Stealth BioTherapeutics (NASDAQ:MITO): Q3 GAAP EPS of -$0.04 in-line.
Cash and cash equivalents of $37.23M.
Thursday, November 14, 2019
Exicure teams up with Allergan in hair loss disorders
Exicure (NASDAQ:XCUR) will collaborate with Allergan (NYSE:AGN) subsidiary Allergan Pharmaceuticals International to discover and develop treatments for hair loss disorders based on Exicure’s proprietary SNA technology.
Under the terms of the agreement, Exicure will receive $25M upfront, up to $97.5M in development and regulatory milestones per program, up to $265M in commercial milestones per program and tiered mid-single-digit-to-mid-teens royalties on net sales. If Allergan exercises its option to exclusively in-license a candidate, it will be responsible for clinical development and commercialization. Exicure will conduct discovery and development in two programs.
Exicure will host a conference call this morning at 8:30 am ET to discuss the partnership.
XCUR is up 24% premarket.
FDA OKs Axonics SNM device for urinary clinical symptoms
The FDA approves Axonics Modulation Technologies’ (NASDAQ:AXNX) Axonics r-SNM System for clinical indications of overactive bladder and urinary retention.
The rechargeable device modulates the sacral nerves that control muscles and organs that contribute to bladder control.
The company will host a conference call today at 4:30 pm ET to discuss Q3 results and recent business developments.
BioNTech EPS beats by €0.02, misses on revenue
BioNTech (NASDAQ:BNTX): Q3 GAAP EPS of -€0.14 beats by €0.02.
Revenue of €28.66M (+40.5% Y/Y) misses by €0.17M.
Amarin shares halted pending news
Nasdaq has suspended trading in Amarin (NASDAQ:AMRN) pending the release of news. In this case, it is the outcome of an FDA advisory committee meeting today on a CV benefit claim for Vascepa (icosapent ethyl).
Teva to resume making pediatric cancer drug after shortage caused ‘a nightmare’
Teva Pharmaceuticals will resume producing the vital cancer drug vincristine after a shortage caused a “nightmare situation” for physicians and patients, according to STAT.
Vincristine is used to treat several childhood cancers, including leukemias, lymphomas and brain tumors.
Teva stopped making vincristine in July, saying it was selling the drug at a loss. That left Pfizer as the sole supplier of the drug, but Pfizer was also experiencing manufacturing difficulties that made the shortage even worse.
An unnamed Teva spokesperson told STAT that when the company decided to stop making the drug, there was no indication of a shortage and that Teva was only supplying 3 percent of the market in the U.S.
Teva still makes the drug in other countries, a move the spokesperson told STAT is commonplace when Teva is the only manufacturer.
Teva aims to make vincristine available as early as possible in 2020.
“Because vincristine is such a lifesaving medicine — and there is no reliable single supply anticipated in the near term — we have decided to re-introduce the product and plan to manufacture it in our plant in the U.S., which provides the fastest route to market,” Teva told STAT.
Wednesday, November 13, 2019
Regular use of prescription drugs for pain, sleep increases frailty risk by 95%
Researchers from the Oregon Research Institute (ORI) and Florida Atlantic University (FAU) are the first to demonstrate statistically significant links between self-reported regular use of prescription drugs for pain and/or sleep, and longitudinal risk of frailty in adults ages 65 and older. Frailty consists of deficits in a variety of functional measures, and is a reliable predictor of loss of independence, increased use of health care resources, and mortality. The possible implications of current research findings are especially serious given that it is common for older Americans to use two or more prescription drugs at the same time and many of these prescription drugs are for pain and sleep, including analgesics and sedatives.
Results, published online in the Journal of the American Geriatric Society, estimate long-term frailty risks and rank the long-term risks of two classes of prescription drugs. Researchers found over eight years of follow-up, those who self-reported regular use of prescription drugs for pain and sleep had a 95 percent increased risk of frailty compared to those who did not report regular use of these drugs. For regular prescription drug use for pain only or for sleep only, the increased risks were 58 percent and 35 percent, respectively.
Co-authors Gulcan Cil, Ph.D., associate scientist, ORI, Juyoung Park, Ph.D., associate professor in FAU’s Phyllis and Harvey Sandler School of Social Work within the College for Design and Social Inquiry, and senior scientist Andrew Bergen, Ph.D., ORI, analyzed data from the Health & Retirement Study (HRS), a nationally representative longitudinal cohort of older Americans. For their analysis, they selected a large cohort (N=7,201) of community-living non-frail older adults (age 65 to 104, mean 72, median 70) from the HRS. Analyses were adjusted for demographics and other drug use.
“Co-use of multiple prescription medications is a growing phenomenon, especially among older adults,” said Park. “Geriatric medicine societies, including the American Geriatric Society, have developed guidelines to help prescribers avoid potentially inappropriate prescribing or PIP, which requires assessment of several types of PIP, including the benefits and risks associated with certain drug classes.”
“Our study shows that regular self-reported use and co?use of prescription drugs for pain and for sleep are significantly associated with increased incidence of frailty,” said Bergen. “We recommend further research to estimate the frailty risk of pain and sleep measures and of prescription pain and sleep drugs.”
The HRS dataset used by the researchers is sponsored by the National Institute on Aging (NIA) of the National Institutes of Health and the Social Security Administration (SSA) and is conducted by the University of Michigan. RAND HRS data products used in this study are produced by RAND Center for the Study of Aging with funding from the NIA and SSA.
Park will present this work at the Gerontological Society of America Annual Scientific Meeting (geron.org/2019) on Nov. 16 in Austin, Texas.
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