Provention Bio Inc. (PRVB) stock had recently traded at $6.03 at the time of writing which is a -38.06% downward movement in the after-market trading session. PRVB stock dropped -2.36% which closed Thursday’s session at $9.73. The stock volume was 1.56 million shares which was higher than the average daily volume of 0.93 million shares within the past 50 days. In the past 12 months, the PRVB shares have moved up by 16.03%, however, in the past six months and past 3 months, it lost -31.97% and -44.02%. In the past week, the shares went down by -7.24%. Furthermore, PRVB has a current market of $568.73 million and its outstanding shares total 56.63 million.
The recent pattern of downward movement in after-hours trading has come adjacent with the announcement made by PRVB stock stating the FDA has found deficiencies for Teplizumab’s application approval.
Insight on Provention Bio’s background
Provention Bio Inc. (PRVB) is a biopharmaceutical company that specifically focuses on the development of investigational therapies. The focus on investigative therapies is to tackle in an innovative and effective way to treat the diseases which can be debilitating and can also cause life-threatening immune-mediated diseases.
PRVB stock’s Pipeline Projects
Provention Bio Inc (PRVB) has many projects in its pipeline which include additional clinical-stage product candidates specifically for celiac and lupus treatment as well as other autoimmune diseases. These are candidates that have shown the proof of concept and proof of mechanism for the pre-clinical or clinical studies.
Announcement of FDA’s update on Biologic License Application of Teplizumab
Provention Bio Inc (PRVB) announced on 8th April 2021 that it received a notification from the Food and Drug Administration that mentioned finding deficiencies on the subject of post-marketing requirements for the review of the ongoing Biologic License Application process of teplizumab.
Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb). It is used to delay or prevent the onset of type 1 diabetes (T1D) in at-risk individuals. Multiple clinical studies with up to 1000 subjects have proven the efficacy of the drug for T1D by preserving beta-cell function – which is responsible for the body’s insulin production. Subsequently, the clinical trials also showed teplizumab to make the patients less reliant on external insulin. The FDA had accorded teplizumab with Breakthrough Therapy Designation to expedite the review of the drug.
Outlook of PRVB stock
However, despite the downturn of the stock, market sentiment may change drastically given Provention Bio Inc.’s optimism regarding the application of teplizumab. The CEO Ashleigh Palmer remained headstrong and confident about the review and is adamant on fulfilling the further data requirements of FDA. A conference call has been scheduled by the firm to discuss the recent developments and an audio webcast will also be available on the Company’s website afterwards. Moreover, the FDA has also stated that notification does not communicate the final decision – indicating towards a possible positive outcome. The Food and Drug Administration authority has also shown willingness to discuss the additional data requirements along with the ongoing review. The fulfilment of the additional requirements will be the deciding factor in FDA’s final decision regarding teplizumab’s BLA.