Dynavax Technologies Corporation (NASDAQ:DVAX)
Dynavax Technologies Corporation (NASDAQ:DVAX) stock has been in rally mode ever since it reported positive results for its metastatic melanoma candidate drug, SD-101. Renewed interest in the stock comes on the heels of growing optimism that the Food and Drug Administration will approve the company’s hepatitis B vaccine, Heplisav-B.
S-101 Positive results
Data presented at the American Society of Clinical Oncology (ASCO) indicates that SD-101 produced 100% overall response rate in seven anti-PD 1/L1 patients. The drug’s complete response rate in combination with Merck’s Keytruda came in at 29%. The results indicate a meaningful increase over the use of KEYTRUDA alone with an overall response rate of 33% and complete response rate of 6%.
The trial result indicates that SD-101 did indeed boost Keytruda efficacy levels in metastatic Melanoma without an increase in side effects. Dynavax Technologies Corporation (NASDAQ:DVAX) can negotiate a commercialization deal with Merck & Co., Inc. (NYSE:MRK) given the positive SD-101 results.
“These results are supported by tumor shrinkage in patients who had previously progressed on anti-PD-1 treatment and by confirmatory laboratory biomarker assessments in tumor biopsies. If these clinical results are sustained in the ongoing trial, this combination, which mobilizes both innate and adaptive immune responses in patients, could represent an important advancement in immuno-oncology,” said Antoni Ribas of the Jonsson Comprehensive Cancer Center.
SD-101 expands Dynavax Technologies Corporation (NASDAQ:DVAX) reach into a multibillion skin cancer drug market. The ability to access such a sizeable market has caught the attention of investors. Based on the Phase ½ trial results, SD-101 should act as a near term value driver, especially after the biotechnology company inks a commercialization deal with Merck.
Heplisav-B could propel Dynavax Technologies Corporation (NASDAQ:DVAX) higher in the market after an FDA approval. Expert observers claim the odds of approval are high given its superior trial results to the current standard of care.
Approval of the Hepatitis B vaccine would present Dynavax Technologies Corporation (NASDAQ:DVAX) with a $500 million market opportunity in the United States alone. At the moment, the only major concern is that the company’s need to raise money for the vaccine’s roll out as well as the development of SD-101.
Dynavax Technologies Corporation (NASDAQ:DVAX) shed 1.90% in market value in Tuesday’s trading session to end the day at $7.75 a share.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica Grey has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.