Vanda Pharmaceuticals Inc. is challenging the FDA's imposition of a partial clinical hold on its study of the NK1 antagonist tradipitant, saying that the agency has illegally prohibited it from studying the gastroparesis drug in humans for more than 12 weeks "without conducting unnecessary and unethical animal studies," work it said would result in the death of dozens of dogs without producing additional scientific insight.
Roche Holding AG's Genentech Inc. has agreed to pay Xencor Inc. $120 million up front for rights to develop and commercialize IL-15 cytokine therapies, starting with the preclinical asset XmAb-24306.
Eisai Co. Ltd. and Purdue Pharma LP, partners in the development and commercialization of a dual orexin receptor antagonist for insomnia, said the drug improved subjective measures of both sleep onset and maintenance at the end of the six-month, placebo-controlled treatment period of a large phase III study. The data were incorporated into the pair's December FDA new drug application for lemborexant, which Eisai said could potentially reduce the risk of nighttime falls.
Eisai Co. Ltd. and Purdue Pharma LP, partners in the development and commercialization of a dual orexin receptor antagonist for insomnia, said the drug improved subjective measures of both sleep onset and maintenance at the end of the six-month, placebo-controlled treatment period of a large phase III study. The data were incorporated into the pair's December FDA new drug application for lemborexant, which Eisai said could potentially reduce the risk of nighttime falls.
Shares of Titan Pharmaceuticals Inc. (NASDAQ:TTNP) climbed 34.2 percent to close at $1.65 on Friday after the drugmaker heralded a double-digit increase in shipments of its implantable opioid addiction maintenance product, Probuphine (buprenorphine). Titan, which regained U.S. and Canadian commercial rights to Probuphine from Braeburn Inc. in May 2018, attributed the improvement in part to its recruitment of new commercial and medical affairs personnel, its re-engagement with prescribers and efforts to better identify areas where it can be most successful.
Fast-moving Caelum Biosciences Inc. said Alexion Pharmaceuticals Inc., acting to diversify its rare hematology portfolio, is betting $60 million in equity and development funding on CAEL-101 for light chain (AL) amyloidosis, also gaining an option to buy the young company if phase II data on the drug warrant for "pre-negotiated economics."
Dewpoint Therapeutics Inc., a U.S.-German startup working to industrialize the drugging of biomolecular condensates – membraneless compartments found inside cells – has launched with a $60 million series A led by its founding investor, Polaris Partners. Samsung's Samsara Biocapital, 6 Dimensions Capital, Ecor1 Capital, Alexandria Venture Investments and Bayer AG's Leaps investment arm also participated. If successful, the company could open new avenues to working with transcription factors and RNA in cancer, neurodegenerative disorders, immune diseases and other indications.
Neurocrine Biosciences Inc. has agreed to pay Voyager Therapeutics Inc. $165 million up front and up to $1.7 billion in milestone payments for rights to develop and commercialize four experimental adeno-associated virus-based gene therapies, starting with one for Parkinson's disease and another for Friedreich's ataxia (FA). The complex agreement, which includes co-commercialization options for Voyager, broadens Neurocrine's pipeline of movement disorder drugs while simultaneously extending Voyager's cash runway into 2022, advancing each company's goals "beyond what we could have done apart from one another," Neurocrine CEO Kevin Gorman said.
A phase III study designed to support use of Alexion Pharmaceuticals Inc.'s long-acting C5 complement inhibitor, Ultomiris (ravulizumab), in complement inhibitor-naïve patients with atypical hemolytic uremic syndrome (aHUS) met its primary endpoint, putting the company on track to seek FDA approval for the indication by midyear, with EU and Japanese filings to follow. Though met with skepticism in some quarters over a perceived lack of differentiation from Soliris (eculizumab), Piper Jaffray analyst Christopher Raymond said the results showed Ultomiris holding its own in patients sicker than those in an earlier Soliris trial.
Leveraging a little-used Securities Act rule made freshly relevant by the ongoing U.S. government shutdown, Gossamer Bio Inc. has set terms for a $230 million IPO. The San Diego-based company, which is developing therapies primarily for immunology and inflammation, has set terms for an offering of 14.4 million shares for $16 each. Barring a reevaluation of its approach should the SEC restore normal operations, the filing will become effective Feb. 12, with Gossamer listing on Nasdaq under the symbol GOSS.
