Alnylam Pharmaceuticals develops and commercializes RNA interference (RNAi) therapeutics, with news centered on its approved medicines, TTR franchise, clinical pipeline and financial performance. Company updates commonly address AMVUTTRA/vutrisiran and ONPATTRO/patisiran for transthyretin-mediated amyloidosis, GIVLAARI/givosiran for acute hepatic porphyria, OXLUMO/lumasiran for primary hyperoxaluria type 1, and partner-commercialized RNAi medicines.
Recurring developments include quarterly product revenue reports, guidance, clinical and real-world data for ATTR-CM and other cardiovascular programs, pipeline progress across cardio-metabolic disease, neuroscience and hematology, disease-awareness collaborations, and investor conference presentations. Alnylam also reports on its Alnylam 2030 strategy and commercialization of RNAi medicines in global markets.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced upcoming presentations at several virtual healthcare conferences. Key dates include:
- Jefferies Virtual Healthcare Conference on June 1, 2021, at 2:30 PM ET
- Bernstein 37th Annual Strategic Decisions Conference on June 3, 2021, at 9:00 AM ET
- Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021, at 10:30 AM ET
- 44th Nasdaq Investor Conference on June 15, 2021, at 10:00 AM ET
Webcasts will be available on the company's investor website, with replays accessible within 48 hours post-event.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced the initiation of a clinical study for a biannual dosing regimen of vutrisiran, targeting hereditary transthyretin-mediated amyloidosis (hATTR). This follows positive results from the HELIOS-A Phase 3 study using a quarterly dosing regimen. The biannual regimen aims to align treatment frequency with patient visits, potentially enhancing adherence. The company is also advancing a pre-clinical program using the IKARIA platform to achieve over 90% TTR reduction with annual dosing. Positive RTE results are expected in 2022, supporting potential additional regulatory filings.
Alnylam Pharmaceuticals (Nasdaq: ALNY) revealed plans for management to present at two upcoming virtual conferences. The events are the BofA Health Care Conference on May 11, 2021, at 2:45 pm ET and the UBS Global Healthcare Virtual Conference on May 25, 2021, at 3:00 pm ET. Investors can access the live audio webcast on the company's website, with a replay available within 48 hours post-event. Alnylam is at the forefront of RNA interference therapeutics, focusing on innovative medicines for rare genetic and other diseases with a diverse pipeline of investigational products.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced promising early results from the 12-month analysis of the ILLUMINATE-A Phase 3 study of OXLUMO (lumasiran), targeting primary hyperoxaluria type 1 (PH1). The data, presented at the ASPN/PAS virtual meeting, revealed significant reductions in urinary oxalate levels among patients, with notable improvements in nephrocalcinosis observed in 46% of those treated for 12 months. OXLUMO's safety profile remains acceptable, with injection site reactions being the most common adverse effect. Alnylam anticipates reporting further data later this year.
Alnylam Pharmaceuticals reported strong first-quarter 2021 results, with total net product revenues of $135.8 million, marking an 89% increase year-over-year. ONPATTRO drove growth with revenues of $102 million, up 13% quarter-over-quarter. OXLUMO's initial launch generated $9 million in revenues. The company filed an NDA for vutrisiran, with positive HELIOS-A Phase 3 results and accelerated enrollment in HELIOS-B expected to complete by late 2021. Alnylam aims to transition into a top five biotech by 2025 with its P5x25 strategy while maintaining a strong cash position of $1.71 billion.
Alnylam Pharmaceuticals announced successful outcomes from the HELIOS-A Phase 3 study of vutrisiran, targeting transthyretin-mediated amyloidosis. The investigational RNAi therapeutic met primary and secondary endpoints at nine months, showing a significant 83% mean reduction in serum TTR levels and improvements in the Neuropathy Impairment Score and quality of life measures. A New Drug Application has been submitted to the FDA for vutrisiran's approval. The treatment demonstrated a favorable safety profile, with no drug-related discontinuations or deaths reported.
Alnylam Pharmaceuticals (Nasdaq: ALNY) will release its first-quarter 2021 financial results on April 29, 2021, before market opens. The company's management will hold a conference call at 8:30 am ET to discuss these results and future expectations. Interested parties can access the call via phone or through a live audio webcast on Alnylam's investor website. Alnylam aims to leverage its RNA interference (RNAi) platform to address various diseases, showcasing a strong pipeline and ongoing commitment to innovation in the biotech sector.
Alnylam Pharmaceuticals (Nasdaq: ALNY) reported positive interim results from its Phase 1 study of ALN-AGT, a novel RNAi therapeutic for hypertension. The study showed significant dose-dependent reductions in serum angiotensinogen (AGT) and blood pressure, with a maximum 17 mm Hg reduction in 24-hour systolic blood pressure at the 800 mg dose. The treatment was well tolerated, with most adverse events being mild. The company plans to initiate Phase 2 KARDIA studies in mid-2021, suggesting ALN-AGT may transform hypertension management.
Alnylam Pharmaceuticals (Nasdaq: ALNY) will present an overview at the 20th Annual Needham Virtual Healthcare Conference on April 13, 2021, at 1:30 pm ET. A live audio webcast will be accessible via the Investors section of the Company's website, with a replay available within 48 hours post-event. Alnylam is a leader in RNA interference (RNAi) therapeutics, aiming to transform treatments for rare genetic, cardio-metabolic, hepatic infectious, and CNS diseases. Their portfolio includes commercially available products like ONPATTRO, GIVLAARI, OXLUMO, and Leqvio.
Alnylam Pharmaceuticals (Nasdaq: ALNY) announced pivotal results from the ILLUMINATE-A Phase 3 study of lumasiran, an RNAi therapeutic for primary hyperoxaluria type 1 (PH1). Published in NEJM, the study showed a significant 53.5% reduction in urinary oxalate levels compared to placebo at six months. Notably, 84% of patients on lumasiran reached normal or near-normal oxalate levels. The treatment had a favorable safety profile with no severe adverse events reported. OXLUMO is the first approved therapy for PH1, addressing a critical unmet medical need for patients.