Regeneron Pharmaceuticals - REGN STOCK NEWS

Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for linvoseltamab, targeting the treatment of adult patients with relapsed/refractory multiple myeloma. The treatment is specifically for patients who have undergone at least four prior therapy lines or those with three prior lines who are refractory to their last treatment.

The FDA's decision is expected by July 10, 2025. The resubmission follows the resolution of third-party fill/finish manufacturing issues, which was previously the only approvability concern. The application is supported by data from the LINKER-MM1 trial and is currently also under review by the European Medicines Agency (EMA) for the same patient population.

Regeneron Pharmaceuticals (REGN) presented positive Phase 3 QUASAR trial results for EYLEA HD® (aflibercept) Injection 8 mg in treating macular edema following retinal vein occlusion (RVO). The trial met its primary endpoint, demonstrating that EYLEA HD patients dosed every 8 weeks achieved non-inferior vision gains compared to EYLEA® 2 mg dosed every 4 weeks.

Key findings show that 88% of patients maintained an 8-week dosing schedule after 3 initial monthly doses, and 93% after 5 initial monthly doses. The safety profile remained consistent with previous trials, with ocular pressure increase reported in 5% of patients. The data will support a supplemental Biologics License Application to the FDA in Q1 2025.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive three-year results for EYLEA HD® (aflibercept) Injection 8 mg in wet age-related macular degeneration (wAMD) patients from the Phase 3 PULSAR trial extension study.

Key findings after three years of EYLEA HD treatment show that 77% of patients achieved dosing intervals of ≥3 months, 58% ≥4 months, 40% ≥5 months, and 24% achieved 6-month intervals, while maintaining vision and anatomic improvements. Patients who switched from EYLEA® 2 mg to EYLEA HD also maintained improvements with extended dosing intervals: 79% achieved ≥3 months and 43% achieved ≥4 months intervals.

The safety profile remained consistent with previous trials, with ocular treatment emergent adverse events including cataract, retinal hemorrhage, and reduced visual acuity. The intraocular inflammation rate was 2.4% for patients switching from EYLEA to EYLEA HD and 1.9% for patients starting with EYLEA HD.

Regeneron (REGN) reported strong Q4 2024 financial results with revenues increasing 10% to $3.79 billion and full-year 2024 revenues up 8% to $14.20 billion. Key highlights include:

- Dupixent global net sales grew 15% to $3.70 billion in Q4 and 22% to $14.15 billion for full year
- Combined EYLEA HD and EYLEA U.S. net sales increased 2% to $1.50 billion in Q4
- Libtayo global net sales rose 50% to $367 million in Q4

The company announced significant shareholder returns including:
- Initiation of $0.88 quarterly dividend program
- Additional $3.0 billion share repurchase authorization, bringing total capacity to ~$4.5 billion

Regulatory submissions were made for EYLEA HD pre-filled syringe, Dupixent in bullous pemphigoid, and other key products. Positive Phase 3 results were reported for EYLEA HD in retinal vein occlusion and Libtayo in high-risk adjuvant cutaneous squamous cell carcinoma.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science have announced the top 40 finalists for the 2025 Regeneron Science Talent Search (STS), America's oldest and most prestigious STEM competition for high school seniors. The competition, now in its 84th year, will award over $1.8 million in prizes, with individual awards ranging from $25,000 to $250,000.

The finalists, selected from 300 scholars and nearly 2,500 total entrants, represent 39 schools across 16 U.S. states. Their research projects cover diverse topics including species migration, crop protection, disease diagnosis using AI, and genetic and cancer therapies. The competition will take place from March 6-12, 2025, in Washington D.C., with the top 10 winners being announced on March 11.

The program's alumni have achieved remarkable success, including 13 Nobel Prizes and 23 MacArthur Fellowships. Each finalist's school receives $2,000 to support math and science programs, demonstrating the competition's commitment to fostering scientific innovation and education.

Regeneron Pharmaceuticals (NASDAQ: REGN) and Society for Science announced the top 40 finalists for the 2025 Regeneron Science Talent Search (STS), America's longest-running STEM competition for high school seniors. The finalists, selected from 300 scholars and 2,500 total entrants, represent 39 schools across 16 U.S. states.

The competition, now in its 84th year, will award more than $1.8 million in prizes, with individual awards ranging from $25,000 to $250,000 for the top winner. The finalists will participate in a week-long competition from March 6-12, 2025, featuring rigorous judging and public research presentations.

Research projects span diverse areas including species migration, crop protection, disease diagnosis using AI, and genetic and cancer therapies. The program has a notable track record, with alumni winning 13 Nobel Prizes and 23 MacArthur Fellowships.

Regeneron Pharmaceuticals (REGN) provided key business updates at the J.P. Morgan Healthcare Conference. Dupixent now treats over a million patients globally, with recent approval in COPD. EYLEA HD and EYLEA maintained U.S. anti-VEGF market leadership, achieving $6 billion in combined U.S. net sales for 2024, up 1% year-over-year. Fourth quarter sales reached $1.5 billion.

Libtayo exceeded $1 billion in 2024 sales and demonstrated significant clinical benefits in high-risk CSCC treatment, showing a 68% reduction in disease recurrence risk. The company resubmitted the Linvoseltamab BLA, with launch expected mid-2025. Regeneron's pipeline includes approximately 40 investigational candidates, with advanced programs targeting a market opportunity exceeding $220 billion by 2030.

The company also announced collaboration with Truveta to expand its DNA-linked healthcare database, aiming to sequence up to 10 million additional individuals.

Regeneron Pharmaceuticals (REGN) announced positive results from the Phase 3 C-POST trial of Libtayo® (cemiplimab) for high-risk cutaneous squamous cell carcinoma (CSCC) post-surgery treatment. The trial demonstrated a 68% reduction in disease recurrence or death risk compared to placebo, with a median follow-up of 24 months.

The study enrolled 415 patients, randomized to receive either Libtayo or placebo for up to 48 weeks. Safety analysis showed adverse events in 91% of Libtayo patients versus 89% in placebo group, with Grade ≥3 adverse events occurring in 24% versus 14% respectively. Treatment discontinuations were 10% in the Libtayo arm compared to 1.5% in placebo.

Regeneron plans to submit these results to the FDA in the first half of 2025. Notably, Libtayo is the first immunotherapy to show significant benefit in high-risk CSCC in the adjuvant setting, while a recent Phase 3 trial with Keytruda® failed in the same application.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced a strategic collaboration with Truveta, Inc. and its U.S. health systems network, investing $119.5 million in Truveta's Series C financing round. The partnership launches the Truveta Genome Project, which aims to sequence up to ten million additional de-identified patient volunteers with linked electronic health records (EHRs).

The project will expand Regeneron Genetics Center's existing database of nearly three million exomes. RGC will conduct exome sequencing, genotyping, and imputation of the volunteers using biospecimens from Truveta's health system members. This data will integrate with Truveta's medical database, which represents over 120 million patients across 30 health systems.

Illumina, Inc. will also invest $20 million in the financing round. RGC will maintain exclusive rights to perform research-related sequencing on collected samples and access de-identified EHR data from study participants. The collaboration aims to accelerate drug target discovery, optimize clinical trials, and advance healthcare delivery.