After gaining a nod from an advisory committee (AdCom) recommendation, Dynavax Technologies Corporation (NASDAQ:DVAX) has Cantor analyst Elemer Piros willing to bet on this biotech player for the win in his initiation coverage.
Anticipating the drug maker stands “poised for an approval” for its novel HBV vaccine candidate HEPLISAV-B, designed to prevent HBV in adult patients, the analyst assigns a 95% probability of success for the lead asset, initiating an Overweight rating on DVAX stock with a $24 price target, which implies a just under 19% upside from current levels. (To watch Piros’ track record, click here)
With Dynavax’s HEPLISAV-B set for a review by the FDA with November 9th as the amended PDUFA date, the analyst believes the firm’s drug offers unique advantages “by providing adequate protection with a regimen with fewer injections within a shorter period of time,” elaborating: “Moreover, the vaccine’s increased rate of efficacy in hard-to-treat unvaccinated sub-populations offers a significant untapped commercial opportunity.”
Meanwhile, considering the FDA’s AdCom put forth a positive recommendation back in July when chatting about HEPLISAV-B’s safety profile, the analyst sees good chances for approval- especially considering that the drug maker is joining forces with the agency to create key elements of a surveillance plan following marketing.
This is a drug that delivers “better protection with fewer injections,” opines Piros, who notes that in a matter of just a month, the two injections required are finished- a massive improvement considering the current standard of care sees a series of three injections that take well past six months to complete. “We expect the successful launch for HEPLISAV-B, which we believe could revitalize a market that has significant opportunity for expansion into sub-populations with high unmet need and capture a significant portion of the market.”
Lastly, the analyst contends Dynavax could boast a $350 million technology valuation for its immune-oncology pipeline, and the revenue from this meaningful HBV opportunity could bolster further development of the drug maker’s pipeline, which includes assets SD-101 and DV281. “Given the potential cash flow generation from the HBV franchise, we believe the immuno-oncology programs could rapidly expand and shift towards late stage development,” underscores Piros.
Wall Street seems to agree with Piros’ newfound confidence in this biotech stock, with TipRanks analytics demonstrating DVAX as a Strong Buy. Based on 5 analysts polled by TipRanks in the last 3 months, all 5 rate a Buy on Dynavax stock. The 12-month average price target stands at $27.50, marking a nearly 32% upside from where the stock is currently trading.