Theriva Biologics (NYSEMKT:TOVX) stock is rocketing on Wednesday after getting an orphan drug designation from the U.S. Food and Drug Administration (FDA).
That FDA designation covers Theriva Biologics’ VCN-01, which is a potential treatment for pancreatic cancer. It’s currently undergoing a Phase 2b clinical trial alongside chemotherapy as a “first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC).”
With this designation, Theriva will benefit from several advantages as it develops VCN-01. Among these are possible market exclusivity for seven years, tax credits for clinical trials, a waiver of application fees, lower annual product fees, clinical protocol assistance and the potential to join expedited development programs.
Steven Shallcross, CEO of Theriva Biologics, said the following about the FDA news:
“The FDA’s decision to grant orphan drug designation to VCN-01 highlights the urgent need for new treatment options for patients with PDAC, which has one of the lowest survival rates among all cancers […] Efforts to improve upon the standard of care treatment have largely stalled, despite the growing incidence of PDAC, and the need for novel therapies in this indication is acute.”
Investors in TOVX stock will also keep in mind that this isn’t the first time the FDA has granted an orphan drug designation to VCN-01. It previously did so for the treatment of retinoblastoma.
TOVX Stock Movement Today
Following news of the new FDA designation, shares of TOVX stock are seeing heavy trading. That has some 5 million shares changing hands as of this writing. This is a massive increase compared to its daily average trading volume of about 129,000 shares.
TOVX stock is up 59.5% as of Wednesday morning.
Investors seeking out more of the most recent stock market news will want to stick around!
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On the date of publication, William White did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
