Axonics Modulation Technologies Inc., of Irvine, Calif., reported revenue of $1.3 million for the third quarter of 2019, up from $0.2 million in the same period last year, but below Wall Street's forecast of $1.4 million. CEO Raymond Cohen attributed the miss to a seasonal slowdown in implants of Axonics' rechargeable sacral neuromodulation (r-SNM) system in international markets, as well as some U.S. physicians who were waiting for the device to win urinary approval. That milestone came Thursday when the U.S. FDA approved Axonics' r-SNM for the treatment of overactive bladder (OAB) and urinary retention. The indication for urinary retention represents the largest segment of the market for SNM devices and comes just two months after FDA approved the r-SNM to help patients with fecal incontinence. (See BioWorld MedTech, Sept. 10, 2019.)
Senseonics Inc., of Germantown, Md., reported gloomy results for its 2019 third quarter, with revenue of $4.3 million, down 17% from the same period last year. The tally also fell far short of the consensus on Wall Street, which estimated third-quarter revenue of $6.07 million.
SAN JOSE, Costa Rica – Cross reality (XR) technology is gaining traction in the med-tech sector thanks to advancements in the virtual reality (VR), augmented reality (AR) and mixed reality (MR) fields that comprise it, triggered by a surge of investments that have driven cash flow to med-tech startups. The new technology is already impacting the health care sector.
It appears that the spirit of giving has come early, with leading biopharmaceutical companies providing investors with a surprise present of a significant jump in their share prices in October. The reversal in the sector's fortunes was catalyzed by an outpouring of positive news, including strong third-quarter financial results that has spilled over into early November.
BOSTON – At the AACR-NCI-EORTC Molecular Targets meeting in October, speakers in the second plenary session gave examples both of how far protein degradation has come as a pharmacological approach, and how far it could still go.
Arkuda Therapeutics, a new company targeting progranulin and lysosomal biology to treat neurodegenerative diseases, has completed a $44 million series A financing.
"Global approval doesn't mean Australia approval. Government needs a new way of valuing the benefit of therapies that are a one-off cure differently than other drugs."
President Donald Trump has officially nominated Stephen Hahn to the position of FDA commissioner, a position held on an interim basis by Ned Sharpless since April. Hahn has held the position of CEO of the MD Anderson Cancer Center in Houston since May 2018.
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