Portola Pharmaceuticals Inc (NASDAQ:PTLA) shares were cracked lower on Tuesday following news that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had additional questions for the company about its application to push Ondexxya into the EU healthcare market. The drug is currently under review for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.

Generally speaking, when you get news that a regulatory authority wants to extend a review process, it’s bad news. This case was no different. Shares of the stock took a sharp hit, dropping as much as 7% on the news.

Portola Pharmaceuticals Inc (NASDAQ:PTLA) frames itself as a commercial-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of novel therapeutics that could advance the fields of thrombosis and other hematologic diseases.

The company’s two FDA-approved medicines are Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo), an antidote for patients treated with rivaroxaban and apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding; and Bevyxxa (betrixaban), an oral, once-daily Factor Xa inhibitor for the prevention of VTE in adult patients hospitalized for an acute medical illness.

It is also advancing cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic cancers. In addition, the company is developing PRT2761, a Syk inhibitor candidate for the treatment for allergic conjunctivitis.

Portola Pharmaceuticals, Inc. has collaboration agreements with Bristol-Myers Squibb; Pfizer Inc.; Bayer Pharma, AG; Janssen Pharmaceuticals, Inc.; Daiichi Sankyo, Inc.; Dermavant Sciences GmbH; and Ora, Inc.


A Straightforward Picture

We started off by noting that PTLA just hit the wires with the announcement that the CHMP in the EU has additional questions for the company on its push to establish Ondexxya in the EU market as a treatment for excessive effects of anticoagulant treatments.

According to the release, the CHMP informed Portola yesterday that it will provide a list of outstanding questions related to the data package the company submitted for Ondexxya last quarter, which will require additional responses from the company. The preliminary timetable provided to the company by the CHMP sets a deadline of January 29, 2019 for responses to the questions followed by a 30-day assessment period for the CHMP to review the company’s responses.

One thing to note here: given that this latest drop was so very clearly driven by this extension of review time, signs that the drug will be authorized for marketing in the EU would likely provide a very quick boost to shares.

“We will work diligently to address the Committee’s questions as they review and further consider the data package supporting the MAA,” said Scott Garland, Portola’s president and chief executive officer. “We look forward to continuing the dialogue as we progress toward a formal opinion and potential European approval early next year.”

Portola Pharmaceuticals Inc (NASDAQ:PTLA) managed to rope in revenues totaling $14.2M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 270.4%, as compared to year-ago data in comparable terms.

In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($370.3M against $61.1M).

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