Moderna Inc. dropped its long-anticipated S-1 filing, allowing industry watchers to exhale. The Cambridge, Mass.-based company is seeking to raise $500 million, including overallotments – the same amount the company raised privately in February – in what many observers were calling biopharma's biggest IPO. Except that it's not, unless some qualifiers are used and provided that Moderna doesn't decide to upsize as the book-building begins. Read More
Harpoon Therapeutics Inc.'s series C financing of $70 million plus cash on hand "basically enables all four of [our] development programs" to enter the clinic, CEO Gerald McMahon told BioWorld. "Near-term, we'll have clinical data on the first two in the 2019-2020 time frame." Read More
LONDON – Amal Therapeutics SA raised €21.2 million (US$23.8 million) in the second closing of its series B, enabling it to move forward with a phase I/II trial of its novel peptide vaccine, ATP-128, in combination with an anti-PD-1 checkpoint inhibitor. Read More
PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd.'s allogeneic cell therapy candidate, MPC-150-IM, failed to meet the primary endpoint in a phase IIb trial in end-stage heart failure patients implanted with a left ventricular assist device (LVAD), but it delivered meaningful clinical results that may make it approvable. Read More
SAN FRANCISCO – New data from two midstage studies of Gilead Sciences Inc.'s farnesoid X receptor (FXR) agonist reported during the American Association for the Study of Liver Diseases meeting showcased the company's ongoing efforts to establish new strengths beyond viral hepatitis C, where time and competition have eroded its dominance. Though still active on the next frontier of the hepatitis battle, hepatitis B virus, most of the company's liver disease pipeline today is focused on nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and primary biliary cirrhosis (PBC). Read More
SAN FRANCISCO – A new online map of hepatitis C virus (HCV) screening, diagnosis and treatment data built by Abbvie Inc. is shedding added light on where the infection is most common in the U.S. and where gaps in treatment exist. HCV is the most common chronic infectious disease in the country, with an estimated 3.4 million people infected, the company said. It plans to update the data twice yearly. Read More
SAN FRANCISCO – Surprising no one, progression to cirrhosis in patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) cirrhosis in the U.S. is associated with increased health care resource utilization (HCRU) and costs, a Bristol-Myers Squibb Co.-sponsored study has found. The analysis could provide critical ammunition for drug developers such as BMS seeking to deploy economic arguments for the role of pharmaceutical intervention in reducing the condition's contribution to the upward march of health care costs. Read More
SAN FRANCISCO – New preliminary phase II data on a 1-mg dose of NGM-282 and existing data on a 3-mg dose of the nonalcoholic steatohepatitis (NASH) candidate, in development by NGM Biopharmaceuticals Inc., show "unprecedented antifibrotic activity" at week 12 of an open-label study, the study's principal investigator, Stephen Harrison said. Read More
Maxcyte Inc., of Gaithersburg, Md., said it entered a research agreement with Kite, a Foster City, Calif.-based Gilead Sciences Inc. company, which will use its flow electroporation technology platform to enable nonviral cell engineering. Read More
Diamedica Therapeutics Inc., of Minneapolis, is seeking to raise up to $15 million, including overallotments, in a U.S. IPO. The company's shares trade in Canada on the Toronto Stock Exchange Venture Exchange as DMA and the U.S. Over-the-Counter market as DMCAF. Diamedica plans to list on Nasdaq as DMAC. Read More
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hold a joint meeting Wednesday to consider an application by Specgx LLC, a business unit of Mallinckrodt plc, of Staines-Upon-Thames, U.K., for an abuse-deterrent, immediate-release tablet formulation of oxycodone. If approved, MNK-812 would be only the second immediate-release opioid to get abuse-deterrent labeling in the U.S. Read More
