Provention Bio, Inc. (PRVB) stock prices were down by a marginal 1.19% as of the market closing on July 1st, 2021, bringing the price per share down to USD$8.33 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 3%, bringing it up to USD$8.58.
EMDAC Approval
May 27th, 2021 saw the company announce that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S Food and Drug Administration voted in favor of teplizumab. With 10 affirmations and 7 negations, the question asked was whether the data presented showed the treatment to have benefits that outweighed the risks in support of approval to delay clinical type 1 diabetes mellitus.
TN-10 Study
Safety and efficacy data from the pivotal TN-10 Study guided the EMDAC decision, which showed a single 14-day course of the treatment to have deferred insulin-dependent, clinical-stage disease. Stage 2 type 1 diabetes was delayed by a median of at least 2 years in presymptomatic patients as compared to the placebo. With early stage TID patients constituting a significant unmet need, the Committee Members evaluated the pros and cons of the clinical data.
FDA Designations
Teplizumab was granted Breakthrough Therapy designation by the FDA and a priority review designation for the Biologics License Application. The Prescription Drug User Fee Act (PDUFA) has been scheduled for July 2nd, 2021. Having been previously disclosed, the treatment’s Pharmacokinetic comparability was not a topic of discussion for the Advisory Committee meeting. PRVB maintains that the FDA’s insistence on PK comparability considerations is likely to delay potential BLA approval timelines.
Scope of Teplizumab
With over 1.6 million Americans being affected by TID, the autoimmune disease that results from beta cell destruction has a significant scope. TID is typically diagnosed in childhood or young adulthood, but TID onset can occur at any age after symptoms appear in the absence of sufficient insulin production. TID typically reduces life expectancy by more than a decade, with the average reduction being 16 years in people diagnosed before the age of 10.
Future Outlook for PRVB
With the PDUFA taking place later today, the company is hopeful for a positive outcome and additional opportunities to continue its trajectory of success. Investors are hopeful that PRVB will be able to see its trial candidates through to commercialization and proliferation of the large unaddressed TID market.
