Auxilium Pharma (AUXL) stock still riding the wave of Xiaflex sBLA approval expectation on December 6

Date of FDA Decision (PDUFA): December 6, 2013
Company name: Auxilium Pharmaceuticals & Biospecifics Technologies
Stock ticker: AUXL and BSTC
Location: Malvern, Pennsylvania

Type of application: Supplemental BLA – novel indication
Name of drug: Xiaflex (Collagenase clostridium histolyticum)
Indication: Peyronie's Disease

Auxilium Pharmaceuticals' Xiaflex (Collagenase clostridium histolyticum or CCH) for the treatment of Peyronie's disease is due to receive an FDA verdict on Dec 6th, 2013, and judging by the company's stock behavior, the public (as well as analysts) remain hopeful about the biologic's approval. 

Xiaflex's PDUFA date recently faced a 3-month FDA delay, caused by new information Auxilium presented for review. 

On November 23 the company also released additional results from Xiaflex's Phase III IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trial, presented at the 19th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) in New Orleans. 

According to a recent press release by the company:

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.

Auxilium's share price gained a dollar on the news and continues to climb up to the scheduled PDUFA date of December 6. 

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