Arrowhead up 3% on launch of new NASH study

Dosing is underway in a Phase 1/2 clinical trial evaluating Arrowhead Pharmaceuticals’ (ARWR +3.2%) ARO-HSD in healthy volunteers and patients with nonalcoholic steatohepatitis (NASH) or suspected NASH.

The estimated completion date of the 74-subject study is November 2021.

ARO-HSD is an RNAi therapeutic designed to dampen the production of an enzyme called HSD17B13, a hydroxysteroid dehydrogenase that plays a key role in the metabolism of hormones, fatty acids and bile acids. Lower activity of the enzyme may reduce the risk of developing both alcohol-related and non-alcohol-related liver disease.

https://seekingalpha.com/news/3548052-arrowhead-up-3-on-launch-of-new-nash-study

Ziopharm down despite pipeline advancement and cash influx

Investors are not showing any enthusiasm for Ziopharm Oncology (ZIOP -6.2%) on the heels of its Q4 report released after the close yesterday.

Results were generally in line with views considering that it does not generate any revenues yet.

The company has refilled its cash coffers with a $20.3M prepayment from it R&D agreement with MD Anderson Cancer Center and ~$98M from an equity offering. Its current balance of ~$177M should be sufficient to fund operations into mid-2022.

Key H1 milestones:

Start of dosing in NCI-led Phase 2 Sleeping Beauty TCR-T study in solid tumors.

Initiation of enrollment in Phase 1 Sleeping Beauty CD19-specific CAR-T RPM study with membrane-bound IL-15 at MD Anderson.

Complete enrollment and report initial data from Phase 2 study of Controlled IL-12 platform + Libtayo (cemiplimab-rwlc).

Data readouts from Phase 1 trials of Controlled IL-12 as monotherapy and in combination with Opdivo (nivolumab).

The only analyst action has been Raymond James which cut its fair value target to $5.50 (from $6.50) while maintaining its Buy rating.

https://seekingalpha.com/news/3548078-ziopharm-down-6-despite-pipeline-advancement-and-cash-influx

World Bank plans financial and technical aid package to help with coronavirus

The World Bank said it would announce a package of financial and technical support later on Tuesday to assist with the health and economic impacts of the global coronavirus outbreak.
World Bank President David Malpass and Muhammad Pate, the bank’s global director for health, nutritition and population, would announce the measures in a telephone conference at 2:30 p.m. EST, the Bank said in a statement.
The International Monetary Fund and the World Bank said on Monday they stood ready to help member countries deal with the coronavirus outbreak, including through emergency funding.
https://www.reuters.com/article/us-health-coronavirus-world-bank/world-bank-plans-financial-and-technical-aid-package-to-help-with-coronavirus-idUSKBN20Q29M

Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Biotech stocks came under selling pressure in February, although the degree of weakness was not as worse as the broader market, thanks to strong upward moves by stocks that are levered to COVID-19 epidemic.
The FDA approved three new molecular entities, or NMEs, in February, taking the total number of NME approvals for the year-to-date period to six. Notable among the approvals for the month were Agile Therapeutics Inc’s AGR 1.73% contraceptive patch Twirla, Baudax Bio Inc’s BXRX 0.26% non-opioid pain medication Anjeso and Esperion Therapeutics Inc’s ESPR 5.1% cholesterol-lowering therapy Nexletol. Merck & Co., Inc. MRK 0.04% faced a rejection, as the FDA shot down its application for Keytruda dose updation.
PDUFA dates are binary events that invariably serve as make-or-break catalysts for stocks. These dates are deadlines by which the FDA reviews a new drug application before announcing its decision concerning the approvability/non-approvability of the drug.
Here are the key PDUFA dates scheduled for March.

Bristol-Myers Squibb Seeks Label Expansion For IO Combo In Liver Cancer

• Company: Bristol-Myers Squibb Co BMY 0.88%
• Type of Application: sBLA
• Candidate: Opdivo+Yervoy
• Indication: advanced hepatocellular carcinoma
• Date: March 10

The FDA accepted Bristol-Myers Squibb’s sBLA in November, granting it Breakthrough Therapy Designation and Priority Review, for the treatment of patients with advanced hepatocellular carcinoma, previously treated with sorafenib.
The application was filed based on data from the Opdivo+Yervoy cohort of the Phase 1/2 CheckMate-040 study.

Eton’s Epilepsy Drug Approval In Doubt After FDA Request For New Study

• Company: Eton Pharmaceuticals Inc ETON 8.53%
• Type of Application: NDA
• Candidate: EM-105
• Indication: Epilepsy
• Date: March 17

EM-105 is an innovative formulation of lamotrigine being developed by Acuta Pharma as an adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older. Eton has acquired U.S. marketing rights to it.
Lamotrigine is one of the widely used anti-epilepsy medications in the U.S., with annual sales exceeding $700 million.
Updating on the FDA review, Eton said in February the FDA requested Eton and Acuta to make changes to the Dosage and Administration section of the product’s prescribing information to simplify the dosing information for intended users. In connection with this, the FDA sought a human factors validation study with the revised labeling to demonstrate that the intended users can prepare and administer the oral suspension safely and effectively.

Bristol-Myers Squibb MS Drug Acquired Through Celgene Buy Awaits FDA Nod

• Company: Bristol-Myers Squibb
• Type of Application: NDA
• Candidate: Ozanimod
• Indication: Epilepsy
• Date: March 25

Celgene, which is now part of Bristol-Myers Squibb, announced FDA acceptance of its NDA for ozanimod in June, with the investigational asset being evaluated as a treatment option for patients with relapsing form of multiple sclerosis in the U.S.
Ozanimod has also been accepted for review in the EU, with a decision due in the first half of 2020.

Can IntelGenx’s Migraine Drug Clear FDA Hurdle After 7-Year Wait?

• Company: IntelGenx Technologies Corp. IGXT 1.32%
• Type of Application: NDA
• Candidate: Rizaport VersaFilm
• Indication: acute migraines
• Date: March 26

Intelgenx is knocking the FDA door for its migraine drug for the fourth time following three prior rejections. The company’s initial regulatory application was filed in June 2013. Rizaport is an oral soluble film formulation of rizatriptan benzoate, the active drug in Maxalt.

Rockwell Medical Seeks Label Expansion For Anemia Drug

• Company: Rockwell Medical Inc RMTI 7.54%
• Type of Application: sNDA
• Candidate: IV Triferic
• Indication: anemia in chronic kidney disease
• Date: March 28

Rockwell commercially launched Dialysate Triferic mixed with liquid bicarbonate last May to deliver iron to patients via the dialysate. The company is now seeking approval for intravenous formulation of the drug.

Label Expansion of AstraZeneca’s Lung Cancer Drug

• Company: AstraZeneca plc AZN 1.46%
• Type of Application: sBLA
• Candidate: Imfinzi
• Indication: previously untreated extensive-stage small cell lung cancer
• Date: First quarter (estimated to be March 29 based on the FDA acceptance of the application with Priority Review on Nov. 29)

https://www.benzinga.com/general/biotech/20/03/15431740/attention-biotech-investors-mark-your-calendar-for-these-march-pdufa-dates

Why South Korea may have more coronavirus cases than the US

Global health experts say the speed and scope of South Korea’s novel coronavirus diagnostic capability exhibit impressive and significant lab capabilities that no other countries, including the U.S., can match at the moment.
South Korea had tested a total of 66,652 people for the COVID-19 coronavirus virus as of 4 p.m. local time Thursday, whereas Japan had reported administering roughly 1,890 tests and the U.S. only 445. The huge discrepancy compared to other countries reflects how quickly South Korea’s numbers have been rising, experts say.
The total number of confirmed cases so far in South Korea is 1,766, up 505 from the day before. Of the 66,00 people who have been tested, more than 25,000 are still awaiting lab results.

More than 10,000 people a day are being tested around the clock, propelled by a sense of concern that the virus may spread outside of Daegu area, where around 80 percent of all confirmed cases have been found.
“This week is crucial for us in determining whether we have successfully dealt with COVID-19,” South Korea Prime Minister Chung Sye-Kyun said.
The tests are being run at 79 designated health centers, in addition to authorized private hospitals and public health labs across the country.

Medical staff take samples from passengers with suspected symptoms of the COVID-19 coronavirus at a drive-through screening clinic of a hospital in Daegu on Feb. 27, 2020.Yonhap/AFP via Getty Images

“We have quickly selected these institutions after training and evaluation programs held on Feb. 7 and 20,” official Park Hyun Kyu at Korea’s Center for Disease Control told ABC News. “They do preliminary screening, then send all positively sampled results to us for final diagnosis.”
Dr. Todd Ellerin, Director of Infectious Disease at South Shore Health in Massachusetts, says the massive number of tests is impressive.

“I think it’s excellent,” said Ellerin, who confirmed the validity of the South Korean tests. “It’s an urgent situation right now, and that’s how we should be adjusting.”
Doctors from around the world agree.
“Impressive testing going on here. All hail these labs!” Ian M. Mackay, a virologist at Australia’s University of Queensland, tweeted.

ɪᴀɴ ᴍ ᴍᴀᴄᴋᴀʏ, ᴘʜᴅ ✔ @MackayIM

Impressive testing going on here. All hail these labs! https://twitter.com/0bFuSc8/status/1231875971306938368 …

0bFuSc8 @0bFuSc8

24FEB S. KOREA #COVID19
• +70 new cases (131 today), total cases 833

• 0 deaths, (2 today), total 7
No other epi data released w/this evening update.https://www.cdc.go.kr/board/board.es?mid=a30402000000&bid=0030&act=view&list_no=366329&tag=&nPage=1 …@KrutikaKuppalli @HelenBranswell @ScottGottliebMD @UNMC_DrKhan @MackayIM @V2019N
1/

299

4:42 AM – Feb 24, 2020

“I definitely respect their earnestness and transparency,” tweeted Dr. Eric Feigl-Ding, an epidemiologist at Boston’s Harvard Chan School of Public Health.

“Very detailed COVID-19 reporting … demonstrating a significant diagnostic capability,” tweeted Dr. Scott Gottlieb of Washington, D.C.’s American Enterprise Institute.

A big reason for South Korea’s success is how quickly they were able to get test kits ready, Ellerin said.
“One thing China did was that [after] the first case came in November, activity began in late December and by January 10th China shared the sequence with the public and they already had test kits on that day.”
Officials say the rapid implementation was possible because the South Korean government was able to shorten the process for the newly developed test kits to be approved by its version of the Food and Drug Administration.
“It would normally take about a year to get a test kit approved, but FDA gave out emergency approval to acceptable applicants on a temporary basis,” Park told ABC News.

For the testing itself, medical institutions, spread out across local communities, follow detailed instructions provided by the central health authorities and screen applicants with suspicious respiratory symptoms. The meticulous process takes from half an hour to an hour per person.
“It just takes a lot of time because the tester has to change suits to a new one every time,” said Park.
“All medical teams dispose of their quarantine suits and inspection tools by using it just once, and new medical tools are used for each patient, every time,” an official with Samsung Medical Center, one of the largest testing centers in Seoul, told ABC News.
As number of tests continues to stack up, several locations have set up “drive-thru” centers that could minimize contact between the potential patient and medical staff. This new idea shortens time spent on testing to just 10 minutes per person since the medics do not have to change quarantine suits for every patient.
Applicants must drive to the site in their privately owned vehicles wearing masks. Tests are conducted at a makeshift tent outside of buildings to prevent spreading indoors.
“When I got there, someone opened the car door for me,” Koo Ji-young told ABC News after receiving his test results for a $140 fee. “First, they take a chest X-ray, then measure body temperature using a noncontact measuring device. A doctor stuck a long stick into my nose and made me spit phlegm.”
The government has called for more volunteer nurses and doctors to help meet the rising demand for tests.
“As of [Wednesday] morning, 205 people have registered to volunteer. We still need more,” Health Vice Minister Kim Gang-lip said during a media briefing.

In Daegu, where 80 percent of all confirmed cases have been reported, 28,000 residents who have reported symptoms of flu or cold will be tested by the end of the month, officials said. Authorities have also pledged to test more than 200,000 followers of a secretive sect at the center of the recent outbreak.
Ellerin, the infectious disease director, said the massive amount of testing also creates valuable data.
“This is a contagious respiratory virus,” said Ellerin. “For instance, during flu season, roughly ten percent get affected. With South Korea’s 55 million population, you could easily imagine 5 million getting this.”
“Sometimes we tend to overestimate,” he said. “So let’s see where this leads to.”
https://abcnews.go.com/International/massive-coronavirus-testing-program-south-korea-underscores-nimble/story?id=69226222

GenMark Spikes Higher On COVID-19 Test Kit Shipment

GenMark Diagnostics, Inc GNMK 31.13% shares, where were languishing around 52-week lows, found support Tuesday from COVID-19 related news.
The Carlsbad, California-based provider of automated, multiplex molecular diagnostic testing systems announced initial shipments of ePlex Research Use Only test kits designed to detect COVID-19 virus to its Hong Kong distributor as well as several U.S. customers that have access to clinical samples.
The company said it plans to use this information to support submission of an Emergency Use Authorization, or EUA, to the FDA.
“In just one month, our team completed the design, manufacture and shipment of initial tests to customers for validation of our assay design using clinical samples,” interim CEO Scott Mendel said in a statement.
Separately, the company reported fourth-quarter results, showing 24% year-over-year revenue growth and a narrower loss of 17 cents per share — a penny wider than the 16 cents per share loss estimated by analysts.
Co-Diagnostics Inc CODX 11.79%, which has a COVID-19 diagnostic test in the market, has seen its shares rise from penny stock territory at the end of 2019 to about $18.
GenMark shares were rallying 27.92% to $4.49 at the time of publication, while Co-Diagnostics was moving in sympathy, down 16.11% at $14.94.
https://www.benzinga.com/general/biotech/20/03/15465784/genmark-spikes-higher-on-covid-19-test-kit-shipment

NY confirms second case of coronavirus

Gov. Andrew Cuomo (D) on Tuesday confirmed a second case of coronavirus in New York state.
The governor said during a press conference that the patient is a man in his 50s who lives in Westchester County and works as an attorney in Manhattan.
The patient, who is now hospitalized, had no known connection to the virus or central locations where the virus has spread, indicating it could be spreading to other communities. The individual had traveled on a flight to Miami, but officials said that wasn’t during his infectious period.
One of the patient’s children attends the Salanter Akiba Riverdale (SAR) Academy in the Bronx. The school decided to close for the day on Tuesday, Cuomo said.
Cuomo said the second case was not a “cause for anxiety” as experts expected the disease to surface in multiple areas of the state and expected that it would most likely spread.
“I’m telling you it is inevitable but that this will continue to spread,” he said, adding that 80 percent of people who contract the virus will “self-resolve.”

A state lab in Albany confirmed the case overnight, according to The New York Times.
The governor also said two families from Buffalo, who recently traveled to areas in Italy that are experiencing outbreaks, are also being tested for the virus and are isolated.
“We don’t see any direct connection,” Cuomo said, according to the Times.
Cuomo announced the first identified case of coronavirus in the state Sunday, saying the victim is a health care worker who was recently visiting Iran, which has been struck with the second-highest number of deaths from the virus outside of China.
The coronavirus, which was identified in China in late December, has spread globally to infect more than 91,000 people worldwide and causing more than 3,100 deaths.
In the U.S., at least 105 cases have been identified, with at least six deaths, all of which were in Washington state, according to data from Johns Hopkins University.
https://thehill.com/policy/healthcare/public-global-health/485644-cuomo-confirms-second-case-of-coronavirus-in-new-york