17.01.2019 07:00:29

FDA Panel Nod For Osteoporosis Drug, PTIE Gets Research Funding, ALDR On Watch

(RTTNews) - Today's Daily Dose brings you news about Alder Biopharma's after-hours stock movement; Mirati's stock offering; FDA panel recommendation of Amgen/UCB's osteoporosis drug Evenity; and Pain Therapeutics' grant award.

Read on…

Shares of Alder Biopharmaceuticals Inc. (ALDR) were up more than 21% in after-hours on Wednesday on no specific news.

The Company's lead investigational product is Eptinezumab, a monoclonal antibody for migraine prevention. The Biologics License Application for Eptinezumab is expected to be submitted this quarter. (Q1, 2019).

ALDR closed Wednesday's trading at $11.65, up 1.48%. In after-hours, the stock was up 21.89% to $14.20.

An FDA panel has recommended approval of Amgen (AMGN) and UCB's EVENITY, proposed for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

Eighteen of 19 members voted yes for approval, and they emphasized the need for post-marketing follow-up.

EVENITY was granted marketing authorization - its first approval anywhere in the world - by the Japanese Ministry of Health, Labor and Welfare on January 8, 2019. The drug is under review by the European Medicines Agency.

AMGN closed Wednesday's trading at $198.89, down 0.25%.

Mirati Therapeutics Inc. (MRTX) has offered to sell 1.61 million shares of its common stock to the public at a price of $62.00 per share.

The Company has also granted the underwriters a 30-day option to purchase up to an additional 241,935 shares of common stock in connection with the public offering.

The aggregate gross proceeds from this offering are expected to be approximately $100.0 million. The offering is expected to close on or about January 22, 2019, subject to customary closing conditions.

Recent event:

On January 7, 2019, the Company announced a clinical collaboration with Bristol-Myers Squibb for the planned phase III trial in non-small cell lung cancer to evaluate Sitravatinib in combination with Opdivo.

Under the terms of the collaboration, Mirati will sponsor and fund the clinical trial and Bristol-Myers Squibb will provide Opdivo at no cost. The phase III pivotal trial is expected to start in the first half of 2019.

MRTX closed Wednesday's trading at $62.47, down 3.60%.

MediPharm Labs Corp. (MLCPF.OB) has signed three cannabis oil sales agreements, subsequent to the receipt of its sales license from Health Canada on November 9, 2018.

The first large shipments of cannabis oil supply, aggregately valued at over $10 million, left the Company's dock last month.

MLCPF.OB closed Wednesday's trading at $1.51, up 1.48%.

Pain Therapeutics Inc. (PTIE) has been awarded $1.5 million in research funding by the National Institutes of Health.

The grant award is intended to support, over the next eighteen months, the Company's on-going development of new technology to detect Alzheimer's disease with a simple blood test.

PTIE closed Wednesday's trading at $1.12, up 2.75%.

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