Markets have hit new intraday highs on Wednesday, continuing to climb in the wake of the White House announcements. Although the health care sector has been attacked by the U.S. government in the past, it now has one of the brightest outlooks, considering that the president is looking to expedite the U.S. Food and Drug Administration (FDA) decisions and clear an easier past to drug approval.
24/7 Wall St. has compiled a list some of the biggest biopharma stocks moving on Wednesday and given a little color on each, including a recent trading history and consensus price target.
Dynavax Technologies Corp. (NASDAQ: DVAX) reported that the FDA has accepted the company’s responses to the Complete Response Letter (CRL) issued back in November 2016 for its Biologics License Application (BLA) for heplisav-B, the company’s vaccine candidate for immunization against hepatitis B infection in adults. The FDA has established August 10, 2017 as the Prescription Drug User Fee Act (PDUFA) action date.
Shares of Dynavax were last seen trading up over 56% at $7.05, with a consensus analyst price target of $22.00 and a 52-week trading range of $3.20 to $23.62.
Skyline Medical Inc. (NASDAQ: SKLN) received an Innovative Technology contract from Vizient. The contract was based on a recommendation of Streamway by hospital experts with expertise in this category who serve on one of Vizient’s member-led councils.
Dr. Carl Schwartz, CEO of Skyline, commented:
We are delighted that STREAMWAY has been awarded the Innovative Technology contract, which will provide new avenues to reach member organizations as potential customers for STREAMWAY. We also are honored that the system has been recognized by Vizient for its innovation. The award is the culmination of more than a year’s work for Skyline, beginning with a presentation and subsequent participation in Vizient’s Summit. The award has permitted STREAMWAY to be added to Vizient’s contracts outside of its competitive bidding cycle.
Shares of Skyline were trading up 47% at $2.83, in a 52-week range of $0.08 to $6.05.
When Amicus Therapeutics Inc. (NASDAQ: FOLD) reported its 2016 full-year results before the markets opened on Wednesday, the company posted a net loss of $1.49 per share on $5.0 million in revenue. This fell short consensus estimates from Thomson Reuters that called for a net loss of $1.40 per share and $5.86 million in revenue. However, there were more redeeming factors in the report.
John F. Crowley, board chair and chief executive of Amicus, commented:
Throughout 2016 we made significant progress with the international launch of our first commercial product Galafold and continued to advance and expand our robust pipeline of first- and/or best-in-class medicines for people living with devastating rare diseases. During 2017 we are laser focused on five key strategic priorities to advance our vision to develop and deliver great medicines for patients and to create significant shareholder value: 1) advancing the international launch of Galafold for Fabry disease, 2) completing our regulatory submission for migalastat in Japan (J-NDA), 3) establishing our novel Pompe treatment paradigm ATB200/AT2221 as a highly differentiated therapy, 4) successfully completing our Phase 3 clinical study in patients with epidermolysis bullosa, and 5) maintaining our financial strength. With one commercial-stage medicine and two medicines in clinical development, as well as a biologics platform for future growth, we are building a leading global biotechnology company focused on delivering meaningful benefits for patients living with devastating rare diseases.
Cash, cash equivalents and marketable securities totaled $330.4 million at the end of the quarter, compared to $214.0 million last year.
Shares of Amicus were trading up over 12% at $7.32, with a consensus price target of $11.06 and a 52-week range of $4.41 to $9.83.
Pacira Pharmaceuticals Inc. (NASDAQ: PCRX) also released its fourth-quarter results early Wednesday. The company posted $0.09 in earnings per share (EPS) and $72.9 million in revenue for the quarter. Consensus estimates from Thomson Reuters were $0.01 in EPS and $73.07 million in revenue.
In the report, the company also noted that its Phase 4 study of Exparel in patients undergoing total knee arthoplasty has met its co-primary endpoints for postsurgical pain and opioid reduction.
Looking ahead, the company expects Exparel net product sales to be in the range of $290 million to $310 million in 2017. The consensus sales target from analysts in 2017 is $314.9 million.
Shares of Pacira traded up 17% at $51.15, with a consensus analyst target of $51.00 and a 52-week range of $29.95 to $65.64.