Biotech: The Week Ahead

We cover the major trial milestones, PDUFA dates and FDA calendar for the week ahead across the biotech sector

The biotech sector used an almost three percent gain in trading on Friday to springboard deeply in the black for the week. The trigger for the large rally yesterday was investors viewed the proposals to bring down 'high drug prices' by the Trump administration to be largely 'benign'. Continuing efforts to speed up generic and biosimilar candidates being the probably the most effective part of the somewhat vague initiatives. It certainly was a more positive regulatory environment than the industry could have expected to receive had the 2016 elections gone the other way. Investors breathed a large sigh of relief on Friday now that the lay of the land is largely known.

So what lies ahead in the upcoming week for the biotech sector? We take a look at some of the major trial milestones, PDUFA dates and the FDA calendar across the industry for next week in the paragraphs below.

"A paranoid is someone who knows a little of what's going on. ”― William S. Burroughs

The only PDUFA date on the calendar is for Erenumab to treat migraines on Thursday. This is a joint effort between drug giants Novartis (NVS) and Amgen (AMGN). We also have the 21st Annual Meeting The American Society of Gene and Cell Therapy or ASGCT event going on in Chicago from May 16th to May 19th.

Here are a few of the companies presenting which could be a catalyst for their stocks depending on the reception their data gets.

Audentes Therapeutics (BOLD) is presenting Phase I/II data for its compound AT132 for the treatment of X-Linked Myotubular Myopathy Wednesday morning. The company will also present preliminary Phase I/II data for its compound AT342 to treat Crigler-Najjar Syndrome. A solid preview of those trials was posted on SeekingAlpha this morning.

Later that same day, Voyager Therapeutics (VYGR) will be presented Phase 1b data around its drug candidate VY-AADC01 for the treatment of advanced Parkinson’s disease. Dosing for Phase 2/3 studies should begin early this summer. The stock was up over eight percent in trading on Friday, perhaps partly on anticipation of this presentation.

Finally, Rocket Pharmaceuticals (RCKT) will be presenting updated Phase I/II data via a Poster for its LVV-based gene therapy to treat Fanconi anemia on Friday.

Elsewhere, GTx, Inc (GTXI) will be presenting date around its open-label Phase II study for its compound Enobosarm to treat Stress urinary incontinence at the American Urological Association conference.

Finally, the International Investigative Dermatology meeting will take place in Orlando this week. Among the names presenting mid-stage trial data will be RXI Pharmaceuticals Corporation (RXII), Fibrocell Sciences (FCSC) and ProQR Therapeutics (PRQR).

And that is what biotech investors can look forward to as far as trial data in the week ahead.

For those looking for growth ideas outside the biotech sector, my colleagues at Investors Alley are running a huge Mother's Day weekend sale on the Growth Stock Adviser (A investment newsletter I used to run back in the day). This sale lasts only through Sunday. To check out their special holiday offers which includes the report "Data Cartel Investing: 3 Tech Stocks to Own for the Next Generation Internet*", just click [HERE]((

Thank You & Happy Hunting,

Bret Jensen

Founder, The Biotech Forum, The Busted IPO Forum & The Insiders Forum

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