What have been the top mergers & acquisitions, announced or completed, among bio/pharma companies thus far in 2024? Deal-making to increase market positions in oncology, including antibody drug conjugates and radiopharmaceuticals, are among the top deals.

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

The companies and deals leading thus far in 204
Although mergers and acquisitions (M&A) activity has not seen a mega-deal thus far in 2024, there have been several large-scale acquisitions of note. Among the companies making key moves are Novo Nordisk, Bristol-Myers Squibb, AbbVie, Vertex Pharmaceuticals, Gilead Sciences, and Roche. Below is a roundup of the top M&A announced or completed, thus far in 2024.

Novo’s $16.5-billion pending acquisition of Catalent. The largest acquisition thus far in 2024 is unique in that it not a deal among bio/pharma companies but of a large bio/pharmaceutical company acquiring a CDMO to expand its manufacturing network. In February (February 2024), Novo Holdings, the parent company of Novo Nordisk, announced plans to acquire the CDMO Catalent for $16.5 billion as a means for Novo to add manufacturing capacity for its blockbuster glucagon-like peptide 1 (GLP-1) agonists for treating Type 2 diabetes and obesity, Ozempic/Wegovy/Rybelsus (semaglutide). The deal, which is expected to close later this year (2024), will net Novo three fill–finish sites and related assets in Anagni, Italy, Bloomington, Indiana, and Brussels, Belgium. After closing, Novo Holdings plans to sell the three fill–finish sites to Novo Nordisk for $11 billion. The Catalent acquisition is expected to gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.

Bristol Myers Squibb’s $14-billion acquisition of Karuna Therapeutics. The largest deal thus far directly among bio/pharmaceutical companies was Bristol-Myers Squibb’s $14-billion acquisition of Karuna Therapeutics, a Boston-based bio/pharmaceutical company specializing in neuroscience-based drugs. The acquisition was announced in December 2023 and completed in March 2024.

Karuna’s lead drug candidate is KarXT (xanomeline-trospium), an antipsychotic drug, currently slated for US Food and Drug Administration (FDA) review for later this year (2024). It has a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2024, for the treatment of schizophrenia in adults. KarXT is also in registrational trials both as an adjunctive therapy to existing standard-of-care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease, with potential to expand to additional indications, including bipolar I disorder and Alzheimer’s disease agitation. The acquisition also included early-stage and preclinical assets. With the closing of the deal, Karuna is now a wholly owned subsidiary of BMS. 

AbbVie’s $10.1-billion acquisition of Immunogen. Bio/pharma companies with oncology drug assets are always a much sought-after acquisition target, and there have been several large deals in which large bio/pharma companies have acquired oncology assets, including antibody drug conjugates (ADCs). ADCs are composed of both biologic and small-molecule components and consist of a small-molecule compound (for oncology applications, typically a cytotoxic compound) linked to a monoclonal antibody. In 2023, Pfizer’s $43-billion acquisition of Seagen, a Bothell, Washington-based bio/pharma company specializing in ADCs and other oncology drugs, was the largest M&A in 2023 and highlighted interest in ADCs. Chief among ADC deals thus far in 2024 was AbbVie’s $10.1-billion acquisition of ImmunoGen, a Waltham, Massachusetts-based bio/pharmaceutical company. The acquisition was announced in November 2023 and completed in June (June 2024).

ImmunoGen’s commercial product is Elahere (mirvetuximab soravtansine-gynx), an ADC for treating platinum-resistant ovarian cancer. Elahere is an ADC targeting folate receptor alpha (FRα) with a maytansinoid payload DM4, a tubulin inhibitor designed to kill the targeted cancer cells. Elahere received FDA accelerated approval in 2022 for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Phase III results will support a marketing authorization application to the European Union and a supplemental biologic license application to the FDA in order to gain full approval. Ongoing clinical development programs are underway to expand into earlier lines of therapy and enter other large patient segments of the ovarian market over the next 5-10 years, said AbbVie in a November 30, 2023, press statement, when first announcing the acquisition.

ImmunoGen’s pipeline includes a Phase I asset, IMGN-151, an anti-FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications. Pivekimab sunirine, currently in Phase II development, is an anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for treating relapsed/refractory BPDCN.  

AbbVie’s $8.7-billion acquisition of Cerevel Therapeutics. This week (August 1, 2024), AbbVie completed a key deal to boost its position in neuroscience-based drugs with its $8.7-billion acquisition of Cerevel Therapeutics, a Cambridge, Massachusetts-based bio/pharmaceutical company. The companies announced the deal last December (December 2023) and completed it this month (August 2024).

Cerevel has a pipeline of multiple clinical-stage and preclinical candidates with potential across several diseases, including schizophrenia, Parkinson’s disease, and mood disorders.  A key clinical product is emraclidine, an antipsychotic being evaluated in Phase Ib/II studies for treating schizophrenia. The drug is also being evaluated for treating dementia-related psychosis in Alzheimer’s disease and Parkinson’s disease. Emraclidine is currently in a Phase I study in elderly healthy volunteers in support of a potential Alzheimer’s disease psychosis program. 

Cerevel has multiple clinical assets that are complementary to AbbVie’s priority areas within neuroscience. Tavapadon, a drug for the management of Parkinson’s disease, is currently in Phase III studies and has potential as both a monotherapy and adjunctive treatment. CVL-354, currently in Phase I, is a drug for treating major depressive disorder. Darigabat, currently in Phase II, is a drug for treatment-resistant epilepsy and panic disorder.

BMS’ $5.8-billion acquisition of Mirati Therapeutics. Earlier this year (January 2024), Bristol-Myers Squibb (BMS) completed its acquisition of Mirati Therapeutics, a San Diego, California-based bio/pharmaceutical company, in a $5.8-billion deal ($4.8 billion at closing and $1.0 billion in contingency value rights payments). The acquisition was announced in October 2023. 

With the acquisition, BMS added a commercialized lung-cancer medicine, Krazati (adagrasib), to its oncology portfolio as well as several clinical assets. These drug candidates include Mrtx1719, in Phase I development for treating several cancers, including non-small-cell lung cancer (NSCLC), cholangiocarcinoma (bile duct cancer), and melanoma, and  Mrtx1133, in Phase I development, for treating pancreatic cancer, NSCLC, and colorectal cancer.

Vertex Pharmaceuticals’ $4.9-billion acquisition of Alpine Immune Sciences. Another key deal thus far in 2024 was from a smaller company, Vertex Pharmaceuticals, a Boston-based bio/pharmaceutical company, which announced the acquisition of Alpine Immune Sciences, a Seattle, Washington-based clinical-stage bio/pharmaceutical company developing protein-based immunotherapies, for approximately $4.9 billion.

Alpine’s lead molecule, povetacicept (ALPN-303), is in Phase II development to treat  IgA nephropathy, a progressive, autoimmune disease of the kidney that can lead to end-stage-renal disease. Povetacicept is on track to enter Phase III clinical development in the second half of 2024.

Gilead Sciences’ $4.3-billion acquisition of CymaBay Therapeutics. In March (March 2024), Gilead Sciences completed its $4.3-billion acquisition of CymaBay Therapeutics, a Newark, California-based clinical-stage bio/pharmaceutical company.

CymaBay’s lead candidate is seladelpar, an oral drug for treating primary biliary cholangitis (PBC), a rare, chronic, cholestatic liver disease. The drug was granted priority review by FDA with a PDUFA target action date of August 14, 2024. Seladelpar also received FDA breakthrough therapy designation for treating PBC, including pruritus (itching) in patients without cirrhosis or with compensated cirrhosis. The drug also received PRIME status from the European Medicines Agency (EMA), a process by which the EMA facilitates regulatory review for drugs meeting unmet medical need, as well as orphan drug designation in the US and Europe for treating PBC.

BMS’ $4.1-billion acquisition of Rayzebio. Radiopharmaceuticals have been a target for M&A among some companies, and Bristol Myers Squibb (BMS) joined the ranks with its $4.1-billion acquisition of RayzeBio, a San Diego, California-based clinical-stage radiopharmaceutical company, The acquisition was announced in January 2024 and completed in February (February 2024).

RayzeBio has a position in actinium-based radiopharmaceutical therapeutics targeting solid tumors, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs), small-cell lung cancer, hepatocellular carcinoma, and other cancers. Its lead program is RYZ101 (225Ac-dotatate), a small-cell lung cancer drug candidate in Phase III development targeting somatostatin receptor 2 (SSTR2) in patients with SSTR-positive GEP-NETs who have previously been treated with lutetium-177-based somatostatin therapies. Its pipeline also includes: RYZ801, a proprietary peptide for treating hepatocellular carcinoma, now in investigational new drug (IND)-enabling studies; an asset targeting CA9, which is expressed in renal cell cancer and currently in IND-enabling studies; and multiple preclinical assets to treat solid tumors. 

On the manufacturing side, BMS gained a manufacturing facility in Indianapolis, Indiana, with GMP drug production slated to have begun in the first half of 2024. 

Roche’s $3.1-billion acquisition of Carmot Therapeutics. Looking to target the strength of the market for diabetes and obesity drugs, Roche acquired Carmot Therapeutics, a Berkeley, California-based bio/pharmaceutical company, in a deal worth up to $3.1 billion ($2.7 billion at closing plus $400 million in potential milestone payments). The deal was announced last December (December 2023) and closed in January (January 2024).

The acquisition provides Roche with three clinical-stage assets with potential in treating obesity and diabetes. These include: (1) CT-388, a once-weekly subcutaneous injectable in Phase II, for treating obesity in patients with and without Type 2 diabetes; (2) CT-996, a once-daily oral small-molecule drug, in Phase I, for treating obesity in patients with and without Type 2 diabetes; and (3) CT-868, a once-daily subcutaneous injectable, in Phase II, for treating Type 1 diabetes patients with overweight or obesity. These drug candidates are incretins, which are gut hormones that are secreted after food intake and play a role in modulating blood glucose by stimulating insulin secretion and suppressing appetite. Roche says the incretin-based portfolio could also be expanded to other indications where incretins play a role, including cardiovascular, retinal, and neurodegenerative diseases. 

Other key deals
Outside of these top deals, there have been other smaller deals of note thus far in 2024 from Novartis, AstraZeneca, J&J, and Ono Pharmaceutical.

Novartis advanced its antibody-based oncology drug portfolio with its EUR 2.7 billion ($2.9 billion) acquisition of  MorphoSys, a Planegg, Germany-based bio/pharmaceutical company. The acquisition included MorphoSys’ pipeline of antibody-based drugs, but not MorphoSys’ lone commercial product, Monjuvi/Minjuvi (tafasitamab-cxix), which is being acquired separately by Incyte Pharmaceuticals, a Wilmington, Delaware-based bio/pharmaceutical company.

With the acquisition of MorphoSys, Novartis gained MorphoSys’ pipeline of antibody-based drugs. The key drug candidate from MorphoSys’ pipeline is pelabresib, in late-stage development, for treating myelofibrosis, a rare type of blood cancer. Other key pipeline candidates are tulmimetostat, in early-stage development for treating solid tumors or lymphomas.

AstraZeneca made a play in radiopharmaceuticals with its acquisition of Fusion Pharmaceuticals, a Hamilton, Ontario, Canada-based clinical-stage bio/pharmaceutical company, in a $2.4-deal billion deal ($2 billion upfront and $400 million in milestone payments). The acquisition was completed in June (June 2024). Fusion specializes in developing radioconjugates to treat cancer. Fusion’s lead candidate is FPI-2265, an actinium-based radioconjugate as a potential new treatment for patients with metastatic castration-resistant prostate cancer (mCRPC), currently in a Phase II trial. FPI-2265 targets prostate-specific membrane antigen (PSMA), a protein that is highly expressed in mCRPC, according to information from AstraZeneca. The acquisition also includes R&D and manufacturing facilities.

AstraZeneca also bolstered its rare-disease drug portfolio with the acquisition of Amolyt Pharma, a clinical-stage bio/pharmaceutical company, in an $1-deal billion (includes $800 million upfront and $250 million in milestone payments), a deal completed last month (July 2024). Amolyt’s lead candidate is eneboparatide, a Phase III investigational therapeutic peptide for treating hypoparathyroidism, a rare disease in which the body produces abnormally low levels of the parathyroid hormone, which is key to regulating and maintaining a balance of calcium and phosphorus in the body. 

In March (March 2024), Johnson & Johnson (J&J) made a play in oncology and ADCs with its $2-billion acquisition of Ambrx Biopharma, a San Diego-based bio/pharmaceutical company specializing in ADCs. Ambrx is advancing a portfolio of clinical and preclinical programs in multiple cancer indications, including: ARX517, an ADC for prostate cancer; ARX788, an ADC for breast cancer; and ARX305, an ADC for renal-cell carcinoma.

Another move in oncology was from Ono Pharmaceutical, an Osaka, Japan-based bio/pharmaceutical company, which completed its $2.4-billion acquisition of Deciphera Pharmaceuticals, a Waltham, Massachusetts-based bio/pharmaceutical company, in June (June 2024).

The acquisition adds to Ono’s oncology operations and provides the company with commercial operations in the US and Europe. Deciphera’s key commercial product is Qinlock (ripretinib), which is approved in over 40 countries and marketed globally, including in the US, Europe, and China, for the treatment of fourth-line gastrointestinal stromal tumors, a type of cancer that begins in the digestive system. A key late-stage drug candidate is vimseltinib, now in Phase III development, for treating patients with tenosynovial giant cell tumors, a group of rare tumors that cause the synovium, bursae, or tendon sheaths to thicken and overgrow and damage the surrounding tissue and structures of affected limbs.