Cardiome Shares Takes a Hit Following FDA Denial

Cardiome's stock price saw significant decreases on both its stocks as a reaction to the NDA resubmission denial from the FDA.


Cardiome Pharma (NASDAQ:CRME; TSX:COM) faced a decline in its stock Tuesday morning (August 22)–both on the NASDAQ and the TSX–after US Food and Drug Administration (FDA) regulators denied a New Drug Application (NDA) resubmission for Brinavess, a corrective treatment for an arrhythmic heartbeat.

Dr. William Hunter, president and CEO of the company said the company requested a resubmission of the NDA taking a base of the six years Brinavess has been available in 33 countries.

Despite the data Cardiome expected would back up their product, the agency replied saying that information would “not be sufficient.” Hunter added the company will continue their conversation with the FDA on the path for regulation.

On the NASDAQ, Cardiome has suffered a 12.31 percent decline  in it stock following the denial of the FDA as of 3:55 p.m. EST, while on the TSX the decrease was 11.04 percent as of 3:40 p.m. EST on Tuesday.

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Cardiome “disappointed” with the FDA’s decision

“We are disappointed that the Agency did not find these data compelling enough to recommend a resubmission, especially when several regulatory bodies in major jurisdictions around the world,” Hunter said.

Cardiome said it still believes Brinavess is the best option available and will continue to explore every possible way for its entrance to the US market.

Brinavess was approved by Health Canada, the country’s regulatory agency for medicine, earlier this year. A move which prompted Cardiome to expect an approval from the US. The drug will begin generating revenue for the company during their third quarter according to Jonathan Mather, director and global head of regulatory affairs with Cardiome.

“We are pleased that Health Canada believed, as we do, that BRINAVESS provides an attractive alternative to the currently available treatment options of recent onset atrial fibrillation,” Mather said.

Brinavess has also received approval in Europe, according to Cardiome, for “the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.”

Cardiome released their financial report for the second quarter of the year on August 8 in which the company disclosed an $8.5 million net loss, turning to a $0.26 loss per share. Revenue saw a small decline to $5.8 million compared to the same period of time last year when Cardiome generated 5.9 million.

According to reporting from BioPharma DIVE, Brinavess has been seeking US approval for over 10 years now and has fallen short on several roadblocks in its path to approval.

Investor Takeaway

Cardiome’s both US and Canadian stocks haven’t seen favourable performances. While an increase is visible during the summer months, the company’s recent news brought their stock back down. On a year-to-date period on the NASDAQ, shares of Cardiome have decreased 13.95 percent while on the TSX, the company’s stock is down 22.13 percent.

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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

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