Aimmune Therapeutics Inc (NASDAQ:AIMT) shares closed up 15% on Thursday after the company’s principle nemesis in the peanut allergy space, DBV Technologies (Nasdaq: DBVT), announced the withdrawal of its Biologics License Application (BLA) for peanut allergy.
As you may already know, AIMT’s big pipeline play is AR101, which would have been in direct competition with the DBVT asset in a very limited space. The BLA withdrawal opens up the playing field in what could become a winner-take-all kind of game. At the very least, it removes a serious question for AIMT shareholders.
Aimmune Therapeutics Inc (NASDAQ:AIMT) trumpets itself as a clinical-stage biopharmaceutical company, develops and commercializes product candidates for the treatment of peanut and other food allergies.
The stock has been in a declining trend over the past month (but what hasn’t?).
As noted above, DBVT just announced that “after discussions with the U.S. Food and Drug Administration (FDA), its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn. DBV is currently working closely with the agency to resubmit the application for Viaskin Peanut as quickly as possible.”
The company noted in its release that “this action was based on verbal and written correspondence with the FDA on December 18th, 2018. Following feedback from the agency, DBV Technologies concluded that the current BLA, which was submitted on October 18th, 2018, lacks sufficient detail regarding data on manufacturing procedures and quality controls. The FDA did not cite concerns related to the clinical module of the BLA for Viaskin Peanut, and the Company believes that the additional information needed to support this filing is available without further clinical studies.”
As we have stated, this is schadenfreude time for AIMT investors. The company just announced the submission of its investigational new drug (IND) application for AR201 for the treatment of egg allergy as well, further helping to fuel the gains.
The company also announced an exclusive supply agreement for egg protein with Michael Foods, Inc., the largest U.S. processor of value-added eggs. Aimmune expects to initiate a Phase 2 clinical trial of AR201 for the treatment of egg allergy in 2019.
It was a wild day for the stock, and it came against a market backdrop that is best characterized as painful and scary for most investors across the market. Hence, the gap and go action is all the more potent.
Take it From the Top
Aimmune Therapeutics Inc (NASDAQ:AIMT), as noted, has a lead Characterized Oral Desensitization ImmunoTherapy product candidate: AR101, an investigational biologic for the treatment of patients with peanut allergy.
The company has strategic collaboration with an affiliate of Nestle Health Science US Holdings, Inc. for the advancement of food allergy therapeutics. The company was formerly known as Allergen Research Corporation and changed its name to Aimmune Therapeutics, Inc. in May 2015. Aimmune Therapeutics, Inc. was founded in 2011 and is headquartered in Brisbane, California.
AR101 is a new, peanut-derived investigational oral biologic drug for use in oral immunotherapy in patients with peanut allergy.
The drug, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), delivers a daily dose of peanut protein with a characterized protein profile, analyzed to ensure consistent major allergen content. The amount of active ingredient in each AR101 capsule is controlled to ensure minimal variability of allergen content across doses of a given strength. AR101 is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets.
The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient’s choice.
Aimmune Therapeutics Inc (NASDAQ:AIMT) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($255.2M against $37.5M).