After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.
Amarin Corp. plc's sale of $400 million in American depositary shares (ADSs) ahead of the Sept. 28 PDUFA date for Vascepa (icosapent ethyl) boosted investor confidence while sparking buzz about another player in the space: Acasti Pharma Inc., of Laval, Quebec, which has a krill oil-based product due to report pivotal data soon.
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.
Seongnam, Korea-based Bridge Biotherapeutics Inc. nailed down a deal with Boehringer Ingelheim GmbH (BI) to develop the former's phase I autotaxin (ATX) inhibitor, BBT-877, for fibrosing interstitial lung diseases, including idiopathic pulmonary fibrosis (IPF).
Kalvista Pharmaceuticals Inc. made big news in October 2017 by way of its handsome deal with Merck & Co. Inc. to advance KVD-001, an intravitreal injection candidate to treat diabetic macular edema (DME).
Just over a month after adding an indication to the label for Zerbaxa (ceftolozane/tazobactam), Merck & Co. Inc. gained FDA clearance of Recarbrio (imipenem, cilastatin and relebactam) 1.25 g for injection. The new combo antibacterial is indicated for adults who have limited or no alternatives for the treatment of complicated urinary tract infections (cUTI).
Trefoil Therapeutics Inc.'s $28 million from an oversubscribed series A financing will let the company finish a phase IIa proof-of-concept study as researchers edge toward attacking corneal endothelial dystrophy, including Fuchs dystrophy, a disease that leads to the deterioration of the endothelial layer on the back surface of the cornea.
"We tried to land on Mars and we got to the moon," Novavax Inc. President of R&D Gregory Glenn told BioWorld, referring to the Gaithersburg, Md.-based firm's phase III trial with the respiratory syncytial virus (RSV) vaccine called Resvax. And it was more than anyone had done thus far, he added.
Prospects for the new wave of migraine therapies targeting calcitonin gene-related peptide (CGRP) – with three approved already and more in developers' pipelines – have been the topic of talk lately, with analysts such as Evercore ISI's Umer Raffat pointing to what some might see as a dispiriting level-out in sales among those treatments to reach the market so far.
Word from the FDA to Axsome Therapeutics Inc. about the effort with oral N-methyl-D-aspartate (NMDA) receptor antagonist AXS-05 in depression – and the company's accelerated push with the compound – had Wall Street watching the NMDA space with even more interest than usual.
