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Monday, July 20, 2020

Royalty Pharma to acquire part of PTC’s royalty interest in risdiplam for $650M

Royalty Pharma (NASDAQ:RPRX) is purchasing ~43% of the royalty up to a specified amount.
PTC (NASDAQ:PTCT) has previously disclosed that it is entitled to tiered royalties ranging from 8% to 16% on worldwide net product sales of risdiplam.
Risdiplam, to be marketed by Roche, is an investigational, orally administered survival motor neuron-2 (SMN2) splicing modifier for the treatment of spinal muscular atrophy (SMA).
The acquisition is expected to have minimal impact on RPRX’s adjusted cash receipts and adjusted cash flow in 2020 and 2021.

Annexon sets IPO terms

Annexon Biosciences (ANNX) plans to offer 10M shares at a price of $14-$16 per share.
Proceeds will be used to fund clinical trials, R&D activities, for working capital and other general corporate purposes.
Previously: Annexon on deck for IPO (July 2)

FDA accepts Karyopharm application for expanded Xpovio multiple myeloma use

The FDA has accepted for review Karyopharm Therapeutics’ (NASDAQ:KPTI) supplemental marketing application seeking approval to use Xpovio (selinexor) to treat multiple myeloma (MM) patients who have received at least one prior line of therapy. The agency’s action date will be in Q1 2021.
The FDA approved the nuclear export inhibitor a year ago for MM patients who have received at least four prior lines of treatment.

BioXcel Therapeutics rallies on positive BXCL501 data

BioXcel Therapeutics (NASDAQ:BTAI) soars 34% premarket on the heels of its announcement that BXCL501, its proprietary sublingual thin film formulation of dexmedetomidine, met the primary and secondary endpoints in two late-stage studies in schizophrenia and bipolar disorder.
In patients with schizophrenia (SERENITY I) and a second study of bipolar disorder (SERENITY II), highly statistically significant and clinically meaningful reductions in the Positive and Negative Syndrome Scale, Excitatory Component (PEC) score at two hours, the primary endpoint, were reported for both high and low dose cohorts of BXCL501 compared to placebo (p<0.0001).
In SERENITY I trial, 67% and 87% of patients achieved response rate (>40% reduction in PEC scores) at 120 mcg and 180 mcg dose level, respectively.
69% and 85% of patients showed response at 120 mcg and 180 mcg doses, respectively in SERENITY II trial.
Both studies also met the key secondary endpoint, demonstrating improvement in PEC scores beginning as early as 20 minutes in patients with bipolar disorder, at both dose levels (120 and 180 mcg), and as early as 20 minutes in patients with schizophrenia for the 180 mcg dose level.
Exploratory efficacy endpoints confirmed the primary endpoint, with duration of response lasting at least four hours after treatment.
No new safety signals were observed.
The Company is also exploring the potential of BXCL501 in other hyperarousable disease states, such as post-traumatic stress disorder, traumatic brain injury, alcohol withdrawal and as a treatment for phobias.

Vaccine names on the move ahead of Oxford study

Coronavirus vaccine players are on watch this morning ahead of Phase 1 trial results of AstraZeneca’s (NYSE:AZN) COVID-19 vaccine developed with the University of Oxford, which are set to be published in in The Lancet.
Reports last week suggested the journal will release positive news – the vaccine is believed to be in one of the most advanced stages of clinical trials. “Tomorrow. Vaccines. Just saying,” Lancet editor Richard Horton tweeted on Sunday.
Overnight, the U.K. secured early access to 90M doses of vaccines in development by drugmakers, including Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX) and Valneva (OTC:INRLF), while GlaxoSmithKline inked a deal with CureVac to develop mRNA-based vaccines and antibodies.
In just six months since the coronavirus outbreak, 140 vaccine candidates are in the pre-clinical trial stage and 23 have entered the clinical evaluation stage, according to the World Health Organization.
In the U.S. there is mistrust of an approved vaccine, with a recent poll finding just 50% of people saying they would be willing to get it.
Related tickers: Pfizer (PFE) +3%, BioNTech (BNTX) +5.9%. Novavax (NASDAQ:NVAX) +4.8%, Inovio Pharmaceuticals (NASDAQ:INO) +2.1%; Moderna (NASDAQ:MRNA) +0.7%; AstraZeneca (AZN) (-1.9%), Dynavax (NASDAQ:DVAX) (+7.0%), GlaxoSmithKline (NYSE:GSK) (-1.2%), iBio (NYSEMKT:IBIO) (+30.0%), Inovio Pharmaceuticals (INO) (+3.8%), Altimmune (NASDAQ:ALT) (+4.5%), VBI Vaccines (NASDAQ:VBIV) (+3.7%), Pfizer (PFE) (+3.9%)

Uber offers COVID-19 contact tracing help amid ‘chaotic’ U.S. response

Uber Technologies Inc has quietly launched a service to give public health officials quick access to data on drivers and riders presumed to have come into contact with someone infected with COVID-19, company officials told Reuters.
The service, offered free of charge, could help burnish the image of the ride-hailing giant, which recently launched a new ad campaign spotlighting its “No Mask, No Ride” policy in the United States.
Now being promoted to government health officials in all the countries where it operates, the service provides health departments with data about who used Uber’s services and when and allows health agencies to urge affected users into quarantine, the company officials said.
Information on an individual can be accessed in a few hours, the officials said, with the company considering COVID-19 an emergency involving danger of death or serious physical injury. (ubr.to/2Wy3v4Z)
Though Uber has provided the data for months now, it has not been put to use in many U.S. virus hotspots.
A recent Reuters review of contact tracing policies by 32 U.S. state and local health departments found most did not use ride-hailing data to track the virus spread. Among those neglecting the data are Texas and Florida, states that have seen a surge in new infections.
Unlike several other countries, the United States has no federal program or mobile application to trace the contacts of people with coronavirus infections, a measure deemed crucial by the World Health Organization in fighting the COVID-19 pandemic.
The U.S. Centers for Disease Control and Prevention (CDC) did not respond to requests for comment.
Dozens of U.S. states in recent weeks began hiring thousands of workers to interview infected patients, identify people they have been in contact with and then order those individuals to isolate. Ride-hailing data could play an important role in that effort, health officials and experts said, because it identifies a larger set of people outside the direct social circle of an infected individual.
“This data could be potentially life-saving in cities where many people use those services,” said Mieka Smart, an epidemiology professor at Michigan State University and a member of the COVID-19 contact tracing workgroup in Flint.
Uber has long provided data to U.S. law enforcement officials in emergencies or criminal investigations, companies officials said. It first began to focus on health-related issues in 2019, when a resurgence of U.S. measles cases prompted several health departments to request data, the officials said.

In January, company executives flew to Los Angeles to meet with the local health department and CDC officials to discuss how Uber’s data could best be used, according to Uber’s chief of global law enforcement, Mike Sullivan.
The discussion quickly turned to the novel coronavirus, which at the time was only beginning to spread outside of China.
“Our timing ended up being beneficial in that it allowed us to get ahead before COVID started ramping up globally,” said Sullivan, a veteran U.S. prosecutor who leads a team of 100 Uber employees handling data requests around the clock.
In the first half of the year, Uber received a total of some 560 coronavirus-related requests from public health departments in 29 countries, most of which were processed by the company within two hours, company officials said. That compares to only 10 requests from health departments globally in 2019.
Out of the total, 158 requests were filed by health authorities in nearly 40 locations around the United States.
Using the new portal, designed for exclusive use by public health departments, data can be sought based on trip receipts or passenger names. Health officials are prompted to specify what action they want Uber to take as part of the service.
“We want to make sure that they are the experts and we follow their recommendations” on whether to block temporarily a driver, rider or courier from using Uber’s service, Sullivan said. Uber customers with a confirmed infection are automatically blocked from the platform for at least 14 days.
Uber has seen an increase in contact tracing requests from countries credited for their initial success in containing the virus, such as Australia and New Zealand, Sullivan said. He added that contact tracing was also much more coordinated in several European countries than in the United States, including in the UK.
U.S. contact tracing efforts vary from region to region. In some areas, the effort is coordinated on the state level, while cities or counties take charge in others, requests from health departments show.
In Massachusetts, for example, local health departments gather trip details if an infected person tells investigators they have taken a ride-hailing trip. That information is then transferred to the state’s health department, which reaches out to Uber or Lyft to request data.
Lyft said it provided data to U.S. and Canadian health officials through its Law Enforcement Request system, but declined to provide further details, citing privacy reasons.

In California, local officials handle the entire contact tracing process. San Francisco so far has requested ride-hailing data related to the coronavirus pandemic in a handful of cases, according to Michael Reid, a physician who heads the city’s contact tracing program.
“In the end, we need all the data we can to be effective,” said Reid. “Whether it’s Uber or Lyft, or the priest telling you who was in church on Sunday.”

SIEMENS HEALTHINEERS: Buy rating from Bernstein

Analyst Lisa Bedell Clive from Bernstein research considers the stock attractive and recommends it with a Buy rating. The target price is still set at EUR 47.