RMB. a post on the biotech values board that may answer some of your questions
more DD later
BioBS2012
Re: Whalatane post# 250148
Friday, December 22, 2023 6:21:59 AM
Post# of 250202
Kiwi - I have looked at $UNCY and also keep an eye on it since their last setback which caused it to drop below $1. From my quick take, they are pursuing a 505(2) path to regulatory approval us PK data - with their sales pitch being a reduced pill burden given their technology.
This is really the only claim they can make, as under the regulatory pathway they have chosen, their label will be essentially identical to that of the reference product (Fosrenol). From a pill burden advantage, my take is that they fall in-between the current binders and Tenapanor (XPHOZAH). Some other points to keep in mind
* their current study will finish in 2Q 2024 and NDA filing to follow so lets say 3Q 2024, plus 10 months for approval assuming no CRL - so approval in late 1Q 2025 at the earliest or in 2Q 2025 if it is all smooth sailing.
* based on their cash position at the end of 3Q 2023 they will need to raise capital soon - either following data release or before, but I doubt that the raise would be at prices greater than a $1 so stock is going to hover around here for a while - buy opportunities on the dips if you strongly believe in the company or love to trade.
* management - a few Spectrum alumini in senior roles, so not very comforting. Their commercial guy is up there - only he won't have much to do for at least another year so the Q is - will he hang around?
* from a commercial success, I see the following hurdles (I do not know the answers to these Q's) - how do they prices it vis-a-vis Fosrenol, and other generic binders, once they do get approval? Will insurance cover, based on no clinical advantage over Fosrenol, beyond just a reduced pill burden - where XPHOZAH still beats it?
* the biggest UNKNOWN risk in my view is the following - under the 505(b)2 regulatory route, $UNCV will have to certify that they do not infringe any Fosrenol patents in the Orange Book when they submit their NDA. Takeda will then have the option not do anything (best case scenario for $UNCV), or they may choose to sue for infringement (even they don't think they will win). If Takeda sues, the FDA immediately puts things in the deep freeze for 30 months or until a patent dispute resolution is reached (whichever is earlier).
I think the above covers most of the issues one can use to make their own investments decisions.
Cheers and best wishes for the Holidays to all.
May everyone's investments prosper in 2024 !!
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Kiwi
