Kranus Health GmbH has raised $6.5 million in series A funding to ramp commercialization of its digital therapy for treating erectile dysfunction (ED). Eleven European investors participated in this fundraising. The round was led by early-stage health care venture capitalists Karista SAS, while Peak Pride Management GmbH also joined the funding round.
Sumitovant Biopharma Ltd. subsidiary Urovant Sciences GmbH is out-licensing overactive bladder (OAB) treatment vibegron to Pierre Fabre Médicament to register and commercialize the drug in the EU, U,K, and Switzerland. Under the terms of the deal, Basel, Switzerland-based Urovant will receive up to $75 million in up-front payments, regulatory and sales milestones and royalties, while Urovant will retain full commercialization rights to vibegron in the U.S. and certain other markets.
More than five years after agreeing to collaborate in a deal that had the potential to top $1 billion, Akebia Therapeutics Inc. executed an agreement to terminate its troubled partnership to develop vadadustat with Otsuka Pharmaceutical Co. Ltd. Otsuka will pay Akebia a $55 million settlement fee.
Failure to ovulate and release mature oocytes is one of the most common female infertility problems. With increasing age or conditions like obesity, no oocytes are released even on ovulation induction with hormonal treatment.
From 20 years of research on metabolic change as a result of salt intake, Karen Duggan discovered in 2003 that a naturally occurring molecule in the human body, native vasoactive intestinal peptide (VIP), was capable of reversing fibrosis caused by hypertension and other chronic diseases such as diabetes. From that discovery, Vectus Biosystems Ltd. was founded, and the company has developed a new class of mimetic drug candidates and a drug library based on VIP.
The U.S. FDA sent a refuse to file letter to Nymox Pharmaceutical Corp. regarding its NDA for fexapotide triflutate, a pro-apoptotic protein intended for treating benign prostatic hyperplasia. The letter noted that more long-term safety data was needed for the application, the company said.
Fairtility Ltd.’s artificial intelligence (AI)-trained embryo classification system offers patients struggling with infertility and their physicians a better way to maximize the likelihood of implantation following in vitro fertilization (IVF) without the risk of a multiple pregnancy, a study in the Nature portfolio journal Scientific Reports found.
The company conference call related to Akebia Therapeutics Inc.’s complete response letter (CRL) for vadadustat, an HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease, brought on the ongoing and perhaps inevitable comparisons with a similar product from Fibrogen Inc., rejected by the agency last August.
Opinion on Wall Street said the matter could have gone either way, but in the end Akebia Therapeutics Inc.’s vadadustat, a HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease (CKD), garnered a complete response letter (CRL) instead of approval from the FDA. The news slammed Akebia shares (NASDAQ:AKBA), which closed at 82 cents, down $1.61, or 66%. Specifically, the agency said that the data in the NDA do not support a favorable benefit-risk assessment of vadadustat in dialysis-dependent (DD) and non-DDs patients.
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