The FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually. Shares in Verrica (NASDAQ:VRCA), already down from a peak of nearly $14 just before a second complete response letter in September 2021, fell nearly 59% to $2.30 in morning trading.
Pharmazz posts positive phase III data in stroke
Privately held Pharmazz Inc. posted positive top-line data for its phase III study of sovateltide, a highly selective endothelin B receptor agonist for treating acute ischemic stroke. The Willowbrook, Ill.-based company conducted the study in India with about 158 participants. The results at 90 days showed patients improving at least two points on a scale using a modified Rankin score. Pharmazz had planned to talk to the FDA about launching a phase II study but since the new data are so solid it may ask for a phase III in the U.S. with the expectation that participants could number as many as 500.
Castle Creek raises $112.8M to finish phase III with EB candidate
Paragon Biosciences-backed Castle Creek Biosciences Inc. pulled off an oversubscribed and upsized preferred stock financing of $112.8 million. The money should let the firm finish a phase III study and roll out top-line results of its lead ex vivo product candidate for recessive dystrophic epidermolysis bullosa, FCX-007, made of dermal fibroblasts that produce extracellular matrix proteins, including collagen. Participants in the financing included Paragon along with Fidelity Management & Research Co., Valor Equity Partners, and a group of health care-focused investors new to the investment pool.
Clock is ticking on China-based securities on US exchanges
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned yesterday during remarks at the annual meeting of the International Council of Securities Associations. As a result, the issuers of those securities would no longer have access to U.S. capital markets because they are not in compliance with the country’s regulatory requirements. Among those issuers are several China-based biopharma and med-tech companies, some of which have been put on notice by the SEC already.
Not an antibody company: Elasmogen banks £8M to advance VNAR platform
Elasmogen Ltd. has secured a “transformational” £8 million (US$10 million) in new funding with which to move its shark-based, antibody-like constructs toward the clinic. This comes as the underlying platform technology has matured to the point where it can reliably turn out hits against novel and cryptic epitopes that cannot be targeted by antibody drugs, and there is now evidence of their efficacy in clinically relevant models of disease. The money will enable Elasmogen to advance three antibody-drug conjugate programs and to turn the handle on the platform technology, adding more products to the portfolio, said Caroline Barelle, co-founder and CEO.
Also in the news
Agenus, Alzecure, Ardelyx, Astrazeneca, Bavarian Nordic, Chinook, Citius, Codagenix, Cornerstone, Curevac, Elevation, Ellipses, Endeavor, Enlivex, Evelo, Evgen, Ferring, Gilead, Harbour, Insilico, Ironwood, Jaguar, Janssen, Junshi, Karyopharm, Medexus, Obseva, Olix, Oncotelic, Osivax, Oxford, Pharmazz, Phathom, Rapt, Redhill, Second Genome, Sunrock, Terremoto, Teva, Valneva, Verrica