Success in two pivotal studies of high dose Eylea (aflibercept) has significantly strengthened Regeneron Pharmaceuticals Inc.’s market position. But the company will face stiff competition from biosimilars and Roche Holding Group’s recently approved Vabysmo. After struggling for much of the year, the Tarrytown, N.Y.-based company’s stock (NASDAQ: REGN) rose about 20% this week. It closed 2% upward on Sept. 9 at $724.32 per share.
Positive data from Unity Biotechnology Inc.’s phase II study of UBX-1325, a senolytic BCL-XL inhibitor for treating diabetic macular edema, boosted the stock out of the penny range. Shares of the South San Francisco-based company’s stock (NASDAQ:UBX) rose sharply, 54% on Aug. 12, to $1.31 each.
Shares in Oxurion NV dropped 40.3% percent May 9 on news that one of its two clinical-stage assets, THR-687, failed to demonstrate efficacy in a phase II trial in diabetic macular edema (DME). The candidate, a small-molecule pan integrin receptor antagonist, failed to demonstrate efficacy in Part A of the trial, called Integral, in which treatment-naïve patients received one of two doses of THR-687.
Less than two years on from its formation, central nervous system diseases specialist Accure Therapeutics SL has landed a $1 billion-plus agreement to out-license the lead program ACT-01, a first-in-class molecule with neuroprotective properties that is in a phase IIa study in acute optic neuritis. Taking on ACT-01 is ophthalmology specialist Oculis SA, which once it has positive data from the phase IIa, intends to expand to broader indications, including glaucoma and geographic atrophy.
After showing power in its frequency of dosing and efficacy, Vabysmo (faricimab) has been approved by the FDA for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema. The bispecific monoclonal antibody was developed by Roche Holding AG units, Chugai Pharmaceutical Co. Ltd. and Genentech Inc.
Curacle Co. Ltd. is training its sights on more partnerships after nabbing a licensing and collaboration agreement with Théa Open Innovation, a subsidiary of Laboratoires Théa SAS. The deal, for CU06-RE, Curacle’s oral treatment for diabetic macular edema and wet age-related macular degeneration (wet-AMD), includes $6 million up front for Curacle and as much as $157.5 million in potential development, regulatory and sales milestones, as well as royalties on sales.
Adverum Biotechnologies Inc. CEO Laurent Fischer said the firm chose the more prudent route in scrapping development of gene therapy ADVM-022 (AAV.7m8-aflibercept) for diabetic macular edema (DME) as a result of dose-limiting toxicity in the phase II Infinity trial.
LONDON – A year on from delivering positive phase IIb data, Oculis SA has raised $57 million in an oversubscribed series C, to take OCS-01, a topical nanoparticle formulation of dexamethasone, through two phase III trials.
HONG KONG –Uni-Bio Science Group Ltd. and Dotbio Pte. Ltd. formed a partnership to develop therapeutics for patients with retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal neovascularization.
LONDON – Oxular Ltd. has raised $37 million in a series B, enabling the company to take OXU-001, its long-acting treatment for diabetic macular edema (DME) into phase II development later this year.
