Biotech week ahead, Feb. 7

 Biotech stocks managed to close the week ending Feb. 4 with gains. Stocks recovered along with the broader markets early in the week, but came under pressure midweek amid negative reaction to some big pharma earnings. The sector came back up in the final session for a firm finish.

Merck & Co., Inc. 

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 issued mixed 2022 guidance and Swiss pharma giant Roche Holding AG 

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 warned of slowing growth in 2022. Biogen, Inc. 

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 shares moved to the downside as they reacted to weak guidance and not-so-promising commentary about sales of the company's Alzheimer's drug Aduhelm.

On the regulatory front, the Food and Drug Administration approved Viatris Inc.'s 

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 generic version of AbbVie, Inc.'s 

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 dry eye disease drug Restasis. Sanofi 

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 received the nod for its medication Enjaymo, targeting a rare blood disorder known as cold agglutinin disease.

LogicBio Therapeutics, Inc. 

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 shares shed over 50% during the week after the FDA imposed a clinical hold on a Phase 1/2 study of its AAV-delivered genomic editing therapy LB-001 to treat a rate metabolic disorder in children.

Here are the key catalysts for the unfolding week:

Healthcare Conferences

18th Annual World Symposium 2022: Feb. 7-11 (hybrid format, in San Diego, California and virtually)
Guggenheim Healthcare Talks: Oncology Conference (virtual): Feb. 9-11
11th Annual Glaucoma 360 New Horizons Forum: Feb. 11(hybrid format, in San Francisco, California and virtually)
Angiogenesis, Exudation, and Degeneration 2022 – Virtual Edition: Feb. 11-12

Adcom Meeting

The FDA's Oncologic Drugs Advisory Committee is scheduled to meet on Thursday, Feb. 10 to discuss the biologic license application for sintilimab injections, submitted by Lilly's partner Innovent.

The proposed indication for this product is in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.

Clinical Readouts/Presentations

WORLDSymposium Presentations

REGENXBIO Inc. 

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: interim results from the Phase 1/2 clinical trials of RGX-121 for the treatment of mucopolysaccharidosis type II, also known as Hunter Syndrome, and RGX-111 for the treatment of mucopolysaccharidosis type I, also known as Hurler Syndrome (Wednesday)

AVROBIO, Inc. 

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: updated clinical data from the collaborator-sponsored Phase 1/2 clinical trial of AVR-RD-04 in cystinosis (Wednesday)

4D Molecular Therapeutics, Inc. 

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: updated interim clinical data from the ongoing 4D-310 Phase 1/2 trial in patients with Fabry disease (Wednesday)

Sio Gene Therapies Inc. 

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: update on the Phase 1/2 trial of AXO-AAV-GM1, its AAV 9-based gene therapy for the treatment of Type I, i.e. early infantile onset, and Type II, i.e. late infantile and juvenile onset GM1 gangliosidosis (Wednesday)

Denali Therapeutics Inc. 

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: Interim 49-week results of a phase 1/2 study of intravenous DNL310 (brain-penetrant enzyme replacement therapy) in MPS II (Thursday)

Freeline Therapeutics Holdings plc 

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: Phase 1/2 safety and efficacy data for FLT190 for the treatment of patients with Fabry disease (Friday)

Passage Bio, Inc. 

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: Safety, biomarker and preliminary efficacy results following ICM administration of PBGM01 in children with late onset infantile GM1-gangliosidosis (Friday)

Angiogenesis, Exudation, and Degeneration Meeting Presentations

Graybug Vision, Inc. 

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: full-data analysis and highlight patient cases from the 18-month Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (Friday)

REGENXBIO & Clearside Biomedical, Inc. 

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: updated interim data from the ongoing Phase 2 ALTITUDE trial of RGX-314 for the treatment of diabetic retinopathy and update on the AAVIATE Phase 2 study of suprachoroidal RGX-314 in neovascular AMD (Saturday)

Earnings

The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule

Monday

Amgen, Inc. 

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 (after the market close)

Tuesday

Haemonetics Corporation 

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 (before the market open)
Incyte Corporation 

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 (before the market open)
Pfizer Inc. 

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 (before the market open) (after the market close)
QIAGEN N.V. 

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 (after the market close)
Inspire Medical Systems, Inc. 

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 (after the market close)
Deciphera Pharmaceuticals, Inc. 

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 (after the market close)

Wednesday

Teva Pharmaceutical Industries Limited 

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 (before the market open)
Seagen Inc. 

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 (after the market close)

Thursday

AstraZeneca PLC 

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 (before the market open)
Alnylam Pharmaceuticals, Inc. 

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 (before the market open)
Laboratory Corporation of America Holdings 

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 (before the market open)
23andMe Holding Co. 

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 (after the market close)
Bio-Rad Laboratories, Inc. 

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 (after the market close)
DexCom, Inc. 

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 (after the market close)
Illumina, Inc. 

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 (after the market close)
Ultragenyx Pharmaceutical Inc. 

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 (after the market close)

Friday

Neurocrine Biosciences, Inc. 

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 (before the market close)

IPOs

IPO Pricing

Gaithersburg, Maryland-based Arcellx, Inc. 

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 has filed a preliminary prospectus with the SEC to offer 8.25 million shares in an initial public offering. The biopharma, which is focusing on developing immunotherapies for patients with cancer and other incurable diseases, expects to price the offering between $15 and $17. The shares are expected to trade on the Nasdaq under the ticker symbol ACLX.

Providence, Rhode Island-based Ocean Biomedical, Inc. 

OCEA

 has filed to offer 2 million shares in an IPO. The company expects to price the offering in the range of $10-$12. The biopharma focuses on licensing tech and innovations and developing them into products. It has applied to list its shares on the Nasdaq under the ticker symbol OCEA. The company had previously filed for a public listing in July 2021 and had not proceeded with the plans.

IPO Quiet Period Expiry

Hillstream BioPharma, Inc. 

HILS+3.85%+ Free Alerts

https://www.benzinga.com/general/biotech/22/02/25437534/the-week-ahead-in-biotech-feb-6-12-pfizer-astrazeneca-earnings-conference-presentations-ipos-and-

Japan considers allowing Shionogi’s COVID oral tablets this spring

 Japan is considering allowing Shionogi & Co Ltd to start selling its COVID-19 antiviral oral tablets as early as this spring after giving the pharmaceutical company special permission to skip the final stage of the clinical trial, the Mainichi daily reported on Monday.

Shionogi said on Jan. 17 it started a Phase III trial in Japan of its COVID-19 vaccine candidate S-268019 that will compare its results to that of an approved vaccine.

https://wtvbam.com/2022/02/06/japan-considers-allowing-shionogis-covid-oral-tablets-this-spring-mainichi/

Ottawa mayor declares state of emergency to deal with trucking blockade

 

Ottawa Mayor Jim Watson on Sunday declared a state of emergency to help deal with an unprecedented 10-day occupation by protesting truckers that has shut down much of the core of the Canadian capital.

"(This) reflects the serious danger and threat to the safety and security of residents posed by the ongoing demonstrations and highlights the need for support from other jurisdictions and levels of government," he said in a statement.

Watson, who complained earlier in the day that the demonstrators outnumbered police and controlled the situation, did not give details of what measures he might impose.

The "Freedom Convoy" began as a movement against a Canadian vaccine requirement for cross-border truckers but has turned into a rallying point against public health measures and Prime Minister Justin Trudeau's government.

Amid residents' fury at the lack of official response, Ottawa police relocated some protesters and put up fresh barricades on Sunday, saying they are "collecting financial, digital, vehicle registration ... and other evidence that will be used in criminal prosecutions."

They also announced they would clamp down on people attempting to bring in canisters to refuel the hundreds of large trucks blocking most roads in the city center.

Protesters have paralyzed downtown Ottawa for the past nine days, with some participants waving Confederate or Nazi flags and some saying they want to dissolve Canada's government. Convoy organizers say they will not leave until the vaccine mandates are ended.

Canadian Public Safety Minister Marco Mendicino said on Sunday that the government would not back down on the issue.

"We put the question of vaccines and vaccine mandates on the ballot ... in the (2021) election and we're simply carrying out the promise that we made with the support of the vast majority of Canadians," he said on CBC television.

Amid incessant horn blaring and occasional fireworks, a polished supply chain -- including portable saunas, a community kitchen and bouncy castles for children -- has sustained the protesters.

The well-organized blockade has relied partly on funding from sympathizers in the United States, police said. GoFundMe took down the Freedom Convoy's donation page, angering some U.S. Republican lawmakers who pledged to investigate the move by the website.

Former U.S. President Donald Trump and Tesla CEO Elon Musk have praised the truckers.

Police said they had charged four people with hate crimes and were investigating threats against public figures jointly with the U.S. Federal Bureau of Investigation.

Trudeau, who is isolating after testing positive for COVID-19 last week, has ruled out using the military to disband the protest. Due to security concerns, Trudeau and his family left their downtown home last weekend and his location has not been disclosed.

The prime minister has said the convoy represented a "small fringe minority" and the government would not be intimidated. About 90% of Canada's cross-border truckers and almost 79% of the population has had two COVID-19 vaccine shots.

Convoy organizers said they would refrain from using their horns on Sunday for four hours "as a gesture of goodwill".

A senior member of the Liberal government said the ease with which the convoy shut down the area around the parliament and the seeming impotence of police was a "national humiliation".

Senior opposition Conservatives who encouraged the protests, including taking selfies with truckers, did not reply to requests for comment. Last week, the party ditched its leader in part for not initially backing the blockade enthusiastically enough.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/Ottawa-mayor-declares-state-of-emergency-to-deal-with-trucking-blockade-37797093/

Goldman: For The First Time In 2022, We See Massive Net Inflows Into Stocks This Week

 One week ago, when the turmoiling market was on edge over even the smallest tremor following a record-ugly start to the year for risk assets, and emini liquidity hit the lowest level since the March 2020 crash meaning even a modest buy or sell program could move spoos by dozens of points...

... Goldman's flow trader Scott Rubner pointed out something which changed the facade of market risk dynamics overnight: a record number of index puts had been purchased by institutional investors who were hedging further downside en masse, in effect putting an end to the liquidation panic.

That, coupled with a near record negative dealer gamma...

... which could only go up as risk bounce and shorts were squeezed, and several other reasons why the furious selloff was exhausting itself, helped explain why stock managed to stage a remarkable rebound - at least until Facebook's meta-hearse implosion - and yet the S&P still closed well in the green last week.

So now that the bulk of earnings season has passed, and despite some high profile tech misses - most notably Facebook - is it safe to say that markets have finally stabilized? For the answer we go to Rubner's weekly tactical flow of funds note, which recaps where investors are putting their money to work in 2022. What is most notable this time, is that according to Rubner, while we are still not “all clear” after week 5, for the first time in 2022, net demand is set to exceed net supply this coming week. Meanwhile, all eyes remain on key-technical levels...

Here are the biggest highlights from Rubner's latest Flow of Funds note (as usual, the full note is available to professional subscribers):

1. Global Equities logged a massive +$106B worth of inflows YTD. Annualizing ~$1.2 Trillion. January 2022 Equity inflows logged the second best start to the year on record with $84.2 Billion worth of inflows. And yet, Rubner notes that this time there is a twist: the biggest theme in the market place, this new money is going into Rest-of-World Equities, not US. This, as the Goldman trader notes, is new.

2. January 2022 Equity inflows logged the 6th largest monthly inflows of all-time

3. February is historically the 3rd largest month for inflows and 2nd largest in 1H. Investors are rotating now.

4. ROW board room demand exceeds USA board room demand. European equities logged +$4.818B worth of inflows this week. This is the largest weekly inflow since May 10th, 2017 (+$6.059B) – post ECB (out of bonds). But it is Emerging Market Equities that have been the 2022 Allocation winner, with back to back to back to back inflows.

5. YTD scoreboard: For context in USD terms: Brazil #2 (+11.89%), Colombia #3 (+10.58%), Peru #6 (+9.06%), and Chile #9 (+7.46%) vs. SPX -6.06%, significantly benefits from these non-USD inflows, and have broadly not seen inflows during this cycle.

6. Value/EM/ROW/Cyclical 2022 board room allocations have room to expand in the context of what happened in January 2021 (lasted until March Quarter-end). i.e., when investors rotate in a big way, it lasts for a few weeks.

7. Inflows into Equities is a “2021 new thing”. The cumulative 10-year inflows into stocks before 2021 was zero. Bonds have seen 3x more inflows than equities and Cash has seen 2x more inflows than equities over the past decade. Rubner writes that "I am watching this chart, as I am watching yields this morning."

8. Bond “outflows” are not very common. There is just too much money sitting in bonds for RIA/PWM allocations if yields continue to move higher. But now outflows are rolling.

Rubner says that he has become popular among credit pods who are tracking “passive credit outflows”. -$1.5 Trillion of negative yielding bonds went “non-negative” on Thursday, the largest 1 day on record. Negative yielding bonds are now below $5 Trillion, the lowest level in over five years years (and down from a record $18 Trillion).

9. Investment Grade Bonds and High Yield Bonds drove the outflows from bonds this week. Watch further widening in CDX HY. We like HYG and LQD put spreads. This is also new.

 

Key flow highlights aside, and looking at Mark-to-Market post Payrolls, Rubner writes that in his view, "we have not met the conditions to go from “Red Light” to “Green Light” this week, but I think we are certainly in yellow and improving " as conditions are in place move back from systematic to subjective and markets will move more freely. The Goldman trader hopes "to clear the last end of this systematic checklist in week 6. All eyes, on 4438, the 200-day moving average, which needs to hold after the weekend."

Another potential bullish inflection point: Systematic Selling fades after next week, after a lot of selling

10. Systematic Supply. Similar to Nomura, Goldman estimates that systematic strategies sold -$74.1B over the past week and -$111.9B over the past one month. That is a lot with multiple indices currently short: But more importantly, systematic supply faded by EOD Friday and assuming a flat tape, there is +$30B of equity demand over the next 1 month. This is important because the up vs down scenarios become balanced vs. skewed to the sell side. The bottom line: CTA’s are now net short. This becomes more balanced going forward and subject to new market moves.

And while the CTA picture is increasingly favorable, liquidity is also improving, but still remains challenged.

11. Liquidity. Top book liquidity in ES1 (E-mini futures) is currently $5M. The ranks in the 3rd percentile on a 10-yr rank (so zeroth percentile). There have been 6 instances in the last 10 years that top book liquidity on the S&P 500, most liquid future in the world, were this low. (This is pre-March fwiw). I find it really hard to monitor price discovery during the overnight session given lunar holiday next week. This could be really choppy.

As noted above, dealer Gamma is getting longer and rebuilding:

12. Dealer Gamma. S&P 500 dealer gamma is now flat (from short). The current dealer gamma position ranks in the 8th percentile on a 3-year rank. The long dealer gamma position, which stocks have enjoyed as a market buffer for so long, is no longer present. Hedging activity has been exacerbated by those dealers hedging customer delta with demand for puts. The market could move freely both to the upside and downside, but this has mattered given the low liquidity provided by futures hedging (mostly end of day).

Just as notable, the institutional demand for index hedges - which was the highlight of last week's note - has dropped by 56% since last Monday.

13. Put Buying. We have been averaging $1 Trillion worth of puts per day. Largest on record. There has been several days this week where put notional set records. Monday for example $2.2 Trillion notional traded in US options market, with 64% puts ($1.4 Trillion) further adding LP hedges and taking the street further short gamma.

Another notable reversal, the passive Market on Close Impact has started to improve - we have had 4 days of large MOC imbalances to buy after weeks of massive MOC for sale imbalances.

14. Equity Passive flow redemptions and MOC Impact. As a reminder, recently Rubner notes that every day, he watches MOC imbalances get posted at 3:50pm NY time, "and it feels like a new day. There are 2,670 ETF’s that trade in the US. Passive redemptions are starting to happen. SPY has seen the largest outflows YTD (-$21.8B), followed by QQQ (-$7.98B), followed by IVV (-$1.8B) outside of bonds. Inflows are still happening broadly, but these redemptions will have the largest impact. “A reminder, if you ask me for money, I sell.” 23.66 cents of every $1 of SPY sold is from the top 5 stocks. I cannot predict the outcome here, but $1.226 Trillion of capital has gone into passive funds in the last 66 weeks."

15. Sentiment. Everyone says sentiment is negative but not panic-y, well how negative? Since 1987, the AAII Bull vs. Bear has been below .45 (it is currently .44). This has only happened 51 times out of 1,799 readings or 2.8% of times. This is rare and has historically been a contrarian indicator with positive hit rates 1m (79%), 3m (81%), and 6m (82%) with high absolute returns. That said, household allocations to equities has risen, so stabilizing sentiment to reduce passive outflows will be key to watch.

16. Retail. This, as Rubner notes, has always been his swing factor. After what felt like margin/deleveraging all week from retail, this changed by the end of the week. On Wednesday, FOMC day, I have retail as a MASSIVE buyer. >$22.6B worth of retail buy demand, which ranks in the 98% percentile on a 1 year basis. This follows big sell days. The retail buy demand in tech of $9B was the largest on record, and 100% percentile.

17. Money Market Funds, “cash on the sidelines”. This money has been raised, and potentially looking for a home (“down 5%”). This week saw some minor money market inflows.

Last but perhaps most important, corporates - i.e., stock buybacks - are now coming out of the blackout window in a big way next week.

18. Buybacks. Corporate blackout window ends substantially next week, led by tech stocks, with 65% of the S&P 500 market cap coming out of the earnings blackout by Monday, and Goldman's trading desk estimates >$5.5B worth of daily demand during the open window which closes back on March 14th.

The full Goldman note is available to professional subs.

https://www.zerohedge.com/markets/goldman-first-time-2022-we-see-massive-net-inflows-stocks-week

Gottlieb expects mask requirements to be lifted in schools where COVID-19 cases are low

 Former Food and Drug Administration chief Scott Gottlieb said on Sunday the nation could expect to see mask mandates lifted in schools where COVID-19 prevalence is low.

"I think you're going to see governors start to do that," Gottlieb told host Martha Raddatz on ABC's "This Week" when asked about government leaders lifting mask requirements in schools. 

"A lot of kids haven't known a normal school day for two years. We need to try to lean forward aggressively to try to restore that and reclaim it when we can."

Gottlieb told Raddatz that state leaders in areas with low COVID-19 case rates and high vaccine rates may start to lift mask mandates, adding that "we are at a point where we can safely contemplate that."

"That doesn't mean this isn't going to continue to spread," the former FDA chief clarified. "But when prevalence is low, you have a lot of people who've been infected, who have some level of immunity for a period of time, and you have high vaccination rates, we can start to lean forward and take a little bit more risk and try to, at least, make sure that students in schools have some semblance of normalcy for this spring term."

Gottlieb has previously pushed for safety precautions on lifting COVID-19 measures, saying last week that the U.S. must "prescribe very clear goalposts for how we take these mitigation measures off." He said that the U.S. needs to be "aggressive" in lifting preventive measures, a sentiment he reestablished Sunday. 

https://thehill.com/homenews/sunday-talk-shows/593029-gottlieb-expects-mask-requirements-to-be-lifted-in-schools-where

CVS, Walgreens remove limits on at-home COVID-19 tests

 Pharmacy chains CVS and Walgreens have removed all limits on at-home COVID-19 tests, The New York Times reported. 

In December, both companies placed a cap on the number of tests customers could buy in stores and online to keep up with the spread of the omicron variant. 

Representatives of both companies told the Times that they have now been able to increase their inventory of the over-the-counter virus testing kits.

The decision comes as COVID-19 cases have dropped significantly in recent weeks, to an average of about 300,000 cases a day in the U.S., down from more than 800,000 in mid-January. 

Throughout the pandemic, the U.S. has struggled with COVID-19 testing shortages, which was highlighted by long lines at testing sites and empty shelves at pharmacies around the holidays. 

The Biden administration launched a website last month where people can order four free virus testing kits for their households through the United States Postal Service.

The Centers for Medicare and Medicaid Services also announced last week that the 60 million Americans who have Medicare coverage will be provided with free COVID-19 testing kits by the start of spring, the Times noted. 

https://thehill.com/policy/healthcare/public-global-health/593033-cvs-walgreens-remove-limits-on-at-home-covid-19-tests

'Experts open the door' to lifting last mask mandates

 As the spike in coronavirus cases caused by the omicron variant wanes, some experts say it is time to start lifting more restrictions, setting up a heated debate, particularly over mask mandates in schools.

People are exhausted with the pandemic after roughly two years, and health advocates warn that pandemic rules cannot last forever. 

“We cannot remain in a perpetual state of emergency,” said Leana Wen, a public health professor at George Washington University. “People burn out.”

Many aspects of life have already returned to something like normal. Bars and restaurants are open and packed across the country, and countless travel restrictions have been lifted. 

But some locations, including New York and Washington, DC, still have mask mandates for the general public, and in schools, mask requirements are more common.

Vaccinations remain as the key source of protection. People who are vaccinated and boosted have strong protection against severe disease, even if there is still a chance they get mild illness. 

Wen noted that school-aged children aged 5 and up can now all be vaccinated.

And Pfizer last week began the application for its COVID-19 vaccine for children as young as six months.

Ashish Jha, dean of the Brown University School of Public Health, said that restrictions in general should be lifted as cases come down, but not just yet, given that cases are still high.

“I've been saying for weeks that as cases recede we can soon relax public health restrictions,” Jha tweeted. “I think of this like the weather. When it is bucketing rain umbrella, rain coat, boots, are all essential. When the storm turns into a drizzle, those become less critical.”

The possibility of a future variant that has greater ability to evade the vaccines’ protection, or that causes more severe disease, leads some experts to call for loosening restrictions during the coming lull to give people a respite in case they need to return later.

"If we don’t take the off-ramps, nobody will listen when we need to have an on-ramp," tweeted Jeremy Faust, a professor at Harvard Medical School.

Cases in the U.S. have fallen significantly from the peak during the omicron wave in mid-January, from approximately 800,000 new cases per day to about 350,000 per day, which is still quite high. More experts are putting a focus on hospitalizations, which have now peaked nationally, though again are still at the high level of around 123,000 a day, according to a New York Times tracker. 

Asked about people returning to more normal activities, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky on Wednesday cautioned that hospitalizations “are still quite high and [we are] certainly having hospital capacity challenges in many parts of the country still.”

“We really do have to look to our hospitalization rates and our death rates to look to when it is time to lift some of these mitigation efforts,” she said. “We will continue to reevaluate, and we know people are anxious.”

The matter of lifting restrictions has received a new burst of political attention as Republicans push to scale back measures such as mask mandates. 

Virginia’s new Republican governor, Glenn Youngkin, has drawn controversy and an American Civil Liberties Union-backed lawsuit from parents over an order making masks optional in schools in the state. 

Senate Minority Leader Mitch McConnell (R) more broadly said Wednesday that “it is time for the state of emergency to wind down.”

On the Democratic side, Denver Mayor Michael Hancock this week lifted the city’s mask mandate and proof of vaccination requirement for businesses.

“This virus is something we're going to have to manage and learn to live with,” Hancock said. 

A Monmouth University poll this week found that a large majority of Americans, 70 percent, agreed that “it’s time we accept that Covid is here to stay and we just need to get on with our lives.”

Republicans continue to fight hard against President Biden’s vaccine mandates, which many public health experts have praised as a crucial way to get more people vaccinated and help return to normal.

Advocates have also been pushing the Biden administration and Congress for more funding for global vaccination efforts, which can help prevent new variants from emerging. 

Some experts are pushing back against the calls for returning to normal, pointing to more vulnerable people. 

“The great, white middle — stretching right and left across the political spectrum and the op-ed pages of the Times — is ready to move on,” Gregg Gonsalves, a professor at the Yale School of Public Health, wrote in The Nation. “The thing is: Those left behind don’t have the choices or the resources that those with privilege do, whether they are poor, living with disabilities or chronic medical conditions — or just too old to matter.”

Wen, a former health commissioner for the city of Baltimore, said the CDC should at least set new benchmarks for under what circumstances masks would no longer be needed. 

“It’s precisely because of the threat of future variants that we need to let up on restrictions now,” she said. “I’m not trying to sound the all-clear at all...I’m saying we need to take advantage of the lull that we have coming up.”

https://thehill.com/policy/healthcare/592931-experts-open-the-door-to-lifting-last-mask-mandates