It was a difficult start to the week for Heron Therapeutics (HRTX). Monday saw shares plunge after the small-cap biotech received another CRL (complete response letter) for its experimental post-operative pain medication, HTX-011.
Following the verdict, Stifel analyst Derek Archila acknowledges that the current sentiment surrounding HRTX is negative, but he remains optimistic about the candidate.
“While we think investors are losing confidence/patience with HRTX on getting HTX-011 over the goal line (2 CRLs and a PDUFA extension), the issues raised by the FDA in the CRL appear to be of a minor nature, and management’s commentary on the conference call make us confident they are addressable. No issues in terms of clinical efficacy, safety or CMC were brought up in the CRL.” said Archila.
HTX-011 was rejected because of four non-clinical issues. Three were linked to “confirming excipient exposure in pre-clinical reproductive toxicology studies,” and one was related to changing the manufacturing release specs.
Management stated it plans to request a meeting with the FDA in which they will discuss how to provide the correct information regarding the excipient exposure. At worst, Heron will need to conduct reproductive toxicology studies for six months. The other lingering issue was, by and large, an administrative one which could be easily resolved.
For Archila, the main question remains how long it will take to fix these issues and re-submit the NDA. This is hard to gauge. Without the need for additional studies, Archila estimates a new NDA could be submitted within two months. Should new studies be required, on top of the six months it would take to run the study, a further six months would be required to sift through the data and conduct a Class II review.
“So, is it possible HTX-011 could get approved in 2020?” Archila asked before answering, “In our view, yes, technically it could, but we would be conservative and assume a one-year delay.”
With approval still very likely, Archila keeps a Buy rating on Heron shares. Even though he cut the price target from $29 to $21, there’s still room for shares to gain 36% over the next year. (To watch Archila’s track record, click here)
The rest of the Street’s enthusiasm for Heron hasn’t soured, either. All 9 reviews posted over the last three months rated the stock a Buy. HRTX’s Strong Buy consensus rating is backed by an average price target of $31.33, which implies possible upside of a painkilling 102%. (See Heron stock analysis on TipRanks)
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