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Watch These April Biotech Catalysts

Apr. 02, 2018 2:09 PM ETMRK, DVAX, RARE11 Comments
John Engle profile picture
John Engle


  • April is set to play host to a number of impactful biotech catalysts.
  • This article addresses two catalysts scheduled in the next two weeks.
  • Ultragenyx has a date with PDUFA destiny for Burosumab, a treatment for a rare bone disease.
  • Dynavax will be presenting important further data on SD-101, its cancer immuno-therapy used in combination with Merck's Keytruda.
  • Both companies have near-term, as well as long-term, upside potential and are worthy of investors’ further interest.

Anticipating and reacting to event-driven catalysts is a key piece of the biotech investing game. And each new month brings new catalysts for investors to watch. Today, we will discuss two interesting biotechs with catalysts this month: Ultragenyx Pharmaceutical (RARE) and Dynavax Technologies (DVAX). We will likely follow this article up in a week or two with a couple more interesting catalysts to watch in April.

Let's take a look at each of these companies, their catalysts, and the likely outcomes.

Ultragenyx: A RARE Chance to Shine?

Ultragenyx specializes in developing therapies for rare genetic diseases. Its principal product candidate is Burosumab, which has been tested, or is being tested, in a few different diseases. The lead indication is in the treatment of X-Linked Hypophosphatemia, or XLH, an exceptionally rare bone disease brought about by the excess activity of a hormone that reduces serum levels of phosphorus and vitamin D, leading to weakness, pain, and a host of skeletal and growth abnormalities. In April 2017, the company reported that positive results from its pivotal Phase 3 clinical trial. It followed up in December with additional data showing further improvement in patients, as well as improvements in patients switched at the halfway mark from placebo to study group. Armed with positive trial results for the treatment of a rare and painful disease, Ultragenyx is now awaiting the FDA's verdict on approval.

The Catalyst

The FDA PDUFA decision on Burosumab is scheduled for April 17th. Ultragenyx is preparing for the commercialization of this ultra-rare therapy, for which the current treatment is infusions of phosphorus and vitamin D. A drug that can attack the hormone causing the deficiencies in the first place would be a major advancement in the treatment of XLH. Burosumab already enjoys Breakthrough Therapy Status. The question now is whether the FDA is sufficiently convinced

This article was written by

John Engle profile picture
Investment professional specializing in deep value opportunities, growth plays, special situations (long + short) across a range of asset classes and industries.Current Role(s): President, Almington Capital Merchant Bankers; Chief Investment Officer, The Cannabis Capital Group.Asset Classes: publicly traded securities (stocks + fixed income), private equity, real estate, venture capital, cannabis, fintech.https://subscriptions.seekingalpha.com/lp_premium_beat_the_market_4/?source=affiliate:42612986Education: MA, Trinity College Dublin (economics + philosophy); Diploma (finance), London School of Economics & Political Science; MBA, University of Oxford.

Analyst’s Disclosure: I am/we are long DVAX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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