Biotech week ahead, April 26

 Biopharma stocks came back from the weakness seen in the first two sessions to close the week ended April 23 higher. Johnson & Johnson 

JNJ 0.19% and Roche Holding AG RHHBY 0.35% each reported fairly robust results.

Four healthcare stocks, including biotechs and medical device makers, debuted on Wall Street this week, raising $413.3 million in gross proceeds.

Ocugen, Inc. OCGN 3.66% was among the biggest gainers of the week, having advanced over 110% on the back of a positive clinical readout for a partnered COVID-19 vaccine candidate.

Here are the key catalysts for the unfolding week:

Conferences

International Organization for Medical Physics', or IOMP, International Medical Physics Week: April 26-30
UBS Asia Virtual Healthcare Summit: April 27-29
B. Riley's Neuroscience Investor Conference: April: April 28—29
2021 Society of Biological Psychiatry, or SOBP, annual meeting: April 29-May 1
Association for Research In Vision and Ophthalmology, or ARVO, 2021 Virtual Meeting: May 1-7

PDUFA Dates

The Food and Drug Administration is scheduled to announce its verdict on Sol-Gel Technologies Ltd.'s SLGL 0.21% new drug application for Epsolay in the treatment of inflammatory lesions of rosacea. The PDUFA date, or the deadline for announcing the decision, is Monday.

The FDA will also rule on Protalix BioTherapeutics, Inc.'s PLX 4.64% biologic license application for pegunigalsidase alfa in Fabry disease. The PDUFA date is set for Tuesday.

By Thursday, the regulatory agency is mandated to make a decision on Ardelyx, Inc.'s ARDX 0.61% new drug application for tenapanor in hyperphosphatemia.

Clinical Readouts/Presentations

Nanobiotix S.A. NBTX 5.13% is scheduled to present at the IOMP's physics week, further data from the Phase 1 expansion data for NBTXR3 in head and neck cancer.

Cyclerion Therapeutics, Inc. CYCN 4.68% will host a webinar at 8 a.m., Tuesday, to provide a corporate update on clinical programs for its CY6463 in Alzheimer's disease with vascular pathology and mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes.

Trillium Therapeutics Inc. TRIL 0.22% will host its virtual R&D Day for analysts and investors at 10:00 am – 1:00 pm on Wednesday, wherein it will provide a clinical update for TTI-622 in refractory lymphoma or multiple myeloma, and TTI-621 in diffuse Large B-cell Lymphoma (DLBCL), cutaneous T-cell lymphoma.

Aptinyx Inc. APTX is due to present at the SOBP annual meeting, data from the Phase 2a exploratory study of NYX-783 in posttraumatic stress disorder.

Annovis Bio, Inc. ANVS 5.27% is scheduled to release in April interim data for ANVS401 in Alzheimer's and Parkinson's diseases.

Lineage Cell Therapeutics, Inc. LCTX is set to present at the ARVO annual meeting updated interim results from a Phase 1/2a study of its lead product candidate, OpRegen, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration.

Earnings

Monday

Brainstorm Cell Therapeutics Inc. BCLI 4.85% (before the market open)
Masimo Corporation MASI 0.37% (after the close)

Tuesday

Eli Lilly and Company LLY 0.91% (before the market open)
AtriCure, Inc. ATRC 1.46% (after the close)
Amgen Inc. AMGN 0.78% (after the close)
Illumina, Inc. ILMN 1.6% (after the close)

Wednesday

Boston Scientific Corporation BSX 0.49% (before the market open)
Surmodics, Inc. SRDX 0.9% (before the market open)
Integra LifeSciences Holdings Corporation IART 0.34% (before the market open)
Alkermes plc ALKS 1.72% (before the market open)
Apellis Pharmaceuticals, Inc. APLS 4.04% (after the close)
Alimera Sciences, Inc. ALIM 5.94% (after the close)
OPKO Health, Inc. OPK 2.29% (after the close)
Hologic, Inc. HOLX 1.77% (after the close)
Viking Therapeutics, Inc. VKTX 0.82% (after the close)

Thursday

Syneos Health, Inc. SYNH 0.17% (before the market open)
NovoCure Limited NVCR 4.23% (before the market open)
West Pharmaceutical Services, Inc. WST 0.47% (before the market open)
Merck & Co., Inc. MRK 0.13% (before the market open)
Evelo Biosciences, Inc. EVLO 3.41% (before the market open)
Baxter International Inc. BAX 0.17% (before the market open)
Bristol-Myers Squibb Company BMY 0.41% (before the market open)
Blueprint Medicines Corporation BPMC 2.75% (before the market open)
Alnylam Pharmaceuticals, Inc. ALNY 0.76% (before the market open)
Laboratory Corporation of America Holdings LH 0.58% (before the market open)
Abiomed, Inc. ABMD 2.22% (before the market open)
Amarin Corporation plc AMRN 1.16% (before the market open)
Agios Pharmaceuticals, Inc. AGIO 0.83% (before the market open)
ResMed Inc. RMD 0.54% (after the close) (after the close)
MiMedx Group, Inc. MDXG 5.36% (after the close)
BioMarin Pharmaceutical Inc. BMRN 1.22% (after the close)
Pacific Biosciences of California, Inc. PACB 1.57% (after the close)
Bio-Rad Laboratories, Inc. BIO 0.23% (after the close)
Emergent BioSolutions Inc. EBS 1.88% (after the close)
ChemoCentryx, Inc. CCXI 0.78% (after the close)
DexCom, Inc. DXCM 1.13% (after the close)
Gilead Sciences, Inc. GILD 0.24% (after the close)
Merit Medical Systems, Inc. MMSI 2.98% (after the close)
LeMaitre Vascular, Inc. LMAT (after the close)
MacroGenics, Inc. MGNX 3.39% (after the close)
Vertex Pharmaceuticals Incorporated VRTX 0.89% (after the close)
Seagen Inc. SGEN 2.49% (after the close)

Friday

AbbVie Inc. ABBV 1.11% (before the market open)

IPOs Quiet Period Expiries

Achilles Therapeutics plc 

ACHL 3.3%    https://www.benzinga.com/general/biotech/21/04/20779951/the-week-ahead-in-biotech-april-25-may-1-fda-decisions-for-sol-gel-protalix-bio-ardelyx

7 high frequency economic indicators

 These indicators are mostly for travel and entertainment.    It will interesting to watch these sectors recover as the vaccine is distributed.   

IMPORTANT: Be safe now - if all goes well, we could all be vaccinated by June.

----- Airlines: Transportation Security Administration -----
The TSA is providing daily travel numbers.

Click on graph for larger image.

This data shows the seven day average of daily total traveler throughput from the TSA for 2019 (Light Blue), 2020 (Blue) and 2021 (Red).

The dashed line is the percent of 2019 for the seven day average.

This data is as of April 18th.

The seven day average is down 42.1% from the same day in 2019 (57.9% of last year).  (Dashed line)

There was a slow increase from the bottom, with ups and downs due to the holidays - and TSA data has picked up in 2021, but down over the last week.

----- Restaurants: OpenTable -----
The second graph shows the 7 day average of the year-over-year change in diners as tabulated by OpenTable for the US and several selected cities.

IMPORTANT: OpenTable notes: "we’ve updated the data including downloadable dataset from January 1, 2021 onward to compare seated diners from 2021 to 2019, as opposed to year over year." Thanks!

Thanks to OpenTable for providing this restaurant data:

This data is updated through April 17, 2021.

This data is "a sample of restaurants on the OpenTable network across all channels: online reservations, phone reservations, and walk-ins. For year-over-year comparisons by day, we compare to the same day of the week from the same week in the previous year."

Note that this data is for "only the restaurants that have chosen to reopen in a given market". Since some restaurants have not reopened, the actual year-over-year decline is worse than shown.

Dining picked up during the holidays, then slumped with the huge winter surge in cases.  Dining was picking up again, but turned down last week.

----- Movie Tickets: Box Office Mojo -----
This data shows domestic box office for each week and the median for the years 2016 through 2019 (dashed light blue).  

Blue is 2020 and Red is 2021.  

The data is from BoxOfficeMojo through Apr 15th.

Note that the data is usually noisy week-to-week and depends on when blockbusters are released.

Movie ticket sales were at $33 million last week,  down about 75% from the median for the week.

----- Hotel Occupancy: STR -----
This graph shows the seasonal pattern for the hotel occupancy rate using the four week average.

The red line is for 2021, black is 2020, blue is the median, and dashed light blue is for 2009 (the worst year since the Great Depression for hotels - before 2020).

Occupancy is now above the horrible 2009 levels.

This data is through April 10th. Hotel occupancy is currently down 15% compared to same week in 2019). Note: Occupancy was up year-over-year, since occupancy declined sharply at the onset of the pandemic. However, occupancy is still down significantly from normal levels.

Notes: Y-axis doesn't start at zero to better show the seasonal change.

----- Gasoline Supplied: Energy Information Administration -----

This graph, based on weekly data from the U.S. Energy Information Administration (EIA), shows gasoline supplied compared to the same week of 2019.

Blue is for 2020.  Red is for 2021.

As of April 9th, gasoline supplied was off about 5.1% (about 94.9% of the same week in 2019).

Gasoline supplied was up year-over-year, since at one point, gasoline supplied was off almost 50% YoY in 2020.

----- Transit: Apple Mobility -----
This graph is from Apple mobility. From Apple: "This data is generated by counting the number of requests made to Apple Maps for directions in select countries/regions, sub-regions, and cities." This is just a general guide - people that regularly commute probably don't ask for directions.

There is also some great data on mobility from the Dallas Fed Mobility and Engagement Index. However the index is set "relative to its weekday-specific average over January–February", and is not seasonally adjusted, so we can't tell if an increase in mobility is due to recovery or just the normal increase in the Spring and Summer.

This data is through April 17th for the United States and several selected cities.

The graph is the running 7 day average to remove the impact of weekends.

IMPORTANT: All data is relative to January 13, 2020. This data is NOT Seasonally Adjusted. People walk and drive more when the weather is nice, so I'm just using the transit data.

According to the Apple data directions requests, public transit in the 7 day average for the US is at 66% of the January 2020 level. It is at 62% in Chicago, and 61% in Houston (the Houston dip was a weather related decline) - and moving up recently.

----- New York City Subway Usage -----
Here is some interesting data on New York subway usage (HT BR).

This graph is from Todd W Schneider. This is weekly data since 2015. 

Most weeks are between 30 and 35 million entries, and currently there just above 10 million subway turnstile entries per week.

This data is through Friday, April 16th.

Schneider has graphs for each borough, and links to all the data sources.

He notes: "Data updates weekly from the MTA’s public turnstile data, usually on Saturday mornings".

https://www.calculatedriskblog.com/2021/04/seven-high-frequency-indicators-for_19.html

U.S. Lifts Pause on J&J's Covid Vaccine

 Vaccinations with Johnson & Johnson's Covid-19 shot should resume, U.S. health regulators said after investigating rare blood-clotting cases, restoring a key tool for filling gaps in the mass vaccination campaign.

To alert doctors and recipients to the condition that led to a pause in the vaccine's use last week, J&J and regulators plan to add language to the shot's label and fact sheets warning of the clotting condition risk.

The U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention on Friday lifted their recommendation to pause use of the shots, saying the benefits outweigh the risks. Their decision followed a vote by a federal vaccine advisory committee that recommended restarting use of J&J's Covid-19 vaccine in the U.S.

"This vaccine was shown to be safe and effective for the vast majority of people," CDC Director Rochelle Walensky told reporters, though she warned that some women might be at risk of the blood-clotting condition.

J&J's vaccine should be back in circulation as soon as this weekend, the FDA's vaccines chief Peter Marks said, ending a pause that began last week and aiding some vaccination sites that wrestled with limited supplies after the shot was pulled.

Its availability could ease supply constraints that have cropped up since the pause at areas and vaccination sites that were counting on J&J's vaccine. It could also fulfill demand among people who prefer to get a single shot, rather than two doses spaced weeks apart required for protection from the Pfizer Inc. and Moderna Inc. vaccines.

"Some people want a one and done. Some people won't have access to another vaccine in the near future," Dr. Walensky said.

Yet the back-and-forth over the vaccine's use could also prompt some people concerned about safety to seek the other shots or even avoid getting vaccinated. After the FDA and CDC recommended to pause use of J&J's vaccine, health experts expressed concern the move could exacerbate hesitancy to get vaccinated.

Dr. Walensky said the rate of the rare clot condition in J&J vaccine recipients was about 1.9 cases per million people overall, but 7 cases per million women ages 18 to 49 years. In women over 50, the case rate was 0.9 per million.

J&J has agreed with the FDA to add language to the vaccine's label warning about the clot risk, J&J Chief Medical Officer Joanne Waldstreicher told members of the vaccine committee during its meeting.

Dr. Waldstreicher said resumption of vaccinations with J&J's shot would likely prevent many more deaths and hospitalizations from Covid-19 than the number of rare clot cases that may occur in people receiving the vaccine.

"We believe the J&J Covid vaccine is central to the effort to end the pandemic," Dr. Waldstreicher said.

A CDC official said that if vaccinations with J&J's shot resumed, it could prevent up to 1,400 deaths from Covid-19 and up to 3,500 admissions to hospital intensive-care units over a six-month period, though there could be up to 45 cases of the rare blood-clot condition.

"The benefits clearly outweigh the risks, though there are differences in age groups, and particularly for women less than 50 years of age," said Dr. Katherine Poehling, a member of the Advisory Committee on Immunization Practices that made the recommendation, who is also a professor of pediatrics and epidemiology at Wake Forest School of Medicine.

After the ACIP's vote, J&J said the committee vote was an important step toward continuing vaccinations and the company will collaborate with health authorities to ensure the clot condition can be identified early and treated effectively.

J&J vaccine injections were put on hold after reports of a rare blood-clot condition in a small number of recipients, including at least three fatalities.

Many public-health authorities, however, contended that the benefits of the vaccine outweigh the risks. The risk of blood clots is much higher from Covid-19 disease than from the vaccines associated with these complications, Jean Connors, a hematologist at Brigham and Women's Hospital in Boston, said in an interview.

Blood clotting all over the body is one complication of severe forms of the disease. About 15% to 20% of Covid-19 patients who are admitted to intensive-care units develop blood clots, Dr. Connors said.

Earlier in the week, Europe's medicines regulator recommended adding warning language to the J&J's shot, but said its benefits outweighed its risks.

The ACIP advises the CDC on vaccines and includes doctors and public-health officials. It voted 10 to 4, with one abstention in favor of lifting the recommended pause and restarting use among all adults following a six-hour meeting. It was the ACIP's second emergency meeting in 10 days to discuss the J&J vaccine.

The committee met after authorities had identified a total of 15 cases of women experiencing blood clots combined with low blood-platelet counts after receiving the J&J vaccine, according to a presentation by a CDC official during Friday's ACIP meeting. Three of the women have died.

Two of the cases were in women 50 and older, while the rest were between 18 and 49 years of age. The symptoms, including severe headaches and nausea, started around one to two weeks after vaccination.

The CDC is calling the rare condition "thrombosis with thrombocytopenia syndrome," or TTS.

Most of the women had blood clots in veins that drain blood from the brain, but some had clots only in other parts of the body, according to the CDC's presentation to the ACIP panel during its meeting. The condition is also marked by low levels in the blood of platelets, which play a role in clotting.

The CDC is investigating fewer than 10 potential additional cases of TTS, Tom Shimabukuro, a CDC vaccine-safety official, said during the ACIP meeting.

He also cited one case of a woman who experienced TTS and died, but she was excluded from the case count partly because she also had contracted Covid-19 after receiving the J&J vaccine.

Dr. Shimabukuro said the rare combination of clots with low platelet counts is similar to cases that have been reported in Europe among recipients of AstraZeneca PLC's Covid-19 vaccine. He said this rare condition wasn't seen in people who received the messenger RNA-based vaccines from Pfizer and Moderna.

Though the incidence of the clot risk appears low, some ACIP members expressed concern about its seriousness. "It's not an insignificant risk, " said committee member Pablo Sanchez, who is also a pediatric infectious diseases specialist Nationwide Children's Hospital in Columbus, Ohio. "It makes me nervous."

Some committee members wanted their recommendation to also state that women under 50 should be aware of the clot risk and may choose a different Covid-19 vaccine.

The FDA authorized use of J&J's vaccine in late February, the third Covid-19 shot to be cleared -- after shots from Pfizer with its partner BioNTech SE, and Moderna. J&J's vaccine was cleared for people 18 years and older.

Before the pause, J&J's vaccine made up a relatively small portion of all available Covid-19 vaccine doses, as the company increased production. Nearly eight million doses of J&J's vaccine had been administered at the time of the pause, according to the CDC.

Still, public-health officials view the J&J vaccine as particularly useful in vaccinating hard-to-reach populations, such as the homebound and homeless.

In addition to requiring just one dose, it can be stored in a standard refrigerator for longer periods than the other vaccines.

Since J&J had distributed millions of doses before the recommended pause, vaccination sites should have supplies readily available.

FDA and CDC officials said they will continue to investigate the rare blood-clotting condition, though they expressed confidence the vaccine could be safely used.

Acting FDA Commissioner Janet Woodcock said authorities initially recommended the pause because there was a "risk window" in which many people had recently received J&J's vaccine and authorities didn't know how many would develop the clot condition. They also didn't know how many doctors would know how to recognize the rare condition and treat it appropriately.

During the pause, authorities received information that reassured them the number of cases wasn't large, and that doctors were using the right treatments. "As we did this scientific evaluation of recent days, I think we became more and more confident about this decision today," Dr. Woodcock said.

J&J, of New Brunswick, N.J., has a federal contract to supply about 100 million doses of its vaccine for U.S. use by midyear. J&J has said it is committed to supply that amount, but production issues at a contract manufacturer's plant in Baltimore could affect timing of the delivery of doses.

Production of J&J's vaccine at the plant recently stopped during an FDA inspection, which identified unsanitary conditions and other problems.

Awareness by physicians of the blood-clotting condition associated with the vaccine -- and how to treat it quickly and appropriately -- will help reduce illness and death from it, Dr. Connors said.

Four of the first six patients who developed clotting and low platelets after vaccination were treated with heparin, which can worsen their condition. Health authorities now say non-heparin blood thinners should be used.

"Now that we are aware of this syndrome, the risks of dying from it are lower as we believe that we can more quickly identify those that have it and treat it appropriately," Dr. Connors said.

The European Medicines Agency is probing the blood-clotting condition among people who took the vaccine developed by AstraZeneca and its partner, the University of Oxford.

The EMA said Friday the blood-clotting condition occurs in one of every 100,000 people vaccinated with the AstraZeneca-Oxford shot.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/U-S-Lifts-Pause-on-J-J-s-Covid-Vaccine-5th-Update-33052321/

Do J&J and AstraZeneca Vaccines Cause Blood Clots? What Are Symptoms?

 Use of Johnson & Johnson's vaccines could resume as soon as this weekend after U.S. health regulators lifted the pause on the shots Friday evening. J&J and regulators plan to add language to the vaccine's label warning of a risk of blood clots.

The decision, announced by the Food and Drug Administration and the Centers for Disease Control and Prevention, came after a federal vaccine advisory panel voted earlier that day to resume the shots. The vaccine's benefits outweigh its risks for people 18 years of age and older, the FDA said.

The CDC has now identified 15 cases of blood clots, all in women who received the J&J vaccine. Three of the women have died, according to the CDC. The symptoms, including severe headache and nausea, began around one to two weeks after they got the vaccine.

European regulators are looking into similar clotting in people who received a Covid-19 vaccine developed by AstraZeneca PLC and the University of Oxford, not yet approved for use in the U.S. European regulators have said the benefits of using the AstraZeneca vaccine outweigh its potential risks, though they recommended that European Union governments add a warning to the vaccine's product information.

Why was the J&J vaccine paused?

U.S. health authorities recommended the pause while they investigated reported cases of blood clots. Six women, ages 18 to 48, were initially reported to have experienced the clots as well as low levels of platelets, which help with clotting. The total number of cases has since risen to 15, all among women. Three have died.

The cases are extremely rare -- more than 7 million doses of the J&J shot have been given in the U.S. so far. Regulators and researchers still don't know whether the vaccines cause the side effects.

What are the symptoms of blood clots I should look out for?

If you've gotten the J&J vaccine within the past three weeks, you should look for symptoms such as severe headache, abdominal pain, leg pain or shortness of breath. If you have any of those symptoms, which differ from the flulike symptoms that people have reported following vaccination, you should contact your doctor or other healthcare provider.

For each of the 15 clotting cases, symptoms occurred around one to two weeks post-vaccination, whereas the flulike symptoms tend to occur within a day or so of receiving the vaccine.

But health authorities say there is no need to panic. For those who got the J&J vaccine more than a month ago, the risk for blood clotting is very low, said Anne Schuchat, the principal deputy director at the CDC. People who recently received the vaccine within the last couple of weeks and have any of those symptoms should contact their healthcare provider and seek medical treatment, Dr. Schuchat said.

"This is an extremely rare event," but it can also be very serious, said Vivek Cherian, an internal medicine physician affiliated with the University of Maryland Medical System. "Just be aware of those side effects. And if you get them, don't sit on them."

How serious is the risk of blood clots? Don't all vaccines have risk?

The risk appears low, given there were only a handful of cases reported among the millions of doses given. The European Medicines Agency says the blood-clotting condition occurs in one out of every 100,000 people vaccinated with the AstraZeneca shot.

J&J Chief Medical Officer Joanne Waldstreicher told members of the federal advisory panel on Friday that J&J's shot would likely prevent many more deaths and hospitalizations from Covid-19 than the number of rare clot cases. A CDC official said that if J&J's vaccinations resumed, they could prevent as many as 1,400 deaths from Covid-19 and up to 3,500 intensive-care admissions over six months, while there could be up to 45 cases of the blood clotting condition.

The EU's health agency has said that since clotting is also a risk associated with Covid-19, the benefits of using J&J's vaccine outweigh its potential risks. The European Medicines Agency had previously said the same of AstraZeneca's vaccine.

All drugs and vaccines can come with risks. But health authorities want to be especially careful with shots like the Covid-19 vaccines, which are being given so widely, especially since there are alternatives available.

What is concerning is that blood clots can be serious or life-threatening if they do occur and aren't treated properly. The FDA and CDC told doctors to avoid a blood thinner called heparin.

Who is most at risk?

It is still unclear. Thirteen of the 15 cases following the J&J vaccine were among women between 18 and 48 years, suggesting younger women might be at higher risk. Two cases were in women 50 and older.

A similar pattern was seen with clotting side effects among people given AstraZeneca's Covid-19 vaccine. In fact, the U.K.'s medicine regulator recently recommended that people under 30 years shouldn't get the AstraZeneca shot, while Canadian authorities urged stopping its use for people under 55 years.

How is J&J's vaccine different from the others that are available?

The J&J vaccine, like the shot from AstraZeneca, uses a new technology to help people's immune systems mobilize against the new coronavirus. The two viral-vector vaccines contain a virus that causes the common cold, but which has been rendered harmless. That virus is engineered to include genetic instructions that trigger a protective immune response.

The Pfizer Inc. and Moderna Inc. vaccines use a different technology, called messenger RNA, to achieve the same goal. A CDC official said authorities weren't seeing clotting and low platelet counts among patients who received those vaccines. Researchers are investigating whether the viral-vector technology may play a role in the clotting side effects.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Do-J-J-and-AstraZeneca-Vaccines-Cause-Blood-Clots-and-What-Are-the-Symptoms-33052316/