Health and Healthcare

Alder Biopharma Soars on Positive Mid-Stage Trial Results

Chris Lange

Published: March 28, 2016 10:50 am

Last Updated: January 13, 2020 11:28 am

Alder Biopharmaceuticals Inc. (NASDAQ: ALDR) led the bulls on Monday morning following the release of its mid-stage clinical trial results. The company announced positive top-line data from two clinical trials evaluating ALD403. Just earlier this month, 24/7 Wall St. pointed out that this was one of the stocks to watch with an upcoming FDA decision.

For some background, ALD403 is Alder’s proprietary monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide.

Positive top-line data from a Phase 2b study of patients with chronic migraine demonstrated that ALD403 acted rapidly and prevented migraine over the entire 12-week study period, meeting both primary and secondary efficacy endpoints. Additionally, positive Phase 1 study data demonstrated that the pharmacokinetics and pharmacodynamics by intravenous, subcutaneous or intramuscular injection of ALD403 support a quarterly single injection dosing strategy.

The 300 mg and 100 mg dose levels of ALD403 met the primary efficacy endpoint of the study, a 75% reduction in migraine days over the entire 12 weeks in 33% and 31% of patients, respectively.

Today’s ALD403 Phase 2b data confirm and expand on our previous data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group. Evaluation of ALD403 continues to exhibit a potential best-in-class profile, which includes immediate, significant and durable migraine prevention with infrequent quarterly dosing. Today’s data also support our quarterly dosing strategy via a single intravenous, subcutaneous or intramuscular injection. With our commitment to the accelerated development of ALD403 reinforced by today’s positive results, we look forward to advancing our development plan, and assuming FDA approval, independently marketing ALD403 in the U.S. to meet the critical medical needs of the 13 million patients nationwide who are candidates for migraine prevention therapy.

Shares of Alder were last seen up 57% at $27.06, with a consensus analyst price target of $44.67 and a 52-week trading range of $15.82 to $54.90.