Welcome to our dedicated page for Alk-Abello A/S news (Ticker: AKBLF), a resource for investors and traders seeking the latest updates and insights on Alk-Abello A/S stock.
News for ALK-ABELLO AS B SHS NEW (AKBLF) centers on its activities as a global specialty pharmaceutical company focused on allergy and allergic asthma. Company announcements highlight developments in allergy immunotherapy, diagnostic tools, and related treatments that support people with allergies and the healthcare professionals who care for them.
Recent news has emphasized regulatory milestones for ODACTRA, ALK’s house dust mite allergen tablet for sublingual immunotherapy. Releases describe U.S. Food and Drug Administration approvals expanding ODACTRA’s indication to additional age groups, along with clinical trial data on efficacy and safety in children and adolescents with house dust mite–induced allergic rhinitis, with or without conjunctivitis.
ALK’s news flow also covers diagnostic and testing products. The company has announced FDA approval and licensing of its AccuTest allergy skin testing devices and allergen well trays, designed for single and multi-head skin prick testing. Another recurring topic is penicillin allergy evaluation, where ALK reports that it has become the sole manufacturer and distributor of PRE-PEN, described as the only FDA-approved diagnostic skin test for the evaluation of penicillin allergy in specified settings.
In addition, ALK has reported on portfolio expansion into ear, nose and throat and pediatric care through the acquisition of OTIPRIO, a ciprofloxacin otic suspension indicated for conditions such as bilateral otitis media with effusion during tympanostomy tube placement and acute otitis externa.
Visitors to this news page can review company press releases on product approvals, clinical data, acquisitions, and portfolio updates related to allergy immunotherapy, diagnostics, and associated treatments.
ALK (AKBLF) announced FDA approval for expanded indication of ODACTRA® to treat house dust mite-induced allergic rhinitis in children ages 5-11 years, extending from the previous 12-65 years age range. The approval stems from a landmark Phase 3 trial involving 1,458 children - the largest pediatric trial of house dust mite allergen immunotherapy to date.
The study demonstrated a 22% relative reduction in total combined rhinitis score versus placebo. ODACTRA is administered as a sublingual tablet, offering a convenient alternative to injection-based treatments. The safety profile aligned with adult/adolescent findings, with mostly mild to moderate adverse events. The most common treatment-related adverse events included oral pruritus, throat irritation, and ear pruritus, with no reported serious adverse events or anaphylaxis cases in the pediatric group.
ALK, a global pharmaceutical company focused on allergy prevention, diagnosis, and treatment, has announced FDA approval for its new AccuTest™ line of allergy skin testing devices. The innovative product range includes:
1. AccuTest-1™: Single skin prick testing device
2. AccuTest-8™ and AccuTest-10™: Multi-head applicators with 8 and 10 heads respectively
3. AccuTest™ 48-well and 60-well allergen trays
These devices feature improved ergonomics, smaller tine lengths and diameters for increased accuracy and patient comfort. The allergen trays have an air-tight locking mechanism and non-slip rubber bottom for stability. A recent study suggests that AccuTest™'s lower device variability may increase result reliability compared to two currently FDA-approved skin prick tests.
ALK announced the FDA approval of ODACTRA, an allergen extract tablet for sublingual use, now indicated for treating house dust mite (HDM)-induced allergic rhinitis in individuals aged 12 to 17, alongside adults aged 18 to 65. This expands ODACTRA's use, building on its initial launch for adults in 2017. With nearly 50% of allergy patients sensitive to HDMs, this approval targets a significant market need. The 28-day MT-18 trial confirmed ODACTRA's safety and efficacy in adolescents, showing a 22% reduction in total combined rhinitis scores. This treatment offers a convenient home-administered option, enhancing allergy management for teenagers.
ALK, a global pharmaceutical company, has acquired OTIPRIO® (ciprofloxacin otic suspension) from Otonomy, Inc. This acquisition enhances ALK's presence in ear, nose, and throat (ENT) and pediatric markets. OTIPRIO is approved for treating bilateral otitis media with effusion during tympanostomy tube placements and acute otitis externa in pediatric patients. The strategic purchase follows an exclusive co-promotion agreement signed in June 2020, reinforcing ALK's aim to offer innovative healthcare solutions and expand its U.S. commercial footprint.
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