Tag: Aimmune Therapeutics

AR101

European Phase 3 Trial of AR101 Peanut OIT Candidate Meets Primary...

Company Intends to Submit European MAA in Mid-2019.
AR101

US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut...

If Approved, AR101 Will Be the First Medicine for This Life-Threatening Condition.
AR101

Aimmune Therapeutics Presents New AR101 Data Including Demonstrated Reduction in Accidental...

AR101-Treated Patients Who Completed PALISADE Had 95% Increased Probability of Tolerating Any Dose of Peanut Protein in Exit Challenge Compared to Placebo.
AR101 Delayed by Gov't Shutdown

Government Shutdown Delays Review of AR101 Peanut Oral Immunotherapy Candidate

The FDA has shelved consideration of the drug until funding is restored.
AR101

Aimmune Submits FDA Application to Offer AR101 for the Treatment of...

“We have requested FDA Priority Review and look forward to working with the agency to bring what could be the first approved treatment in food allergy to patients as quickly as possible.”
Eggs

Aimmune to Begin Phase 2 Trials of Egg Allergy OIT Candidate

AR201 for Egg Allergy Phase 2 Initiation Planned for 2019.
AR101+dupilumab

Aimmune Therapeutics Announces Initiation of Phase 2 Study of AR101 With...

Trial Will Build on the Positive, Pivotal Phase 3 PALISADE Trial of AR101.
AR101+dupilumab

Phase II Trials of AR101 with Dupilumab for Peanut Allergy to...

Study scheduled to commence next week.
Stressed Boy

European Study Shows Significant Psychosocial Burden Associated with Peanut Allergy

Data discussed at EAACI 2018 reveal uncertainty, bullying and high levels of anxiety around food.
AR101

Peanut OIT Phase 3 Trial Results Show Therapy Effective for Ages...

Aimmune plans to submit a Biologics License Application for AR101 to the FDA by the end of 2018.

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