethylating agent, or HMA, therapy.

ONTX closed Tuesday's trading at $0.43, up 6.10%.

Rexahn Pharmaceuticals Inc. (RNN) has entered into a clinical trial collaboration agreement with Merck (MRK) to evaluate the combination of Rexahn's RX-5902 and KEYTRUDA in a phase II trial in patients with metastatic triple negative breast cancer.

Under the terms of the agreement, Rexahn will sponsor the RX-5902 and KEYTRUDA study.

RNN closed Tuesday's trading at $1.71, up 7.55%.

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