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Daré Bioscience Jumps 25% On FDA Approval Of Vaginosis Treatment

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Updated: 8 Dec 2021

Daré Bioscience Inc (NASDAQ: DARE) stock has jumped 25% premarket this morning following a 10% rise yesterday. This is off the back of FDA approval for Daré’s Xaciato as a treatment for bacterial vaginosis. This emphasizes how crucial the Food and Drug Administration is to the valuations of development pharmaceutical companies.

Daré Bioscience is just such one development pharmaceutical company. The aim is to develop, prove then bring to market products surrounding women’s health – in contraception, fertility, vaginal health and so on. 

The past few years for Daré have not been that exciting it’s fair to say. The stock price has grumbled along without all that much movement – something which has rather limited trading options. This news might well change that corporate background.

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Bacterial vaginosis is one of those things. But before men dispose of it as being of no interest, it’s estimated to affect 21 million women in America each year. That’s a pretty big addressable market. It’s also not an STD or even, really, transmissible. It’s an imbalance in the body’s own regulation of the vaginal flora. It can be particularly dangerous to pregnant women.

Topical treatments, of the kind Daré has just had approved by the FDA, are what would be desired for of course pregnant women taking drugs is something undesirable.

So, FDA approval, perhaps being able to come to market in 2022, a large addressable market, thus the stock price jump for Daré.

That isn’t, though the end of the matter. It’s not just the drug itself that matters, nor even the complaint that is to be treated. The interesting proof here is that a hydrogel solution delivers the necessary drug to that vaginal target effectively. It is this which might well be the longer-term determinant of Daré’s stock price.

The same idea – and in some cases the same delivery method – is being investigated for tamoxifen delivery, for sildenafil and so on. How those actually work out is something we’ll all find out in due time. But the point is that having shown – to FDA standards – the base idea works for drug delivery through a hydrogel delivered vaginally then that’s a part of those further developments already done.

Like every clinical development pharmaceutical company in the end Daré’s valuation will be determined by what it develops that actually gets licensed and what of that then sells. The FDA is a vital chokepoint in this process. 

In the short term and now the valuation is going to be driven by the reaction to this news of FDA approval of Xaciato, the bacterial vaginosis treatment. 

The medium term is where it will all become more interesting. For there it will be consideration of how the success of this first impacts upon prospects for approval of those further ones. At which point we can expect volatility in that Daré stock price. As opinions change about prospects then so too will the perceived value of the company. Being on the right side of such price changes is a trading opportunity.

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