Craig-Hallum analyst Alexander Nowak started Senseonics with a Buy rating and $6.50 price target while noting that its novel continuous glucose monitor is nearing FDA approval and a largely untapped $23B market opportunity awaits.
Monday, June 11, 2018
Sunday, June 10, 2018
Bacteriophages: Overlooked driver of Parkinson’s disease?
In the first study of its kind, researchers from the New York-based Human Microbiology Institute have discovered the role certain bacteriophages may play in the onset of Parkinson’s disease (PD). The research is presented at ASM Microbe, the annual meeting of the American Society for Microbiology, held from June 7th to June 11th in Atlanta, Georgia.
The researchers, led by George, Tetz, M.D., Ph.D., Human Microbiology Institute, showed that the abundance of lytic Lactococcus phages was higher in PD patientswhen compared to healthy individuals. This abundance led to a 10-fold reduction in neurotransmitter-producing Lactococcus, suggesting the possible role of phages in neurodegeneration. Comparative analysis of the bacterial component also revealed significant decreases in Streptococcus spp. and Lactobacillus spp. in PD.
Lactococcus are regulators of gut permeability and are enteric dopamine producers, which plays a primary role in PD. “The depletion of lactococcus due to high numbers of strictly lytic phages in PD patients might be associated with PD development and directly linked to dopamine decrease as well as the development of gastrointestinal symptoms of PD,” said Dr. Tetz.
To explore bacterial and bacteriophage community compositions associated with PD, the researchers used shotgun metagenomics sequencing data of fecal microbiome from 32 patients with PD and 28 controls.
The results indicate that the decrease in Lactococci in the PD patients was due to the appearance of strictly lytic, virulent lactococcal phages belonging to the c2-like and 936 groups that are frequently isolated from dairy products. These results open a discussion on the role of environmental phages and phagobiota composition in health and disease.
“Bacteriophages have previously been overlooked as pathogenic factors, and the study points out their pivotal role in pathogenesis,” said Dr. Tetz. Future research is needed to explore bacterial viruses as a diagnostic and treatment target for therapeutic intervention.
Bernstein: What Activism Means For Allergan Shareholders
Allergan plc AGN 4.34% shares popped 5.6 percent Thursday on news of a possible stake by Carl Icahn. Attention from the activist investor would heighten the pressure for a strategic shift that’s already being applied by Appaloosa and Senator Investment Group.
The Rating
Bernstein analyst Aaron Gal maintained an Outperform rating with a $232 price target.
The Thesis
Bernstein identifies unrecognized intrinsic value in the stockt that can be attributed more to external events than mismanagement. The potential demands for a board shakeup are futile, in Gal’s view. (See the analyst’s track record here.)
“We do not see the governance at Allergan as particularly faulty (they were willing to sell the company) and while governance improvements are always a good thing and the suggestion by the activists are logical, we do not believe these ideas are material enough to alter the company prospects,” the analyst said in a Friday note.
Gal expects a debate around CEO replacement or segment sales, the latter of which may be premature ahead of readouts for CGRP and rapastinel.
“If these are successful, future growth of the business will be a lot more secure,” Gal said “If they fail, then Allergan will be growth challenged and it would be time to seek breaking up the company as way to unlocking value.”
CDC warns residents in eight U.S. states of cut-fruit Salmonella outbreak
The FDA and U.S. Centers for Disease Control are investigating an outbreak linked to 60 illnesses and at least 31 hospitalizations in five states. No deaths have been reported and the agencies urged residents in the eight states to throw out any melon that may have been recalled.
On Friday, Caito Foods LLC, a unit of SpartanNash Co, recalled fresh-cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit products containing one of those melons produced at a Caito Foods facility in Indianapolis.
The recalled products were distributed to Georgia, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, and Ohio and sold in clear, plastic containers at stores including Costco Wholesale Corp, Kroger Co, Payless, Owen’s, Sprouts, Trader Joe’s, Walgreens, Walmart Inc, and Whole Foods, a unit of Amazon.com Inc.
FDA Commissioner Scott Gottlieb in a Twitter post late on Sunday urged people in the eight states to check the “fridge and freezer for recalled pre-cut melon linked to Salmonella outbreak.”
Of the 60 cases reported to date, 32 were reported in Michigan.
“Reports of illnesses linked to these products are under investigation, and Caito Foods is voluntarily recalling the products out of an abundance of caution,” the company said in a statement, adding it “has ceased producing and distributing these products as the company and FDA continue their investigation.”
Salmonella can result in serious illness and produce significant and potentially fatal infections in young children, frail or elderly people and others with weakened immune systems the company said.
The CDC said evidence suggested that melon supplied by Caito Foods “is a likely source of this multistate outbreak.”
The investigation is ongoing to determine if products went to additional stores or states, the agencies said.
Autoimmune disease biotech Kezar Life Sciences sets terms for $70 million IPO
Kezar Life Sciences, which is developing small molecule therapeutics to treat autoimmune diseases and cancer, announced terms for its IPO on Friday.
The San Fancisco, CA-based company plans to raise $70 million by offering 4.7 million shares at a price range of $14 to $16. Insiders intend to purchase $30 million worth of shares in the offering. At the midpoint of the proposed range, Kezar Life Sciences would command a fully diluted market value of $295 million and an enterprise value of $187 million.
Kezar Life Sciences was founded in 2015 and plans to list on the Nasdaq under the symbol KZR. Jefferies, Cowen & Company, Wells Fargo Securities and William Blair are the joint bookrunners on the deal. It is expected to price during the week of June 18, 2018.
FDA Action Alert: Cordis and PneumRx
Although there are no U.S. Food and Drug Administration (FDA) approvals expected for this week, there are two Adcom meetings. Advisory Committees are used by the agency to obtain independent expert advice on scientific, technical, and policy matters.
Cordis’ INCRAFT AAA Stent Graft System
On Tuesday, June 12, 2018, there will be an Adcom meeting of the “Circulatory System Devices Panel of the Medical Devices Advisory Committee,” from 8:00 a.m. to 6:00 p.m. held at the Hilton Washington, DC in Gaithersburg, Maryland. The meeting will be to discuss and make recommendations, as well as vote on the premarket approval application of Cordis’ INCRAFT AAA Stent Graft System.
Part of the company’s Aortic Portfolio, the Stent-Graft System is designed to treat infrarenal abdominal aortic aneurysms. It is called an “advanced Endovascular Aneurysm Repair (EVAR)” technology.
The application is based on the company’s Inspiration trials. It met its primary safety and effectiveness endpoints, but there were higher than anticipated adverse events. The meeting will discuss how the safety issues impact the device’s long-term safety and effectiveness in addition to its benefit/risk profile.
The product has been cleared for use in Canada and Europe since 2014. According to FDA documents, the system had failed to be approved in the U.S. in July 2015, April 2016 and July 2017, requesting additional data. “Due to the time required to understand the significance of these events, including the completion of the root cause analysis, clinical study data well beyond the one-year primary analysis was captured and reported. These data included additional observations of effectiveness-related events, most notably new observations of transrenal stent fractures, Type 1 endoleaks, aneurysm expansion, graft occlusion and other patency-related events, and limb migrations.”
Cordis is a subsidiary of Cardinal Health.
PneumRx’s PNEUMRX ELEVAIR Endobronchial Coil System
On Thursday, June 14, 2018, the “Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee” will meet at the Gaithersburg Holiday Inn from 8:00 a.m. to 6:00 p.m. The committee will be discussing PneumRx’s premarket approval application for the PNEUMRX ELEVAIR Endobronchial Coil System. The device is investigational in the U.S.
The device is used as a minimally invasive, bronchoscopic approach to reducing hyperinflation in severe emphysema patients. They are implants intended to improve exercise capacity, lung function and patient quality of live who have severe emphysema. It is made up of a sterile single-use Coil implant and a sterile, disposable delivery system made up of a cartridge, catheter, guidewire and forceps. It is deployed using a bronchoscope.
In an FDA document describing waivers for one of the panelists, it noted, “A successful, robust discussion of this subject matter by the Panel requires participants with expertise in lung volume reduction, lung transplants and pulmonology. This subject matter requires more clinical experts than the Anesthesiology and Respiratory Therapy Devices Panel’s current composition of pulmonologists, thoracic surgery and chronic obstructive pulmonary disease experts. Because this is such a unique area of discussion, there is a need for additional relevant expertise to supplement the standing members.”
The document further describes the difficulties the agency has had in finding experts specific to this device for the Adcom, stating, “Thus far, the division has eliminated approximately 10 lung transplant and pulmonology experts due to unavailability and conflicts. Because a limited number of clinical centers offer lung transplantation programs, there is much competition among lung transplantation studies to find sites and investigators to perform their medical research, resulting in a significant proportion of lung transplantation experts with direct involvement with the device sponsor or its competitors. Therefore, it is challenging to find an expert in this field who is not currently directly involved with the device sponsor or one of its competitors.”
Measles cases surge amid Venezuela’s crisis
Venezuela, devastated by economic and political crises, accounted for 85 percent of cases of measles reported across Latin America and the Caribbean over the past year, the Pan-American Health Organization reports.
Of the 11 countries that reported cases, Venezuela had the overwhelming majority of cases, but also 35 deaths since mid-2017, the international organization said.
More specifically, “there were eleven countries that reported 1,685 confirmed measles cases across the region,” of which 1,427 were in Venezuela, a PAHO report released Saturday found.
The disease is on the rise in the South American nation led by leftist President Nicolas Maduro; the trend has continued this year where cases have been reported in 17 out of 23 states, and in the capital.
In neighboring countries, where Venezuelans have migrated due to grim economic conditions, many of the reported cases have been among Venezuelan immigrants, the report said.
Venezuela says it does not have 85 percent of the basic medical supplies it needs even including vaccines. Maduro’s government blames US sanctions for the woes.
The government on April 6 launched a new vaccine campaign against 14 diseases including measles and TB.
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