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BIOL On Watch, CELG Faces FDA In Sep., Scott Gottlieb Resigns

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Today's Daily Dose brings you news about Invitae's secondary offering; BIOLASE's fourth-quarter financial results; Celgene's regulatory catalyst in September; and Endologix's reverse stock split, and the resignation of Scott Gottlieb as FDA Commissioner.

Read on...

BIOLASE Inc. (BIOL), the global leader in dental lasers, has reported a 3% growth in revenues for the fourth quarter ended December 31, 2018.

Net revenue for the fourth quarter of 2018 was $13.0 million, an increase of 3%, compared to net revenue of $12.6 million in the year-ago same quarter. Excluding the non-core imaging business, revenue for the fourth quarter of 2018 increased 9% to $12.7 million from $11.6 million for the fourth quarter of 2017.

Net loss for the fourth quarter of 2018 widened to $6.9 million or $0.33 per share, from $3.8 million, or $0.23 per share for the fourth quarter of 2017.

BIOL closed Tuesday's trading at $2.51, up 1.62%. In after-hours, the stock was up 3.98% to $2.61.

Celgene Corp.'s (CELG) New Drug Application for Fedratinib, proposed for the treatment of patients with myelofibrosis, a serious bone marrow disorder that disrupts the body's normal production of blood cells, has been accepted for Priority Review by the FDA.

The FDA decision on Fedratinib is expected on September 3, 2019.

CELG closed Tuesday's trading at $86.25, up 0.59%.

Endologix Inc. (ELGX) has implemented a 1-for-10 reverse stock split, and the shares will begin trading on a reverse stock split-adjusted beginning with the opening of trading on March 6, 2019.

As a result of the reverse split, there will be approximately 10.3 million shares of common stock issued and outstanding, noted the Company.

ELGX closed Tuesday's trading at $0.66, up 8.62%.

Alessandro Riva, Executive Vice President, Oncology Therapeutics at Gilead Sciences Inc. (GILD) is quitting the company by the end of the month. The company has commenced a search for his successor.

Dr. Riva joined Gilead in January 2017 as Senior Vice President, Hematology and Oncology Therapeutics Area Head.

During his tenure, he has been instrumental in expanding the company's oncology programs, playing a critical role in the acquisition of Kite Pharma and guiding the strategy and development of Gilead's broader oncology pipeline, the Company noted.

GILD closed Tuesday's trading at $64.39, down 1.62%.

Invitae Corp. (NVTA) has offered to sell 9 million shares of its common stock to the public at a price of $19.00 each.

The gross proceeds to Invitae from the offering are expected to be $171.0 million.

The offering is expected to close on or about March 8, 2019, subject to customary closing conditions.

The underwriters have a 30-day option to purchase up to an additional 1.35 million shares of the Company's common stock.

Invitae is a revenue-generating genetics company.

Last month, the Company reported better-than-expected financial results for the fourth quarter and full year ended December 31, 2018.

Net loss for the fourth quarter of 2018 narrowed to $29.84 million or $0.40 per share on total revenue of $45.35 million. Analysts polled by Thomson Reuters were expecting a loss of $0.45 per share and total revenue of $40.78 million. Net loss was $40.49 million or $0.78 per share and total revenue was $25.39 million in the fourth quarter of 2017.

NVTA closed Tuesday's trading at $20.03, down 1.72%.

The FDA Commissioner Scott Gottlieb is resigning from the post, effective April 5, 2019. He was sworn in as the Commissioner of Food and Drugs on May 11, 2017.

Lauding the tenure of Scott Gottlieb as FDA Commissioner, HHS Secretary Alex Azar issued the following statement…

"All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA. He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family.

Scott's leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more. The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years".

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