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Tuesday, October 1, 2019

Ziopharm +4.0% after FDA clears IND for CD19-specific CAR-T made with RPM

Ziopharm Oncology (NASDAQ:ZIOPgains 4.0% in premarket trading after the U.S. Food and Drug Administration allow it to proceed with a phase 1 clinical trial to evaluate CD19-specific CAR-T, produced using rapid personalized manufacture, for an investigational treatment for patients with relapsed CD19leukemias and lymphomas.
Up to 24 patients will be enrolled to evaluate infusion of donor-derived RPM CAR-T in patients with CD19+ leukemias and lymphomas who have relapsed after allogeneic bone marrow transplantation. This study will be conducted at The University of Texas MD Anderson Cancer Center under an investigator-initiated trial expected to begin later this year.
https://seekingalpha.com/news/3502832-ziopharm-plus-4_0-percent-fda-clears-ind-cd19-specific-car-t-made-rpm

Online brokers tumble after Schwab cuts commissions to zero

E*Trade (NASDAQ:ETFC) sinks 14%, TD Ameritrade (NASDAQ:AMTDslides 14%, Interactive Brokers (IEX:IBKRfalls 4.6%, and Charles Schwab (NYSE:SCHWfalls 6.1% after Schwab announces that it will reduce U.S. stock, ETF, and options online trade commissions from $4.95 to zero, starting Oct. 7, 2019.
The company said there’s no minimum account size to open a full-featured Schwab brokerage account.
https://seekingalpha.com/news/3502850-online-brokers-tumble-schwab-cuts-commissions-zero

Biogen announces leadership changes

Biogen (NASDAQ:BIIB) announces an update to its senior leadership team.
Effective immediately, Alfred Sandrock, Jr., M.D., Ph.D., has been named Executive VP, R&D, in addition to his responsibilities as Chief Medical Officer.
Alphonse Galdes, Ph.D., has been appointed Executive VP, Pharmaceutical Operations and Technology.
Michael D. Ehlers, M.D., Ph.D., has decided to step down as Executive VP, R&D, and will leave Biogen effective October 11, 2019, to pursue a new career opportunity.
Sandrock joined BIIB in 1998 and has served on Biogen’s Executive Committee since 2015.
Galdes joined the company in 1995 and has served on the Executive Committee since September 2019.
https://seekingalpha.com/news/3502852-biogen-announces-leadership-changes

FDA clears Luminex’s ARIES MRSA Assay

The FDA grants 510(k) clearance for Luminex’s (NASDAQ:LMNX) ARIES MRSA Assay, an integrated, in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization.
The Luminex ARIES System is a sample to answer, real-time instrument designed to increase laboratory efficiency and  ensure result accuracy.
https://seekingalpha.com/news/3502870-fda-clears-luminexs-aries-mrsa-assay

Welltower cut to Equal Weight by Barclays

Target to $93 from $88
https://www.benzinga.com/stock/WELL/ratings

Acadia started at Outperform by RBC

Target $60
https://www.benzinga.com/stock/ACAD/ratings

New Sanofi CEO Aims to Prioritize Investment on Winnable Areas

Sanofi new Chief Executive Paul Hudson said Tuesday that the company needs to better focus its investment to prioritize areas where it can win.
In his first press conference for Sanofi, Mr. Hudson said he was spending his first weeks in the job deciding in which areas the company should direct investment.
“We need to make good choices,” said the new CEO, who joined Sanofi from Novartis last month. “I’m bringing a sense of urgency and prioritization.”
Sanofi is one of the most diversified companies in the industry, spanning branded prescription drugs, vaccines and over-the-counter treatments. Within branded drugs, it produces medicines ranging from insulin for diabetes to specialty medicines for rare diseases.
Asked whether he would maintain that diversification, Mr. Hudson said the board “should expect that I should look with clear eyes at how we allocate capital.”
Regarding the company’s branded drug pipeline, Mr. Hudson said he would set a high bar for investment, requiring that drugs are the first of their kind and the best of their kind.
“We have to be more critical to decide whether we have literally life-changing science,” he said.
Sanofi, maker of Lantus, the world’s best-selling insulin, has long been associated with diabetes. But with sales of that product falling amid increased competition and pricing pressure in the all-important U.S. market, that franchise is shrinking. Mr. Hudson said he would not treat the diabetes franchise any differently from any other therapeutic area when deciding how best to allocate resources.
On deal-making, he said the company would first establish its priorities then “look at where we have gaps, where we should be stronger and find the best approach to deal with that.”
Mr. Hudson said he would provide a strategy update to investors at an event in December.
https://www.marketscreener.com/SANOFI-4698/news/Sanofi-New-Sanofi-CEO-Aims-to-Prioritize-Investment-on-Winnable-Areas-29317781/