RE: Fanregratinib NDA2 Jan 2026 09:57
The two NDA acceptances are indicative of the great gains that have been achieved in oncology over the last 20 years…..to have a commercial success you now need to have significantly better efficacy than the current standard of care and this is leading to either biomarker specific targets (much smaller in number) or combination therapies (more expensive as more than one drug is needed). The margins available are squeezed by ever tighter government procurement processes (NICE, NRDL etc). There is still potential for new treatment mechanisms, which is why the ATTC is critical to HCMs future.
There are a number of paths the company can take:
At the optimistic end, ATTC represents a breakthrough and the company thrives.
AZ pushes Savolitinib hard as Tagrisso as a monotherapy loses exclusivity…and the company gets sustainable strong global revenues
The company continues with its own portfolio, breaks even within China and makes regular but limited profits. They should participate in China consolidation with similar companies to boost shareholder returns.
At the negative end, the company muddles along slowly burning through its cash pile and becoming an also ran than no-one wants to take over.
In 2016 HCM was probably a bright light with considerable potential, now it is one of many with some potential but less than others. The market is yet to be convinced about ATTC and AZs commitment is unproven, so I think market perception will probably depend on how HCM approaches consolidation within China….and that needs a new CEO and backing from the Board and key shareholders.