In a regulatory filing, Aimmune Therapeutics (AIMT) recently said it had been notified by the U.S. Food and Drug Administration that as a result of the ongoing government shutdown, the agency will not commence review of its application for AR101 for peanut allergy in children and adolescents. Aimmune's drug might not be the only one facing delays. Piper Jaffray analyst Christopher Raymond has told investors that Celgene (CELG), with its ozanimod resubmission expected in the first quarter of 2019, and Biogen (BIIB), which had filed on December 17 an NDA for its BIIB098, could also be impacted if the government shutdown continues.
FIVE MORE WEEKS OF FUNDING LEFT: The FDA has about five weeks of funding left to review new drug applications during the shutdown, commissioner Scott Gottlieb said earlier this week on Twitter. " We’ve stretched carryover drug user fees to get a longer runway should the shutdown continue, by for example sharply reducing any overhead charges to CDER/CBER. The slower burn rate gives us about five weeks left as of this week. These numbers could change," his tweet reads. " We’re getting many questions about when #FDA can continue to accept medical product applications during the lapse in funding. The questions tonight relate to one particular biotech firm. However, I'm addressing the issues generally, and not specific to one product. […] For products covered by a user fee program, if the product sponsor submitted the application and paid any required fees before the lapse, FDA can use its limited carryover user fee funding to continue reviewing the application. […] However, during the lapse, FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review. […] More specifically, for products not covered by a user fee program, like most blood and allergenic extract products, FDA does not have carryover user fee funding to continue reviewing pending or accepting new applications." The partial government shutdown began on December 22 after Congress and White House failed to reach a spending deal, and has since became the longest government shutdown in U.S. history.
REVIEW OF AR101 DELAYED: In a regulatory filing on January 14, Aimmune Therapeutics announced that it has been notified by the FDA that as a result of the government shutdown and lapse in appropriations, the FDA will not commence review of the company's Biologics License Application, or "BLA," for AR101, the company's investigational biologic oral immunotherapy for the treatment of peanut allergy in children and adolescents ages 4-17. "The FDA indicated that it will initiate review of the BLA when the U.S. government shutdown and lapse in appropriations has ended. As previously announced, the company submitted its BLA for AR101 on December 21, 2018, prior to the U.S. government shutdown," Aimmune stated. Commenting on the announcement, Piper Jaffray's Raymond told investors that while it does not change his bullish thesis on the shares, the "story is now held somewhat hostage" by a rather arbitrary triage protocol by the FDA as the agency manages through dwindling funds caused by the government shutdown. Further, the analyst acknowledged that he was "quite surprised" by the decision and wonders "if other shoes are likely to drop" as the FDA begins to see additional process breakdowns. Raymond reiterated an Overweight rating and $60 price target on Aimmune's shares.
OTHERS TO WATCH: "Like any good government agency, FDA appears to be prioritizing non-revenue generating activities," Raymond highlighted in his research note. The analyst said he has checked with Alexion Pharmaceuticals' (ALXN) management and the company remains "confident" that the Soliris NMO sBLA, filed at the end of December, will be reviewed during the shutdown because its orphan designation means its user fee was waived. Additional names under his coverage that could be impacted include Celgene, with its ozanimod resubmission expected in the first quarter of 2019, and Biogen, that filed an NDA for its BIIB098 prior to Gottlieb's original cutoff date, among others. The government shutdown could also soon jeopardize highly anticipated new drugs from Janssen (JNJ), Sanofi (SNY), and Novartis (NVS) for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies, according to STAT News.
"Trump Effect" is The Fly's recurring series of exclusive stories that highlight stocks that are being impacted, or are predicted to be impacted, by the comments, actions and policies of President Trump and his administration.
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