Regeneron Pharmaceuticals

2024 saw over 25 pediatric FDA approvals, including givinostat for Duchenne muscular dystrophy, FluMist for influenza, clonidine hydrochloride for ADHD, dupilumab for eosinophilic esophagitis, epinephrine nasal spray for anaphylaxis, and roflumilast cream for atopic dermatitis.

Regeneron's phase 3 QUASAR trial of EYLEA HD met primary endpoint, showing improved BCVA in RVO patients. EYLEA HD, with 8-week dosing, demonstrated better vision with fewer injections than EYLEA. Safety profile similar to EYLEA. Regeneron plans to submit data to FDA in Q1 2025.

Bayer announced positive phase III QUASAR study results for aflibercept 8 mg, showing non-inferior visual acuity gains compared to Eylea™ 2 mg in retinal vein occlusion patients, with extended treatment intervals and a well-tolerated safety profile. Aflibercept 8 mg has potential as a new standard of care for exudative retinal diseases, offering less frequent injections at comparable efficacy and safety.

FDA approved tapinarof cream 1% for atopic dermatitis in ages 2 and older, representing a non-steroidal option with a new mechanism of action. It improves skin barrier and reduces inflammation, showing a remittive effect. Over 80% of participants aged 2-17 in ADORING 3 trial achieved clear or almost clear skin, with 52% reporting completely clear skin.

EYLEA HD showed non-inferior vision gains with an 8-week dosing regimen compared to EYLEA's 4-week regimen in treating macular edema due to retinal vein occlusion. Safety profiles remained consistent with known EYLEA HD and EYLEA profiles. A supplementary biologics license application to the FDA is planned for Q1 2025.

Regeneron Pharmaceuticals, Inc. announced its sixth consecutive inclusion in the Dow Jones Sustainability World Index and fifth in the North America Index, highlighting its leadership in responsible practices. Regeneron scored in the top 1% of biotechnology companies globally, focusing on Societal Healthcare, Human Capital Management, and Corporate Governance. The company's responsibility strategy aims to improve lives, foster integrity, and build sustainable communities.

Digital transformation in pharma is crucial, with 75% of organizations implementing Pharma 4.0. Key drivers include patient demands, regulatory changes, and competition. Top technologies include AI, IoT, blockchain, and digital twins. Strategic insights focus on R&D, supply chain, marketing, and patient engagement.

Matthew Budoff, MD, discusses the rising prevalence of obesity in type 1 diabetes (T1D) and its cardiovascular implications, emphasizing the need for a treatment paradigm shift to address obesity and cardiometabolic complications. New therapies like SGLT 1/2 inhibitors and GLP-1 receptor agonists show promise, with GLP-1 agonists offering significant benefits in weight reduction and cardiovascular risk mitigation. Early use of calcium scoring or CT angiography is recommended to identify subclinical atherosclerosis. Budoff highlights GLP-1 receptor agonists as a game-changing therapeutic class addressing obesity, diabetes, and cardiovascular health.

Focke Ziemssen, Michelle Sylvanowicz, Winfried M. Amoaku, Tariq Aslam, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian, Jean-François Korobelnik, Xiaofeng Lin, Anat Loewenstein, Paul Mitchell, Moira Murphy, David R. Owens, Nick Parker, Ian Pearce, Francisco J. Rodríguez, Jude Stern, S. James Talks, David T. Wong, Tien Yin Wong, and Jane Barratt disclose various financial interests including travel grants, personal fees, advisory board memberships, speaker fees, research sponsorship, and consulting roles with companies such as Allergan, AbbVie, Alimera, Bayer Healthcare, Biogen, Boehringer Ingelheim, Janssen, Novartis, Novo Nordisk, Merck, Regeneron, Roche, Sanofi, and others.

Stan Smith, MAIA Biotechnology director, acquired 25,000 shares and warrants at $1.872 and $2.08 per share, respectively. MAIA's stock gained 139% in a year. The company expanded its Phase 2 trial, THIO-101, for third-line non-small cell lung cancer treatment, with promising interim results. MAIA considers an accelerated approval pathway based on trial outcomes.