A roundup of news from the large and mid-sized bio/pharmaceutical companies featuring Eli Lilly and Company, Takeda, Moderna, Sobi, Zealand Pharma, and Zydus Life Sciences. Highlights below. 

For the latest news roundup on small and Emerging Pharma companies, see Biotech Briefs.

Manufacturing News 
*Fresenius Kabi Recalling One Lot of Injectable Due To Glass Particles 
Pipeline and Product Updates 
*Lilly Files Lawsuits Against US Entities Selling Illegal Versions of Investigational Obesity Drug 
*Takeda Gets FDA Nod for Rare-Disease Sleep-Disorder Drug 
*Moderna Gets FDA OK for mRNA Seasonal Flu Vaccine 
Mergers and Acquisitions 
*Sangamo Therapeutics Sells Select Assets to Lilly, PTC Therapeutics 
*Zealand Sell Rights to Takeda Investigational Peptide Drug for $100 M 
Partnering 
*Sobi, Innate Pharma in $580-M Pact for mAb Cancer Immunotherapy 
* Zydus’ Sentynl Therapeutics, Mereo in $475-M Pact for Small-Molecule Liver Drug 
Restructuring 
*Emergent BioSolutions Announces $40-M Restructuring 

Manufacturing News 

Fresenius Kabi Recalling One Lot of Injectable Due To Glass Particles 
Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne (tocilizumab-aazg) injection 400-mg/20-mL (20 mg/mL) 20-mL vials to the user level due to an internal investigation at the firm that found the product contained glass particles. The drug was distributed nationwide in the US to wholesalers, distributors and direct customers. Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. 

Tyenne is indicated for treating moderately to severely active rheumatoid arthritis, giant cell arteritis, active polyarticular juvenile idiopathic arthritis, active systemic juvenile idiopathic arthritis, chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome, and certain hospitalized adult patients with COVID-19. 

Source: US Food and Drug Administration 

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Pipeline and Product Updates 

Lilly Files Lawsuits Against US Entities Selling Illegal Versions of Investigational Obesity Drug 
Eli Lilly and Company has filed six new lawsuits against US entities selling illegal versions of retatrutide, the company’s investigational drug for treating obesity, Type 2 diabetes, and other related indications. The drug is in Phase III trials, and no medicine containing retatrutide has yet been approved for human use by any regulatory agency and it is not available for sales to consumers.  

Lilly notes that the US Food and Drug Administration (FDA)  has specified that sales of unapproved retatrutide to consumers are illegal, that retatrutide cannot be lawfully compounded, and that so-called “research-use only” products “are of unknown quality and may be harmful to [consumers’] health.” Lilly’s lawsuits target US entities selling illegal retatrutide products, including compounding pharmacies, medical spas, and online sellers that falsely claim their drugs are for “research-use only” when they are actually intended for human use. Lilly has also referred more than 200 individuals and entities to FDA, the US Department of Justice, state attorneys general, law enforcement, and professional licensing boards and is working with global regulators, law enforcement, and customs authorities to stop this illegal market. The company has reported more than 14,000 websites, advertisements, social media posts, and product listings that unlawfully market retatrutide in over 100 countries to internet service providers, social media platforms, and e-commerce companies. 

Source: Eli Lilly and Company
 
Takeda Gets FDA Nod for Rare-Disease Sleep-Disorder Drug 
Takeda reports that the US Food and Drug Administration (FDA) has approved Orzeyful (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for treating narcolepsy type 1 (NT1, narcolepsy with cataplexy), a rare, chronic neurological disease resulting in excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), cognitive symptoms, and disrupted nighttime sleep. The drug is considered a key potential growth driver for the company.  

Source: Takeda

Moderna Gets FDA OK for mRNA Seasonal Flu Vaccine 
Moderna reports that the US Food and Drug Administration (FDA) has approved, its mRNA seasonal influenza vaccine, mFlusiva, for use in adults 50 years and older, marking the first approval of a mRNA seasonal flu vaccine, according to the company. The vaccine has been accepted for regulatory review in the European Union, Canada, and Australia. Regulatory submissions in additional countries are planned during 2026. 

Source: Moderna 

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Mergers and Acquisitions 
 
Sangamo Therapeutics Sells Select Assets to Lilly, PTC Therapeutics 
Sangamo Therapeutics, a genomic medicine company, has successfully concluded a court-supervised auction process under US bankruptcy proceeding and has selected winning bids in selling separate assets respectively to PTC Therapeutics, a Warren, New Jersey-based bio/pharmaceutical company, and Eli Lilly and Company.  

PTC Therapeutics was selected as the successful bidder for Sangamo’s Fabry disease program, isaralgagene civaparvovec, for $111 million upfront, plus up to $100 million in potential future milestone payments, comprising of $80 million upon receiving accelerated approval and $20 million upon receiving traditional or full approval from the US Food and Drug Administration. 

Lilly has been selected as the successful bidder to acquire Sangamo’s capsid delivery, zinc finger, and modular integrase (MINT) platforms and the prion disease program, ST-506, for $50 million in cash consideration at closing. 

In addition, various bidders have been selected for certain Sangamo tools and equipment for $2.55 million in cash consideration at closing. 

The proposed asset sales remain subject to final approval by the US Bankruptcy Court for the District of Delaware. Sangamo will present the winning bids for Court confirmation at sale hearings expected to occur in the third quarter of 2026. Subject to Court approval and the satisfaction of customary closing conditions, the asset sale transaction with Lilly is expected to close on or about September 4, 2026, and the asset sale transaction with PTC Therapeutics is expected to close following completion of review under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. 

Sangamo continues to solicit and review offers for its other key assets, including the clinical-stage programs, ST-503 for chronic neuropathic pain and giroctocogene fitelparvovec for hemophilia A, as well as Sangamo’s cell-therapy and regulatory T cell assets. 

Source: Sangamo Therapeutics 

Zealand Sell Rights to Takeda Investigational Peptide Drug for $100 M 
Zealand Pharma, a Copenhagen, Denmark-based bio/pharmaceutical company, has entered into a $100-million royalty purchase and sale agreement with Royalty Pharma a New York-based investment firm buying bio/pharmaceutical royalties, in exchange for Zealand Pharma’s economic interests related to rusfertide, a drug for treating polycythemia vera, a rare and chronic blood disorder, and partnered drug between Takeda and Protagonist Therapeutics, a Newark, California bio/pharma company. Rusfertide is an injectable peptide that mimics hepcidin, a natural hormone that manages iron in the blood and red-cell production.   

In 2012, Zealand Pharma and Protagonist Therapeutics entered into a research collaboration agreement to develop disulfide-rich peptides (DRPs) with Zealand Pharma responsible for preclinical and clinical drug development of DRPs discovered under the collaboration. The research collaboration was terminated in 2014, and Protagonist’s payment obligations to Zealand Pharma were clarified in a settlement agreement reached in 2021. In 2024, Protagonist and Takeda entered into a worldwide license and collaboration agreement for rusfertide. 

Under the agreement, Zealand Pharma will receive $100 million for the sale of its economic interests related to rusfertide, including rights to a 1% royalty on potential future global net sales of rusfertide and regulatory and commercial milestones. Of the $100 million, Zealand Pharma will receive an upfront payment of $50 million upon closing of the transaction. The remaining $50 million is due upon the first anniversary of the closing of the agreement. Zealand Pharma will retain the right to a 0.25% royalty on annual net global sales of rusfertide greater than $1.5 billion while Royalty Pharma will retain a 0.75% royalty on sales above $1.5 billion. 

The US Food and Drug Administration has set a Prescription Drug User Fee Act review goal date for the new drug application for rusfertide in the third quarter of 2026. Takeda is responsible for global commercialization.  

Source: Zealand Pharma  

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Partnering 

Sobi, Innate Pharma in $580-M Pact for mAb Cancer Immunotherapy 
Swedish Orphan Biovitrum (Sobi), a Stockholm, Sweden-based bio/pharmaceutical company focused on rare diseases, has formed a strategic partnership with Innate Pharma, a Marseille, France-based clinical-stage bio/pharmaceutical company developing immunotherapies for cancer, in a $580-million deal ($75 million upfront and $505 million in milestone payments).  

The partnership enables the initiation of a confirmatory Phase III study for lacutamab for treating cutaneous T-cell lymphoma (CTCL), a step toward filing for accelerated approval of lacutamab in Sézary syndrome, a subtype of CTCL. CTCL is a group of rare non-Hodgkin lymphomas that includes Sézary syndrome, a rare and aggressive leukemic form, and mycosis fungoides, the most common subtype in CTCL.  

Under the agreement, Innate will conduct the Phase III confirmatory trial in CTCL, supporting a planned accelerated approval filing in Sézary syndrome. The planned Phase III study will subsequently support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides. Sobi will receive exclusive global rights to commercialize lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase III results.  

Under the agreement, Sobi will pay Innate Pharma $75 million, payable on closing. Innate will be eligible to receive up to a further $40 million in respect of near-term development milestones connected to Sézary syndrome. Additionally, Innate will be eligible to receive up to $465 million related to the option for Sobi to get full development rights and to future regulatory and commercial milestones. Innate will be eligible to receive tiered double-digit royalties on net sales. Closing of the transaction is subject to closing conditions, including the receipt of transaction related antitrust clearance. 

Innate is advancing two partnered late-stage assets: lacutamab, developed with Sobi for T-cell lymphomas, and monalizumab, developed with AstraZeneca for non-small cell lung cancer. In addition, it has a proprietary pipeline centered of antibody-drug conjugates (ADCs), led by IPH4502, an ADC in clinical development for solid tumors, and a preclinical portfolio of ADC candidates.  

Source: Innate Pharma and Sobi  

Zydus’ Sentynl Therapeutics, Mereo BioPharma in $475-M Pact for Small-Molecule Liver Drug 
Sentynl Therapeutics, a Solano, California-based bio/pharmaceutical company focused on rare diseases and wholly owned subsidiary of Zydus Lifesciences, an Ahmedabad, India-based bio/pharmaceutical company, and Mereo BioPharma, a London-based clinical-stage bio/pharmaceutical company focused on rare diseases, have entered into an option and license agreement for the US commercial and global manufacturing rights to alvelestat, a Phase III drug candidate for treating alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD), a rare, inherited liver disease, in a deal worth up to $475 million ($40 million upfront and $435 million in closing). Alvelestat is an oral small-molecule drug designed to specifically inhibit neutrophil elastase, a key enzyme involved in inflammation and the destruction of lung tissue. 

The option and license agreement grants Sentynl the exclusive right to acquire a license to commercialize alvelestat for AATD-LD in the US, with Mereo retaining commercial rights in the rest of the world. The agreement also grants Sentynl global rights to manufacture alvelestat for AATD-LD and on option exercise, provides funding for the alvelestat Phase III development program, which could be initiated in early 2027. 

Under the agreement, Mereo will receive a non-refundable option fee from Sentynl and, on exercise of the option, the company would also receive $40 million in upfront and R&D payments. Mereo is also eligible to receive up to $435 million in regulatory and commercial milestone payments, as well as double-digit tiered royalties on US net sales of alvelestat. Mereo will lead the global Phase III study and regulatory interactions until the study is completed. However, during the option period, the companies will collaborate to advance manufacturing and streamline the Phase III study design. 

Source: Mereo BioPharma  

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Restructuring 

Emergent BioSolutions Announces $40-M Restructuring  
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, has announced a restructuring of its business operations expected to result in annualized savings of approximately $40 million when fully implemented, which includes a reduction of approximately 90 roles. The company made the announcement as part of its second-quarter 2026 results. The company reported second-quarter revenues of  $234.3 million, an improvement of 66% versus prior year, but a net loss of $180.2 million worsening 1,402% versus the prior year, largely due to a $191.3-million non-cash impairment charge. 

Emergent BioSolutions provides medical countermeasures for biological, chemical, and public health threats, such as anthrax, smallpox, mpox, Ebola, and opioid overdose, alongside contract manufacturing services.  

As part of the restructuring, the company is creating a new Growth organization that integrates the capabilities of R&D, Business Development, and Strategy into one function led by Stephanie Duatschek, Senior Vice President, Chief Global Strategy & Franchise Development Officer, who will assume the role of Executive Vice President, Chief Growth Officer, with responsibility for the company’s strategic growth 

Source: Emergent BioSolutions