Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months of 2025, biopharma dealmaking was robust with a collective value of $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. These three December deals helped revive the surge in dealmaking that had cooled in November.
Attention has turned to the regulatory path worldwide after Belite Bio Inc. unveiled positive top-line data from the phase III Dragon study with oral, daily tinlarebant in Stargardt disease type 1, the most common form of the rare affliction.
Opus Genetics Inc. will be sitting down with the U.S. FDA to talk about positive three-month data from the pediatric cohort of its ongoing phase I/II trial called OPGx-LCA5-1001 – partially funded by the agency – evaluating OPGx-LCA5, a gene augmentation therapy for ultra-rare Leber congenital amaurosis type 5 (LCA5). The affliction is a severe form of retinal dystrophy that renders babies blind in the first year of life.
As Wall Street awaits phase IIb data from Kala Bio Inc. with KPI-012 in persistent corneal epithelial defect, odds are being weighed for that candidate – and others in development – against the lone approved treatment used in a market already worth more than $1 billion.
To say the team at Ollin Biosciences Inc. has some experience in ophthalmology would be an understatement. The company, which emerged from stealth with $100 million in venture capital and two in-licensed assets with plans to add more, brings to the table years of expertise from work on blockbuster retinal disease drugs Lucentis (ranibizumab, Roche AG) and Vabysmo (faricimab, Roche AG).
At the 12th Aging Research & Drug Discovery (ARDD) Meeting, which is being held this week in Copenhagen, Life Biosciences Inc. announced that it is developing its partial epigenetic reprogramming technology for liver disease as well as optic neuropathies. The company’s chief scientific officer Sharon Rosenzweig-Lipson estimated that its ER-100 would enter clinical trials in early 2026, putting it on track to be the first application of partial epigenetic reprogramming to enter the clinic.
After Outlook Therapeutics Inc. took receipt of another complete response letter (CRL), Wall Street focused on the odds that the U.S. FDA will demand a new study with ONS-5010, or Lytenava (bevacizumab-vikg) against wet age-related macular degeneration (AMD).
Showing similar results as the first phase III trial completed in 2022, Nicox SA’s nitric oxide-donating bimatoprost eye drop, NCX-470, met the primary endpoint in the phase III Denali trial for open-angle glaucoma or ocular hypertension, clearing the way for regulatory filings in both the U.S. and China.
After announcing in April that it would discontinue development of its lead candidate, sozinibercept (OPT-302), in wet age-related macular degeneration (AMD), Opthea Ltd. has come to a settlement agreement that will allow it to avoid bankruptcy and continue operations.
Remegen Co. Ltd. is out-licensing its VEGF/FGF dual-target fusion protein drug, RC28-E, to Santen Pharmaceutical (China) Co. Ltd. in a carve-out deal worth more than ¥1.3 billion (US$180 million).
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