DUBLIN – Antibiotics developer Venatorx Pharmaceuticals Inc. raised $42 million in a series B round that will fund a registration trial of its lead program, VNRX-5133, which it has penciled in for the first half of next year.
"This is an exciting opportunity for us," Rich Daly, chairman and CEO of Neuralstem Inc., said about top-line phase II data of NSI-189 to treat major depressive disorder (MDD). Those aren't necessarily words that might follow a miss on the primary efficacy endpoint – a statistically significant reduction in depression symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS) – which sent the company's shares (NASDAQ:CUR) tumbling as much as 60 percent Tuesday before closing at $2.81 for a loss of $2.77, or 49.6 percent.
The scientific campaign for a better version of Velcade (bortezomib, Takeda Oncology Co.) for multiple myeloma (MM) that began at Proteolix Inc. survived two mergers and ultimately failed, but led to the formation of Kezar Life Sciences Inc., with a promising approach, not to cancer but to autoimmune disorders.
Strong sales of Biogen Inc.'s pricey spinal muscular atrophy drug, Spinraza (nusinersen), helped the company cruise past consensus estimates and hit record second-quarter sales on Tuesday.
PARIS – A bird in the hand is worth two in the bush. And in that spirit, the newest research on a wide variety of prevention strategies other than vaccination are being presented at the meeting of the International AIDS Society (IAS) this week, despite the conviction that a vaccine will ultimately be necessary to end the HIV pandemic.
Neon Therapeutics Inc., of Cambridge, Mass., and Apexigen Inc., of San Carlos, Calif., plan to test Neon's NEO-PV-01, a neoantigen vaccine based on DNA mutations from patients' individual tumors, in combination with Apexigen's CD40 agonist antibody, APX-005M, in a phase Ib trial in patients with metastatic melanoma.
Bristol-Myers Squibb Co., of Princeton, N.J., said the FDA accepted its supplemental BLAs to update dosing of PD-1 inhibitor Opdivo (nivolumab) to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications.
Nabriva Therapeutics plc, of Dublin, named Francesco Maria Lavino chief commercial officer. He will be based out of the company's U.S. headquarters in King of Prussia, Pa.
Gemphire Therapeutics Inc., of Livonia, Mich., entered a loan and security agreement with Silicon Valley Bank for a term loan of up to $15 million, subject to funding in up to three tranches.
The FDA issued guidance Monday on dealing with informed consent in clinical trials that involve no more than minimal risk to subjects, in keeping with a provision in the 21st Century Cures Act.