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.
Since the mid-April pricing of Hookipa Pharma Inc.'s IPO, the New York-based firm has endured a bumpy ride on Wall Street, with shares sliding steadily since backers bought 6 million at $14 each for $84 million in proceeds. But among those keeping the faith are analysts at Evercore ISI, who recently hosted a webinar to highlight the research ongoing at Hookipa, which Ravi Mehrotra called "one of the most interesting companies we've come across."
FDA clearance of Retrophin Inc.'s enteric-coated (EC) version of Thiola (tiopronin) 100-mg and 300-mg tablets for cystinuria – a rare, inherited disorder that causes levels of cystine to build up in urine, which leads to recurrent kidney stones – gave patients new dosing flexibility and set Wall Street abuzz about options for the San Diego-based firm as well.
Alexion Pharmaceuticals Inc. gained expansion from the FDA of the label for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.
Recent bad phase IIb news from Inflarx NV with IFX-1, a first-in-class anti-human complement factor C5a monoclonal antibody in the moderate to severe skin disease hidradenitis suppurativa (HS), also dinged shares of Chemocentryx Inc., which has small-molecule avacopan targeting the C5a receptor in a registration-grade phase II study targeting the same indication – but the story's hardly over in HS or vasculitis.
