Eisai reports positive Alzheimer data, shares jump!

Biogen/Eisai’s phase 3 trial of lecanemab in MCI meet primary endpoint

Eisai (ESALY) and Biogen (BIIB) “announced positive topline results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease, AD, and mild AD with confirmed presence of amyloid pathology in the brain.

#Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.

#Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai’s FY2022, which ends March 31, 2023.

Amyloid-related imaging abnormalities

Additionally, Eisai will present the Clarity AD study results on November 29, 2022, at the Clinical Trials on Alzheimer’s Congress, and publish the findings in a peer-reviewed medical journal. Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 in the analysis of Intent-to-treat population.

Starting as early as six months, across all time points, the treatment showed highly statistically significant changes in CDR-SB from baseline compared to placebo.

All key secondary endpoints were also met with highly statistically significant results compared with placebo.

Key secondary endpoints were the change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography, the AD Assessment Scale-cognitive subscale14, AD Composite Score and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment.”

ESALY last traded at $39.79. BIIB last traded at $197.50.

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Rail Traffic Declines as Growth Slows!

North American rail traffic down 1% for the week ending September 17

The Association of American Railroads, AAR, reported U.S. rail traffic for the week ending September 17. For this week, total U.S. weekly rail traffic was 490,654 carloads and intermodal units, down 2.9% compared with the same week last year.

Total carloads for the week ending September 17 were 239,528 carloads, up 2% compared with the same week in 2021, while U.S. weekly intermodal volume was 251,126 containers and trailers, down 7.3% compared to 2021.

Five of the 10 carload commodity groups posted an increase compared with the same week in 2021.

They included coal, up 3,948 carloads, to 72,774; nonmetallic minerals, up 2,491 carloads, to 35,163; and motor vehicles and parts, up 2,185 carloads, to 13,879.

Commodity groups that posted decreases compared with the same week in 2021 included metallic ores and metals, down 3,192 carloads, to 21,581; miscellaneous carloads, down 1,623 carloads, to 8,250; and forest products, down 1,362 carloads, to 9,076. North American rail volume for the week ending September 17, on 12 reporting U.S., Canadian and Mexican railroads totaled 342,034 carloads, up 3.5% compared with the same week last year, and 341,595 intermodal units, down 4.7% compared with last year.

Total combined weekly rail traffic in North America was 683,629 carloads and intermodal units, down 0.8%.

North American rail volume for the first 37 weeks of 2022 was 25,025,034 carloads and intermodal units, down 2.4% compared with 2021.

Publicly traded companies in the space include CSX (CSX), Canadian National (CNI), Canadian Pacific (CP), Kansas City Southern (KSU), Norfolk Southern (NSC), Union Pacific (UNP) and Trinity Industries (TRN), Greenbrier (GBX), FreightCar America (RAIL) and Wabtec (WAB).

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KnowBe4 receives buyout offer!

KnowBe4 confirms receipt of $24 per share proposal from Vista

KnowBe4 (KNBE) confirmed the receipt of a non-binding proposal from Vista Equity Partners to acquire all outstanding shares of the Company for $24 per share in cash.

KnowBe4, Inc. engages in the development, marketing, and sale of its Software-as-a-Service-based security awareness platform. The company provides a platform incorporating security awareness training and simulated phishing with analytics and reporting that helps organizations manage the ongoing problem of social engineering.

The company also offers Security Coach, a solution to address human behavior risks through human detection and response; and PasswordIQ that would be used to mitigate risk related to password hygiene issues, such as weak or breached passwords. It serves its customers directly through inside sales teams for enterprise and small and medium businesses, as well as indirectly through channel partners and managed service providers.

The proposal represents a 39% premium to KnowBe4’s closing price on September 16, 2022.

The Company’s Board of Directors regularly considers opportunities to enhance value for its stockholders.

In response to an inquiry from Vista, the Board formed a special committee of the Board, comprised solely of independent directors, to engage with Vista and take other actions that it deems appropriate, with the assistance of independent financial and legal advisors.

Consistent with its mandate, and in consultation with its legal and financial advisors, the Special Committee will carefully review the Vista proposal and other potential value creation opportunities to determine the course of action that it believes is in the best interests of KnowBe4 and its stockholders.

KNBE is up 29% to $22.30.

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Rig Counts Rise as Oil Stablizes!

Baker Hughes reports U.S. rig count up 4 to 763 rigs

Baker Hughes (BKR) reports that the U.S. rig count is up 4 from last week to 763.

U.S. Rig Count is up 251 rigs from last year’s count of 511 with oil rigs up 239, gas rigs up 58 and miscellaneous rigs up 4.

The U.S. Offshore Rig Count is unchanged at 16, up one year-over-year.

The Canada Rig Count is up 6 from last week to 211, with oil rigs up 3 to 140, gas rigs down 4 to 63.

The Canada Rig Count is up 47 rigs from last year’s count of 156, with oil rigs up 45, gas rigs up 3 and miscellaneous rigs down 1.

The International Rig Count is up 27 rigs to 860 and up 81 from last year’s count.

The Baker Hughes rig counts are counts of the number of drilling rigs actively exploring for or developing oil or natural gas in the U.S., Canada and international markets.

The Company has issued the rig counts as a service to the petroleum industry since 1944, when Hughes Tool Company began weekly counts of the U.S. and Canadian drilling activity. The monthly international rig count was initiated in 1975.

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West Texas Intermediate (WTI) is up 28 cents to $85.34 per barrel (down from a high of $123.70). Brent crude is up $0.72 to $91.54 per barre (down from a high of $127.98). Gasoline last traded at $2.418 per gallon (down from a high of $4.31 per gallon).

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Spectrum Brands shares tumble on DOJ action

DOJ sues to block Assa Abloy deal to buy Spectrum Brands unit

On September 8th, 2021, Spectrum Brands Holdings (SPB) announced it has entered into a definitive agreement to sell its HHI segment to ASSA ABLOY (ASAZY) for $4.3B in cash, which it said represents over 14 times HHI’s expected FY21 Adjusted EBITDA. Click here to read our blog.

The U.S. Department of Justice filed a civil antitrust lawsuit today to block Assa Abloy’s (ASAZY) proposed $4.3B acquisition of the Hardware and Home Improvement division of its rival, Spectrum Brands Holdings (SPB).

Assa and Spectrum are two of the three largest producers of residential door hardware in the concentrated, $2.4 billion U.S. industry, the DOJ said.

The complaint, filed in the U.S. District Court for the District of Columbia, alleges that the merger would eliminate important head-to-head competition between ASSA ABLOY and Spectrum, risking higher prices, lower quality, reduced innovation and poorer service in the sale of at least two types of residential door hardware: premium mechanical door hardware and smart locks.

The complaint, which seeks to enjoin the transaction under Section 7 of the Clayton Act, alleges that ASSA ABLOY and Spectrum have competed for years to be leaders in the U.S. markets for premium mechanical door hardware and for smart locks.

The proposed transaction would transform these markets, giving Assa “a near-monopoly in premium mechanical door hardware and more than a 50% share in smart locks, leaving only one significant competitor,” the DOJ said.

SPB is down 10% to $52.85.

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Altimmune announces positive results, shares tumble!

 Altimmune announces results from Phase 1b study of pemvidutide

Altimmune (ALT) announced “positive” topline results from its 12-week Phase 1b study of pemvidutide in subjects with non-alcoholic fatty liver disease.

NAFLD. The trial was a randomized, double-blind, placebo-controlled study, with Dr. Stephen A. Harrison, Medical Director, Pinnacle Research, serving as the Principal Investigator.

The primary efficacy endpoint was the percent reduction in liver fat content from baseline, and the key secondary efficacy endpoint was the % weight loss from baseline, both at 12 weeks of treatment.

The trial was conducted without adjunctive diet and exercise interventions that are the standard for obesity trials.

Ninety-four subjects were randomized and treated at 13 sites across the U.S.

Mean BMI at baseline was approximately 36 kg/m2 and mean liver fat content, as measured by MRI-PDFF, was approximately 22%.

Twenty-seven subjects had type 2 diabetes at baseline, and approximately 75% of study subjects were of Hispanic ethnicity.

The trial met its primary endpoint in all pemvidutide treatment groups.

At the 1.8 mg dose, pemvidutide achieved a mean reduction of liver fat content of 68.5%, with 94.4% of subjects achieving a 30% reduction in liver fat, 72.2% achieving a 50% reduction in liver fat, and 55.6% of subjects achieving normalization of liver fat, defined as liver fat fraction of 5% or less.

In addition, mean serum alanine aminotransferase levels declined in all subjects, and in subjects with baseline serum ALT above 30 IU/L, levels declined more than 17 IU/L at all dose levels and 27.0 IU/L in the 2.4 mg dose cohort.

The trial also met its key secondary endpoint in all pemvidutide treatment groups. Employing an efficacy estimand, mean weight losses of 4.9% in subjects without diabetes and 4.4% in subjects with diabetes were achieved at the 1.8 and 2.4 mg doses, respectively.

Pemvidutide was reported to be generally well tolerated. Gastrointestinal events comprised the majority of the adverse events.

Even without dose titration, the symptoms experienced by subjects were predominantly mild and transient in nature, consistent with known GLP-1 class effects.

“We are pleased with the results of this trial, including the extent of liver fat and serum ALT reductions. Weight loss was within our target range, and good tolerability was observed without the need for dose titration. In addition, no clinically significant ALT elevations were observed,” said Vipin Garg,, President and Chief Executive Officer of Altimmune.

“With these positive results in hand, we look forward to reporting data from the 24-week NAFLD trial, as well as 24-week interim data from our MOMENTUM obesity trial.”

ALT shares opened down 58%, now down 25.5% to $15.21.

Piper Sandler

Piper Sandler analyst Yasmeen Rahimi said she is surprised to see the negative pre-market stock reaction in shares of Altimmune (ALT) after the company announced topline results from its 12-week Phase 1b study. She thinks it may be attributed to the 4.7% weight-loss which came in below Street’s expectations. However, the analyst points out that this measure is in alignment with the 6% placebo adjusted seen with Eli Lilly’s (LLY) tirzepatide and 4% placebo adjusted weight loss with Novo Nordisk’s (NVO) semaglutide at 12 weeks. Rahimi, who calls the study a “big win with a clean safety profile,” believes that the stock reaction due to weight loss percentage is “overdone” and argues that the totality of data “suggests that pemvidutide could be a serious player in the obesity/NASH space.” Rahimi has an Overweight rating and $25 price target on Altimmune shares.

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FOMC to raise rates by 75 bp on September 21

Fed’s Waller supports ‘significant increase’ in policy rate at next meeting

The Federal Reserve release a transcript for a speech to be delivered by Governor Christopher Waller at the 17th Annual Vienna Macroeconomics Workshop, in which he plans to state:

Christopher Waller

Christopher J. Waller took office as a member of the Board of Governors of the Federal Reserve System on December 18, 2020, to fill an unexpired term ending January 31, 2030.

Prior to his appointment at the Board, Dr. Waller served as executive vice president and director of research at the Federal Reserve Bank of St. Louis since 2009.

There are three takeaways from my speech today.

First, inflation is far too high, and it is too soon to say whether inflation is moving meaningfully and persistently downward. The Federal Open Market Committee is committed to undertake actions to bring inflation back down to our 2% target.

This is a fight we cannot, and will not, walk away from.

The second takeaway is that the fears of a recession starting in the first half of this year have faded away and the robust U.S. labor market is giving us the flexibility to be aggressive in our fight against inflation.

For that reason, I support continued increases in the FOMC’s policy rate and, based on what I know today, I support a significant increase at our next meeting on September 20 and 21 to get the policy rate to a setting that is clearly restricting demand.

The final takeaway is that I believe forward guidance is becoming less useful at this stage of the tightening cycle.

Future decisions on the size of additional rate increases and the destination for the policy rate in this cycle should be solely determined by the incoming data and their implications for economic activity, employment, and inflation.” 

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