Why Audentes Therapeutics Inc (NASDAQ: BOLD) stock is under pressure

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Audentes Therapeutics Inc (NASDAQ: BOLD) stock plunged 18.73% on October 10th, 2018and continued its weak moment, falling over 10.9% (as of 11 Oct, 11:02 AM GMT-4; Source: Google finance). The company has announced the pricing of its underwritten public offering of 5,200,000 shares of its common stock at a price to the public of $29.00 per share.  The gross proceeds to Audentes from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by Audentes, are expected to be $150.8 million.  The offering is expected to close on October 15, 2018, subject to customary closing conditions.  In addition, Audentes has granted the underwriters a 30-day option to purchase up to an additional 780,000 shares of common stock.

Why Audentes Therapeutics Inc (NASDAQ: BOLD) stock is under pressure

Last week, Audentes reported updated data from the Phase I/II ASPIRO trial of AT132 to treat X-linked myotubular myopathy (XLMTM) showing that the gene therapy led to improvements in neuromuscular and respiratory function from baseline up to 48 weeks post-treatment. The updated data included 16- to 48-week follow-up assessments among seven patients that received a 1×1014 vector genomes per kg (vg/kg) dose of AT132 in the first cohort, and four-week follow-up from one patient that received a 3×1014 vg/kg dose in the second cohort. Data were presented at the World Muscle Society meeting in Argentina. No new serious adverse events (SAEs) were observed since May, when Audentes reported interim data from five patients in the first cohort followed up to 24 weeks, including six SAEs. Audentes reported data from its 24-week muscle biopsy analyses of the first dose cohort in August, and said an IDMC recommended proceeding to the second dose cohort. AT132 is an adeno-associated viral serotype 8 (AAV8) vector delivering the myotubularin 1 (MTM1) gene

Moreover, Data continue to show significant improvements in neuromuscular and respiratory function as assessed via CHOP INTEND and MIP in all treated patients, including the Cohort 2 sentinel patient.  All treated patients in Cohort 1 have shown significant reductions in ventilator use, and three patients have now achieved ventilator independence.

The independent Data Monitoring Committee (DMC) has reviewed the preliminary safety and efficacy data from the Cohort 2 sentinel patient and has recommended continuing with enrollment of the remaining three patients in Cohort 2, which is expected to commence in the coming weeks.  In addition, with the goal of gaining alignment with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the potential registration pathway for AT132 under its Regenerative Medicine Advanced Therapy (RMAT) and Priority Medicines (PRIME) designations, Audentes plans to hold initial discussions with both regulatory bodies beginning in the fourth quarter of 2018.


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