Today will be a make or break day for BioCryst Pharmaceuticals’ (BCRX) lead drug candidate. Orladeyo, (berotralstat), the biotech’s oral treatment for the prevention of hereditary angioedema (HAE) attacks will face an FDA approval decision.
A rare disease defined by unpredictable and possibly life-threatening periodic swelling attacks, hereditary angioedema affects approximately one in 50,000 people. The most common attacks are on the arms and legs, but the condition can also cause irritation to the intestinal tract while the lungs’ airways can also be affected.
The FDA has granted approval for 7 other products tackling HAE attacks, but they are all delivered either subcutaneously or intravenously. Should Orladeyo cut the mustard, it will be the first oral treatment for HAE to make it to market.
The drug could also gain approval in Japan this month and in Europe in 2Q21.
Evercore ISI analyst Liisa Bayko anticipates approval for Orladeyo, swiftly followed by the drug’s launch.
While Bayko points out the bears’ argument rests on the fact Orladeyo’s efficacy is not as good as market leader Takhzyro’s, standing in its stead is the bulls’ counter argument: patients would rather take an oral solution if given the choice. According to Bayko this is a stance reiterated by physicians surveyed by the investment firm, who are “excited” about Orladeyo’s oral administration.
Bayko says there is “significant big pharma interest in the therapeutic areas BCRX is pursuing,” and tells investors to make use of the opportunity while BioCryst stock remains undervalued.
“With investors largely in a wait see mode, we see an opportunity for significant upward momentum in valuation as BCRX grows investor confidence with approval and executes a strong launch,” the analyst opined. “The current $700M valuation does not reflect much value for the $500M+ opportunity for Orladeyo… We think this could attract new investors to BCRX, those who like growth stories without binary risk.”
As a result, Bayko rates BCRX an Outperform (i.e. Buy) rating along with a $12 price target. The implication for investors? Potential upside of a strong 140%. (To watch Bayko’s track record, click here)
Overall, Bayko’s colleagues are on the same page. Based on 5 Buys and 2 Holds, the stock has a Moderate Buy consensus rating. The average price target stands at $8.75 and implies shares could add 75% over the next 12 months. (See BioCryst stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.