Lack of Panel Could Be Positive for Dynavax (DVAX) - RBC
- S&P 500, Nasdaq set records as tech, banks lead
- Texas Instruments (TXN) Tops Q4 EPS by 20c, Issues Solid Q1 Outlook
- Intuitive Surgical (ISRG) Tops Q4 EPS by 10c; $2B Accelerated Share Repurchase
- Seagate Technology (STX) Tops Q2 EPS by 30c
- After-Hours Stock Movers 01/24: (BOBE) (STX) (WDC) Higher; (NEWT) (MRCY) (CA) Lower (more...)
News and research before you hear about it on CNBC and others. Claim your 2-week free trial to StreetInsider Premium here.
RBC Capital analyst Simos Simeonidis weighed in on Dynavax Technologies (NASDAQ: DVAX), saying while things are pretty murky, the lack of a need for a panel could actually be a positive for DVAX.
Simeonidis commented, "DVAX shares were down 30% on Friday on FDA’s update that the November 15th panel, announced just four weeks earlier, was cancelled “to allow time for the FDA to review and resolve several outstanding issues”. Investors interpreted this to mean “there’s no need for a panel, because we have a lot of outstanding issues to discuss before we can even decide whether this BLA needs a panel”. However, and even though this initial interpretation may ultimately end up being the correct one, another way, and perhaps the more appropriate way to interpret this is, is “there’s no need for a panel, because the types of questions we have can be answered just via communication with the company, without needing to hold a panel”. Dynavax put out its own press release over the weekend and we spoke with management. Given 1) the different tenor of the FDA announcement and the company’s press release and 2) the opaqueness of the process of communicating with FDA, it is very difficult to be certain about the reasons behind this change in course by FDA. However, we have always viewed the lack of a need for convening panel as an indication that the outstanding questions would fall in the “fairly straight forward to answer” category, which should be a positive for DVAX, given the vaccine’s clear efficacy. Similarly, we have felt that convening a panel would be a risk for DVAX shares, because this would be the forum where safety data would be very closely scrutinized, and the potential for a negative vote could come from further dissection (and perhaps recounting) of the Dynavax-reported safety numbers."
The firm maintained a Sector Perform rating and price target of $16 on DVAX.
Shares of Dynavax Technologies closed at $10.91 yesterday.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- RBC Capital Starts Performance Food Group (PFGC) at Sector Perform
- Halliburton (HAL) PT Lowered to $60 at Credit Suisse; Reiterates Outperform
- Mercury Computer (MRCY) PT Raised to $30 at Jefferies Following 2Q Report
Create E-mail Alert Related CategoriesAnalyst Comments, FDA, Trader Talk
Related EntitiesRBC Capital
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!