Sell-Side Remains Optimistic On Sage Despite Depression Drug Disappointment

Sage Therapeutics Inc (NASDAQ: SAGE) shares were savagely sold off Thursday following a negative readout for its lead asset in major depressive disorder.

The Analysts

Morgan Stanley analyst Matthew Harrison maintained an Overweight rating for Sage shares but lowered the price target from $217 to $125. (See his track record here)

H.C. Wainwright analyst Douglas Tsao reiterated a Neutral rating and reduced the price target from $160 to $87. (See his track record here)

Raymond James analyst Dane Leone maintained a Market Perform rating. (See his track record here)

SAGE-217 Remains an Active Drug With a Path to Market

Despite the MOUNTAIN study miss, SAGE-217 remains an active drug with a path to market, Harrison said in a note. The analyst said various factors such as compliance, severity of patients being enrolled etc. influenced the results.

The management continues to communicate with the FDA and plans to compile all data to determine potential changes to studies or potentially additional studies to ensure success, the analyst noted.

“We are encouraged by the manageable tolerability profile and mgt.’s commentary around a higher dose option being attractive in the commercial setting,” Harrison wrote in the note.

Morgan Stanley is confident of the company delivering positive results in the upcoming studies due in 2020.

As such, the firm sees Sage shares significantly higher by year end 2020.

Visibility on Launch Now Less Clear

SAGE-217 can ultimately make it to the market, although visibility on the timing has become less clear, Tsao said.

The analyst sees the need for another confirmatory trial since the magnitude of the effect wasn’t impressive, irrespective of the difference to placebo.

“The ongoing REDWOOD study (fixed, repeat treatment) could fill the need for a second study, but another efficacy study of similar design to MOUNTAIN may ultimately be needed,” the analyst wrote in the note.

The importance of the planned REDWOOD and SHORELINE studies has now heightened to restore shaken investor confidence, Harrison said.

H.C. Wainwright said the MOUNTAIN study results have increased the importance of the sales of Sage’s commercial drug Zulresso, as it now represented a greater proportion of the company’s overall valuation.

The firm noted that Sage has a deeper pipeline apart from its GABAA PAMs, especially its portfolio of NMDA modulators, which have the potential to create significant value over the long term.

Approval In Other Indications Likely

The MOUNTAIN study results have been reflected by the stock movement, Leone said. The analyst expects ongoing clinical development of SAGE-217 to generate substantial debate within the investor and clinical community.

As such, the analyst awaits a clearer outline of clinical catalysts for 2020.

Leone took down his estimates for SAGE-217 in MDD to zero. The analyst said he now expects the management to fully pivot to Treatment-Resistant Depression program during 2020 and not pursue an MDD regulatory approval.

The analyst still models SAGE-217 approval for patients with post-partum depression and also depressed patients presenting with insomnia.

https://www.benzinga.com/analyst-ratings/analyst-color/19/12/14946247/sell-side-remains-optimistic-on-sage-therapeutics-despite-depression-drug-disappoin

Novo Nordisk takes neighborhood approach to preventing diabetes in Philly

Philadelphia ranks fourth among large cities in prevalence of Type 2 diabetes. That’s one of the reasons Novo Nordisk chose the home of the Liberty Bell as the second U.S. city in its localized initiative to prevent Type 2 diabetes.

Called “Cities Changing Diabetes,” the effort has now spread to 25 cities around the world. Novo Nordisk studies each city for about a year in advance to figure out the unique challenges each one faces, said Dr. Todd Hobbs, chief medical officer for Novo Nordisk in North America. The goal is to partner with 50 cities by the end of 2023.

In the case of Philadelphia, that meant sponsoring research conducted by public health organizations, which found that the characteristics of the city’s neighborhoods may make people more or less prone to diabetes. The research identified three types of neighborhoods where developing diabetes is more likely. Those are areas that are “socially cohesive” with strong community structures in place, “polarized by change” in areas where disruptive change affects trust and civic engagement, and “less anchored” places where there is less of a sense of community.

“At the kickoff, we pulled together public and private stakeholders who want to be engaged, but maybe don’t have the overall resources and coordination needed to make these things successful,” Hobbs said, noting that the next step will be an advisory council meeting and deciding what will be the major effects moving forward.

“What we don’t do is come in and just drop a bunch of money or resources and hope that something sticks or helps,” he added.

Philadelphia represents an ongoing thematic expansion as well. As Hobbs said, “It’s not just diabetes. In Philadelphia we’re also talking about obesity which is a driver of much of the diabetes epidemic. Over the five or six years we’ve been involved in the cities program globally, now we’re really speaking to both of them. Because diabetes is not just about glucose and sugar, it’s about obesity and all the other associated co-morbidities.”

While the effort is a social health initiative, Novo Nordisk markets treatments thta It’s also a disease it’s targeting with semaglutide, a compound already approved in two forms as Ozempic and Rybelsus.

Houston was one of the original Cities Changing Diabetes launched five years ago. Today, it has six initiatives that reach 75,000 people in the city on diabetes prevention and resource management. The approach in Houston focused on individual behavioral characteristics of people, versus the neighborhood approach in Philadelphia to find those who are more vulnerable to developing diabetes.

“It’s a problem in cities because that’s where people with diabetes live. Two-thirds of the growing number of people with diabetes are living in cities. But every city’s challenges to address this major problem are very unique and very different,” Hobbs said.

https://www.fiercepharma.com/marketing/novo-nordisk-adds-philadelphia-to-its-roster-cities-involved-its-diabetes-prevention

Biogen stacks the deck but the path forward is no clearer in Alzheimer’s

The presentation of Biogen’s hugely complex aducanumab pivotal programme confirms that the US regulator is destined to make another polarising decision.

After scrapping and then resuscitating its Alzheimer’s project aducanumab, Biogen needed to make a very strong case for pushing on. That attempt came yesterday at a medical conference, CTAD, and it seems that the hugely complex presentation failed to substantially shift opinions in either the medical or financial communities, many of which were firmly entrenched either way.

Biogen has insisted that it will file for approval next year, setting the FDA up to make a decision that, inevitably, many will disagree with. And yesterday’s presentation will not have made life easier for the regulator. By allowing a company employee to present the data – highly irregular for a medical conference – and having no real dissenting voices among the reviewers, Biogen has remained in control of the message.

That message is clear: aducanumab is an effective drug, dosed high enough and for long enough, and represents a real step forward for Alzheimer’s disease. This almost puts a moral obligation on the FDA to grant approval. It will also make running any sort of confirmatory trial incredibly hard, because if physicians and patients believe this interpretation, enrolling a trial in which subjects might receive a placebo becomes almost impossible.

Biogen has said it is preparing to re-dose patients who were originally enrolled in the Engage and Emerge studies. The company presumably hopes that this endeavour will be sufficient to clear up any remaining questions that regulators may have.

But this would be a deeply imperfect way of rigorously examining aducanumab, and there are a lot of unanswered questions here, as well as unseen data. Even if one stands by the way that Biogen has re-analysed the results, the clinical relevance of the efficacy signal teased out remains a subject of debate. And this is before safety is considered – something that must not be easily dismissed with an agent that will be dosed chronically.

The advisory committee hearing that will inevitably be convened next year will provide the FDA’s first thoughts on all this, and will be a hugely pivotal moment for the biopharma sector. A green light will be interpreted as Sarepta 2.0, and a further demise in standards of evidenced-based medicine. Roadblocks will be criticised for delaying patients’ access to potentially life-changing therapies.

History suggests that Biogen will prevail here. Either way, Alzheimer’s is now set to be one of the big stories of 2020.

https://www.evaluate.com/vantage/articles/news/trial-results/biogen-stacks-deck-path-forward-no-clearer-alzheimers

Bariatric Surgery May Raise Risk for Colon Cancer Years Later

Individuals who undergo bariatric surgery may be at increased risk for developing colon cancer years later, according to a study published online Dec. 4 in the International Journal of Cancer.

Wenjing Tao, from the Karolinska University Hospital in Solna, Sweden, and colleagues compared the incidence of colorectal cancer for adults with obesity in Denmark, Finland, Iceland, Norway, or Sweden in 1980 to 2015 who had and had not undergone bariatric surgery.

The researchers found that 9.9 percent of the 502,772 cohort participants with an obesity diagnosis underwent bariatric surgery. After bariatric surgery, there was an increase in the overall standardized incidence ratio (SIR) of colon cancer (SIR, 1.56; 95 percent confidence interval [CI], 1.28 to 1.88), with SIRs higher ≥10 years after surgery. In surgical versus nonsurgical participants, the overall hazard ratio (HR) of colon cancer was 1.13 (95 percent CI, 0.92 to 1.39) and the HR was 1.55 (95 percent CI, 1.04 to 2.31) 10 to 14 years after bariatric surgery. The risk for rectal cancer was not significantly increased with bariatric surgery (SIR, 1.14; 95 percent CI, 0.83 to 1.52; HR, 1.08; 95 percent CI, 0.79 to 1.49); with longer follow-up periods, there was an increase in risk estimates.

“An increased risk of colorectal cancer following bariatric surgery might merit surveillance of patients undergoing such surgery,” the authors write.

Abstract/Full Text (subscription or payment may be required)

https://www.physiciansbriefing.com/hematology-oncology-12/weight-loss-surgery-bariatric-1005/bariatric-surgery-may-raise-risk-for-colon-cancer-years-later-752723.html

How Well Are You Aging? A Blood Test Might Tell

Imagine a blood test that could spot whether you are aging too quickly.

New research suggests it’s not the stuff of science fiction anymore.

The scientists analyzed plasma — the cell-free, fluid part of blood — from more than 4,200 people between the ages of 18 and 95, and found a link between 373 proteins and aging.

“We’ve known for a long time that measuring certain proteins in the blood can give you information about a person’s health status — lipoproteins for cardiovascular health, for example,” said study senior author Tony Wyss-Coray. He’s co-director of the Alzheimer’s Disease Research Center at Stanford University in California.

“But it hasn’t been appreciated that so many different proteins’ levels — roughly a third of all the ones we looked at — change markedly with advancing age,” he added in a university news release.

The study was published Dec. 5 in the journal Nature Medicine.

“Proteins are the workhorses of the body’s constituent cells, and when their relative levels undergo substantial changes, it means you’ve changed, too,” Wyss-Coray explained. “Looking at thousands of them in plasma gives you a snapshot of what’s going on throughout the body.”

The findings suggest that physical aging doesn’t occur at a steady pace, but is uneven and has three distinct surges — ages 34, 60 and 78.

At those ages, there are spikes in levels of specific proteins in the blood with noticeable changes, according to the researchers.

Eventually, a blood test for these proteins might be able to identify people who are aging more rapidly than normal and at increased risk for age-related conditions such as Alzheimer’s disease or heart disease.

Such a test might also help identify drugs or other factors that slow or speed aging, the study authors said.

However, any clinical use of such a blood test is at least five to 10 years away, the researchers noted.

“Ideally, you’d want to know how virtually anything you took or did affects your physiological age,” Wyss-Coray said.

More information

Healthfinder.gov offers tips on protecting your health as you age.

SOURCE: Stanford University, news release, Dec. 5, 2019

https://consumer.healthday.com/senior-citizen-information-31/misc-aging-news-10/how-well-are-you-aging-a-blood-test-might-tell-752705.html

Distracted by Their Smartphones, Pedestrians Are Landing in the ER

 Talking and texting on your smartphone is a big no-no for drivers, but new research suggests the same should be true for pedestrians.

According to one database, more than 2,500 men and women went to an emergency room for head and neck injuries sustained while using a smartphone between 1998 and 2017. When that number is extrapolated to include the whole country, the total is likely to be more than 76,000 people.

“As an emergency physician, I have personally taken care of patients that have walked into traffic, fallen in holes and other dangerous situations while on a phone,” said Dr. Teresa Murray Amato, chair of emergency medicine at Long Island Jewish, in Forest Hills, N.Y.

The dangers of smartphone distraction are heightened by not paying attention to the environment and situation you’re in, said Amato, who had no role in the study.

The researchers make the same point.

“People are not paying attention and getting head and neck injuries because they’re walking with a cellphone, and fall and break their nose or jaw,” said lead researcher Dr. Boris Paskhover, from the department of otolaryngology–head and neck surgery at Rutgers New Jersey Medical School, in Newark.

When people are walking, they’re looking at their phone and not their surroundings. “If you’re not paying attention to where you’re walking and what you are doing, you can get injured,” he said.

Amato agreed that people who are texting or looking at their phones while doing other tasks, such as walking, are at a higher risk of head and neck injuries.

“These injuries are more likely to be caused by tripping, falling or walking into an object,” she said.

Injuries caused by distraction due to cellphones can be quite serious and cause permanent damage, Amato noted.

This study only looked at head and neck injuries from one database, but Paskhover said that injuries to arms, legs and other body parts — and even deaths — have occurred while walking and being distracted by a cellphone.

Most people understand the dangers of texting and driving, Amato said, but the risk of serious head injuries associated with walking while using a cellphone may be underrated.

The most common injuries were to the head (33%), face, including eyelid, eye area and nose (33%), and neck (13%), the researchers found.

Cuts and scrapes were the most common complaint, but about 18% of patients suffered internal organ injury.

Most of those injured were between ages 13 and 29 (60%). For those under 13, most injuries were caused by the cellphone itself (82%), such as a phone battery exploding.

Among people aged 50 to 64, however, most injuries were from using a cellphone while walking (68%). For those over 65, using a cellphone while walking accounted for more than 90% of the injuries, the researchers said.

The only way to prevent these injuries is to not keep your nose glued to your phone or your ears blocked by headphones, but to pay attention to the world around you, Paskhover said.

The report was published online Dec. 5 in JAMA Otolaryngology–Head and Neck Surgery.

SOURCES: Boris Paskhover, M.D., department of otolaryngology–head and neck surgery, Rutgers New Jersey Medical School, Newark, N.J.; Teresa Murray Amato, M.D., chair, emergency medicine, Long Island Jewish, Forest Hills, N.Y.; Dec. 5, 2019, JAMA Otolaryngology–Head and Neck Surgery, online

https://consumer.healthday.com/health-technology-information-18/cellphone-health-news-729/distracted-by-their-smartphones-pedestrians-are-landing-in-the-er-752779.html

November was healthcare’s second strongest hiring month of 2019

The federal government’s November jobs report highlights healthcare industry’s resiliency, with monthly job growth the second highest it’s been all year.

Healthcare industry added an impressive 45,200 jobs in November, according to preliminary estimates from the U.S. Bureau of Labor Statistics. That’s up significantly from an unusually weak October in which the industry made just 11,900 new hires, a number the BLS revised downward from its original estimate. It’s also the highest healthcare hiring since March, when the industry added 49,900 jobs.

While strong, one weak spot in last month’s healthcare hiring was skilled-nursing facilities, which shed 1,700 jobs. That’s a steeper drop than in October, in which the already weak sector shed 1,300 jobs. Skilled-nursing hiring was likely impacted in both months by a new CMS payment model that has prompted layoffs in the skilled nursing sector.

The ambulatory sector comprised three-quarters of healthcare’s new hires last month, which is typical. Within that, physicians’ offices added 16,100 jobs, a noteworthy improvement after having shed 700 jobs in October. Dentists’ offices saw a rebound, too, adding 6,400 jobs after losing 3,600 in October. Home health grew by 8,500 jobs, compared with 4,200 last month. Outpatient care centers added 1,700 jobs, down from 3,400 in October.

The only ambulatory sector that lost jobs last month was in the offices of other health practitioners, which shed 2,400 jobs. Hospitals added 9,900 jobs in October, which is closer to the norm for the sector. Hospitals added just 2,100 jobs in October, which was abnormally low.

Residential mental health facilities added 1,200 jobs in November, and community care facilities for the elderly added 1,400 jobs. Medical and diagnostic laboratories added 2,100 jobs, down from 3,000 in October.

The healthcare sector has added 414,000 jobs over the past 12 months, according to the BLS.

Across all industries, manufacturing had the strongest November, having added 54,000 jobs. That marked a strong rebound after losing 43,000 in October. The BLS noted that the shift reflected the return of workers who were on strike in October. More than 76% of manufacturing’s new hires were in motor vehicle parts. Leisure and hospitality also had a strong November, having added 45,000 jobs during the month. Professional and technical services added 30,600 jobs.

The overall unemployment rate ticked down to 3.5% in November compared with 3.6% in October. Total nonfarm payroll employment rose by 266,000 jobs, far exceeding analysts’ expectations and up significantly from an estimated 128,000 in October.

The BLS noted that job growth has averaged 180,000 per month in 2019, compared with an average monthly gain of 223,000 in 2018.

https://www.modernhealthcare.com/providers/november-was-healthcares-second-strongest-hiring-month-2019