Gilead stock trending up on anticipated sofosbuvir approval on Sunday, Auxilium surges intraday prior to Xiaflex Peyronie's verdict

The FDA is due to deliver two drug approval verdicts today and over the weekend on Gilead's Sovali (sofosbuvir) for the treatment of Hepatitis C and Auxilium's Xiaflex (collagenase Clostridium histolyticum) for the treatment of Peyronie's disease.

Following a unanimously positive FDA AdCom review, Sovaldi is likely set to reach the market by Sunday. The public seems to agree, with a 93% confidence vote on our LinkedIn FDA approvals group.

Gilead's stock is steadily trending on the positive expectations today: 

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Auxilium, despite a generally positive stock performance, continues to evoke mixed feelings from analysts and followers. Questions remain about whether the limited benefits of Xiaflex compensate for the relatively serious side effects. Despite this, Peyronie's disease sufferers are seemingly psyched for the drug to reach the market, according to the Peyronie's grapevine. 

Despite the side effects, Xiaflex would automatically provide benefits for the sufferers as it would be the first and only non-surgical treatment for Peyronie's disease. Without an AdCom, the general gist is that FDA can go either way on this Xiaflex sBLA. General expectations for AUXL's stock price are slightly on the negative side, trending in the $15-20$'s, judging by a few votes on this poll.

Here is what AUXL looks like right now: 

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According to a recent press release by Auxilium: 

Highlights of the data presented related to the use of XIAFLEX in PD include:

• An open-label baseline analysis from IMPRESS 3 showed a mean penile curvature deformity (PCD) of 53.0 degrees and a mean PD symptom bother score of 7.3. In this study, both co-primary endpoints of change in PCD and PD symptom bother were met with statistical significance compared to baseline. The mean percent change in PCD was 34.4 percent and the mean change in PD symptom bother score was 3.3 from baseline. 

• An additional poster examined different subgroups of men treated with XIAFLEX based on their prior PD treatment, erectile dysfunction scores and prostatectomy history. The clinical outcomes related to PCD and PD bother did not vary among these subgroups. 

• A third presentation of the Phase 3 data compared adverse events related to XIAFLEX injections among men with a curvature greater than or equal to 30 degrees versus lesser than 30 degrees, and concluded that there was no clinically meaningful difference.

Yesterday Moody's Investors Service downgraded AUXL from "stable" to "negative" outlook,  mostly related to Auxilium's marketed drug Testim. We are still hoping for positive news today!