Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (“EMA”) for CT-P55, its biosimilar to Novartis’ COSENTYX® (secukinumab). The application covers all indications held by COSENTYX® in Europe, including plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, juvenile idiopathic
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Public Company Advisory News Roundup: SEC Division Issues Order Approving Nasdaq’s New $5 Million Market Value Continued Listing Requirement; Order Subsequently Stayed
The latest issue of the Goodwin Public Company Advisory News Roundup has been posted, covering the period from July 20, 2026 – July 30, 2026. The Roundup highlights the latest developments in SEC and stock exchange regulatory activity, corporate governance
Accord BioPharma Launches OSVYRTI® and JUBEREQ® Denosumab Biosimilars
On July 23, 2026, Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., announced the commercial launch of OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), FDA-approved interchangeable biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. OSVYRTI® is indicated for the treatment
Outlook Therapeutics Secures FDA Approval for LYTENAVA™
On July 24, 2026, Outlook Therapeutics, Inc. announced that the FDA approved LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (known as “nAMD” or “wet AMD”), marking the first FDA-approved ophthalmic formulation of bevacizumab in the United States.
SEC Stay Puts Nasdaq’s New $5 Million MVLS Listing Standard on Hold
On July 29, 2026, Nasdaq’s new continued listing requirement requiring companies to maintain at least $5 million in Market Value of Listed Securities (MVLS) was automatically stayed. The rule, which the SEC approved on July 22, would have required
SEC Proposes to Modernize Electronic Delivery Requirements
On July 16, 2026, the SEC proposed new Regulation E-Delivery, which would permit covered entities to use electronic media as the default method for delivery of offering documents, company reports, shareholder communications, and other materials under SEC rules if they
HHS Sets Timeline to End COVID-19 Emergency Use Authorizations
On June 30, 2026, the U.S. Department of Health and Human Services (HHS) announced that COVID-19 Emergency Use Authorization (EUA) declarations will terminate on December 26, 2026, for medical devices and on June 29, 2027, for drugs and biological products.
SEC Approves Nasdaq’s New $5 Million Market Value Continued Listing Requirement
On July 22, 2026, the SEC approved Nasdaq’s proposal (Release No. 34-105971) to adopt a new continued listing requirement based on Market Value of Listed Securities (“MVLS”). Under new Nasdaq Rules 5450(a)(3) and 5550(a)(6), companies listed on the
SEC Announces Roundtable on 24-Hour Equity Trading
On July 23, 2026, the SEC announced that it will host a public roundtable on September 17, 2026, to discuss preparations for potential 24-hour trading in the U.S. equity markets. The roundtable will focus on overnight trading infrastructure, market operations
Formycon and OneSource Specialty Pharma Partner to Manufacture Biosimilars
Formycon AG (“Formycon”) announced its partnership with OneSource Specialty Pharma Limited (“One Source”) on July 14, 2026. OneSource, located in Bangalore, India, will complement Formycon’s biosimilar development experience with its biologics manufacturing capabilities. OneSource has an integrated biologics platform that