Thursday was a breakout day for a few biotech companies. Some made absolutely massive runs, while others fell off a cliff. Although the sector is feeling the pinch from the recent market downturn, there are some standouts.
24/7 Wall St. has picked a few of those standouts from Thursday to highlight. We have included information about each company, as well as recent trading activity and the consensus analyst price target.
Zogenix Inc. (NASDAQ: ZGNX) shares jumped on Thursday after the firm announced that after reviewing a couple issues with the U.S. Food and Drug Administration (FDA), the company intends to resubmit its New Drug Application (NDA) for Fintepla (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in the third quarter of this year.
The two issues being reviewed in the Refusal to File letter issued by the FDA on April 5, 2019, were that certain nonclinical studies were not submitted to allow assessment of the chronic administration of fenfluramine, and the application contained an incorrect version of a clinical dataset.
Shares of Zogenix were last seen up about 18% at $46.46, in a 52-week range of $33.43 to $62.75. The consensus price target is $57.09.
Inovio Pharmaceuticals Inc. (NASDAQ: INO) shares dipped slightly on Thursday after the firm announced that it has completed its enrollment of 198 participants for its pivotal Phase 3 registration trial (Reveal 1) of VGX-3100, a novel DNA-based immunotherapy being tested to treat cervical dysplasia caused by human papillomavirus.
Dr. J. Joseph Kim, Inovio’s president and CEO, commented:
This establishes an important milestone for the company as it brings Inovio another step closer to providing an innovative treatment alternative to the women suffering with cervical dysplasia for whom surgery is the only option today. Both the U.S. and Europe represent large markets in need of a non-invasive treatment option for women, and we’re now focused on enrolling the confirmatory study (REVEAL 2) to generate a U.S. FDA submission in 2021.
Shares of Inovio traded down 3% at $2.93, in a 52-week range of $2.15 to $6.30. The consensus price target is $10.25.
Novavax Inc. (NASDAQ: NVAX) saw a couple developments on Thursday that helped to pump up its stock. First, the firm announced an arrangement under which Paragon Gene Therapy will assume the leases to two Novavax product development and manufacturing facilities, giving it immediate access to state-of-the-art manufacturing equipment, people and space to accelerate the growth of its gene therapy development and manufacturing business.
Separately, Novavax announced it will utilize the accelerated approval pathway for licensure for NanoFlu, its nanoparticle seasonal influenza vaccine candidate. The FDA acknowledged in a recent letter that the accelerated approval pathway is available to Novavax for its NanoFlu vaccine. Novavax expects to initiate its pivotal Phase 3 clinical trial by the fall of 2019 with topline clinical data expected in the first quarter of 2020. These immunogenicity data are expected to support a U.S. biologics license application.
Shares of Novavax were up about 16% to $6.42. The 52-week range is $4.64 to $51.60 and the consensus price target is $20.43.
Aclaris Therapeutics Inc. (NASDAQ: ACRS) shares sharply dropped sharply after the firm announced results from its midstage trial in alopecia areata. Unfortunately, the trial did not achieve statistical superiority at the primary or secondary endpoints, calling into question the future of the study.
The study was a Phase 2 clinical trial of ATI-502, and it did not reach statistical significance due to high rates of disease resolution in vehicle-treated patients. Alopecia areata is an autoimmune disease characterized by partial or complete loss of hair on the scalp, face or body. The scalp is the most commonly affected area.
Shares of Aclaris were down about 40% at $2.68, in a 52-week range of $2.56 to $21.97. The consensus price target is $19.83.
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