t's taken some time, but Dynavax Technologies Corporation (NASDAQ:DVAX) is finally starting to pick up some much needed speculative attention and – on the back of this added interest – gaining strength. We last looked at the company back at the start of March, highlighting Dynavax's potential as a PDUFA runner ahead of decision day for the company's lead development asset – a hepatitis B vaccine called Heplisav B.Subsequent to our coverage, the company lost a bit of value, but for all intents and purposes traded flat throughout March, April and May. At May 31, Dynavax shares went for $5.50 a piece. At last close (June 6) the company traded at $7 a share.In our opinion, this is just the beginning.The recent gains don't actually come on the back of any Heplisav B volume; at least not directly. The company presented early stage data from a secondary pipeline asset – an intratumoral TLR9 agonist called SD-101 – at ASCO. Dynavax is investigating the drug in combination with Merck & Co., Inc. (NYSE:MRK)'s Keytruda and, as per the latest data presentation, it looks pretty good. Specifically, in patients with metastatic melanoma, the drug appears to improve the efficacy of Keytruda without bringing about a worsening of the latter's side effects. That's great news, as it could translate to a licensing deal between the two companies at some point; a deal that could both inject cash into Dynavax and improve its topline long term.It's great news, but we recommend readers push it to the back of their minds right now.The real value here, as we've repeatedly pointed out to our readers, is rooted in Heplisav B. For those new to the program, it's been a wild ride for Dyanvax and its shareholders, having suffered repeated knockback from the FDA rooted in everything ranging from safety to manufacturing concerns.We think the rough times are very much in the rearview mirror, however, and that this asset is going to pick up an approval when it comes up in front of the FDA, yet again, on August 10.Between now and then, traders are going to load up on the company in anticipation of an FDA decision in line with our expectations. We expect this loading to come in two phases, and we think each of these phases represents a different risk profile, meaning the play is suitable for both our conservative and our aggressive readers.The aggressive play is to take a position right now. Well, the aggressive play would have been to take a position when we first highlighted the company, before the most recent run, but given where things stand, right now is the riskier, but potentially far more rewarding, entry.The more conservative play is to wait until July 28 before taking a position. Why? Because on this day, the Vaccines and Related Biological Products Advisory Committee will convene to discuss, and ultimately put forward a recommendation for, Heplisav B. If the recommendation comes out as favorable. The company is going to run in anticipation of a subsequent FDA approval. The agency doesn’t have to go with the recommendation, of course, so the run will temper somewhat as compared to the eventual appreciation on the back of an FDA green light. This means a conservative trader can wait for the panel review and take a position on its outcome, while leaving a bit of run room for when PDUFA comes around on August 10.It's been a long and winding road to approval for Dynavax and its shareholders and many are down considerably on their initial stakes. With a potential market of $500 million (and an easily achievable one at that) for the drug, however, and compared to the company's current market capitalization of just over $340 million, the end of this summer could see these losses rebuilt and – for a new shareholder – a considerable premium on a well-timed exposure.We will be updating our subscribers as soon as we know more. For the latest updates on DVAX, sign up below!Disclosure: We have no position in DVAX and have not been compensated for this article.
Dynavax Technologies Corporation (NASDAQ:DVAX) Is Finally Getting The Attention It Deserves
