Global Briefs: Novo Nordisk, Jazz & Kite
A roundup of news from Regeneron Pharmaceuticals, Jazz Pharmaceuticals/Saniona, Kite/Interius BioTherapeutics, and Novo Nordisk/BioMed X. Highlights below.
Mfg News
* FDA Moves Out Review Date for Regeneron’s Eye-Care Drug Over Mfg Issues
M&A News
* Kite to Acquire Interius BioTherapeutics for $350 M
Partnering News
* Jazz Pharmaceuticals, Saniona in $1-Bn Epilepsy Drug Pact
* Novo Nordisk, BioMed X in Peptide Delivery Pact
FDA Moves Out Review Date for Regeneron’s Eye-Care Drug Over Mfg Issues
Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two submission for Eylea HD (aflibercept) injection 8 mg, a drug for treating certain eye diseases, due to manufacturing issues. This includes a chemistry, manufacturing and controls (CMC) prior-approval supplement for the Eylea HD prefilled syringe and a supplemental biologics license application seeking approval for both the treatment of macular edema following retinal vein occlusion and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications.
The FDA extended the review periods after determining that information provided since the completion of a recent inspection of a third-party manufacturer constituted a major amendment to each submission. As discussed during Regeneron’s second quarter 2025 earnings announcement, the company says this delay was anticipated and resulted from observations during an FDA general site inspection at the filler for these regulatory applications, Catalent Indiana LLC, which was acquired by Novo Nordisk A/S in December 2024. Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA. Regeneron says that it is its “understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved.”
Eylea HD remains available in the US through vial administration. It is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration and diabetic macular edema and every 8 to 12 weeks for patients with diabetic retinopathy following three initial monthly doses.
Source: Regeneron Pharmaceuticals
M&A News
Jazz Pharmaceuticals, Saniona in $1-Bn Epilepsy Drug Pact
Jazz Pharmaceuticals, a Dublin, Ireland-based bio/pharmaceutical company, and Saniona, a Glostrup, Denmark-based bio/pharmaceutical company, have entered into a global license agreement for Jazz to obtain exclusive worldwide rights to develop Saniona’s SAN2355, an epilepsy drug, in a deal worth up to $1 billion ($42 million upfront and $992 million in milestone payments). Jazz will lead and fund further development, regulatory submissions, and global commercialization activities.
SAN2355 is a preclinical, selective small-molecule activator of Kv7.2/Kv7.3 potassium channels, a mechanism validated for seizure suppression. Prior Kv7-targeting agents have demonstrated clinical efficacy, but dosing appears to be limited by adverse events associated with off-target activation. SAN2355 is selective for Kv7.2/Kv7.3, the Kv7-subtypes responsible for seizure suppression, and avoids activation of other Kv7-subtypes. This selectivity enables SAN2355 to deliver dosing to optimal efficacy and supports its potential as a treatment for epilepsy.
Under the agreement, Saniona will receive an upfront payment of $42.5 million. Saniona is eligible to receive: up to $192.5 million in development and regulatory milestones, including a $7.5-million milestone payment upon initiation of the first Phase I clinical study; up to $800 million in commercial milestone payments based on the achievement of significant and pre-specified annual net sales thresholds; and tiered royalties ranging from the mid-single digits to low-double digits on net sales of commercial products resulting from the development of SAN2355.
Source: Jazz Pharmaceuticals
Kite to Acquire Interius BioTherapeutics for $350 M
Kite, a Gilead Sciences’ company, has agreed to acquire Interius BioTherapeutics, a privately held biotechnology company developing in vivo CAR therapeutics, for $350 million.
This acquisition complements Kite’s expertise in cell therapy by incorporating Interius’s integrating in vivo platform. This approach enables the generation of CAR T-cells directly within the patient’s body. Unlike traditional CAR T therapies that require cell harvesting, engineering and reinfusion, Interius’s approach is designed to be delivered via a single intravenous infusion, thereby eliminating the need for preconditioning chemotherapy and complex cell processing.
Under the agreement, Kite will acquire all of the outstanding share capital of Interius for a total of $350 million in cash consideration, subject to customary adjustments, which is payable at closing. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.
Source: Gilead Sciences
Partnering News
Novo Nordisk, BioMed X in Peptide Delivery Pact
Novo Nordisk and BioMed X, an independent biomedical research institute based in Heidelberg, Germany, have launched a new collaboration for oral delivery of therapeutic peptides. A research team will be formed to work on this challenge with support from BioMed X and Novo Nordisk.
The new project, entitled “Prolonged Retention of Oral Peptide Formulations in the Gut,” will be hosted at BioMed X in Heidelberg. It aims to develop oral formulation technologies that achieve site-specific, prolonged retention of tablets or capsules within the lower small intestine. The key objective is to improve the absorption and bioavailability of peptide-based therapeutics.
Source: BioMed X
