Shares are up 7% after hours.
Wednesday, June 12, 2019
Nuvectra files U.S. application for expanded label
Nuvectra (NASDAQ:NVTR) has submitted an application to the FDA seeking a full-body MR-conditional approval for its Algovita SCS system. It hopes to gain the regulatory nod by year-end.
CymaBay +4.8% as Raymond James fades 45% sell-off
Raymond James has upgraded CymaBay Therapeutics (NASDAQ:CBAY) to Strong Buy after today’s harsh market reaction to experimental data released this morning.
The stock is up 4.8% after hours.
Shares closed the day down 45.5% after disappointing data from an experimental therapy for NASH, a fatty liver disease.
That reaction was “overblown,” Raymond James’ Steven Seedhouse says, noting that the drug wasn’t factored into his models, and that he expected the stock to recover when the market considers the probability that other aggregate improvements “could translate into fibrosis/ballooning/inflammation benefit, irrespective of the lack of liver fat signal.”
Sell-siders on average rate CymaBay an Outperform, while Seeking Alpha authors are Bullish on average and its Quant Rating is Neutral.
Tuesday, June 11, 2019
Resetting Circadian Rhythm
Very brief exposure to light flashes while sleeping can help reset the body’s circadian clock and may prove to be an effective strategy for managing phase shift sleeping disorders.
Light flashes at levels of just 50 lux for 10 μsec every 15 sec induced phase shifts reaching 90% of maximum, reported Jamie Zeitzer, PhD, of Stanford University in California, from a study of 56 healthy young men and women.
The effect was not increased when the flash duration was lengthened to as much as 10 sec, Zeitzer said at SLEEP 2019, the annual joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).
Previously, Zeitzer’s lab had found similar results with flashing light therapy, with a greater magnitude of effect than with continuous light. The current study was aimed at determining how low the flash brightness and duration could go while maintaining the effect.
During the first 14 days of two 16-day parallel studies, participants were asked to maintain a regular sleep/wake cycle — confirmed through actigraphy and sleep logs — to establish circadian phase stabilization.
Then, for the last 2 days, participants slept in specialized time-isolation labs, and circadian pacemaker phase was determined via salivary melatonin onset.
Light exposure occurred the first night in the sleep lab. Participants were forced awake 2 hours after their pre-established regular bedtime and exposed to 1 hour of flashes, delivered at 15-sec intervals.
Flashes of only 8 lux were enough to induce half the maximum phase shift, Zeitzer reported. For context, bright sunlight is about 100,000 lux; outdoor light dips to about 10 lux at twilight. Elevators are typically illuminated at roughly 100 lux.
In an interview with MedPage Today, Zeitzer said the flash light technique has the potential to be an effective therapeutic strategy for any sleep problems related to disruptions in circadian rhythm.
Common phase shift disorders include delayed sleep phase syndrome, characterized by the inability to get to sleep until very late at night; and advanced sleep phase syndrome, characterized by going to sleep very early in the evening and waking earlier than desired.
Current therapeutic strategies for these and other sleep phase disorders are often not terribly effective, Zeitzer said, because they rely on changing patient behavior.
“Anytime you require people to change behaviors there are going to be issues with compliance,” he said. “If we can deliver therapy during sleep, you take behavior out of the equation.”
Zeitzer and colleagues recently completed a preliminary study of the light flash stimulus in teenagers.
He explained that since teens have a biological drive to go to bed later, even a slight phase shift may have a big impact.
The teens in the study received the light flash stimulus nightly, two hours before they were scheduled to wake up. The goal of the stimulus was to reset to teens’ body clocks so that they would naturally feel sleepy about an hour earlier than normal.
“You can get bigger phase shifts, but we didn’t think it was realistic to think that a teen who normally goes to bed at 1 [a.m.] would go to bed at 10:30 [p.m.],” he said.
Funding for this research was provided by the Department of Defense.
Zeitzer reported no relevant relationships with industry related to this study.
AMA Votes Against Neutrality on Medicare for All
Some fear opposition to single-payer could leave association out of healthcare reform talks
The American Medical Association (AMA) House of Delegates on Tuesday reiterated its longstanding opposition to single-payer healthcare systems, including “Medicare for All,” despite warnings that the AMA risks being left out of crucial healthcare reform discussions.
On Tuesday, delegates voted down a proposal to shift the AMA’s official stance on single-payer insurance to neutrality.
“We proposed this amendment because we are concerned about the AMA’s ability to be invited to all healthcare reform conversations,” Daniel Pfeifle, of Sioux Falls, South Dakota, said on behalf of the Medical Student Section. “As long as we maintain our blanket opposition, our AMA cannot ensure we’re part of every conversation.”
“The way humans make decisions is highly influenced by how the options are presented to us,” said Abby Solom of Plymouth, Minnesota, speaking for that state’s delegation. “If we frame the discussion about healthcare delivery options firmly anchored to a position of opposition to one of those options, there is no way we can consider all of the options fairly. It’s disingenuous to believe otherwise. … We should support the medical students’ amendment and study how to best provide healthcare for the people of this country based on AMA principles and without pre-defined conclusions.”
Opponents of the proposal disagreed with the idea that the AMA would be left out of the discussion. “This is our American Medical Association; we’re comfortable that what’s best for patients is also best for the physicians who take care of those patients,” said former AMA president Daniel Johnson, MD. “The question we have to ask is, ‘What is best for [the] patients?'”
Johnson noted that the AMA will still continue to have a seat at the table “because we are the American Medical Association … We’re not conceding anything when we say that we want to continue to be opposed to the solution of single-payer.”
“I think we ought to put a stake in the heart of single-payer,” said former AMA president Donald Palmisano, MD. “We’ve done it before — we ought to do it again.”
The discussion came in regard to a report on the issue of covering the uninsured from the AMA’s Council on Medical Service (CMS), which recommended that the association support efforts included to improve the Affordable Care Act (ACA) and also continue its opposition to single-payer healthcare reform. “The council underscores that the AMA will continue to thoughtfully engage in discussions of health reform proposals, which will vary greatly in their structure and scope,” the report said. “Opposing single-payer proposals does not preclude that engagement, nor mean that the AMA will not evaluate health reform proposals that are introduced. Ultimately, our AMA, guided by policy, will continue forward in its efforts to advocate for coverage of the uninsured.”
In response, the Medical Student Section offered a proposal recommending that the AMA “revise existing policy to remove opposition to single-payer systems while preserving support for pluralism, freedom of choice, freedom of practice, and universal access for patients.”
“We need to get involved at the start — we can’t just be at the final table,” said Joy Lee, a medical student from Washington, D.C., who was speaking for herself. “When we have categorical opposition in our policy we can’t be there from the very beginning. … We are not asking for AMA to support single payer; what we are asking for is for the AMA to be involved in every proposal that comes out so we can shape final policy.”
But before that proposal could be voted on, Jeff White, MD, of Shreveport, Louisiana, who was speaking for himself, offered an opposing amendment, which said the AMA should “recognize that adoption of a single-payor [sic] system, while perhaps providing universal access for patients, is inconsistent with true pluralism, freedom of choice, and freedom of practice.” That amendment was voted down 122-430. The delegates then narrowly voted down the original amendment from the medical students by a vote of 254-292.
Medicare for All was constantly in the air during the first few days of the House of Delegates meeting. On Saturday, Medicare for All advocates — including physicians —rallied outside the meeting hotel and also disrupted the meeting proceedings going on inside, staging a “die-in” on the meeting room floor and unfurling a Medicare for All banner.
On Sunday, outgoing AMA president Barbara McAneny, MD, appeared at a reference committee meeting to discuss the CMS report. “The AMA proposal for reform supports health system reform alternatives that ensure pluralism, freedom of choice, freedom of practice, and universal access for patients,” she said. “While the ACA has made significant progress, more needs to be done in covering the remaining uninsured … The [report] recommendations support individually owned health insurance with tax credits inversely related to income … [It] has potential to cover millions more Americans.”
McAneny reminded the audience that under a previous Medicare reimbursement formula known as the “sustainable growth rate,” doctors would be left each year “wondering if we receive the threatened 20% cuts. Why would we want to expand that to all of healthcare?” she added. “While some may be disappointed that the council did not recommend removing the AMA’s opposition to single-payer proposals, be assured the AMA will be at the table when health reform proposals are introduced and debated.”
On Monday, Seema Verma, administrator of the Centers for Medicare & Medicaid Services, told the AMA delegates that “the impact of Medicare for All on physicians would be particularly detrimental. Now, I know that our system isn’t perfect, but it does afford you some ability to choose which payers you want to do business with, and what payment terms you’re willing to accept. Medicare for All would take away that choice.”
In other news from Tuesday’s meeting session, the delegates elected Lisa Egbert, MD, an ob/gyn from Dayton, Ohio, as the association’s next vice speaker. The person elected to that role usually goes on to become speaker of the House of Delegates and then the organization’s president-elect.
Foundation Offers Grants to Scientists Probing Potential Alzheimer’s Infection
With multiple failed trials in the desperate search for a treatment of Alzheimer’s disease, researchers are focusing on different approaches to develop therapies. Now researchers are seeking to determine if there could be an infectious link to the development of the dreaded form of dementia.
On Monday, the Infectious Diseases Society of America (IDSA) Foundation announced five one-time grants of $100,000 to researchers seeking to identify a potential infectious link to the disease. In its announcement, the foundation said there is “growing evidence” of what it calls an “Alzheimer’s germ.” But what that is could be bacterium, virus, fungi, parasite or prion, the foundation noted. Research is needed to move the needle forward and that is why the grants were announced.
This is the second year the foundation has offered such Alzheimer’s research grants however, this year, the grants are supported by Alzheimer’s Germ Quest, Inc. and The Benter Foundation. Thomas Fekete, chairman of the IDSA Foundation, said the support of the two organizations allowed the research grants to be expanded to five this year. The grants are designed to obtain evidence that an infectious agent or microbial community is correlated to Alzheimer’s disease, as well as promote research in the field of microbial triggers for Alzheimer’s disease.
Leslie Norins, founder and president of Alzheimer’s Germ Quest, said he has reviewed the scientific literature and believes it is clear that a germ, possibly not one yet discovered, is the root cause of most Alzheimer’s disease. Norins said if that germ can be discovered, it will open up pathways to effective diagnosis, treatments and prevention. Norins believes the germ has gone undiscovered because few researchers are looking at the infection angle, older methods of germ detection have been used and there is too little collaboration between Alzheimer’s disease and infectious diseases researchers.
“A number of tantalizing findings suggest an infectious agent may play a role in Alzheimer’s disease, and we are committed to determining if the link is real,” Fekete said.
Earlier this year, Scientists with Cortexyme published research that showed the gingivitis-causing bacteria Porphyromonas gingivalis is linked to Alzheimer’s. Stephen Dominy, Cortexyme’s co-founder and chief scientific officer said at the time the research was published that there was evidence “connecting the intracellular, Gram-negative pathogen, Pg and Alzheimer’s pathogenesis.”
In order to receive a grant, research must be focused on identifying the possible role of an infectious agent that causes Alzheimer’s disease. Awards will support innovative research, including basic, clinical and/or non-traditional approaches. The application period for the grant will remain open through November 30.
The idea of a germ that may be at the root of Alzheimer’s is one of the latest areas to be explored following the failed research into amyloid plaque and tau tangles. Inflammation is also being explored as a potential cause of the disease. The idea is that amyloid and tangles trigger the disease but the resulting inflammation is what leads to dementia. After the amyloid and tangles begin to kill neurons, the brain’s innate immune system reacts with significant levels of neuroinflammation, which causes more cell death and could lead to dementia. Earlier this year, scientists also explored the protein Klotho, which could impact memory. In mice models, the hormone appeared to protect mice from the cognitive decline associated with Alzheimer’s disease.
Ocular Therapeutix: Launch Looms, Insiders Buying
Shares have lost nearly three-quarters of their value since IPO and are in the red by 15% so far in 2019.
Management gave a solid presentation at Jefferies, clearly communicating value proposition of its lead product and hydrogel-based platform.
Preparations have been made to maximize odds of a successful launch for Dextenza to treat postoperative ocular pain.
Additional product candidates and collaborations provide investors optionality. PDUFA date in November for inflammation is also an important event.
The stock is a Speculative Buy. Risks include setback in launch and near-term dilution.
Shares of Ocular Therapeutix (OCUL) have lost nearly three-quarters of their value since IPO was priced at $13 in 2014. Over the past year, the stock has lost half its value and is in the red by roughly 15% so far in 2019.
This busted IPO popped up on my radar after a recent cluster of insider buying(Chairman just bought 45,780 shares, Chief Medical Officer with multiple purchases, etc.). After listening to management’s presentation at Jefferies, I was able to overcome my initial skepticism to realize there is meaningful innovation taking place here. [MORE]
How Abbott’s New Continuous Glucose Monitor Can Change The Company
New data released by Abbott on the FreeStyle Libre Continuous Glucose Monitor shows it lowers blood sugar levels across the board by nearly a full percentage point in diabetics.
The data is consistent for all type II patients regardless of age, sex, or how much insulin they take or for how long they’ve been taking it.
The monitor is painless and requires no calibration and lasts 14 days, longest on the market.
This could make insulin use much more efficient in the US, a market in dire need lower insulin prices, which more efficient use can help deliver.
Abbott is relatively weak in the U.S. market, and a relatively reasonable 3.5% market penetration for this glucose monitor can increase Abbott’s top line by 50%.
In the rush to wow the biotech world with ever more expensive and cutting-edge drugs, the importance of drug efficiency can get lost in the mix. Drug prices can only go so high before economics kicks in and price increases can no longer be supported. Nobody knows exactly where that point is, but it is clear that the trend to find bigger, better, more expensive blockbusters cannot last forever.
Within this biotech backdrop, Abbott Laboratories (ABT) is succeeding by making existing drugs better. And the company may have just hit the proverbial gold mine, this one in diabetes management.
Insulin prices specifically in the United States are way out of control and the government is taking notice, to the detriment of the established diabetes players. While getting insulin prices down directly would of course be desirable, the extremely convoluted United States healthcare system and its vested interests get in the way of accomplishing this with any urgency. Another way to attack the problem of high insulin costs then is to help make insulin use more efficient. In other words, help those who already use insulin to better control their blood sugar levels with it. Over time, this cuts insulin waste and helps manage costs without directly influencing the per-unit price. In standard basic economics parlance, bring down insulin demand. [MORE]
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