Target $130
Tuesday, October 8, 2024
PTC Positive Results, Regulatory Update for Vatiquinone Friedreich Ataxia Program
Statistically significant results on primary endpoint of long-term study analyses -
- Following FDA pre-NDA feedback, submission on track for December 2024 -
'Harris, on The View, aims to help adult caregivers with Medicare benefit expansion'
Vice President Harris on Tuesday introduced a new plan to expand Medicare benefits so that the program covers the costs of long-term home care for older Americans.
The plan, formally announced on ABC’s “The View,” is aimed at helping the “sandwich generation” take care of their aging parents. According to Pew Research, nearly a quarter of all American adults fall into that category — needing to take care of their parents while also still raising their own children.
“There are so many people in our country who are right in the middle. They’re taking care of their kids, and they’re taking care of their aging parents, and it’s just almost impossible to do it all,” Harris said. “Especially if they work. We’re finding that so many are then having to leave their job, which means losing a source of income, not to mention the emotional stress.”
Under the plan, Medicare will cover home care for the first time ever for all of our nation’s seniors and those with disabilities on Medicare who need it, in addition to vision and hearing benefits to help seniors live independently for longer.
It would need congressional action to be put into effect and would likely face long odds of becoming law with Republicans in control of Congress.
But such a plan could offer significant financial relief to families. It’s part of a series of Harris health proposals, such as eliminating medical debt and capping prescription drug costs, that’s broadly popular and easy for voters to understand.
The Harris campaign sees caregiving as a mobilizing issue for female voters, especially older women concerned about their own financial security, a senior campaign official told reporters ahead of the announcement.
According to AARP data, 34 percent of older women in Michigan identify as family caregivers, compared to 30 percent of older voters overall. In Georgia, 37 percent of older women identify as family caregivers, compared to 34 percent of older voters overall.
Seventy-six percent of likely voters 50-plus in Pennsylvania said they would be more likely to support a candidate who provides support for family caregivers who are helping their loved ones live independently in their homes.
Millions of Americans struggle to find affordable home-based care for themselves or their family members, and many wind up taking on the responsibility themselves.
According to the Bureau of Labor Statistics, 14 percent of the adult population provides some form of unpaid eldercare. About 59 percent of those caretakers are women.
Medicare does not cover long-term services and assistance, like home health aides, except under very narrow circumstances, such as if a person is recovering from an acute medical condition. Private insurance doesn’t cover those services either, leaving families to pay out of pocket.
The Harris campaign noted the average cost of a full-time home care aide is almost double the income of the typical Medicare beneficiary, and the problem will only get worse as our population ages.
The Department of Health and Human Services estimated that an average American turning 65 will incur $120,900 in future long-term services and support costs, with families paying for over one-third of that themselves.
According to the nonpartisan health research group KFF, a round-the-clock professional live-in home health aide can cost more than $288,000 a year.
Medicaid is the largest payer of long-term services, but it’s only an option for people with low incomes. Even for qualifying beneficiaries, there’s often an extremely long waitlist for home care providers.
The lack of options often leaves people with no choice but to rely on a family member.
Harris has talked about being a caregiver in the final years of her mother Shyamala’s life following a cancer diagnosis. She brought up the experience again on “The View.”
“It’s just about helping an aging parent, or person, prepare a meal, put their sweater on. And it’s about dignity for that individual, it’s about independence for that individual,” she said. “People are of declining skills to some extent, but their dignity, their pride has not declined.”
Harris’s campaign did not release a detailed spending breakdown, but an estimate by the Brookings Institute, a centrist think tank, estimated a similar plan would cost $40 billion a year.
Democrats tried to create a new home care program under the “Build Back Better” domestic policy legislation that became the Inflation Reduction Act, but it was cut due to spending concerns.
Harris said her plan would be paid for using savings from Medicare’s drug price negotiations.
“We are going to save Medicare the money, because we’re not going to be paying these high prices,” she said. “Those resources are best then put in a way that helps a family.”
MBX drops after 4 sell siders start at Buy
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Pfizer is said to have dropped RSV candidate from pipeline
Pfizer (NYSE:PFE) has decided not to further develop sisunatovir, an antiviral targeted at respiratory syncytial virus (RSV), which was part of the company's $525M acquisition of privately held ReViral in 2022, Endpoints News reported Tuesday.
https://seekingalpha.com/news/4157094-pfizer-is-said-to-have-dropped-rsv-candidate-from-pipeline
Humana Inc.: Bernstein upgrades to outperform from market perform .
price target reduced from USD 405 to USD 308.
https://www.marketscreener.com/quote/stock/HUMANA-INC-13000/
Sage 3rd Neuro Stumble in 6 Months With Disappointing Mid-Stage Alzheimer’s Readout
Sage has decided to discontinue the development of dalzanemdor in Alzheimer’s disease. A study of the candidate in Huntington’s is ongoing, with early data expected later this year.
Sage Therapeutics on Tuesday announced that its investigational oral drug candidate dalzanemdor missed the primary endpoint in the Phase II LIGHTWAVE study in Alzheimer’s disease, failing to significantly improve intelligence versus placebo.
Details of the failure were scant, with Sage revealing only that the trial data “did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo” in terms of scores on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test, a validated tool used to evaluate the presence of brain damage or neurodegenerative conditions. WAIS-IV scores were collected at day 84.
CEO Barry Greene in a statement said that the biotech is “disappointed” by these results, but hopes that the data generated in LIGHTWAVE will “help to inform future research.” Sage shares tanked 21% in premarket trading on Tuesday in reaction to the news, according to Seeking Alpha.
With Tuesday’s setback, Sage will no longer invest in the development of dalzanemdor in Alzheimer’s disease. A Phase II trial in Hungtington’s disease, dubbed DIMENSION, is ongoing and the biotech expects early data from that study to come “later this year,” according to its press release.
In a statement emailed to BioSpace, a Sage representative noted that Alzheimer’s and Huntington’s have differences in their underlying pathophysiology and symptomatology that can influence study outcomes.
“We believe the results of the LIGHTWAVE study do not necessarily predict the results of the DIMENSION study in Huntington’s disease,” the representative said.
An oral drug, dalzanemdor is a potentially first-in-class positive allosteric modulator of the NMDA receptor, which is crucial for various brain functions, including cognition, memory and other executive activities. Dalzanemdor works by enhancing the activity of NDMA receptors, in turn potentially addressing core disease pathways in various neurodegenerative conditions.
This mechanism of action, however, has yet to result in substantial clinical victories for Sage. In April 2024, the biotech reported that dalzanemdor failed the Phase II PRECEDENT trial in Parkinson’s disease, where it was likewise unable to elicit significant improvements in the WAIS-IV Coding Test versus placebo. As in the case of Alzheimer’s, the failure forced Sage to scrap its Parkinson’s program for dalzanemdor.
Even in Huntington’s, where its development is still ongoing, dalzanemdor’s activity appears to be underwhelming. In June 2024, the drug candidate cleared the Phase II SURVEYOR study, eliciting significant improvements in the Huntington’s Disease-Cognitive Assessment Battery composite score. However, analysts at the time were unimpressed. William Blair, for instance, said that it would “remain cautious” regarding dalzanemdor, noting that it does not “view the small numerical changes as definitive.”
Beyond dalzanemdor, Sage’s neuro pipeline has had a difficult couple of months. In July 2024, the biotech reported that its Biogen-partnered neuroactive steroid BIIB124 failed the Phase II KINETIC 2 trial in essential tremor. The companies abandoned their development program for BIIB124 in this indication.
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