Two Interesting Biotech Stocks with Upcoming Catalysts: Kamada Ltd. (KMDA), Dynavax Technologies (DVAX)


Kamada: Jefferies Sees 60% Upside for the Stock

Kamada Ltd (NASDAQ:KMDA) has an upcoming PDUFA date on August 29, 2017 for its anti-rabies IgG product. The drug maker believes the treatment represents an annual market opportunity of more than $100 million of which it expects to take a significant market share. Upon a favorable regulatory outcome Kamada intends to launch the product in the U.S. soon thereafter with its partner Kedrion.

With PDUFA catalyst around the corner, Jefferies’ top analyst Raj Denhoy reiterated a Buy rating on Kamada shares, with a $6.00 price target, which represents a potential upside of nearly 60% from where the stock is currently trading.

Denhoy noted, “The two news items worth watching in 2Q are the FDA regulatory sign off on the US clinical path for Glassia IH and anti-rabies PDUFA date. On the latter, regulatory approval will give KMDA access to a $130mn market in the US with only one competitor. On the clinical path for IH, FDA signoff will only start a long process for approval but should KMDA finally prove that IH is a safe and effective way to deliver AAT, the opportunity to take a large portion of what could be a $1bn market by then is significant.”

According to TipRanks, Denhoy is a 5-star analyst, holding a yearly average return of 14% and a 65% success rate. Denhoy has a 3.3% average return when recommending KMDA, and is ranked #106 out of 4628 analysts.

Dynavax Still One for the Bulls

Dynavax Technologies Corporation (NASDAQ:DVAX) may have suffered a slight setback with the FDA extending the PDUFA date for the biotech firm’s Hepatitis B vaccine candidate Heplisav. Now, the firm will have to wait to find out by November 10th whether the FDA will smile upon DVAX.

Yet, William Blair analyst Y Katherine Xu remains bullish as ever on the stock, from chances to approval to commercial prospects down the line, sizing up the delay as merely a short-term push-back- not a long-term pitfall.

Therefore, the analyst reiterates an Outperform rating on shares of DVAX with a $30 fair value estimate, which implies a just under 77% upside from current levels. (To watch Xu’s track record, click here.)

Xu highlights, “[…] The temporary delay in PDUFA does not impact our outlook on Heplisav, including its eventual approval, the prospect of establishing a commercial partnership, and peak sales estimate. […] The FDA issued an information request today regarding the post-marketing study, resulting in the PDUFA extension, and the key elements to address include: timeline for the final protocol submission, study completion and final report submission; timeliness of accruing patients into the study; time points for data review; measures to control for potential biases between study arms; and updated statistical analysis plan. We believe these topics reflected the concerns expressed at the VRBPAC panel, and that addressing these topics appropriately would ensure timely and responsible conduct of the study.”

TipRanks analytics demonstrate DVAX as a Strong Buy. Based on 4 analysts polled by TipRanks in the last 3 months, all 4 are bullish on Dynavax stock. The 12-month average price target stands at $28.67, marking a 73% upside from where the stock is currently trading.