NOVARTIS

The MET targeting therapies market is poised for significant growth by 2034 due to rising cancer diagnoses, increased awareness, and numerous therapies in clinical trials. Key players include AstraZeneca, AbbVie, and Regeneron, with therapies like ORPATHYS and Telisotuzumab Vedotin in development. Regulatory approvals and precision medicine advancements are driving market dynamics, though challenges like pricing and reimbursement persist.

Novartis' NVP-DFV890, an NLRP3 inhibitor with a unique sulfonimidamide motif, shows reduced hydrolysis and promising PK in humans. It is advancing in Ph. II trials for coronary heart disease and knee osteoarthritis, with discovery and preclinical data presented at EFMC-ISMC 2024.

In 2024, biotech IPOs remained limited, with companies struggling post-debut. M&A activity was tepid, with notable deals like Novo Holdings' $16.5B Catalent merger. Novartis' $1.1B acquisition of Kate Therapeutics highlighted early-stage science's appeal. Neuroscience, GLP-1s, radiopharma, and antibody-drug conjugates were key topics. An Alzheimer’s drug and RSV vaccines marked progress. The industry remains in a downturn, with hopes for diverse breakthroughs in 2025.

Cancer trials face a 95% failure rate despite advancements like CAR T-cell therapies. Nuclear isotopes, used for imaging and therapy, show promise in targeting cancer cells while sparing healthy tissues. Actinium-225 and Lutetium-177 are particularly promising, with challenges including supply, delivery precision, and patient-specific dosing. AI could optimize isotope production, delivery, and personalized treatment plans, though data limitations and high costs remain significant hurdles.

The US biosimilar market surged in 2024, driven by FDA approvals and looming patent cliffs, with 63 biosimilars approved and 42 launched. Innovator companies like Novartis, Biogen, Pfizer, and Amgen are entering biosimilar development to mitigate sales erosion. Challenges include market access, reimbursement barriers, and HCP/patient perception. Education and transparency are crucial for biosimilar adoption, with AI tools potentially aiding HCPs.

Novartis secured public reimbursement of lutetium-177 vipivotide tetraxetan (Pluvicto) for PSMA-positive mCRPC patients in Canada. Pluvicto, approved by Health Canada in 2022 and the US FDA in 2022, offers hope for patients with advanced prostate cancer. The therapy still needs to be added to provincial formularies for patient access.

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.

The Global Nano-Biotechnology Market, valued at $157.5 billion in 2023, is projected to reach $421.5 billion by 2034 with a CAGR of 9.3%, driven by advancements in drug delivery, diagnostics, imaging, and tissue engineering. Key drivers include precision medicine, targeted therapies, and AI integration. Challenges include high development costs and regulatory hurdles, but opportunities exist in emerging markets. North America leads, followed by Europe and Asia-Pacific. Major players include Johnson & Johnson, Abbott, and Novartis.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed due to insufficient enrollment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Median recurrence-free intervals were 11.4 months with niraparib vs. 5.4 months with placebo, though conclusions on efficacy are limited.

UCB's ORCHESTRA study of minzasolmin, an alpha-synuclein misfolding inhibitor for early Parkinson’s, did not meet primary/secondary endpoints. UCB continues research with UCB7583 and glovadalen for Parkinson’s, focusing on alpha-synuclein and dopamine D1 receptor activation.