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alder biopharmaceuticals inc (ALDR) Details

Alder BioPharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical company. It discovers, develops, and commercializes therapeutic antibodies to transform the treatment paradigm for patients with migraine in the United States, Australia, and Ireland. The company’s lead product candidate is eptinezumab, a monoclonal antibody (mAb) inhibiting calcitonin gene-related peptide, which is in the late-stage clinical development for the prevention of migraine. It also develops ALD1910, a preclinical mAb that inhibits pituitary adenylate cyclase-activating polypeptide-38 for migraine prevention; and Clazakizumab, a mAb inhibiting the pro-inflammatory cytokine interleukin-6 that has completed two Phase 2b clinical trials. The company has strategic collaboration with CSL Limited for the development of clazakizumab as a therapeutic option for solid organ transplant rejection. Alder BioPharmaceuticals, Inc. was incorporated in 2002 and is headquartered in Bothell, Washington.

202 Employees
Last Reported Date: 02/25/19
Founded in 2002

alder biopharmaceuticals inc (ALDR) Top Compensated Officers

President, CEO & Director
Total Annual Compensation: $791.6K
Chief Financial Officer
Total Annual Compensation: $398.2K
Chief Operating Officer
Total Annual Compensation: $955.1K
Executive VP, General Counsel & Corporate Sec...
Total Annual Compensation: $594.6K
Compensation as of Fiscal Year 2018.
alder biopharmaceuticals inc
Alder BioPharmaceuticals, Inc. Presents at RBC Capital Markets 2019 Global Healthcare Conference, May-21-2019 09:30 AM

Alder BioPharmaceuticals, Inc. Presents at RBC Capital Markets 2019 Global Healthcare Conference, May-21-2019 09:30 AM. Venue: The InterContinental New York Barclay Hotel, New York, New York, United States. Speakers: Carlos Campoy, Chief Financial Officer.

Alder Biopharmaceuticals, Inc. Announces New Analysis of Patient-Report Outcomes Data from the Promise-2 Phase 3 Clinical Trial of Eptinezumab

Alder BioPharmaceuticals, Inc. announced a new analysis of patient-reported outcomes data from the PROMISE-2 Phase 3 clinical trial of eptinezumab for the prevention of chronic migraine. Eptinezumab is an investigational monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) administered by quarterly infusion for migraine prevention. The new analysis showed improvements in most bothersome migraine symptoms and patients’ global impression of change in their migraine status by Month 1 after treatment, with improvements sustained or increased through the first and second quarterly infusion. Detailed data will be presented at the 71st AAN Annual Meeting in Philadelphia, PA. The analysis evaluated the impact of 100 mg and 300 mg doses of eptinezumab vs. placebo on measures of patient-reported most bothersome symptom (MBS) as well as patients’ global impression of change (PGIC) in their overall migraine status. This study represents the first time patient-reported MBS data has been reported in a chronic migraine prevention study. Safety and tolerability were evaluated in the eptinezumab clinical trials. No serious adverse drug reactions related to eptinezumab were identified within the clinical trial program. Highlights from the data analysis include: At Month 1 after treatment: 45% of patients treated with 100 mg of eptinezumab and 57% of patients treated with 300 mg of eptinezumab indicated their MBS was much improved or very much improved vs. 29% of patients receiving placebo, 45% of patients treated with 100 mg of eptinezumab and 59% of patients treated with 300 mg of eptinezumab indicated their PGIC was much improved or very much improved vs. 32% of patients receiving placebo. At Month 6, three months after the second quarterly infusion: 57% of patients treated with 100 mg of eptinezumab and 57% of patients treated with 300 mg of eptinezumab indicated their MBS was much improved or very much improved vs. 42% of patients receiving placebo, 60% of patients treated with 100 mg of eptinezumab and 60% of patients treated with 300 mg of eptinezumab indicated their PGIC was much improved or very much improved vs. 41% of patients receiving placebo, Eptinezumab’s effect on a patient’s MBS was highly correlated with the patient’s impression of improvement in their overall migraine disease. The correlation was greater than what is observed with more standard measures such as mean monthly migraine days.

Alder BioPharmaceuticals Presents New Data Demonstrating Consistent, Early and Robust Prevention with Eptinezumab for Episodic and Chronic Migraine Across Four Clinical Trials

Alder BioPharmaceuticals, Inc. announced new efficacy data highlighting consistency of early migraine prevention benefit across four clinical trials with eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) and is administered by quarterly infusion for migraine prevention. Detailed data will be presented at the 71st AAN Annual Meeting in Philadelphia, PA. Across the Phase 2 and Phase 3 clinical trials, it was observed that eptinezumab, facilitated by its 100% bioavailability at the end of infusion, showed a rapid onset of migraine prevention. The rapid response observed within Day 1 and Month 1 was sustained through the first quarter following infusion, maintained or further increased through subsequent infusions and consistent across four clinical trials. Safety and tolerability were evaluated in the eptinezumab clinical trials. No serious adverse drug reactions related to eptinezumab were identified within the clinical trial program. Highlights from the Phase 3 Early Relief Data include: Episodic Migraine: 52.3% reduction in the percentage of patients with a migraine on Day 1 in those treated with 100 mg eptinezumab and 54.9% in those treated with 300 mg eptinezumab compared to 24.5% for placebo. Chronic Migraine: 50.3% reduction in the percentage of patients with a migraine on Day 1 in those treated with 100 mg eptinezumab and 51.6% in those treated with 300 mg eptinezumab compared to 27.1% for placebo. The U.S. Food and Drug Administration (FDA) accepted Alder’s Biologics License Application (BLA) for eptinezumab in April 2019, with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. If approved, it will be the first quarterly, anti-CGRP infusion therapy for migraine prevention. PROMISE-1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-1) was a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for episodic migraine prevention. In the study, patients were randomized and 888 received eptinezumab (30 mg, 100 mg or 300 mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at most 14 headache days per month, of which at least four met the criteria for migraine. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week treatment period. Secondary study endpoints include at least 75% and at least 50% responder rates assessed through 12 weeks, and percentage of patients experiencing migraine on the day following administration. In June 2017, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE-1. PROMISE-2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-2) was a Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for chronic migraine prevention. In the study, patients were randomized and 1,072 received eptinezumab (100 mg or 300 mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at least 15 headache days per month, of which at least eight met the criteria for migraine. Patients that participated in the trial had an average of 16.1 migraine days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week, double-blind treatment period. Secondary study endpoints included percentage of patients experiencing migraine on the day following administration and reduction of migraine prevalence days 1-28, reduction of at least 50%, 75%, and 100% from baseline in mean monthly migraine days assessed through 12 weeks, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in patient-reported impact scores on the Headache Impact Test (HIT-6). In January 2018, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE-2. Safety and tolerability were evaluated in the eptinezumab clinical trials. The most common adverse reaction in the clinical trials for the preventive treatment of migraine (those with incidence at least 2% and at least 2% greater than placebo) was nasopharyngitis (swelling of the nasal passages and the back of the throat). No serious adverse drug reactions related to eptinezumab were identified within the clinical trial program.

 

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