Biotech week ahead, March 9

Biotech stocks rebounded in the week ended March 6, recovering from the previous week’s steep sell-off.
The week was light on news flow, barring some smid-cap earnings and COVID-19 treatment and vaccine news.
The following are key catalysts in the unfolding week that a biotech investor should stay tuned to.

Conferences

Barclays Global Healthcare Conference: March 10-12 in Miami, Florida.
American Academy of Allergy Asthma and Immunology, or AAAAI, Annual Meeting: March 13-16 in Philadelphia, Pennsylvania.

PDUFA Dates

The FDA is set to rule on Bristol-Myers Squibb Co’s BMY 0.23% sBLA for Opdivo + Yervoy as a treatment option for patients with advanced hepatocellular carcinoma who were previously treated with Bayer AG BAYRY 1.52% and Onyx Pharma’s Nexavar. The PDUFA date has been set for Tuesday.

Clinical Readouts

Blueprint Medicines Corp BPMC 1.8% is scheduled to present at the AAAAI annual meeting with Phase 2 data for Avapritinib, which is being evaluated for treating indolent and smoldering systemic mastocytosis.

Earnings

Monday

• Matinas BioPharma Holdings Inc MTNB 2.75% (before the market open)
• Minerva Neurosciences Inc NERV 0.94% (before the market open)
• BioXcel Therapeutics Inc BTAI 2.77% (before the market open)
• Assertio Therapeutics Inc ASRT 4.59% (after the close)
• SI-Bone Inc SIBN 5.39% (after the close)
• Xenon Pharmaceuticals Inc XENE 6.83% (after the close)
• Organogenesis Holdings Inc ORGO 4.36% (after the close)
• Deciphera Pharmaceuticals Inc DCPH 4.67% (after the close)

Tuesday

• Precision BioSciences Inc DTIL 3.14% (time not provided)
• Akebia Therapeutics Inc AKBA 3.41% (before the market open)
• Catabasis Pharmaceuticals Inc CATB 2.77% (before the market open)
• InspireMD Inc NSPR 3.61% (before the market open)
• ChemoCentryx Inc CCXI 4.38% (after the close)
• CV Sciences Inc CVSI 4.29% (after the close)
• Fulgent Genetics Inc FLGT 7.22% (after the close)
• Sunesis Pharmaceuticals, Inc. SNSS 5.57% (after the close)
• RA Medical Systems Inc RMED 3.37% (after the close)
• Protagonist Therapeutics Inc PTGX 4.59% (after the close)

Wednesday

• Xeris Pharmaceuticals Inc XERS 15.38% (before the market open)
• Liquidia Technologies Inc LQDA 3.12% (before the market open)
• Galmed Pharmaceuticals Ltd GLMD 1.56% (before the market open)
• INmune Bio Inc INMB 0.24% (before the market open)
• Clearside Biomedical Inc CLSD 7.08% (after the close)
• Calithera Biosciences Inc CALA 5.02% (after the close)
• Unity Biotechnology Inc UBX 5.07% (after the close)
• Navidea Biopharmaceuticals Inc NAVB 1.98% (after the close)
• Cumberland Pharmaceuticals, Inc. CPIX 3.72% (after the close)
• BioLife Solutions Inc BLFS 0.5% (after the close)
• Dynavax Technologies Corporation DVAX 0.48% (after the close)
• Miragen Therapeutics Inc MGEN 7.27% (after the close)
• Pfenex Inc PFNX 0.52% (after the close)
• Thursday
• Aquestive Therapeutics Inc AQST 7.73% (before the market open)
• Avadel Pharmaceuticals PLC AVDL 1.79% (before the market open)
• Axsome Therapeutics Inc AXSM 5.26% (before the market open)
• Aldeyra Therapeutics Inc ALDX 1.4% (before the market open)
• Selecta Biosciences Inc SELB 2.03% (before the market open)
• Lexicon Pharmaceuticals, Inc. LXRX 4.07% (before the market open)
• Provention Bio Inc PRVB 3.15% (before the market open)
• Protalix Biotherapeutics Inc PLX 3.42% (before the market open)
• Evofem Biosciences Inc EVFM 1.18% (before the market open)
• China Biologic Products Holdings Inc CBPO 0.51% (before the market open)
• Corbus Pharmaceuticals Holdings Inc CRBP 2.58% (before the market open)
• Pieris Pharmaceuticals Inc PIRS 7.35% (before the market open)
• X4 Pharmaceuticals Inc XFOR 2.4% (before the market open)
• Polarityte Inc PTE 2.33% (before the market open)
• Rubius Therapeutics Inc RUBY 2.5% (before the market open)
• Agenus Inc AGEN (before the market open)
• ADMA Biologics Inc ADMA 6.56% (after the close)
• BioDelivery Sciences International, Inc. BDSI 2.62% (after the close)
• Bellicum Pharmaceuticals Inc BLCM 8.14% (after the close)
• Celcuity Inc CELC 5.51% (after the close)
• Lineage Cell Therapeutics Inc LCTX 3.75% (after the close)
• Chembio Diagnostics Inc CEMI 1.3% (after the close)
• Harpoon Therapeutics Inc HARP 3.99% (after the close)
• Flexion Therapeutics Inc FLXN 2.56% (after the close)
• Neoleukin Therapeutics Inc NLTX 10.96% (after the close)
• Rockwell Medical Inc RMTI 2.59% (after the close)
• Inovio Pharmaceuticals Inc INO 43.78% (after the close)
• Savara Inc SVRA (after the close)
• Ocular Therapeutix Inc OCUL 6.62% (after the close)
• Y-mAbs Therapeutics, Inc YMAB 1.93% (after the close)

Friday

• PLx Pharma Inc PLXP 2.91% (before the market open)
• Achieve Life Sciences Inc ACHV 5.26% (before the market open)

IPOs

Imara, a biopharma company that is developing therapies for rare hemoglobinopathies, has filed to offer 4.45 million shares in an IPO, to be priced between $16 and $18. The company seeks to list its shares on the Nasdaq under the ticker symbol “IMRA.”

IPO Quiet Period Expiry

Revolution Medicines Inc RVMD 3.09%
https://www.benzinga.com/general/biotech/20/03/15492037/the-week-ahead-in-biotech-march-8-14-bristol-myers-awaits-fda-nod-for-liver-cancer-combo-therapy-

COVID-19 Updates for Ophthalmologists

In light of recent reports of conjunctivitis in patients with COVID-19, the American Academy of Ophthalmology (AAO) has issued updates aimed at limiting transmission of the highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The updates were posted online March 6.
AAO highlights key steps physicians should take to screen patients for SARS-CoV-2, protect themselves against infection while caring for these patients, and minimize office-based spread of the virus.
To date, this novel virus has been associated with 93,090 cases of disease and 3198 deaths in at least 76 countries. In the United States alone, 129 confirmed and presumptive cases and nine deaths have been reported in 12 states.

Two recent studies now also suggest the virus may cause conjunctivitis.
In one of the studies, conjunctivitis was reported in 1 of 30 patients hospitalized for COVID-19 in China. This patient was also the only one who was found to have SARS-CoV-2 in their ocular secretions. The researchers report their findings in an article published online online February 26 in the Journal of Medical Virology.
In the second study, published online February 28 in the New England Journal of Medicine, “conjunctival congestion” was recorded in 9 of 1099 patients (0.8%) with laboratory-confirmed COVID-19 from 30 hospitals throughout China.
Although COVID-19-related conjunctivitis seems to be uncommon, the AAO reminds physicians that other forms of conjunctivitis are common. Patients with conjunctivitis frequently present to eye clinics or emergency departments, which increases the chance that ophthalmologists may be the first clinicians to examine patients who could have COVID-19.

Ophthalmologists and infectious disease physicians must therefore take measures to protect themselves and their other patients while caring for patients who are infected with SARS-CoV-2.
It is very important to screen patients who may be infected with SARS-CoV-2, Sonal Tuli, MD, spokesperson for the AAO and professor and chair in the Department of Ophthalmology, the University of Florida, Gainesville, told Medscape Medical News.
Persons who should be screened include those who have a history of recent travel to regions in which there are high rates of infection, as well as those who have symptoms suggestive of lower respiratory tract infection, such as shortness of breath, fever, and flu-like illness.
“We also have signs near check-in and at the front door to ask patients to let us know if they are experiencing any of the symptoms of COVID-19,” she said. These patients and their family members are immediately isolated, and a mask is placed on their face.
https://www.medscape.com/viewarticle/926365

Plan set for virus-stricken cruise ship to dock in Oakland

A cruise ship carrying people infected with the coronavirus will dock in the port of Oakland, Calif., the vessel’s captain told passengers and crew Saturday night.
“An agreement has been reached to bring our ship into the port of Oakland,” Grand Princess Capt. John Smith told passengers, according to The Associated Press, citing a recording provided by a passenger. “After docking, we will then begin a disembarkation process specified by federal authorities that will take several days.”
Smith reportedly said any passengers needing hospitalization or medical treatment will be transported to California health care facilities while those who don’t require such care “will go to a federally operated isolation facility within California for testing and isolation.” The ship’s crew will be quarantined and treated aboard.

The ship, which is carrying more than 3,500 people from 54 countries, was earlier barred from docking in San Francisco.
The Department of Health and Human Services (HHS) said on Sunday that nearly 1,000 passengers who are California residents will complete a mandatory 14-day quarantine at Travis Air Force Base and Miramar Naval Air Station. Residents of other states will be quarantined at Joint Base San Antonio Lackland in Texas or Dobbins Air Force Base in Georgia.
“The Department of State is working closely with the home countries of several hundred passengers to arrange for repatriation to their countries,” HHS added in a statement.
Vice President Pence has said at least 21 people aboard the ship have tested positive for the virus. President Trump said during an appearance Friday at the Centers for Disease Control and Prevention that he would “rather have the people stay” on board to avoid increasing the number of cases in the U.S.
Another ship, the Diamond Princess, was previously quarantined for two weeks in the port of Yokohama, Japan, with about 700 people aboard becoming infected during the period.
https://thehill.com/policy/healthcare/486483-virus-stricken-cruise-ship-to-dock-in-oakland

Gottlieb: States, cities may have to shut business ‘for national interests’

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said Sunday cities and states will have to consider shutting down their economies for the sake of national interests amid the coronavirus outbreak.
“No city wants to be the first to basically shut down their economy, state and cities are going to have to act in the interest of the national interest,” Gottlieb said on CBS’s “Face the Nation.”
He said communities will need to decide whether to shut businesses, theaters and other large gatherings as the virus continues to spread.
He also said incentives need to be discussed to help localities make these tough choices.

“I think we need to think about how do we provide assistance to the people of these cities, who are going to be hit by hardship as well as the localities themselves to try and give them incentives to do this,” Gottlieb said. “Right now if there’s no economic support to do this, you don’t want to be the first to go.”
https://thehill.com/homenews/sunday-talk-shows/486504-former-fda-commissioner-states-and-cities-may-have-to-shut

US Army orders troop movement stop in South Korea and Italy due to coronavirus

The U.S. Army has ordered a halt to the movement of troops and their families into and out of Italy and South Korea as part of its response to the novel coronavirus.
U.S. Forces Korea said in a statement on Sunday that the Army had ordered  “all Army soldiers and family members moving to or from South Korea” to postpone their travel due to concerns about the coronavirus, which has infected thousands in the country. The order also applies to soldiers scheduled to attend professional military education in the U.S.
The announcement was made shortly after the Army unveiled an identical measure for troops stationed in Italy. U.S. Army Garrison Italy commander Col. Dan Vogel said in a Facebook video message Saturday that the halt to movement would take place “for the next 60 days or until further notice.”

U.S. Forces Korea said its order only applied to Eighth Army soldiers on permanent change of station orders or attending the education courses. It is expected to be in effect until May 6. Stars and Stripes first reported on the Army orders.
Seven people with ties to the U.S. military in South Korea have reportedly tested positive for the coronavirus. The U.S. European Command has also confirmed that one American stationed in Naval Support Activity Naples has tested positive for the virus, Stars and Stripes noted.
The orders arrive amid a sustained increase in coronavirus cases in Italy and South Korea. Italy has reported more than 5,800 confirmed cases of the disease, while South Korea has reported more than 7,300, according to a database managed by John’s Hopkins University.
Italy has the highest number of confirmed cases outside Italy, and the outbreak has led to closures of businesses and schools in the northern part of the country. The Italian government is reportedly planning to lock down the entire Lombardy region of Italy as part of its efforts to contain the virus.
https://thehill.com/policy/defense/486498-us-military-orders-stop-to-movement-for-troops-in-south-korea-and-italy-due-to

Hospital operator NMC Health delays paying salaries to staff

UAE-based hospital operator NMC Health has delayed February salaries to its staff and now expects to make the payments before March 16.

“The company’s current expectation is that the February payroll will be completed before 16th March,” a spokesman for the company said in an email.
The company normally pays its staff by the 25th of each month, a source familiar with the matter told Reuters.
NMC’s stock has been hammered since U.S. based short-seller Muddy Waters launched a campaign of criticism against its financial statements.
Britain’s Financial Conduct Authority (FCA) said on Feb. 27 it would investigate the finances of NMC, whose shares were suspended on the London Stock Exchange in late February.
Last week, the company said it would ask for an informal debt standstill to stabilise its finances and hired Moelis to advise it in talks with banks.

https://www.marketscreener.com/news/Hospital-operator-NMC-Health-delays-paying-salaries-to-staff–30126967/?countview=0

ECB tells staff to work from home in coronavirus test

The European Central Bank has told most of its over 3500 staff to work from home on Monday to test how it could cope with a shutdown over coronavirus concerns, a spokesperson said Sunday.

The ECB has cancelled most of its public events over the next month but said that its rate-setting Governing Council meeting would go ahead as scheduled on Thursday.
“The ECB has facilities in place for large scale remote working and Monday 9 March will serve as a precautionary test for the infrastructure but also for ECB staff in case such large scale usage of the facilities becomes necessary at some point,” a spokesperson said.
The ECB is expected to unveil further stimulus on Thursday to help the economy cope with consequences of the coronavirus outbreak as travel restrictions, falling stock markets and already evident breakdowns in value chains is sapping confidence.
https://www.marketscreener.com/news/ECB-tells-staff-to-work-from-home-in-coronavirus-test–30127520/?countview=0