Health and Healthcare

How Sarepta Is Cashing In on Its FDA Homerun

Chris Lange

Published: September 22, 2016 9:35 am

Last Updated: January 13, 2020 3:17 am

Sarepta Therapeutics Inc. (NASDAQ: SRPT) watched its stock practically double in just the past week alone following a key FDA approval. There were a few factors that played into this approval, but suffice it to say, the departure of Sarepta’s lead critic changed the game. Now, Sarepta is looking to cash in on this approval by announcing a secondary offering.

Making the move for a secondary offering after a stock has jumped massively is one way for companies to literally cash in on their recent success. Although they are diluting shareholders, it could be worse if the price was lower. In some cases having a secondary offering may send the price lower, but in this case the company is looking to fund its continued growth, so investors and analysts are bullish on where Sarepta can go from here.

As we have said before, the FDA has the potential to make or break a company, in this case a single decision is responsible for roughly a 100% jump in the stock. Also check out other key FDA decisions that are coming in the next two months.

The underwriters for the offering are JPMorgan, Goldman Sachs and Credit Suisse.

The company detailed in its most recent SEC filing:

On September 19, 2016, the FDA approved EXONDYS 51 as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of DMD in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping. This indication is based on an increase in dystrophin in skeletal muscles observed in some patients treated with EXONDYS 51. The accelerated approval of EXONDYS 51 is based on the surrogate endpoint of dystrophin increase in skeletal muscle observed in some EXONDYS 51-treated patients. A clinical benefit of EXONDYS 51 has not been established. Continued approval for this indication is contingent upon verification of a clinical benefit in confirmatory trials. Among other requirements we will discuss and finalize with the FDA, in order to verify the clinical benefit of eteplirsen, we are required to conduct a two-year randomized, double-blind, controlled trial of eteplirsen in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

Keep in mind that data from clinical studies of EXONDYS 51 in a small number of DMD patients have demonstrated a consistent safety and tolerability profile. However, the pivotal trials were not designed to evaluate long-term safety. Hence the ongoing trials now.

The company intends to use the net proceeds from this offering principally for the continuation and initiation of further clinical trials, commercialization, manufacturing, business development activities and general corporate purposes.

Shares of Sarepta were up almost 3% to $57.81 shortly after Thursday’s opening bell, with a consensus analyst price target of $68.64 and a 52-week trading range of $8.00 to $58.87.