I believe that $AKBA is more likely than not to receive another CRL for Vadadustat, and that vol is severely mispriced, with the stock having immense downside risk. The PDUFA date is March 27th.
AKBA's prior CRL highlighted two safety issues in dialysis patients leading to poor benefit/risk, stating that the company could explore ways to demonstrate a more favorable risk/benefit through new clinical trials. 
The company however, did not pursue new clinical trials, instead simply opting to update the safety database with Japanese post-marketing data, as well as the alternate dosing regimen study, which per the company is not eligible for the initial label.
The FDA guidance on DILI requests up to date safety data so this is standard, but they simply are not meeting the requests of the original CRL. Seems more like the FDA is accepting this based on material info than ideological shift. fda.gov/media/116737/d…
The crux of the argument is that the increased safety risks are incremental, which was true during the first review. The OND appeal, which was also rejected, would have been a GREAT venue to overturn if that was the prevailing view. Cardiorenal is notoriously tough as is.
Contrast this with say an ARDX, where maybe it was just cardiorenal being picky, that was a fairly standard dispute resolution and reversal. I don't understand why re-litigating the same points post-appeal, with incremental new information is going to reverse prior opinion here.
The other problem with the risk/benefit assessment is that the drug doesn't work well. It's non-inferior to ESA's, but only because the allowed margin is huge. It's also stat sig INFERIOR to ESA's, which highlights there's no reason to embrace incrementally higher safety risk.
Additionally, the FDA has continued to express no interest in holding an adcom for this drug during either review cycle, despite holding them for both roxadustat and daprodustat. This is also peculiar given the pretext for approval would make more sense if expert input supporting
I think the stock should be down >75% on another CRL. Auryxia goes generic in 2025, and product margins are poor anyways. All cash on hand will be used to pay down the debt starting later this year if vadadustat rejected. No coincidence they rolled out new programs at JPM imo
Even if approved, commercial prospects appear rather bleak. Dapro was not stat sig inferior to ESA's, Otsuka terminated their collaboration after the first CRL. They were only able to resell the EU rights to the majority of the drug last year for $10m upfront.
The way the stock has moved to me suggests that it's more in line with a macro bounce than a plausible fundamental shift. Contrast the general reaction in response to regulatory developments versus say an $APLT for example 🤷♂️
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