Reata Pharmaceuticals sold for $7.3B

Biogen to acquire Reata Pharmaceuticals for $172.50 per share in cash

Biogen Inc. (BIIB) and Reata Pharmaceuticals (RETA) announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire Reata for $172.50 per share in cash, reflecting an enterprise value of approximately $7.3B.

Reata has made significant advancements developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases.

Biogen sharply higher on data, Stockwinners

Reata’s FDA-approved SKYCLARYS is the first and only approved treatment for Friedreich’s Ataxia in the United States, with a commercial launch underway, and European regulatory review ongoing.

Ataxia is a degenerative disease of the nervous system. Many symptoms of Ataxia mimic those of being drunk, such as slurred speech, stumbling, falling, and incoordination. These symptoms are caused by damage to the cerebellum, the part of the brain that is responsible for coordinating movement. Ataxia treatment involves a combination of medication to treat symptoms and  therapy to improve quality of life.

People affected by Ataxia may experience problems with using their fingers and hands, arms, legs, walking, speaking or moving their eyes. Ataxia affects people of all ages. Age of symptom-onset can vary widely, from childhood to late-adulthood. Complications from the disease are serious and oftentimes debilitating. 

In addition, Reata is developing a portfolio of innovative products for a range of neurological diseases.

The transaction, which was approved by the boards of directors of both companies, is currently anticipated to close in the fourth quarter of 2023.

Biogen expects this acquisition to be accounted for as a business combination.

The acquisition of Reata is expected to be slightly dilutive to Biogen’s Non-GAAP diluted Earnings Per Share in 2023, roughly neutral in 2024, and significantly accretive beginning in 2025, inclusive of associated transaction costs.

Biogen plans to update its Full Year 2023 Financial Guidance in conjunction with its third quarter 2023 earnings release.

Biogen expects to finance the acquisition with cash on hand, supplemented by the issuance of long term debt.

The transaction is subject to customary closing conditions, including approval by Reata stockholders and the receipt of necessary regulatory approvals.

Biogen has entered into voting and support agreements with certain stockholders of Reata representing approximately 36% of the voting power of Reata’s common stock.

RETA is up 52% or $56.90 to $165.37. BIIB is up 1% to $265.58.

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PGA TOUR and LIV Golf to Merge, Ending Lawsuits

PGA TOUR confirms deal to merge with LIV Golf

The PGA TOUR, DP World Tour (formerly known as the European Tour) and the Public Investment Fund announced a landmark agreement to unify the game of golf, on a global basis.

The proposed merger comes after the PGA Tour and LIV Golf have been embroiled in lawsuits regarding antitrust claims.

The deal would end all pending litigation.

The parties have signed an agreement that combines PIF’s golf-related commercial businesses and rights — including LIV Golf — with the commercial businesses and rights of the PGA TOUR and DP World Tour into a new, collectively owned, for-profit entity to ensure that all stakeholders benefit from a model that delivers maximum excitement and competition among the game’s best players.

In addition, PIF will make a capital investment into the new entity to facilitate its growth and success.

The new entity will implement a plan to grow these combined commercial businesses, drive greater fan engagement and accelerate growth initiatives already underway.

This announcement will be followed by a mutually agreed end to all pending litigation between the participating parties, the companies said.

Further, the three organizations will work cooperatively and in good faith to establish a fair and objective process for any players who desire to re-apply for membership with the PGA TOUR or the DP World Tour following the completion of the 2023 season and for determining fair criteria and terms of re-admission, consistent with each Tour’s policies.

Furthermore, the Public Investment Fund of Saudi Arabia has been involved in promoting golf through its support for the Saudi International tournament, which is part of the European Tour. The PIF has been investing in various sectors, including sports and entertainment, as part of Saudi Arabia’s Vision 2030 plan to diversify the country’s economy.

“We are pleased to move forward, in step with LIV and PIF’s world-class investing experience, and I applaud PIF Governor Yasir Al-Rumayyan for his vision and collaborative and forward-thinking approach that is not just a solution to the rift in our game, but also a commitment to taking it to new heights.

This will engender a new era in global golf, for the better.” Under the terms of the agreement, the Board of Directors of the new entity will oversee and direct all the new entity’s golf-related commercial operations, businesses and investments.

Did you know PGA Tour is a non-profit, tax exempt entity?

Separately, PGA TOUR Inc. will remain in place as a 501(c)(6) tax exempt organization and retains administrative oversight of events for those assets contributed by the PGA TOUR, including the sanctioning of events, the administration of the competition and rules, as well as all other “inside the ropes” responsibilities, with Jay Monahan as Commissioner and Ed Herlihy as PGA TOUR Policy Board Chairman.

Companies that offer golf products include Acushnet Holdings (GOLF) and Topgolf Callaway (MODG).

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Rig Counts declined last week!

Baker Hughes reports U.S. rig count down 9 to 711 rigs.

Baker Hughes (BKR) reports that the U.S. rig count is down 9 from last week to 711 with oil rigs down 5 to 570, gas rigs down 4 to 137 and miscellaneous rigs unchanged at 4.

The U.S. Rig Count is down 16 rigs from last year’s count of 727 with oil rigs down 4, gas rigs down 14 and miscellaneous up 2.

The international offshore rig count for April 2018 was 194. Stockwinners

The U.S. Offshore Rig Count is down 1 to 20, up 4 year-over-year.

The Canada Rig Count is up 2 from last week to 87, with oil rigs up 3 to 42, gas rigs down 1 to 45.

The Canada Rig Count is down 16 rigs from last year’s count of 103 with oil down 13, gas rigs down 3.

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 $1.08 to $72.86 per barrel (52 weeks high of $122.10). Brent crude is up $1.07 to $77.12 per barre (52 weeks high of $123.58). Gasoline last traded at $2.702 per gallon (52 weeks high of $4.31 per gallon).

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Japan’s Mizuho Financial buys Greenhill

Mizuho Financial Group to acquire Greenhill & Co. for $15 per share in cash

Mizuho Financial Group, Inc. (MFG) and Greenhill & Co., Inc. (GHL) announced a definitive agreement for Mizuho to acquire Greenhill in an all-cash transaction at $15 per share, reflecting an enterprise value of approximately $550M, including assumed debt.

Greenhill & Co., Inc.provides financial and strategic advisory services to corporations, partnerships, institutional investors, and governments worldwide. The company offers advisory services related to mergers and acquisitions, divestitures, restructurings, financings, private capital raising, and other similar transactions.

Through this transaction, Mizuho will accelerate its investment banking growth strategy, building on Greenhill’s 27-year history of advising important clients on significant mergers & acquisitions, restructurings and capital raising transactions.

Following completion of the transaction, Greenhill will operate globally from its 15 locations around the world as the M&A and restructuring advisory business of Mizuho.

That business will maintain the Greenhill brand, and the existing Greenhill leadership team will remain in place. Greenhill Chairman & Chief Executive Officer Scott Bok will become Chairman of the M&A and restructuring advisory business.

Current Greenhill Co-Presidents Kevin Costantino and David Wyles will become Co-Heads of the business.

The Greenhill business will sit within Mizuho’s banking division, led by Michal Katz, Head of Banking in the Americas.

With this transaction, Mizuho will welcome Greenhill’s 370 employees, as well as the valued client relationships they have built around the world.

Both management teams are committed to a seamless transition for all clients and employees.

The transaction is expected to close by year end and is subject to approval by Greenhill stockholders, as well as required regulatory approvals and other customary closing conditions.

GHL gained $7.88 to close at $14.66.

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Krystal Biotech shares jump as FDA approves Vyjuvek

Vyjuvek is designed to treat the genetic root cause of DEB

Krystal Biotech (KRYS) announced the U.S. Food and Drug Administration has approved Vyjuvek for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa, or DEB.

DEB is a rare disease that appears at birth or during the first few years of life, and lasts a lifetime. Prognosis is variable, but tends to be serious. Life expectancy is 50 years, and the disease brings with it complications related to infections, nutrition and neoplastic complications.

“Vyjuvek is designed to address the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing.

Vyjuvek is the first-ever redosable gene therapy and the first and only medicine approved by the FDA for the treatment of DEB, both recessive and dominant, that can be administered by a healthcare professional in either a healthcare professional setting or in the home,” the company stated.

With this approval, the FDA issued the Company a Rare Pediatric Disease Priority Review Voucher, or PRV, which confers priority review to a subsequent drug application that would not otherwise qualify for priority review, the company noted.

“Vyjuvek is expected to be available in the United States in the third quarter of 2023, and the company will begin the promotion of Vyjuvek immediately.

Outside of the US, the European Medicines Agency has granted Vyjuvek orphan drug designation and PRIME – PRIority MEdicines – eligibility for the treatment of DEB.

The Company anticipates starting the official Marketing Authorization Application procedure in the second half of 2023 with a potential approval in 2024.

The Company is also working with the Pharmaceuticals and Medical Devices Agency in Japan to study Vyjuvek and seek approval for potential launch in 2025,” the company added.

KRYS is up 8.7% to $95.00 per share on heavy trading volume.

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Diversey Holdings sold for $4.6 billion

Diversey to be acquired by Solenis for $8.40 per share in cash

Solenis and Diversey Holdings (DSEY) announced they have entered into a definitive merger agreement under which Solenis will acquire Diversey in an all-cash transaction valued at an enterprise value of approximately $4.6B.

Diversey Holdings, Ltd. provides infection prevention and cleaning solutions worldwide. It operates in two segments, Institutional, and Food & Beverage. 

Upon completion of the merger, Diversey will become a private company.

Under the terms of the agreement, Diversey shareholders — other than shareholders affiliated with Bain Capital Private Equity — will receive $8.40 per share in cash, which represents a premium of approximately 41.0% over Diversey’s closing share price on March 7, 2023, the last full trading day prior to the transaction announcement, and a premium of approximately 59.0% over Diversey’s 90-day volume-weighted average price.

Bain Capital will receive $7.84 per share in cash and will rollover a portion of its shares of Diversey into an affiliate of Solenis in exchange for common and preferred units of such affiliate.

Headquartered in Wilmington, Delaware, Solenis is a manufacturer of specialty chemicals used in water-intensive industries, which was acquired by Platinum Equity in 2021.

“The merger presents a unique opportunity to enhance value and create a more diversified business with increased scale, broader global reach, and superior customer service capabilities. It will enable the combined company to grow and provide a number of attractive cross-selling opportunities, including meeting increasing customer demand for water management, cleaning and hygiene solutions,” said Phil Wieland, Chief Executive Officer of Diversey.

Solenis CEO John Panichella will lead the combined company following the transition and integration.

Diversey’s Board of Directors formed the Special Committee to evaluate and negotiate the transaction with the assistance of independent financial and legal advisors.

Following this process, the Special Committee unanimously determined that the transaction with Solenis is in the best interests of Diversey and its shareholders, and, acting upon unanimous recommendation by the Special Committee, the Diversey Board of Directors unanimously approved the merger and recommended that Diversey shareholders vote in favor of the merger.

The Special Committee negotiated the terms of the merger agreement with assistance from its independent financial and legal advisors.

In connection with the transaction, Solenis has entered into a support agreement with Bain Capital, pursuant to which Bain Capital has agreed to vote all of its Diversey shares — which represent approximately 73% of Diversey’s outstanding shares — in favor of the transaction, subject to certain terms and conditions set forth therein.

Solenis intends to finance the transaction with a combination of committed debt and equity financing, including the contribution by Bain Capital.

The merger is expected to be completed in the second half of 2023, subject to the satisfaction of customary closing conditions, including approval by Diversey shareholders holding a majority of the outstanding shares of the Company and receipt of regulatory approvals.

Upon closing of the transaction, Diversey’s ordinary shares will no longer be listed on any public market.

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North American rail traffic declined 3.4% last week

North American rail traffic down 3.4% for the week ending February 25

The Association of American Railroads, AAR reported U.S. rail traffic for the week ending February 25, as well as volumes for February 2023.

U.S. railroads originated 905,744 carloads in February 2023, down 1.6% or 15,101 carloads, from February 2022.

U.S. railroads also originated 943,979 containers and trailers in February 2023, down 8.4%, or 86,351 units, from the same month last year.

Combined U.S. carload and intermodal originations in February 2023 were 1,849,723, down 5.2%, or 101,452 carloads and intermodal units from February 2022.

“Coal, chemicals, and grain together account for more than half of all non-intermodal U.S. rail volume.

When all three are down, like they were in February, it’s very hard for total carloads not to be down too,” said AAR Senior Vice President John T. Gray.

On the positive side, several commodities including crushed stone and sand, petroleum products, steel products, grain mill and food products showed very strong performances.

Total U.S. weekly rail traffic was 459,233 carloads and intermodal units, down 5.9% compared with the same week last year.

Total carloads for the week ending February 25 were 226,435 carloads, up 0.1% compared with the same week in 2022, while U.S. weekly intermodal volume was 232,798 containers and trailers, down 11.1% compared to 2022.

North American rail volume for the week ending February 25 on 12 reporting U.S., Canadian and Mexican railroads totaled 327,221 carloads, up 2.9% compared with the same week last year, and 308,029 intermodal units, down 9.3% compared with last year.

Total combined weekly rail traffic in North America was 635,250 carloads and intermodal units, down 3.4%.

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), Greenbrier (GBX), Trinity Industries (TRN), FreightCar America (RAIL) and Wabtec (WAB).

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Netflix Outlines Methods to Stop Credential Sharing

Netflix provides update on sharing guidelines as 100M households share accounts

In an “update on sharing,” Netflix (NFLX) said that,

“Today, over 100 million households are sharing accounts – impacting our ability to invest in great new TV and films.

So over the last year, we’ve been exploring different approaches to address this issue in Latin America, and we’re now ready to roll them out more broadly in the coming months, starting today in Canada, New Zealand, Portugal and Spain.

Our focus has been on giving members greater control over who can access their account.

Set primary location: We’ll help members set this up, ensuring that anyone who lives in their household can use their Netflix account.

Manage account access and devices: Members can now easily manage who has access to their account from our new Manage Access and Devices page.

Transfer profile: People using an account can now easily transfer a profile to a new account, which they pay for – keeping their personalized recommendations, viewing history, My List, saved games and more.

Netflix Spain raises prices

Watch while you travel: Members can still easily watch Netflix on their personal devices or log into a new TV, like at a hotel or holiday rental.

Netflix Canada raises prices

Buy an extra member: Members on our Standard or Premium plan in many countries (including Canada, New Zealand, Portugal and Spain) can add an extra member sub account for up to two people they don’t live with – each with a profile, personalized recommendations, login and password – for an extra CAD$7.99 a month per person in Canada, NZD$7.99 in New Zealand, Euro 3.99 in Portugal, and Euro 5.99 in Spain.”

NFLX is up $1.26 to $364.15.

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Rig Counts Declined last week!

Baker Hughes reports U.S. rig count down 12 to 759 rigs

Baker Hughes (BKR) reports that the U.S. rig count is down 12 from last week to 759 with oil rigs down 10 to 599, gas rigs down 2 to 158 and miscellaneous rigs unchanged at 2.

The U.S. Rig Count is up 146 rigs from last year’s count of 613 with oil rigs up 102, gas rigs up 42 and miscellaneous up 2.

The U.S. Offshore Rig Count is down 1 to 12, down 4 year-over-year. The Canada Rig Count is up 2 from last week to 249, with oil rigs up 2 to 159, gas rigs unchanged at 90.

The Canada Rig Count is up 31 rigs from last year’s count of 218 with oil rigs up 23, gas rigs up 8.

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 down $2.05 to $73.81 per barrel (down from a high of $123.70). Brent crude is down $2.06 to $80.19 per barre (down from a high of $127.98). Gasoline last traded at $2.349 per gallon (down from a high of $4.31 per gallon).

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Stockwinners Portfolio returns 22.8% in 2022

S&P 500 declined 19.6% during the same period

The bear market of 2022 cost most investors dearly whereas Stockwinners readers were able to register double digit returns. Our experience in the past 24 years has taught us how to avoid pitfall of following crowds and Wall Street gurus. In fact, we stayed away from story stocks such Tesla (TSLA), Paypal Holdings (PYPL) and Meta Platform (META). We concentrated on small to medium cap stocks. These stocks typically do not have any exposure to overseas markets and are traded on their own fundamentals.

Russian invasion of Ukraine created unique trading opportunities for investors. The vicious invasion of Ukraine caused energy and commodity prices skyrocket thus offering opportunities in that space. In fact, one of our better performers on the year was EPAM System (EPAM). This software company has about 25 percent of its workforce located in the eastern European country. Those who bought the stock based on our recommendations were rewarded with a 23% return in two days.

Energy stocks were awakened with the invasion. Crude oil shot up to $106.50 from $70 per barrel. This price increase buoyed energy stocks. Amongst our better performers were shares of Par Pacific Holdings (PARR). The refiner shares gained fifteen percent following our recommendations.

Other commodity stocks that were featured in our portfolio included those involved in precious and rare minerals mining. Livent Corporation (LTHM) was one such name. The lithium miner was featured several times with solid returns. The returns were 14%, 12% and 18%. Sigma Lithium Corporation (SGML) was another name in the sector. It gained 14% following our recommendations.

Sierra Wireless, Inc. (SWIR) was another stock that came to our attention. The company provides device-to-cloud Internet of Things (IoT) solutions. Shares were featured in August with success. Stock gained 18 percents in two weeks.

We featured put options (shorting the stock) on several names. One of the names featured was Open Text Corporation (OTEX). Put option on the name returned 325% in 17 days. The put was featured at $1.50 and it was closed 17 days later at $6.40. Another name that was featured several times was Carvana (CVNA). Shares of the used car retailer have fallen from $300 to $3.55.

A strong employment market created opportunity in placement companies. Cross Country Healthcare, Inc. (CCRN) was such name. The company places medical staff. Shares were featured in August and gained 18% in less than two weeks.

Our portfolio can be downloaded here. Additionally, one may download our selections for the past 18 years in a spreadsheet format.

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Kroger in talks to buy Albertsons

Kroger in talks to acquire Albertsons in all-cash deal, CNBC says

Kroger (KR) is in talks to buy Albertsons (ACI) in an all-cash deal that it hopes can be announced as soon as tomorrow morning, CNBC’s David Faber reported on-air, citing his sources. He could not learn of the deal price being discussed, Faber noted. Earlier, Bloomberg also reported earlier that Kroger is in discussions to merge with Albertsons.

Shares of Albertsons (ACI) are up $2.45, or 10%, to $28.12 after both CNBC and Bloomberg said the grocer is in talks to merge with industry peer Kroger (KR), whose shares are down about 1% to $45.53.

Kroger (KR) is in discussions to merger with Albertsons (ACI), Bloomberg’s Michelle Davis reports. According to people familiar with the matter, an agreement could be reached as soon as this week, but caution that no final decisions have been made.

Albertsons Companies, Inc. engages in the operation of food and drug stores in the United States. As of February 26, 2022, it operated 2,276 stores under various banners, including Albertsons, Safeway, Vons, Pavilions, Randalls, Tom Thumb, Carrs, Jewel-Osco, Acme, Shaw’s, Star Market, United Supermarkets, Market Street, Haggen, Kings Food Markets, and Balducci’s Food Lovers Market; and 1,722 pharmacies, 1,317 in-store branded coffee shops, 402 adjacent fuel centers, 22 distribution centers, and 20 manufacturing facilities.

The Kroger Co. operates as a retailer in the United States. The company operates combination food and drug stores, multi-department stores, marketplace stores, and price impact warehouses. As of January 29, 2022, the company operated 2,726 supermarkets under various banner names in 35 states and the District of Columbia.

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Musk offers to buy Twitter at original price!

Twitter jumps after Musk offers deal on original terms

Tesla (TSLA) CEO Elon Musk is proposing to buy Twitter (TWTR) for the original offer price of $54.20 per share, Jeff Feeley and Ed Hammond of Bloomberg reports, citing people familiar with the matter.

Elon Musk

Musk made the proposal in a letter to Twitter, sources told Bloomberg. Shares of Tesla (TSLA) moved well off their highs after Bloomberg reported, and CNBC followed, that its CEO Elon Musk is proposing to buy Twitter (TWTR) for the original offer price of $54.20 per share. Shares of Twitter are halted at $47.93 pending news while Tesla shares paired their gains to up about 2% to $247.29.

Tesla (TSLA) CEO Elon Musk has offered to close his acquisition of Twitter (TWTR) on the terms he originally agreed to, Cara Lombardo and Dana Cimilluca of WSJ report, citing a person familiar with the matter.

Musk’s lawyers communicated the proposal to Twitter’s lawyers overnight Monday and filed a letter confidentially with the Delaware Chancery Court ahead of an emergency hearing on the matter Tuesday, the person said.

The two sides are discussing how to ensure the deal can be closed, according to Lombardo and Cimilluca. The judge overseeing the case requested they come back to her by the end of the day with a potential plan that would allow the litigation to be dropped, a source told the Journal.

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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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Rig Counts Rise – See Stockwinners.com Market Radar to read more

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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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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