Regenera Pharma Ltd. CEO Jordan Rubinson told BioWorld that “there’s over $1 billion dollars of market value, of revenues, in the first five years” if the company can succeed in a planned phase III trial and win approval for RPH-201 in nonarteritic anterior ischemic optic neuropathy (NAION), “essentially a stroke of the optic nerve.”

Soligenix Inc., of Princeton, N.J., said it will participate in a research project grant awarded to the University of Hawai’i at Manoa for the development of a thermostabilized Ebola vaccine, with Soligenix awarded funding of about $700,000 over five years.

For the second time this year, the FDA released a draft biosimilar guidance. The latest one describes what type of information a biosimilar sponsor should obtain about the structural/physicochemical and functional attributes of the reference biologic, how that information should be used to develop an analytical similarity assessment plan for the proposed biosimilar and what statistical approaches are recommended for evaluating analytical similarity.

After a multiyear incubation period at New York-based Pfizer Inc., Springworks Therapeutics LLC sprang to life with four Pfizer-derived candidates and an oversubscribed $103 million kitty to see them to the next stage of development. The syndicate for the company’s series A included Bain Capital Life Sciences, Bain Capital Double Impact, Orbimed and Lifearc (formerly MRC Technology), along with Pfizer, which also handed over global rights to the initial compounds.

Fusion Pharmaceuticals Inc., of Hamilton, Ontario, said it completed a second closing of its series A financing, securing an additional $21 million in capital and bringing the total capital raised to $46 million.

Sinovac Biotech Ltd., of Beijing, reported preliminary top-line data from its phase III trial testing its varicella vaccine against chickenpox.

DUBLIN – Paris-based anti-infectives developer Da Volterra SA is planning a phase II trial of its lead product, DAV-132, in Europe in the coming months and is also looking to open an IND in the U.S. shortly.

Understanding mitochondrial diseases, which are estimated to affect about one in 4,000 people, remains a significant challenge because of the diversity of human disorders at every level that result when the mitochondria of the cell cannot produce the energy the body needs to support growth. In part one, a number of therapies were described that have advanced through to the clinic that target Friedrich's ataxia and other rare mitochondrial diseases. (See BioWorld Insight, Sept. 18, 2017.)