Biocryst Pharmaceuticals (NASDAQ: BCRX) is an American pharmaceutical company. With year-to-date share gains of 114%, the late-stage biotech company, focused on the development of oral drugs for rare and serious diseases, has been in the headlines lately.
Yesterday, following the company’s revelations about its design and endpoints of the ph 3 pivotal programs, Needham analyst Serge Belanger maintained a Hold rating on the stock.
The analyst told investors that the program will evaluate two pivotal trials, REDEEM-1 and REDEEM-2, with the company’s oral Factor D inhibitor, BCX9930, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The enrolling of patients for both pivotal trials is expected to begin in 2H21.
Furthermore, Belanger elaborated that among the two trials, REDEEM-1 is an open-label, active, comparator-controlled of BCX9930 in PNH patients, with an inadequate response to a C5 inhibitor. On the other hand, REDEEM-2 is a placebo-controlled trial of BCX9930 in PNH patients who are not currently receiving complement inhibitor therapy.
The analyst believes that BCX9930 could supersede Orladeyo (berotralstat) as a key value driver for Biocryst. Orladeyo is an oral treatment for the prevention of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years and older. It is currently the company’s lead drug candidate and is approved in the U.S., the European Union, Japan, and the U.K. (See Biocryst stock chart on TipRanks)
Nevertheless, the analyst’s neutral stance displays “continued skepticism regarding Orladeyo’s long-term commercial uptake and a BCRX valuation,” which he believes “captures significant upside of both Orladeyo and BCX9930.”
Belanger commented that the pivotal trial design and endpoints met management’s previous expectations, and if successful, BCX9930 is likely to provide an alternative treatment for PNH patients and potentially offer superior efficacy than existing treatments, including Soliris (eculizumab) and Ultomiris (ravulizumab)
On TipRanks, Biocryst is a Strong Buy based on 6 Buy and 2 Hold ratings. The average Biocryst price target of $19 implies upside potential of 20.3% from the current levels.
According to the new TipRanks’ Risk Factors tool, Biocryst stock is at risk mainly from two factors: Finance and Corporate, and Legal and Regulatory, which contribute 35% and 22%, respectively, to the total risk for the stock. Within the Finance and Corporate risk category, BCRX has 16 risks, details of which can be found on the TipRanks website.
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 analysis before making any investment.
