Protocols

FDA starts the priority review clock for Symbiomix; Cornerstone gets a green light on pivotal studies

→ The FDA accepted Symbiomix’s NDA for Solosec (secnidazole oral granules), an antibiotic designed to treat bacterial vaginosis, and stamped it with a priority review status that will cut the decision process down to six months. The PDUFA date is September 17.

→ Cranbury, NJ-based Cornerstone Pharmaceuticals got a regulatory green light to launch pivotal studies of their lead drug, CPI-613, in patients with acute myeloid leukemia (AML) and pancreatic cancer. Said Cornerstone COO Sanjeev Luther: “The FDA has provided valuable feedback to inform a design that will enhance the robustness of our trials. This would allow the Agency to assess them as registrational trials.”

→ The FDA handed Genentech Breakthrough Therapy Designation status to Rituxan (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. This is Genentech’s 15th BTD.

→ A year after reorganizing its pipeline and slimming down the projects it’s working on, Ignyta says it has also reworked its licensing pact with Eli Lilly on taladegib, which remains a priority. After Lilly had expressed its dissatisfaction, the biotech says in an SEC filing that they agreed to toss a near-term $18 million milestone in favor of a $15 million set of timed payments. Lilly released Ignyta from any claims it had under the old deal and both have the right to do some sub licensing deals.

→ The UK’s Redx is slashing jobs as it refocuses on its lead R&D programs.

La Jolla Pharmaceutical has raised $125 million in a stock $LJPC offering. The biotech priced 3.7 million shares at $33.50


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 41,900+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Head of Business Development
Wren Therapeutics Boston, MA
Life Sciences Venture Professional
Northpond Ventures Washington, DC
Senior Drug Discovery Oncologist
Schrödinger New York, NY

Visit Endpoints Careers ->