Genmab

Johnson & Johnson submits regulatory applications to FDA and EMA for Darzalex Faspro as monotherapy for high-risk smoldering multiple myeloma, supported by AQUILA study data. Smoldering multiple myeloma, an early precursor to active multiple myeloma, currently not treated until progression, but high-risk patients may benefit from early intervention. First AQUILA study data to be presented at 2024 ASH Annual Meeting.

Johnson & Johnson reports positive phase 3 data for Darzalex in smouldering multiple myeloma, filing applications in Europe and US. Darzalex Faspro, a subcutaneous injection, could be the first treatment option for this pre-cancerous condition. Based on AQUILA study results, Darzalex Faspro showed significant PFS reduction and ORR improvement compared to active monitoring. Darzalex, already a $9.7 billion drug, aims to maintain its lead over Sanofi's Sarclisa in the multiple myeloma market.

Johnson & Johnson has submitted applications to the FDA and EMA for DARZALEX FASPRO® to treat high-risk smoldering multiple myeloma, based on Phase 3 AQUILA study data. If approved, it would be the first therapy for this patient population before full-blown disease onset. DARZALEX FASPRO® is currently approved for multiple myeloma indications and is the only subcutaneous CD38-directed antibody treatment. Johnson & Johnson also reported strong Q3 results and raised its full-year guidance, with analyst upgrades following robust sales. The company faces ongoing legal challenges, including a recent $15 million talc cancer case verdict.

Johnson & Johnson submits regulatory applications to FDA and EMA for DARZALEX FASPRO® as a treatment for high-risk smoldering multiple myeloma, supported by Phase 3 AQUILA study data.

In 2024, smaller deals have dominated pharma M&A, with no single deal surpassing $5 billion. Despite this, M&A remains crucial for refilling pipelines and supporting smaller biotechs. Notable deals include Vertex's $4.9 billion acquisition of Alpine Immune Sciences, Eli Lilly's $3.2 billion acquisition of Morphic, and Gilead's $4.3 billion purchase of CymaBay. Oncology and neuroscience have seen significant activity, with Novartis and AstraZeneca leading in oncology, and Bristol Myers Squibb and Lundbeck in neuroscience.

AbbVie, a pharmaceutical firm with strong immunology and oncology portfolios, is compared against key competitors in the Biotechnology industry. Analysis reveals AbbVie's PE ratio is low, suggesting potential undervaluation, while its high PB ratio indicates overvaluation based on book value. A low PS ratio implies undervaluation based on sales. AbbVie's high ROE, EBITDA, and gross profit highlight strong profitability and operational efficiency, but low revenue growth indicates challenges in market expansion.

Novartis ended Q3 positively, promising revenue and operating income from its core business will be at the upper end of its previously stated expectations.

Janssen-Cilag wins EC approval for Darzalex SC in NDMM patients, backed by Phase 3 PERSEUS study showing significant PFS improvement and 75.2% MRD negativity rate.

The anti-CD38 mAb market is set to grow due to strong uptake of DARZALEX and expected entry of SARCLISA subcutaneous formulation, driven by rising cancer and autoimmune disorder diagnoses and increasing clinical trials. DARZALEX dominates with 50% usage in second-line Multiple Myeloma treatment, while SARCLISA trails. Emerging indications include Systemic Lupus Erythematosus and Chronic Kidney Disease. Key companies developing anti-CD38 mAbs are Takeda Pharmaceuticals, HI-Bio, and Genmab. Market dynamics face challenges from biosimilar competition and pricing pressures.

Pharmas focus on Phase II companies, with 40% of M&A deals completed in under six weeks. Capital markets remain uncertain, leading to more private companies with advanced assets. Deals are more competitive, with mid-caps and European players becoming active acquirers.