Fate Therapeutics (NASDAQ:FATE): Q2 GAAP EPS of -$0.36 misses by $0.03.
Revenue of $2.82M (+173.8% Y/Y) beats by $1.73M.
Tuesday, August 6, 2019
ChemoCentryx down 16% after Q2 revenue miss
ChemoCentryx (CCXI -16.3%) slumps after releasing less-than-expected Q2 results yesterday after the close.
Revenue was down 45% to $7.2M due to a higher proportion of avacopan-related costs related to budgeted costs incurred last year under its commercialization agreements with Vifor Pharma.
Net loss: ($15.2M); loss/share: ($0.26).
Topline data from the Phase 3 ADVOCATE study of avacopan in ANCA-associated vasculitis should be available in Q4.
Topline data from three other clinical trials, one for CCX140 (focal segmental glomerulosclerosis) and and two for avacopan (C3 glomerulopathy and hidradenitis suppurativa), should be available in 2020.
Previously: ChemoCentryx, Inc. EPS misses by $0.04, misses on revenue(Aug. 5)
Regenxbio and Novartis down on data issue related to SMA gene therapy
REGENXBIO (RGNX -2.1%) slips on increased volume in response to a data integrity issue related to Novartis (NVS -3.4%) unit AveXis’ gene therapy Zolgensma (onasemnogene abeparvovec-xioi), approved by the FDA in May for pediatric patients with spinal muscular atrophy (SMA).
In a statement, the agency says AveXis notified it about a “data manipulation issue” impacting the accuracy of certain tests performed in animals, the results of which were included in the marketing application. The FDA is “carefully assessing” the situation and “remains confident” that the product should remain on the market, but adds that AveXis failed to inform it on the matter before the product was approved despite being aware beforehand.
AveXis in-licensed RGNX’s NAV AAV9 vector used in Zolgensma in March 2014.
Novo Nordisk Holder Invests in Recycled Chemicals Startup LanzaTech
Novo Holdings, the largest shareholder in Danish drug maker Novo Nordisk AS (NVO), has bought a stake in recycled fuels and chemical startup LanzaTech.
The holding company said Tuesday it had invested $72 million during a series E funding round in the Illinois-based startup, which recycles waste and turns it into fuels like ethanol or polyethylene for consumer goods.
“This locks carbon into a cycle and supports a transition to a circular economy,” Novo Holdings said.
Senior Director Anders Bendsen Spohr will join the board of LanzaTech.
“Novo Holdings’ investment underlines our commitment to supporting the bioindustrials sector and, in particular, companies that are developing cutting-edge technology platforms,” Mr. Spohr said.
US drug distributors propose $10 billion to end state lawsuits over opioids
Drug wholesalers AmerisourceBergen Co, McKesson Corp and Cardinal Health Inc have proposed a $10 billion settlement for claims that they played a part in the U.S. opioid epidemic, Bloomberg reported on Tuesday, citing people familiar with negotiations.
Hundreds of lawsuits by states and cities have been filed nationally accusing drugmakers of deceptively marketing opioids and distributors such as AmerisourceBergen Corp, Cardinal Health Inc and McKesson Corp of ignoring suspicious orders.
Shares of AmerisourceBergen, McKesson and Cardinal Health were down about 5%.
The National Association of Attorneys General, negotiating on behalf of more than 35 states, countered with a demand for $45 billion to cover costs, according to the Bloomberg report.
“We regularly engage with the state attorneys general, but the company has made no settlement offers,” McKesson said in a statement.
Early Data On Alzheimer's Vaccine Trial In Down Syndrome Called Promising
Though often underrepresented and overlooked, they actually make up the world's largest population of individuals predisposed to getting Alzheimer's disease. Because of this, people with Down syndrome offer unique opportunities for clinicians exploring effective treatments for Alzheimer’s that could benefit both the Down syndrome and the general populations.
The company announced this month early clinical results of an ongoing Phase 1b study of an anti-beta-amyloid (Abeta) therapeutic vaccine in people with Down syndrome. The vaccine is being tested for safety, tolerability and its ability to provoke an immune response, or immunogenicity, in adults with Down syndrome. The vaccine is designed to stimulate a patient’s immune system to produce antibodies that specifically target Abeta proteins to prevent beta amyloid plaque accumulation and to boost plaque clearance.Pfeifer said the Phase 2 study has now begun, "assessing the vaccine’s safety, tolerability, immunogenicity, target engagement, biomarkers and clinical efficacy in people with mild to moderate Alzheimer’s disease." The company reported in its Phase 1b clinical study that ACI-24 was “well tolerated in subjects with Down syndrome, demonstrating a favorable safety profile at all doses tested, mirroring previous clinical trial results,” Pfiefer said. Pending final outcomes of the 1b study, the Phase 2 study of the vaccine in subjects with Down syndrome will likely focus on disease prevention and will include biomarker and PET imaging to monitor disease progression, she said.
Because their bodies produce extra amyloid, most people with Down syndrome develop problems with thinking and memory early on. “The reason we are using Down syndrome individuals is that they have very defined genetics,” Pfeifer said. “Basically since birth they have beta-amyloid, which leads to plaques in Alzheimer’s disease. By the time they are 20, they develop Alzheimer’s like symptoms. By the time they are 40, they all have such symptoms. At the age of 60, the probability is almost 100% that they will have Alzheimer’s disease.” (Beta-amyloid is a sticky compound or microscopic brain protein fragment that accumulates in the brain, disrupting communication between brain cells and eventually killing them.)
(PHOTO COURTESY OF ACIMMUNE)
“The reason the study focuses on individuals with Down syndrome is that they have very defined genetics,” Pfeifer said. There are 212,000 people living with Down syndrome in the US and 359,000 in Europe. The neuropathological changes in Down syndrome subjects are very similar but not identical to typical Alzheimer’s disease, Pfeifer said. “People with Down syndrome have an extra copy of chromosome 21, which houses the gene that codes for amyloid precursor protein (APP),” she said. “APP is the parent protein of Abeta, a protein fragment that accumulates into amyloid plaques, a key feature of Alzheimer’s disease.” (Beta-amyloid is a sticky compound or microscopic brain protein fragment that accumulates in the brain, disrupting communication between brain cells and eventually killing them.)
One of the challenges in Alzheimer’s research, Pfeifer said, is that the disease is typically diagnosed once symptoms are already clinically present. “For Alzheimer’s disease in people with Down syndrome, the disease mechanism and approximate timing of onset are known; readily detectable pathological changes occur prior to Alzheimer-like symptoms, enabling treatment prior to disease onset,” Pfeifer continued. “That’s why the Down syndrome population is so important, because it can be an entry point which allows us to test treatments in a more homogenous, genetically defined situation to potentially help people with Down syndrome and a much wider Alzheimer’s population.”
Pfeifer said studying Alzheimer-like symptoms in people with Down syndrome addresses many of the key dilemmas that hinder the discovery of new treatments for everyone, including:
- Uncertain mechanisms and timing of disease-induced brain changes.
- Difficulty offering treatment before disease onset, genetic and age-related variability.
- The risk of including subjects with other forms of age-related dementia.
“The new attention given to people with Down syndrome now impacting society is new,” Pfeifer said. “Now, a lot of people with Down syndrome reach 60 years and older. They are independent and have relationships and are working. It has been completely overlooked. Their specialized genetics may give us hope to develop therapies for the wider population.”
AC Immune clinical pipeline currently includes nine therapeutic and three diagnostic product candidates, with five currently in clinical trials and has collaborations with major pharmaceutical companies including Roche/Genentech, Eli Lilly and Janssen.
https://www.forbes.com/sites/robinseatonjefferson/2019/07/26/early-results-on-alzheimers-vaccine-trial-in-people-with-down-syndrome-promising-researchers-say/#26f6033227df
Timing Right For An Anthem-HCSC Blue Cross Mega Merger?
The departure of top executives at Health Care Service Corp. could open the door to an eventual merger with a number of Blue Cross and Blue Shield plans including Anthem.
The regulatory and political hurdles could be too steep to pull off given the different ownership structures of Health Care Service Corp., also known as HCSC, and Anthem, but these aren’t ordinary times when it comes to deals within the health insurance industry.
Because Anthem, the nation’s second-largest health insurer with 41 million enrollees, is a for-profit publicly-traded operator of Blue Cross plans, the acquisition of HCSC would face additional layers of approvals given HCSC is a mutual health insurer owned by policyholders. HCSC, the nation’s fourth-largest health insurer with 16 million health plan enrollees, owns and operates Blue Cross plans in five states.
Such mergers of investor-owned for-profit plans and a mutual that executives inside HCSC consider “not-for-profit” typically face intense scrutiny among insurance regulators as well as attorneys general and perhaps even state lawmakers given proceeds of such sales can be considered charitable assets depending on state rules.
But sources close to HCSC say the board wasn’t happy with departed chief executive Paula Steiner because she wasn’t thinking big enough for their liking when it came to long-term strategy and potential deals. Health Care Service made billions of dollars and grew under Steiner but the board wants a more aggressive long-term strategy.
“HCSC’s board of directors and new leadership intend to pursue a more forward leaning long term strategy, while continuing to help our members access quality, affordable health care,” HCSC said in a statement, adding that the health insurer “won’t speculate about its strategy or future plans.”
Still, sources say some in executive leadership at HCSC are open to at least looking into large mergers and acquisitions given CVS Health’s $69 billion acquisition last year of Aetna and health insurer Cigna’s $67 billion purchase of the pharmacy benefit manager Express Scripts. Meanwhile, the nation’s largest health insurer, UnitedHealth Group, is spending billions of dollars buying up providers of medical care from urgent care centers to a chain of doctor practices.
Over the years, HCSC has added smaller Blue Cross plans that are considered nonprofit or mutual, but there hasn’t been such an acquisition in years. There have, however, been discussions between HCSC with other Blue Cross plans over the years but such deals eventually failed to come together.
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