FDA : FDA’s Decision to Approve New Treatment for Alzheimer’s Disease

FDA’s Decision to Approve New Treatment for Alzheimer’s Disease
By Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research
Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.
This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain. The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.
We are well-aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review. Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.
At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward. We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.
What the Data Show
The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint. In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion. It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.
We know that the Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020 to review the clinical trial data and discuss the evidence supporting the Aduhelm application, did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval. The option of Accelerated Approval was not discussed by the Advisory Committee. As mentioned above, treatment with Aduhelm was clearly shown in all trials to substantially reduce amyloid beta plaques. This reduction in plaques is reasonably likely to result in clinical benefit. After the Advisory Committee provided its feedback, our review and deliberations continued, and we decided that the evidence presented in the Aduhelm application met the standard for Accelerated Approval. We thank the Advisory Committee for its independent review of the data and valuable advice.
Accelerated Approval
The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need. Approval is based on a surrogate or intermediate clinical endpoint (in this case reduction of amyloid plaque in the brain). A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are required to conduct post-approval studies to verify the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial does not verify the drug’s anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
The Devastation of Alzheimer’s Disease
With all this said, we are extremely aware of the gradual and cumulative devastation that Alzheimer’s disease causes, as patients lose their memory and cognitive functioning over time. In late-stage disease, people can no longer hold a conversation or respond to their environment. On average, a person with Alzheimer’s disease lives four to eight years after diagnosis, but some patients can live up to 20 years with the disease.
The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages. Alzheimer's is the sixth leading cause of death in the United States.
Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients. As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease.
FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm. As an agency, we will also continue to work to foster drug development for this catastrophic disease.

WSJ : Inside Credit Suisse’s $5.5 Billion Breakdown

Inside Credit Suisse’s $5.5 Billion Breakdown
The fallout from the Archegos collapse shows the Swiss bank’s creaky risk-management systems didn’t do their job, leaving the bank vulnerable with out-of-date trading data and big exposure to single stocks, according to people familiar with the matter

In mid-March, shares in ViacomCBS Inc. and Discovery Inc. rocketed skyward. That was great news for Bill Hwang.

His firm, Archegos Capital Management, had borrowed billions from Credit Suisse Group AG CS -0.49% to make wagers on a handful of stocks, including the entertainment companies.

As is standard practice, Archegos had handed over cash to Credit Suisse to secure its bets. With the stocks more than doubling since the start of the year, Archegos asked for some of that money back, and it was credited, according to people familiar with the matter.

The transfer essentially meant Archegos had even less cash on the line backing up its positions. Some of Credit Suisse’s rivals, meanwhile, moved in the opposite direction. They noticed an increasing risk in the concentration of the firm’s positions and demanded it back up its investments with additional cash, according to executives at the banks.

Days later, ViacomCBS plunged, Archegos collapsed and the Swiss bank was stuck with a colossal loss.

Now Credit Suisse is picking over what went so badly wrong. The central questions include, why did it give the money back to Archegos? And more broadly, why did it back risky bets to a level that went wildly beyond all its stated norms and projections? Bank executives had even received a stark warning a year earlier on how the bank was handling risk—but the recommended changes hadn’t been made.

A preliminary conclusion is emerging: Credit Suisse’s creaky risk-management systems didn’t do their job as the bank’s guardrails and left it highly exposed to human errors in judgment, according to current and former people at the bank.

Trading data reviewed by risk managers in the lead-up to Archegos’s March failure was out of date. Credit Suisse’s staff didn’t quickly analyze its growing exposure to single stocks.

An internal audit in April 2020—made after the bank earlier had a loss of about $200 million from a hedge fund’s collapse—identified key problems that would come into play in the Archegos failure. But the bank was slow to roll out the planned improvements.

When employees flagged risks, they didn’t communicate them to higher ups. Contributing to the breakdown in risk controls was a key personnel change in the bank’s prime brokerage unit, which handled the Archegos account, after the death of an experienced manager in a ski-lift accident, people familiar with the matter said.

“The events that led to the losses in the Archegos case which we disclosed in our Q1 results are the subject of a Board level investigation which is looking into all these issues thoroughly,” a Credit Suisse spokesman said in an emailed statement. “We are committed to report the conclusions of that investigation (including the lessons learned).”

A spokesman for Archegos and Mr. Hwang declined to comment.

Credit Suisse amassed more than $20 billion of exposure to investments related to Archegos, equivalent to half the bank’s equity cushion against potential losses, The Wall Street Journal has previously reported. Yet the bank at one point made Archegos hold just a 10th of that amount to back up its bets and protect the bank in case its investments soured, according to a person familiar with the matter.

Taking on such a huge risk appears to have been for only a modest reward. Archegos, which managed the fortune Mr. Hwang made as a hedge-fund manager, produced for Credit Suisse revenue only in the tens of millions of dollars over several years, according to people familiar with the matter.

The collapse of Archegos, piled on top of the insolvency of another key Credit Suisse client, Greensill Capital, has plunged the bank into crisis. Credit Suisse took a $5.5 billion loss on Archegos, the largest related to that firm’s collapse on Wall Street.

It ousted its chief risk officer, investment bank head and others, and turned to investors for $2 billion in fresh capital to shore up the bank’s balance sheet. The Swiss regulator, Finma, said it opened civil enforcement proceedings against Credit Suisse. Regulators in the U.S. and the U.K. are probing the losses from Archegos at multiple banks, the Journal previously reported.

Another Credit Suisse spokesman pointed to comments on April 30 by its new chairman, veteran banker António Horta-Osório, that the bank needs to foster a culture around risk management and personal accountability. The bank said it would have “close engagement with Finma and all relevant regulators” over the matter.

Just over a year before Archegos’s collapse, Credit Suisse Chief Executive Tidjane Thiam presented the bank’s best results in nine years, then said farewell to colleagues at its Zurich headquarters. The bank’s board had ousted him after a lieutenant ordered a spying operation on a Credit Suisse executive leaving for a rival. Mr. Thiam has denied knowledge of the spying.

Mr. Thiam, a former insurance executive, had undertaken a five-year cleanup job that tamed risks in Credit Suisse’s volatile investment-banking arm, while piling resources into the steadier business of wealth management, helping rich people with their money. Mr. Thiam had been hired after Credit Suisse paid $2.6 billion and pleaded guilty in a settlement with U.S. authorities in 2014 for helping wealthy Americans evade tax.

In the overhaul, Mr. Thiam kept the bank’s prime brokerage business, which lends money to hedge funds and other big investors, because it supported a bigger equities business. That was seen as crucial, because rich clients needed access to stock markets for investments and to raise money for their own companies via Credit Suisse.

But Mr. Thiam said the unit should be more disciplined on risk-taking and focus on fewer clients. His team scaled back other parts of Credit Suisse’s investment bank, and dozens of senior people left. Less experienced colleagues frequently took their places, in a “juniorization” that former executives and investors who worked with Credit Suisse said left it more vulnerable to mishaps.

On the same February 2020 day that Mr. Thiam left the bank, Jason Varnish, a top risk manager in Credit Suisse’s prime brokerage, boarded a ski lift at Vail Ski Resort in Colorado. His coat became entangled, and the 46-year-old father of three was killed.

In a memo to staff at the time, the bank said Mr. Varnish “successfully struck the right balance between being commercially minded with clients while maintaining risk discipline for the bank.”

As at other banks, risk management had grown into an extensive operation inside Credit Suisse in recent years. The function gained stature and power after banks took large losses from complex trades during the financial crisis.

Risk management monitors the bank’s operations, seeking to avoid financial and reputational problems. Computer programs abide by rules and processes that are wired into the bank’s technology and must be followed by staff. In addition, at every level, the bank relies on human judgment.

Credit and reputational risk committees vet clients and transactions, and the bank puts limits on how much could be lost from a single client or counterparty. Bank executives, the board and board committees are in charge of the system and making sure it works, with assistance from internal-audit and credit-risk-review departments.

Regulators also play a role in assessing banks’ risk models, which draw on data, assumptions and scenarios to calculate expected outcomes. In 2019, the Federal Reserve said it found weaknesses in how Credit Suisse projected trading losses in an annual stress test and gave it four months to fix them.

The systems were tested when the spreading coronavirus pandemic spooked financial markets. In the volatility, Credit Suisse’s prime brokerage had a loss of about $200 million closing out investments for a flailing hedge fund, Malachite Capital, in March 2020, people familiar with the matter said.

Brian Chin, then head of Credit Suisse’s markets business, oversaw the prime brokerage. An internal audit probed the loss, the size of which shocked some bank executives, the people said.

The audit flagged two failures, according to people familiar with the matter. The first was a lack of drilling down by the bank on Malachite’s trading strategy and how it would fare in volatile markets. The second was the use of an outdated margining system, which didn’t effectively monitor in real time how much risk a position created for the bank as the prices of the underlying securities changed.

Its recommendations included focusing on similar weak points with other clients, including those with high gross exposures through equity derivatives, which are based on the stock-price movements of the underlying asset, the people said. Plans were made to work on “process improvements” over two years, they said.

One effort was to move such trades to a more sophisticated “dynamic margining” system that would draw on additional real-time factors beyond price, such as volatility and concentration risk, according to the people. But changes weren’t in place for Archegos by the time it collapsed.

To fill Mr. Varnish’s senior risk-manager role in the turbulent markets, the bank turned to Parshu Shah, a New York-based salesman in the prime brokerage unit. He had two decades of experience at the bank, carving a niche in financial derivatives that let hedge funds amp up stock bets with borrowed money.

His clients included Archegos, a heavy user of a derivative called a total-return swap, according to people familiar with the matter. The swaps let Archegos post a small amount of collateral to take large stock positions without owning the underlying securities.

Mr. Shah referred a request for comment to Credit Suisse, which declined to comment on his role. He didn’t respond to another request for comment.

Even with the Malachite stumble, Credit Suisse reported its best first-half net profit in a decade last July, mainly from resurgent markets and investment banking.

The new CEO, Thomas Gottstein, who took over from Mr. Thiam in February 2020, said it was the right time to “capture growth opportunities.” His words were seen as a signal for the bank to capitalize on the market’s dizzying rally coming out of the pandemic, according to Credit Suisse executives. The Credit Suisse spokesman said Mr. Gottstein declined to comment.

Mr. Gottstein, who had previously headed Credit Suisse’s domestic unit catering to the rich, promoted Mr. Chin to run the investment bank and gave Lara Warner, Credit Suisse’s chief risk officer, a bigger role overseeing risk and compliance.

The Archegos portfolio rode hot markets, too. The fund’s positions at Credit Suisse dramatically multiplied from summer last year until March 2021, according to people familiar with the matter.

In September, Mr. Shah, who had been on the job for about six months, flagged the growing Archegos exposure to the investment bank’s counterparty-credit-risk team, one of the people familiar with the matter said. It couldn’t be determined if the specialist team, meant to monitor the health of Credit Suisse’s clients, reacted. The matter wasn’t escalated further by Mr. Shah or the counterparty-credit-risk team within the investment bank or to group-level managers, people familiar with the matter said.

Mr. Shah received regular reports indicating growing risks in the Archegos positions, the people said. The executive didn’t adequately flag these reports to senior personnel, they said.

In a total-return swap, a bank receives fees and owns the stock. Credit Suisse became one of the largest holders in some of Archegos’s stocks, according to the bank’s filings to the Securities and Exchange Commission. By the end of 2020, it owned about 6.5% of ViacomCBS’s Class B shares, according to FactSet.

But the bank’s tracking of the shareholdings had a lag, people familiar with the matter said, and the significance of the growing positions wasn’t picked up on, the Journal previously reported.

By mid-March, Credit Suisse’s notional exposure, or the value of the stocks underpinning the Archegos positions, was above $20 billion. Some inside the bank thought the exposure was only a fraction of that figure, in part because of the lagging tracking system, the Journal previously reported.

Mr. Gottstein and Ms. Warner, the chief risk officer, became aware of the bank’s exposure to Archegos in the days leading up to the forced liquidation of the fund, and neither had been aware of the fund as a major client before that, the Journal previously reported.

Days before Archegos blew up, ViacomCBS and Discovery stocks hit new highs. Around the middle of March, Credit Suisse released margin payments back to the fund, the people said.

Returning collateral might be a normal thing to do for a client with a diverse portfolio of holdings that had risen in value. But in the Archegos case, it was a problem because most of what it held was in a handful of stocks. This created special risks since any one stock falling could torpedo the firm.

Archegos also was making highly leveraged bets on some of the same stocks with other investment banks. Credit Suisse wasn’t aware of those moves, according to Credit Suisse executives.

The bank wasn’t fully assessing its risks in the stocks being so concentrated by single name and sector, according to the current and former people at the bank.

On March 22, a Monday, ViacomCBS shares fell when the company said it would issue new stock to invest in streaming services. Archegos got caught in a downward spiral as the stock fell and it couldn’t make margin calls. Other stocks tied to the fund’s trading positions also had been dropping.

In Zurich, Mr. Gottstein and Ms. Warner were entrenched in another crisis. Greensill Capital, a financing partner for a $10 billion set of Credit Suisse investment funds, filed for bankruptcy, putting billions in fund assets in doubt. Greensill ran into trouble because it couldn’t renew credit insurance on supply-chain finance loans it made to companies, exposing holes in Credit Suisse’s oversight of the funds. (The company’s founder, Lex Greensill, in May told a U.K. parliament committee he bears responsibility for Greensill’s collapse and that it relied too much on one insurer.)

In that March week, Credit Suisse was being pelted by questions from regulators, shareholders and fund investors over Greensill.

That Thursday, Archegos summoned its half-dozen lenders to try to hash out a survival plan.

Credit Suisse suggested the banks work together to unwind Archegos’s trades over a month. Some considered it, according to people familiar with the discussions. But no deal was reached and some swiftly unloaded their positions to other investors.

The next Monday, March 29, Credit Suisse warned of a significant loss. In April, it said exiting the positions cost $5.5 billion, and it raised $2 billion in fresh equity. Messrs. Chin and Shah and Ms. Warner were among the staff pushed out.

The Journal previously reported the bank has plans to roll out dynamic margining across client positions. In recent weeks, that system still wasn’t being applied to some positions, people familiar with the matter said.

Credit Suisse recently hired McKinsey & Co. to help identify and fix weak spots in its risk management, people familiar with the bank said.

FT : France opens investigation into Lebanon’s central bank governor

France opens investigation into Lebanon’s central bank governor
Move by financial prosecutor follows Swiss probe into Riad Salamé’s dealings abroad

France’s financial prosecutor has opened an investigation into Lebanon’s central bank governor Riad Salamé, becoming the second European country to probe the embattled banker’s dealings abroad.

The Parquet National Financier (PNF) said its inquiry began in late May and would examine allegations of conspiracy and money laundering as part of an organised group.

The move comes after two anti-corruption groups filed separate complaints to the French authorities asking them to examine whether Salamé had transferred “ill-gotten gains” out of Lebanon ahead of a banking crisis that began in 2019 and prevented millions of citizens from accessing their funds.

The complaints by Accountability Now and Sherpa allege that Salamé, three family members and an associate at the Lebanese central bank used illegal means to build up a “rich patrimony” in Europe.

France has followed Switzerland’s federal prosecutor in scrutinising Salamé’s overseas assets, which he insists are legitimate investments made with money he earned as a Merrill Lynch banker before becoming central bank governor in 1993. Swiss authorities began inquiries last year, which revolve around some $300m that was transferred from accounts held at Lebanon’s central bank to accounts in Switzerland.

Salamé’s lawyer in France dismissed what he described as a “preliminary” inquiry that was “at this stage, merely a communications operation or a political one”.

Salamé denies any wrongdoing.

The inquiries represent a challenge to the reputation of Salamé, who for years was credited with steadying the Lebanese economy in the face of political turmoil and regional conflicts. His legacy has been marred by his much-criticised handling of monetary policy during the severe economic crisis. Yet in the absence of political leadership, Salamé’s role in Lebanon has only become more critical. The World Bank went so far as to call the Banque du Liban “almost an exclusive policymaker”.

Lebanon is suffering a historic economic crisis, founded in decades of poor governance and corruption but exacerbated by the pandemic and last August’s Beirut port disaster. The World Bank last week said the banking crash was “likely to rank in the top 10, possibly top three” financial crises since the mid-19th century, after Lebanon’s economic output fell from an estimated $55bn in 2018 to just $33bn in 2020.

Stéphane de Navacelle, a Paris-based lawyer specialising in white-collar crime, said the inquiry was similar to earlier ones in which French investigators had examined the France-based assets of foreign officials to determine whether they were illegally obtained.

“The PNF is acting on its word to address potential white-collar crime that has a link to France,” said de Navacelle. “The country is increasingly comfortable taking leadership in enforcement when it comes to tracking down ill-gotten assets in cross-border cases.”

In 2017, the PNF seized the assets of Teodorin Obiang, the vice-president of Equatorial Guinea, and secured a conviction against him. It has taken similar actions against the political leaders of Gabon and the Republic of Congo.

France, which ruled Lebanon as mandate-holder after the fall of the Ottoman Empire, had taken the lead in trying to chaperone a deal for a fresh government among Lebanon’s squabbling politicians.

>>> US Gapping down

Gapping down

M&A news:

  • VMC -0.7% (U.S. Concrete (USCR) to be acquired by Vulcan (VMC) for $74.00 per share in cash)

Other news:

  • MGI -9.1% (established $100 mln "at-the-market" equity offering program)
  • ELYS -3.4% (files for $100 mln mixed securities shelf offering)
  • HARP -2.3% (provides progress update for TriTAC clinical programs and ProTriTAC platform)
  • ONEM -1.9% (acquires Iora Health for $2.1 bln)
  • RIDE -1.5% (receives notice of delinquency for late filing)
  • DSX -1.5% (files for $750 mln mixed securities shelf offering)
  • EQOS -1.4% (files for 94,487 share common stock offering by selling shareholders)
  • AYLA -1.1% (files for 2,249,998 share common stock offering by selling shareholders)
  • REI -1.1% (executes targeted hedging transactions to further increase free cash flow generation in 2021)
  • GLT -1% (files for $500 mln mixed securities shelf offering)

Analyst comments:

  • EDU -3.6% (downgraded to Neutral from Outperform at Credit Suisse)
  • TAL -2.4% (double-downgraded to Underperform from Outperform at Credit Suisse)
  • ARCB -1.9% (downgraded to Neutral from Buy at Goldman)
  • PGR -1.9% (downgraded to Underweight from Equal-Weight at Morgan Stanley)
  • WERN -1.9% (downgraded to Sell from Neutral at Goldman)

>>> US Gapping up

Gapping up
In reaction to earnings/guidance:

  • GIII +5.9%

M&A news:

  • USCR +27.8% (U.S. Concrete to be acquired by Vulcan (VMC) for $74.00 per share in cash)
  • MIC +12.8% (MacQuarie Infrastructure announces agreement to sell Atlantic Aviation to (KKR) for $4.475 bln) . 

Other news:

  • ADMP +14% (highlights that the National Institutes of Health has identified its experimental drug, Tempol, as a potentially potent antiviral for COVID-19)
  • CDXC +13% (ChromaDex and Walmart (WMT) launch Tru Niagen in 3,800 Walmart stores across the United States)
  • UIHC +6.3% (files $100 mln mixed securities shelf offering)
  • GLSI +4.8% (publishes additional positive safety data from GP2 phase IIb trial at ASCO 2021)
  • AMYT +3.5% (receives confirmation from FDA that Oleogel-S10 will not require an Advisory Committee Meeting)
  • FLGC +2.5% (expands into EU)
  • AMC +2.2% (continued volatility)
  • IOVA +2% (ASCO presentation)
  • VLDR +1.9% (announced Seabed B.V., which specializes in high quality equipment for offshore surveying and dredging, has selected Puck sensors for its lidar mobile mapping system)
  • DPW +1.5% (to expand the infrastructure of its technology data center in southern Michigan and increase the power capacity to 28MW)
  • TMST +1.1% (will increase base pricing by $50 per ton on all special bar quality products)
  • STMP +1.1% (settles securities class action lawsuit, net cash outflow expected at $66-77 mln)
  • VVNT +1% (appoints David Bywater as CEO)

Analyst comments:

  • NEXT +29.5% (upgraded to Overweight from Equal-Weight at Morgan Stanley)
  • MRUS +5.8% (upgraded to Buy from Neutral at Citigroup)
  • CHRW +2.7% (double-upgraded to Buy from Sell at Goldman)
  • AZUL +2.6% (upgraded to Outperform from Neutral at Bradesco BBI)
  • FATE +1.3% (upgraded to Buy from Neutral at H.C. Wainwright)
  • V +1.2% (upgraded to Overweight from Neutral at Piper Sandler)

>>> US Early premarket gappers

Early premarket gappers

  • Gapping up:
    • CDXC +16.6%, MNOV +10.8%, ADCT +6.7%, UIHC +6.3%, IOVA +2.6%, DPW +1.8%, DSX +1.5%, AMC +1.5%, TMST +1.1%, STMP +1.1%, VVNT +1%, AMGN +0.9%, HARP +0.6%, CAR +0.6%, HUN +0.5%, ULCC +0.5%
  • Gapping down:
    • ELYS -5.8%, AYLA -1.1%, RIDE -1%, GLT -1%

NY Post : Two Sigma: The hot new mover and shaker

Two Sigma: The hot new mover and shaker

Technology-driven hedge fund Two Sigma is in the market for a major space expansion and consolidation that could be worth a fortune to a number of Manhattan landlords.

Although it’s rarely in the press, the international, privately held firm boasts $58 billion in assets under management. It’s currently headquartered in a mini-campus at 100 and 101 Sixth Ave. in Tribeca, according to its Web site.

Now, we’re told by sources that the setup and floor plates there no longer work for the company. With lease expirations looming in 2023, Two Sigma is prowling for larger new digs — of 400,000 to 600,000 square feet — in either the FiDi area or Midtown South. Cushman & Wakefield is said to be leading the search.

Landing Two Sigma would be a breakthrough for several older office buildings that are either vacant or soon will be. Among them: EQ’s 1740 Broadway, Paramount Group’s 60 Wall St., Rudin’s 3 Times Square and 80 Pine St., RXR’s Five Times Square and Nightingale’s 111 Wall St.

Large blocks are also up for grabs at Brookfield’s brand-new Two Manhattan West, Tishman Speyer’s Spiral and L&L Holdings’ 425 Park Ave., as well as at two completely redesigned towers — Brookfield’s 660 Fifth Ave. and Olayan Group’s 550 Madison Ave.

There’s life at last for the long-planned Alamo Drafthouse cinema complex at Fosun’s 28 Liberty St. The Texas-based luxury chain completed its bankruptcy sale to Altamont Capital Partners last week and plans to open the FiDi location this fall.

Progress was slow at 28 Liberty since we first reported Alamo’s 40,000 square-foot lease there back in 2017. Repeated delays were blamed on construction issues related to the tower’s landmark status.

However, the most recent stall clearly had to do with the company’s troubled finances after the pandemic shut down movie theaters in March of 2020.

Now, as cinemas reopen and Hollywood gears up for major production again, Alamo plans to expand with several new theaters around the United States, including one on Staten Island.

The popular Upper East Side eatery Flex Mussels will soon be flexing its muscles — and getting more legroom — when it moves later this year from cramped quarters at 174 E. 82 St. to more spacious digs at 1431 Third Ave., around the corner.

The new location was formerly Turkish cafe Beyoglu. Flex Mussels owner Alexandra Shapiro made the deal through CBRE brokers Gary Trock and Zach Parisi.

Shapiro wanted a new home nearby for Flex Mussels before the pandemic shutdown last year. Trock and Parisi saw an opportunity at the Beyoglu location, where the lease was expiring.

The new space has 1,690 square feet on the ground, 1,770 square feet on the second floor and 1,770 more in the basement — allowing for many more seats than the current 2,000 square feet on East 82nd Street.

In addition, Flex Mussels can also have 30 outdoor seats at its new digs, compared with only eight at the old spot. It will reopen on June 8 and move in the fourth quarter this year or the first quarter of 2022. Flex also has an outpost in the West Village.

The menu offers mussels in 22 different broths, from classic French white wine, garlic and herbs to Thai-style curry-coconut broth, lemongrass, kaffir lime, coriander, lime and ginger.

The Times Square Alliance has a new leader: Tom Harris, who served as acting president after former President Tim Tompkins stepped down in December after 19 years.

It shouldn’t come as a surprise. Harris — a 23-year veteran of the NYPD and a graduate of St. Joseph’s College and Marist College — has spent 13 years at the Alliance. Nonetheless, a search committee led by Alliance board Chairman Eric Rudi spent months on an “exhaustive” search for Tompkins’ permanent successor.

With Broadway theaters still dark and offices mostly empty even as tourists return, the alliance faces possibly the toughest challenge of all the city’s 76 business-improvement districts.

“Times Square is .1 percent of the city landmass and 15 percent of the city’s economy.” Harris said. “We will not recover from this pandemic until Times Square recovers.”