The FDA’s equivalent of a red card – a CRL (complete response letter) – got handed out on June 19 to Nabriva Therapeutics (NBRV). Accordingly, the biotech’s share price has dropped nearly 15% since then.
Nabriva might feel the market’s adverse reaction is a bit unfair. The company received the dreaded CRL for its complicated urinary tract infection (cUTI) treatment, CONTEPO, as a result of the FDA’s inability to inspect two of its manufacturing facilities due to coronavirus-induced travel restrictions.
Nabriva already received a CRL for CONTEPO back in April of last year due to flaws at one of the company’s European CMOs (contract manufacturing organization).
Before resubmitting CONTEPO’s NDA, Nabriva will request a meeting with the FDA to determine the next steps for the treatment’s road to approval and the agency’s plans for concluding the sites’ checkup.
Although H.C. Wainwright’s Ed Acre notes the latest CRL represents an “unfortunate delay to CONTEPO’s approval,” the 5-star analyst highlights some important points:
“(1) this delay does not shorten CONTEPO’s minimum 8- year exclusivity (QIDP plus data exclusivity) which only begins upon its approval; (2) U.S. market launch would not be feasible now given the restrictions of the ongoing COVID-19 pandemic; (3) a $25 million milestone payable to former Zavante stockholders (in cash or equity) upon the first FDA approval of CONTEPO is now delayed; and (4) CONTEPO’s safety is not in question given the FDA did not request that Nabriva stop a pediatric study of CONTEPO that has since been suspended due to COVID-19 restrictions,” Arce said.
However, given the lack of a “commercial field force,” and the worrying fact Nabriva doesn’t have enough cash to even last another 12 months, Arce maintains a Hold rating. Additionally, a lack of clarity regarding business operations, “in the near-term and for the foreseeable future,” is cited as the reason for withholding a price target. (To watch Arce’s track record, click here)
Over the past three months, two other analysts have published a review of Nabriva, one saying Buy while the other recommends a Hold. Therefore, the stock has a Moderate Buy consensus rating. The average price target of $1.50, could provide investors with upside of a plentiful 105%. (See Nabriva stock analysis on TipRanks)
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