FDA Approves First-ever Merkel Cell Carcinoma Drug, HTGM Riding High, FLXN Soars

(RTTNews) - The European Commission has approved Amgen's (AMGN) AMGEVITA as a biosimilar to Humira for the treatment of certain inflammatory diseases.

Humira is AbbVie's (ABBV) flagship drug. It raked in global sales of $16.1 billion last year.

AMGEVITA is Amgen's first biosimilar to be approved by the European Commission. AMGEVITA was approved in the United States by the FDA last September. In the U.S., the brand name is AMJEVITA.

AMGN closed Thursday's trading at $166.04, down 0.84%.

Aeglea BioTherapeutics Inc.'s (AGLE) phase I clinical trial of AEB1102 in two adult patients with Arginase I deficiency has demonstrated that AEB1102 was well tolerated and effective at reducing arginine levels in the blood of both patients.

Treatment with AEB1102 resulted in a dose-proportional decrease in plasma arginine levels of between 25 and 49 percent of pre-dose levels one week after dosing, noted the company.

AGLE closed Thursday's trading at $7.32, down 5.06%.

Shares of Flexion Therapeutics Inc. (FLXN) rose as much as 43% on Thursday, following rumors of a buyout offer of $1 billion from French drug giant Sanofi (SNY).

FLXN was trading around $17 when we alerted our premium subscribers to the stock on September 21, 2016.

The stock touched a high of $28.20 on Thursday, before closing the day's trading at $26.25, up 33.38%.

Is there any substance to the takeover rumors? One will have to wait and see.

Shares of HTG Molecular Diagnostics Inc. (HTGM) soared over 50% in extended trading on Thursday, following completion of its initial technical feasibility testing with QIAGEN GeneReader NGS System.

HTG Molecular and QIAGEN Manchester Limited, a wholly owned subsidiary of QIAGEN N.V. (QGEN), had teamed up last November to combine their technological and commercial strengths with the goal to offer pharmaceutical companies a complete NGS-based solution for the development and commercialization of companion diagnostics, with a focus in oncology. It should be noted that QIAGEN North American Holdings, Inc., another QIAGEN subsidiary, has a minority investment in HTG's common stock.

Separately, the company announced its fourth quarter and full year 2016 financial results.

Net loss attributable to stockholders in Q4, 2016 narrowed to $5.67 million or $0.76 per share from $5.69 million or $0.83 per share in the year-ago quarter. Revenue for the recent fourth quarter improved to $1.5 million from $1.2 million in Q4 2015.

Analysts polled by Thomson Reuters expected the company to incur a loss of $0.76 per share on revenue of $1.81 million.

HTGM closed Thursday's trading at $3.93, up 83.64%. In after-hours, the stock soared another 53.69% to $6.04.

The FDA has approved Merck KGaA and Pfizer Inc.'s (PFE) BAVENCIO Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, a rare and aggressive skin cancer. This indication is approved under accelerated approval.

Continued approval for the indication of metastatic Merkel cell carcinoma may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO, known chemically as avelumab, is the first FDA-approved therapy for patients with metastatic Merkel cell carcinoma.

According to the National Cancer Institute, approximately 1,600 people in the United States are diagnosed with Merkel cell carcinoma every year.

Avelumab is under review in the European Union.

PFE closed Thursday's trading at $34.29, down 0.52.