The share price of Atara Biotherapeutics Inc. began a slow climb up after the company experienced a steep drop earlier this month.
The Thousand Oaks drug maker saw its stock price decrease from a close of $13.16 on Jan. 15 to a close of $6.05 on Jan. 21, a decline of 54%.
But on Jan. 22, the stock price rose by nearly 14% to close at $6.89.
It closed at $6.93 on Jan. 23.
Preceding the sharp decline was the Food and Drug Administration releasing a letter to the company stating concerns about the third-party manufacturer of its blood cancer drug Ebvallo and delaying approval of the drug.
“The complete response letter did not identify any deficiencies related to the manufacturing process, the clinical efficacy, or clinical safety data in the biologics license application, and the FDA did not request any new clinical trials to support the approval of Ebvallo,” Atara said in a release from Jan. 16.
Cokey Nguyen, chief executive of Atara, said the company is working with the unnamed third-party manufacturer, its partner in Europe Pierre Fabre Laboratories and the FDA to address the feedback to support marketing approval for Ebvallo.
“Once the third-party manufacturer compliance issues have been adequately addressed, we will file for a resubmission, which we would expect to be potentially approved within six months of resubmission,” Nguyen said in a statement.
“We are disappointed by the delay and are willing to work with Atara on appropriate next steps to bring Ebvallo to U.S. patients that suffer from this deadly rare disease (the drug treats Epstein-Barr virus positive post-transplant lymphoproliferative disease) with no approved therapies,” Eric Ducournau, chief executive of Pierre Fabre Laboratories in Toulouse, France, said in a statement.
More company announcments
Additionally, on Jan. 21 the company announced that the FDA had suspended Atara’s active investigational new drug applications.
The applications include Ebvallo as well as ATA3219, a drug to treat non-Hodgkin’s lymphoma and systemic lupus erythematosus.
The clinical hold for Ebvallo is directly linked to inadequately addressed compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the complete response letter announced on Jan. 16, Atara said in a release.
“While ATA3219 drug product is manufactured at a separate, fully compliant GMP (good manufacturing practices) certified facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the letter,” according to the release from Atara.
Nguyen said the company would work with the FDA to address the issues expeditiously.
“We are encouraged with ongoing correspondence with the agency and a potential path to submitting the necessary data to release the clinical hold,” Nguyen said in a statement. “Patient safety remains our priority and maintaining the highest standards for our programs.”
Also, Atara said that its board was reviewing its strategic options and that a financial adviser hired to assist in that review had its scope recently expanded to include a wider range of additional strategic alternatives. Those options include an acquisition, merger, reverse merger, other business combinations, sale of assets or other strategic transactions.
“Through this process, Atara is already in active discussions with several potential parties,” it said in the release
And finally, Atara entered a non-binding term sheet with Redmile Group in San Francisco to provide up to $15 million in funding, which Atara believes is sufficient to fund the ongoing activities required to achieve approval of Ebvallo.
“We are pleased to have the strong confidence from a key stockholder in the future of Ebvallo and access to the capital to support the transfer of Ebvallo activities to Pierre Fabre, creating opportunities for value creation through the anticipated U.S. approval and launch,” Nguyen said.
