DUBLIN – With the clock ticking on the April 30 PDUFA date for its Contepo (fosfomycin) NDA, Nabriva Therapeutics plc disclosed late Tuesday that the FDA had slapped a complete response letter (CRL) on the file, citing manufacturing deficiencies at one of its contract manufacturers. The Dublin-based antibiotic developer stressed that the agency was not seeking any additional clinical data and had not raised any new safety concerns about fosfomycin, but investors were less than impressed with the inevitable delay to a U.S. launch of the drug, which is in development for treating complicated urinary tract infection (cUTI). Shares in Nabriva (NASDAQ:NBRV) plunged by as much as 42.5% during premarket trading Wednesday before closing down 27.4% at $2.17.
RNAi therapeutics developer Sirnaomics Inc. closed the second tranche of a $47 million series C financing with a $22 million investment led by CR-CP Life Sciences Fund, a Hong Kong-based joint venture established by China Resources Group and Charoen Pokphand Group in January. Proceeds from the round will support advancement of Sirnaomics' lead candidate, a siRNA-inhibiting polymeric nanoparticle therapy it is evaluating for the treatment of non-melanoma skin cancer (NMSC), cholangiocarcinoma and hepatocellular carcinoma.
A new partnership between Atomwise Inc. and the prolific Silicon Valley-based seed funder Y Combinator (YC) is creating a new launch pad for academic researchers building companies around promising compounds discovered with the artificial intelligence (AI) platform Atomnet, a neural network that can help pare millions of potential molecules down to a curated subset ready for preclinical testing.
RNAi therapeutics developer Sirnaomics Inc. closed the second tranche of a $47 million series C financing with a $22 million investment led by CR-CP Life Sciences Fund, a Hong Kong-based joint venture established by China Resources Group and Charoen Pokphand Group in January. Proceeds from the round will support advancement of Sirnaomics' lead candidate, a siRNA-inhibiting polymeric nanoparticle therapy it is evaluating for the treatment of non-melanoma skin cancer (NMSC), cholangiocarcinoma and hepatocellular carcinoma.
Once hailed by former Gilead Sciences Inc. CEO and President John Milligan as "the beginning of a very important NASH franchise," the oral apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib has again failed to meet the primary endpoint in a phase III trial. Top-line results of the Stellar-3 study for patients with bridging fibrosis due to nonalcoholic steatohepatitis (NASH) did not meet the prespecified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of the condition after failing to meet a similar endpoint for NASH patients with compensated cirrhosis in Stellar-4.
Abbvie Inc.'s Skyrizi (risankizumab), a medicine for adults with moderate to severe plaque psoriasis, won FDA approval and is expected to be available in the U.S. in early May, the company said. Abbvie paid Boehringer Ingelheim GmbH (BI) $595 million up front for rights to the anti-IL-23 therapy and another asset in 2016 while promising further significant milestone and royalty payments to come for the German company.
Following clinical failures in multiple indications, a p38 kinase inhibitor developed by Glaxosmithkline plc has found a new champion in Fulcrum Therapeutics Inc., which has licensed it for the potential treatment of facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder. After securing an exclusive license for the drug in exchange for granting GSK "a high single-digit" percentage ownership of its company, Fulcrum is planning to start a phase IIb study of the drug, called losmapimod, in patients with FSHD at multiple sites in the U.S. and Europe in mid-2019.
Eli Lilly and Co. has agreed to pay privately held Avidity Biosciences LLC $20 million up front and up to $405 million per target to support development of an unspecified number of new antibody oligonucleotide conjugates for immunology and other indications. The multiyear deal, which also includes a $15 million equity investment for Avidity, opens a new front in Lilly's embrace of oligonucleotide-based drugs, the subject of earlier deals it has struck with Dicerna Pharmaceuticals Inc., Ionis Pharmaceuticals Inc. and Noxxon Pharma AG.
Talaris Therapeutics Inc., a company developing an allogeneic cell therapy intended to eliminate the need for chronic immunosuppression among organ transplant recipients, has closed a $100 million series A financing. The financing was led by Blackstone Life Sciences, with participation from Longitude Capital and Qiming Venture Partners USA.
