Biotech Movers: Collegium Pharmaceutical, Inc. (NASDAQ:COLL) and TherapeuticsMD Inc (NASDAQ:TXMD)

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FDA

There have been a few big movers in the biotechnology space at the start this week, with a variety of inputs injecting a degree of volatility into the sector. Exactly how the week will pan out for each of the companies in question remains to be seen, but one thing is for sure – near-term sentiment is likely going to be dictated by the implications of their respective early week developments.

So, as we move into today’s session in the biotechnology sector, here is a look at which companies moved the most on Monday and what we expect each to do as the week matures going forward.

The companies in our crosshairs for the session today are Collegium Pharmaceutical, Inc. (NASDAQ:COLL) and TherapeuticsMD Inc (NASDAQ:TXMD).

Let’s kick things off with Collegium.

This one is a bit of a strange situation. The company announced on Monday that the Food and Drug Administration (FDA) will not meet its predefined prescription drug user fee act (PDUFA) date for the its Supplemental New Drug Application (sNDA) to enhance the label for Xtampza ER (oxycodone extended-release).

Collegium was trying to build on the already approved labeling to include an abuse-deterrent feature for the drug in a target indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

In its currently approved form, Xtampza is forced to compete with a sea of already available opioid assets on the market. The company is seeking an abuse-deterrent label so as to allow the drug to differentiate itself from those assets already approved (and already well-established in the space) and, ultimately, to allow it to attract a larger portion of the pain management market than is currently realistic given wider market conditions.

This sNDA, the one that the agency just turned down, was an attempt to do just that.

As per the latest news (the press release outlining the news was relatively sparse) Michael Heffernan, CEO of Collegium, said that the FDA hasn’t requested any additional scientific information or data and that the company will continue to work closely with the FDA on its sNDA.

Exactly what this means remains to be seen. There is a chance that the agency has some issue with the drug in its current format but any comment on that from our end would just be speculation, so it’s not worth getting into until we have more information.

On that note, management says it will discuss the sNDA on a conference call that was already set up as a discussion of its third-quarter earnings, which are set to hit press early tomorrow morning.

Chances are we will see this one run relatively flat heading into the conference call and that sentiment throughout the end of the week will be determined by the information management puts forward alongside its third-quarter numbers.

Moving on, TherapeuticsMD.

This one’s a little more positive for the company and shareholders.

On Monday, TherapeuticsMD announced that the FDA has indicated it will accept a resubmission of its NDA for an asset called Yuvvexy. The company has been trying to get Yuvvexy approved in a target indication of the treatment of moderate to severe pain during intercourse in postmenopausal women for some time but, earlier this year, suffered a setback when the agency in the US issued a complete response letter (CRL) and outlined the fact that it would need to see some twelve-month safety data on top of the three months’ data already in place.

TherapeuticsMD sat down with the FDA at the end of last weekend and hammered out an agreement that will see the company resubmit the sNDA near-term on the condition that it carries out a post-approval study (to reinforce the existing safety data) as opposed to having to carry out a pre-approval investigation.

This is a great development for a company at this end of the market as it means that TherapeuticsMD will be able to start generating revenues (assuming approval) before it needs to carry out the additional study, which in turn means that shareholders won’t be subject to the substantial degree of dilution that they might otherwise have been if circumstances had remained in place subsequent to the outcome of the FDA’s initial ruling.

We expect this one to continue to appreciate going forward into the resubmission (expected over the next few weeks) and, ultimately, an FDA approval of the application.

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