Surrozen Inc.’s back-end-loaded deal with Boehringer Ingelheim GmbH for the preclinical frizzled class receptor 4 agonist SZN-413 takes aim at vascular function in retinal diseases. The arrangement brings an up-front payment to South San Francisco-based Surrozen of $12.5 million, plus up to $586.5 million in potential development, regulatory and commercial milestone rewards, along with mid-single-digit to low-double-digit royalties on sales. After an initial period of joint research, Boehringer, of Ingelheim, Germany, will take over development and commercial responsibilities. Read More
Nested Therapeutics Inc. emerged from stealth, revealing $125 million in equity funding and plans to bring precision oncology to the next level by probing the genomics and structural biology of key cancer targets more deeply than before, in an ambitious bid to find new driver mutations, new druggable pockets, and new chemistry that will expand the current arsenal of targeted therapies. Read More
Despite clinical responses undermining expectations for the placebo arm of its phase III Alzheimer's disease (AD) study, Lucidity, Taurx Pharmaceuticals Ltd. executives Oct. 6 said they still see the data as supporting their ability to pursue regulatory submissions for hydromethylthionine mesylate (HMTM), an oral tau aggregation inhibitor. For people with mild cognitive impairment especially, they said, "HMTM treatment resulted in sustained improvement in cognition over pretreatment baseline, and normalization of brain atrophy to a rate similar to healthy individuals." Read More
The U.S. Congress has reauthorized several user fee programs at the FDA, and the agency has published the user fee levels for several product types, with most of those fees increasing significantly, an example of which is the increase for new drug applications (NDAs) requiring clinical data from $3.12 million to $3.24 million. Fees for medical device premarket approval (PMA) filings will jump from $375,000 to $442,000, including some hefty adjustments for persistent inflation, a problem that may plague the user fee schedules for fiscal 2024 as well. Read More
Connect Biopharma Holding Ltd.’s IL-4Rα binding candidate, CBP-201, yielded positive data in a pivotal trial in patients with moderate to severe atopic dermatitis in China, positioning the company to engage with Chinese regulators in the next several months to discuss a potential NDA filing. Read More
Although it’s a make-or-break market for many novel drugs, the U.S. is still testing the waters with biosimilars to some extent. That’s expected to change when at least seven biosimilars, including an interchangeable, referencing Abbvie Inc.’s Humira (adalimumab) are set to launch in the U.S. within the first seven months of next year. Next week, BioWorld will look at the significance of that looming competition and how the global biosimilars market is evolving amid a changing landscape of players, policies and pipelines. Read More
New hires and promotions in the biopharma industry, including: Assembly, Celularity, Lifemine, Mallinckrodt, Neurelis, Nuvalent, Rectify, Tarsus, Upstream. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abionyx, Allecra, Alzamend, Anaptysbio, Atai, Eliem, GSK, Monopar, Newamsterdam. Read More
