Dynavax Technologies Corporation (DVAX) Has the Market Buzzing with Heplisav Approval at the Finish Line, Exelixis, Inc. (EXEL) Refractory RCC Drug Going Strong in its Launch


Dynavax’s Advantage Weighs Towards Heplisav’s Benefits

Dynavax Technologies Corporation (NASDAQ:DVAX) shares are racing 5% today after releasing second-quarter earnings. However, this rocket momentum fires after having spiraled up 71% Monday on the heels of the favorable vote from FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC)- 12 to 1, with 3 abstentions betting on the efficacy of Heplisav-B. This is a key stride for the biotech firm, showing the advisory committee assesses data to support the safety profile of its lead drug candidate designed to treat adults with a hepatitis B vaccine.

Cowen analyst Phil Nadeau has been awaiting Heplisav’s “torturous FDA review” for five years, two Complete Response Letters, two VRBPAC meetings coupled with one that never saw the light of day- and he for one is enthusiastic for the good prospects for this HBV vaccine’s approval.

As such, the analyst reiterates an Outperform rating on shares of DVAX with a $30 price target, which represents a 79% increase from where the stock is currently trading. (To watch Nadeau’s track record, click here.)

Nadeau notes, “In 2012 VRBPAC voted that Heplisav’s efficacy had been conclusively established, and therefore Friday’s vote was a clear endorsement of Heplisav’s licensure. Though there was much debate about Heplisav’s safety data, ultimately the panel decided that Heplisav has dramatically superior efficacy, that people who are insufficiently vaccinated are at risk for harm from HBV, and that therefore Heplisav’s benefits outweigh a relatively low risk of myocardial infarction (MI), particularly in light of a post-marketing commitment for further study. Heplisav’s torturous FDA review – which has spanned 5 years, 2 CRLs, 2 VRBPAC meetings (not including a third that was cancelled) – will soon end with the HBV vaccine’s approval. […] Nonetheless, we anticipate that this delay will be relatively short.”

Overall, “DVAX remains significantly undervalued,” concludes Nadeau, who expects that soon enough, Heplisav will be securing a green light from the agency.

For the second quarter, the firm posted a net loss of $20.3 million. An update on the firm’s lead immuno-oncology candidate SD-101 and its Phase I and Phase II results in melanoma are due by start of next year, with data from Phase I and Phase II trials in Head and Neck cancer having good chances for a read-out at the American Society of Clinical Oncology (ASCO) Meeting.

TipRanks analytics exhibit DVAX as a Strong Buy. Out of 4 analysts polled by TipRanks in the last 3 months, all 4 are bullish on Dynavax stock. With a return potential of 98%, the stock’s consensus target price stands at $33.67.

Exelixis Cabometyx Speeding Down the Momentum Tracks

Exelixis, Inc. (NASDAQ:EXEL) disclosed quite a “solid” second-quarter print yesterday, which further shows the strength of Cabometyx, the firm’s drug designed to treat advanced renal cell carcinoma (RCC).

Top analyst Eric Schmidt at Cowen commends the “robust launch” of the advanced kidney drug, believing Exelixis is glancing ahead at a profitable path laden with “additional opportunities ahead.”

“The 2nd interim analysis on cabo’s CELESTIAL HCC trial is nearing while an sNDA for label expansion into poor risk 1st-line RCC remains on track for Q3. We expect EXEL to Outperform as cabo and cobi expand their reach,” highlights the analyst.

Schmidt contends, “Exelixis indicated that Cabometyx growth in Q2 was driven by new patient starts as well as refills. […] Cabometyx continues to gain share from immunotherapies and other oral TKI agents. Management attributed the majority of growth in the quarter (roughly 60%) to community prescribers. Exelixis acknowledged some off-label use of Cabometyx in 1st-line RCC though management did not provide any quantification. The company expects an sNDA for the CABOSUN (1st-line RCC, to be filed in Q3) and a potential positive result from CELESTIAL (pivotal trial in 2nd-line HCC, 2nd interim look nearing) to be significant drivers of future sales growth.”

For the second quarter, Cabometyx brought in a 30% quarter-over-quarter rise in sales of $80.9 million against consensus expectations of $71.1 million, after the drug’s fourth full quarter following its approval in the indication of refractory RCC. Total revenue for the quarter of $99.0 million outclassed consensus of $86.6 million.

In reaction, the analyst reiterates an Outperform rating on EXEL without suggesting a price target.

Eric Schmidt has a very good TipRanks score with a 67% success rate and a high ranking of #22 out of 4,625 analysts. Schmidt garners 34.4% in his yearly returns. When recommending EXEL, Schmidt earns 224.5% in average profits on the stock.

TipRanks analytics demonstrate EXEL as a Buy. Based on 4 analysts polled by TipRanks in the last 3 months, 2 rate a Buy on Exelixis stock while 2 maintain a Hold. The 12-month average price target stands at $29.50, marking a nearly 12% upside from where the stock is currently trading.