Sunesis Pharmaceuticals Inc. (NASDAQ: SNSS) probably wishes that this Friday never happened. The company was already a very speculative cancer drug biotech outfit, and now its status is moving down to a speculative company that just lost its positive case. Sunesis shares were down almost 70% just after the opening bell, in the wake of interactions with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) regarding its plans toward marketing approval for vosaroxin as a treatment for acute myeloid leukemia (AML).

The long and short of the matter is that this drug candidate is now unlikely to be approved in the United States in the fight against AML. That would go for both Europe and the United States. Sunesis even led its release by saying that it will now proceed expeditiously with a marketing authorization application in Europe, while it will evaluate its regulatory and clinical strategies to gain marketing approval in the United States.

Here is what investors need to know about vosaroxin. This is the primary compound in the Sunesis product pipeline. On that front, AML was also the farthest along in Phase 3 and regulatory filings. See an image of the Sunesis pipeline below. You will also see that analysts are jumping ship as well.

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Sunesis’ release said:

With respect to Europe, the company recently met separately with the Rapporteur (United Kingdom) and Co-Rapporteur (Netherlands) assigned to provide advice and guide the company through the Marketing Authorization Application (MAA) process. Based on these substantive discussions, the company was encouraged to proceed with an MAA filing for the indication of relapsed/refractory AML in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company’s pivotal Phase 3 study of vosaroxin and cytarabine in adult patients with relapsed or refractory AML … the company will place near-term focus on the MAA filing, which it will work to complete as expeditiously as possible …

With respect to the United States, after conducting additional safety and efficacy analyses, the company recently met with the FDA. In light of not reaching statistical significance on the protocol-defined primary analysis of overall survival, Sunesis was informed that the Agency did not support a filing and encouraged the company to provide additional clinical evidence to support a future NDA submission … and will evaluate and refine its plan to gain marketing approval in the U.S.

Daniel Swisher, chief executive officer of Sunesis, said:

We are at once encouraged by our interactions with European regulators and disappointed with the outcome of our meeting with their U.S. counterparts. Our belief, supported by many in the medical community, is that the VALOR outcomes for patients with high unmet needs were both compelling and an important step forward in addressing the enduring challenges of treating AML. We look forward to moving ahead with the submission of an MAA filing in Europe. Our confidence in vosaroxin stems not only from the outcomes seen in VALOR, but our ongoing investigator sponsored studies. It is our goal to leverage this body of data to determine a clinical and regulatory path forward for vosaroxin that is time and resource efficient, addresses the needs of patients with AML and maximizes our likelihood of regulatory and commercial success.

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UPDATE FOR FRIDAY’s CLOSE: Sunesis closed down $2.51, or -72% at $0.96 on more than 23.7 million shares. Shares hit an intraday low of $0.92. Average volume is close to 1.8 million shares, but that went up by 400,000 shares on average due to the massive volume on Friday.

Sunesis shares were down more than 70% at $1.02 Friday morning, after closing at $3.47. In the first 20 minutes of the regular session, it had already traded more than 3.5 million shares, compared to its average daily volume of 1.4 million shares. Sunesis has a 52-week range of $1.00 to $8.46. Its market cap at Thursday’s close was $253 million, but that market cap has dropped to around $74 million.

Sunesis had $18.8 million in cash and cash equivalents and $21 million in short-term investments as of March 31, 2015. Its long-term debt was just over $8 million.

Roth Capital slashed its rating to Sell from Buy and slashed the price target to $1.00 from $5.50. While price target data was not initially seen, Cowen downgraded Sunesis to Market Perform from Outperform and Cantor Fitzgerald cut its rating to Hold from Buy.

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