Choose a blog

BioCryst keeps experimental drug alive

BioCryst Pharmaceuticals said this morning that it expects to meet with federal authorities in the second quarter to discuss a new drug application for its experimental Peramivir treatment.

The Durham company recently suspended development of the potent antiviral treatment in this country after inconclusive tests. The feds have supplied $235 million to develop the medication, which rapidly delivers plasma to infection sites to inhibit the spread of influenza.

BioCryst said it has completed a meeting on the future of Peramivir with the U.S. Food & Drug Administration. The 22-year-old company also said it's requesting a new drug application meeting to address outstanding issues.

Peramivir is approved in Japan, Korea and, most recently, China.

Recent product cancellations have forced BioCryst to cut half its staff and also derailed a $101 merger with Presidio Pharmaceuticals.

BioCryst stock is at $1.80, down 6 cents a share in midday trading.

BioCryst 4Q revenues dip in wake of cancellations, restructuring

BioCryst Pharmaceuticals, a Durham drug developer, said it lost about a fifth of its revenue in the fourth quarter as the company continues adjusting to drug delays and a failed merger.

Revenue fell in the fourth quarter to $4.1 million last year from $5.2 million for the same three-month period in 2011. BioCryst's quarterly loss was $11.1 million, versus $13.2 million a year earlier, in the wake of an emergency restructuring that cut half the company's staff.

The per share loss was 22 cents, a few pennies better than analysts were projecting. One of BioCryst's strong suits is a cash reserve of $22 million to $26 million to get the company to its next round of funding or research grants.

“Our team is focused on achieving near-term milestones to rebuild shareholder value,” said CEO Jon P. Stonehouse in a statement.

BioCryst pulls flu drug, mulls future

Durham drug developer BioCryst Pharmaceuticals suffered a second setback in as many weeks and said late Wednesday it is suspending development of an influenza treatment that had been supported with $235 million in federal research funding.

The company, with 42 employees in Durham and 31 in Alabama, said in a conference call with analysts Thursday morning that it is planning to restructure and cut costs as its major source of funding dries up. BioCryst had spent about two-thirds of the federal research grants that had kept the company afloat.

The company has lost much of its value in recent weeks as its stock nose-dived from a high of $4.69 a share last month to $1.38 as of mid-morning Thursday.

The suspension of peramivir, which was deemed ineffective for influenza by an independent panel of experts, is BioCryst's second drug cancellation. A week ago the company said it was suspending work on a Hepatitis C drug in response to concerns about the drug's toxicity.

"The reality is that everyone looked at the company as a peramivir company," said analyst Stephen Brozak of WBB Securities. "That has to be described as a body blow to the franchise."

Durham's BioCryst forced to halt Hepatitis treatment

Durham drug developer BioCryst Pharmaceuticals said Tuesday that it is withdrawing what had been touted as a promising treatment for Hepatitis C in response to concerns about the drug's "toxicity profile."

BioCryst released the news after the close of market trading and said it would hold a teleconference at 8:30 a.m. Wednesday to discuss the situation with analysts and investors.

The 22-year-old drug development company has never brought a product to market in this country but its treatments for gout and for influenza are in advanced stages of human testing.

The company was hoping to move the Hepatitis drug to human testing but halted the drug indefinitely after consultation with the U.S. Food and Drug Administration, the agency that regulates and approves medicines.

"BioCryst agrees with the FDA's cautious approach," the company said in a statement. "FDA has previously placed clinical holds on other nucleotides under development."

 

Durham's BioCryst to buy San Fran company

Durham-based drug developer BioCryst Pharmaceuticals will buy Presidio Pharmaceuticals, a West Coast company, in a $101 million stock deal, the companies said today.

Neither drug developer has a product out on the U.S. market today but both cited the potential synergies of combining their experimental hepatitis C antiviral drugs as well as partnering with oral antivirals made by competitors.

The deal is subject to regulatory review and is expected to close in the first quarter of 2013. The companies will combine under a new corporate name and remain headquartered in Durham, with operations in Birmingham, Alabama, and in San Francisco.

BioCryst is developing drugs to treat gout, influenza and hepatitis C. Its flu treatment, peramivir, was approved in Japan and Korea in 2010. Presidio specializes in developing antiviral treatments for hepatitis C.
 

Cars View All
Find a Car
Go
Jobs View All
Find a Job
Go
Homes View All
Find a Home
Go

Want to post a comment?

In order to join the conversation, you must be a member of newsobserver.com. Click here to register or to log in.
Advertisements