Embecta Corp. engages in the provision of medical devices used in the treatment of diabetes. Its products include pen needles, syringes, and safety devices complemented by a digital application. The company was founded in 1924 and is headquartered in Parsippany, NJ.
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- Embecta Corp. and its top executives are facing a proposed securities class action lawsuit filed in the US District Court for the District of New Jersey. - Investor Harrison Apitz-Grossman alleges the company misrepresented demand for its insulin pen needles and failed to account for the impact of patients not covered by payer plans. - The lawsuit follows a 58% stock drop after Embecta released second-quarter results on May 5 that the company described as "significantly below our expectations." - The complaint claims executives continuously reaffirmed guidance and described the pen needle segment as "resolute" despite allegedly overlooking key market risks.
- Embecta Corp. has entered into a definitive agreement to acquire UK-based medical device innovator Owen Mumford Holdings Limited for up to £150 million, including £100 million upfront and up to £50 million in performance-based payments. - The acquisition will expand Embecta's reach into drug delivery devices supporting therapies across obesity, autoimmune diseases, and anaphylaxis, leveraging Owen Mumford's Aidaptus auto-injector platform. - Owen Mumford generated approximately £69.4 million in revenue in fiscal year 2025, with 80% of sales from the UK and United States. - The transaction is expected to close in Embecta's fiscal third quarter of 2026 and contribute to revenue growth beginning in fiscal year 2027.
- The FDA approved an expanded indication for subcutaneous furosemide injection for heart failure patients, offering a convenient self-administration option. - Aprocitentan received FDA approval for hypertension, providing a new treatment option for adults with uncontrolled blood pressure despite other medications. - The FDA cleared a continuous glucose monitoring (CGM) system featuring an implantable sensor lasting up to one year for diabetes management.
- The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback. - Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data. - Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC). - Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.
- Embecta Corp. secures FDA 510(k) clearance for its tubeless insulin patch pump designed for adults with type 1 and type 2 diabetes. - The system features a 300U insulin reservoir patch pump, lasting up to 3 days, and a Bluetooth-enabled controller with a color touchscreen. - Clinical feedback informed the design, ensuring the 300U reservoir meets the 3-day insulin needs of 64% of type 2 diabetes patients. - Embecta plans to develop a closed-loop system with an insulin dosing algorithm to further advance diabetes management.
- The FDA cleared DaylightRX, the first digital therapeutic for generalized anxiety disorder (GAD), to be used as an adjunct to usual care for patients aged 22 years and older. - Novavax received emergency use authorization (EUA) from the FDA for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older. - Embecta gained FDA 510(k) clearance for its disposable insulin delivery system, designed for adults with type 1 and type 2 diabetes, featuring a 300-unit reservoir.
