As most biotech enthusiasts will be well-aware of, biotech is rife with binary events this week, many of which fall on Tuesday April 30. While PropThink has not opined on all of these events, below, we list those that PropThink has covered, as well as our latest commentary and outlook.
Tuesday, April 30
- FDA briefing documents will be released for the May 2 FDA ODAC advisory panel regarding Aveo Pharmaceuticals’ (AVEO) tivozanib in advanced renal cell carcinoma (RCC). On April 24, Dr. Chaudhry wrote that the drug would receive a positive vote and, subsequently, FDA approval; that article can be seen here.
- FDA Briefing documents will be released two days ahead the ODAC panel for Delcath Systems’ (DCTH) Melblez Kit in the treatment of unresectable ocular melanoma, metastatic to the liver. Dr. Chaudhry believes that the hepatic delivery system will receive a positive vote from the advisory panel, and subsequent FDA approval. Here are the details. We do, however, find the commercial prospects of the system to be questionable and would not be involved in DCTH long-term, even if the advisory panel/approval goes well. As this is a high risk event, it should be considered a speculative trade.
- FDA Approval decision for Raptor Pharma’s (RPTP) Procysbi. RPTP has proven an outstanding run-up trade since Mr. King picked the bottom on February 19th, or from our original coverage in December. We expect Procysbi will receive an approval tomorrow, Tuesday, but considering the uncertainty regarding Procysbi’s pricing and reimbursement, it will likely be a sell-the-news event. We would be taking profits ahead of the approval or very shortly after. PT readers are up 39% from February lows
- FDA approval decision for Titan Pharma’s (TTNP) probuphine. The AdCom vote went well for Titan, and the question now is whether the FDA requests an extension to the PDUFA in order to assess probuphine’s REMS strategy. This is outlined in Jason Napodano’s latest article, but he still sees TTNP as undervalued.
- Pfizer’s (PFE) 1Q conference call (scheduled for 10 am EDT on Tuesday – see here) should include details on the development path forward for Remoxy, Durect (DRRX) and Pain Therapeutics’ (PTIE) abuse-deterrent oxycodone formulation. Jason Napodano’s last article on DRRX, which includes his current price target, can be seen here. And, PropThink contributor Rajesh Patel put together a hedge strategy for DRRX here. A “Go” or “No-Go” decision on the continued development of Remoxy is critical to both companies, but PTIE has little in the way of a pipeline to act as a backdrop to this decision, thus DRRX is the safer way to be involved in Remoxy — of course, with less reward in the case of a positive outcome.
FDA will release briefing documents on the morning of the 30th, and will be updated here.