Imago results and business update

 Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Essential Thrombocythemia (ET) Presented at European Hematology Association (EHA) Meeting 2022 -

- Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Advanced Myelofibrosis Presented at EHA 2022 -

- First Participant Dosed in Investigator-Sponsored Phase 1/2 Study of Bomedemstat in Combination with Atezolizumab in Small Cell Lung Cancer -

- Obtained Advice from FDA Clinical Outcomes Assessment (COA) Group with Regard to Patient Reported Outcome (PRO) Endpoints for the Company’s Planned Phase 3 Trial of Bomedemstat in ET Patients -

https://finance.yahoo.com/news/imago-biosciences-reports-second-quarter-200500441.html

Karuna Closes Public Offering and Full Exercise of Option to Purchase Additional Shares

 Karuna Therapeutics, Inc. (NASDAQ: KRTX) ("Karuna"), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced the closing of its previously announced upsized underwritten public offering of 4,011,628 shares of common stock, including the exercise in full by the underwriters of their option to purchase an additional 523,255 shares at the public offering price of $215.00 per share. Gross proceeds to Karuna in the offering, before underwriting discounts and estimated expenses of the offering, were approximately $862.5 million.

Goldman Sachs & Co. LLC and J.P. Morgan acted as joint book-running managers for the offering. Jefferies also acted as a book-running manager. Stifel, Guggenheim Securities and RBC Capital Markets acted as lead managers, and JMP Securities, a Citizens Company, and Wedbush PacGrow acted as co-managers for the offering.

https://finance.yahoo.com/news/karuna-therapeutics-announces-closing-public-210400115.html

GOP slam Dem plans to increase taxes again in 2023

 Several House Republicans condemned Democrats' apparent plans to increase taxes in 2023 if they were to keep majority control in Congress.

Rep. Richard Neal, D-Mass., the chairman of the powerful House Ways and Means Committee, said Democrats would seek to boost both corporate and individual tax rates if they kept control of the House following the upcoming midterm elections in November, according to Bloomberg reporter Erik Wasson. Neal added that Democrats could seek to revive previously proposed overhauls of the tax code to raise federal revenue and pay for major spending programs.

"For anybody that was even debating whether or not we should remove Speaker Nancy Pelosi from the speakership, now, they have further evidence." Rep. Bryan Steil, R-Wis., the top GOP member of the Select Committee on the Economy, told FOX Business in an interview. "The last thing we should be doing in a recession is raising taxes."

"The Democrats are showing their cards that their plan is to continue to raise taxes and recklessly spend, which is a recipe for the disaster that we're already experiencing with runaway inflation," Steil continued.

Steil was one of many Republican lawmakers who quickly responded in force to Neal's comments.

"This has been their problem from day one," Rep. Tom Emmer, R-Minn., the chairman of the National Republican Congressional Committee (NRCC), told FOX Business. "They don't have an answer for the double-digit inflation that they caused. They don't have an answer for gas prices except destroying our economy so people buy less.

"Remember, every consumer ends up paying those taxes," he continued. "They can tax corporations and make these statements all they want, but it all gets passed through to the consumer on the street."

In response to the report Friday, the NRCC tweeted that Americans should "Vote. Them. Out."

"Congressional Democrats are one trick ponies. Their solution to every problem is to tax more and spend more of other people’s money," Rep. Andy Barr, R-Ky., a senior member of the House Financial Services Committee, told FOX Business. "Today’s historic tax increase during a recession is just another example. Republicans will put an end to this failed economic agenda in the next Congress."

Rep. Kevin Hern, R-Okla., a member of the House Ways and Means Committee and the chairman of the Republican Study Committee's budget and spending task force, said additional taxes on business will only lead to more companies moving operations overseas.

"When you make it more difficult by increasing the tax rates, our businesses will go someplace where they can create a better environment for their workers," Hern told FOX Business. 

Hern added that Democrats want to tax Americans more and make Washington an "even bigger place than it is right now."

"The left's Holy Grail is tax hikes and more government control of our lives," Rep. David Schweikert, R-Ariz., another House Ways and Means Committee member, told FOX Business. "At least the left is being honest about the dystopian future they intend to bring us."

Schweikert said people who believe Democrats aren't in favor of new tax hikes "haven't been listening."

"They're about to raise taxes by over $300 billion, which will ultimately be paid by American consumers," Rep. Blaine Luetkemeyer, R-Mo., the ranking member of the House Small Business Committee, tweeted. "Now Democrats are proudly saying this is only the beginning."

"Democrats aren’t hiding they want to keep raising taxes," Rep. Mike Waltz, R-Fla., added. "Remember when you go to vote."

However, Rep. Bill Pascrell, D-N.J., responded in support of Neal's comments. He said Democrats' top priority is to ensure the wealthy pay "their fair share," while the GOP is committed to allowing billionaires to cheat on their taxes.

Meanwhile, the House is set to vote on the Inflation Reduction Act, a spending package that includes a series of tax hikes. The bill, which passed the Senate on Sunday, includes a corporate minimum tax projected to raise federal revenue by $313 billion, boosts tax enforcement which would increase revenue by about $124 billion and imposes a stock buyback tax on corporations, raising another $74 billion.

While the legislation's tax hikes target high-income Americans, it would indirectly lead to some tax increases for middle- and low-income individuals as well, according to a nonpartisan Joint Committee on Taxation analysis. Middle-class Americans would also be subject to the majority of new Internal Revenue Service audits under the bill.

"They will need to increase the audit rates on middle-class and low-income folks to get the sort of revenues they're claiming from this," William McBride, the vice president of federal tax and economic policy at the Tax Foundation, told FOX Business last week.

In addition, multiple independent studies concluded the bill would have a minimal impact on inflation.

https://www.foxbusiness.com/politics/republicans-slam-dems-plans-increase-taxes-2023-lefts-holy-grail-tax-hikes

Mount Sinai spins out vaccine Castle

 Mount Sinai is readying its clinical archers and manning the research cannons as it spins out a new vaccine company to target infectious diseases and fortify against future pandemics.

The new company—crowned CastleVax—has been established to develop vaccines against “current and potential future pandemic threats, as well as diseases of profound unmet medical need,” according to an announcement Friday. The foundation of CastleVax is a novel vaccine platform developed by a trio of scientists at Mount Sinai’s Icahn School of Medicine. 

Built by Peter Palese, Ph.D, Adolfo García-Sastre, Ph.D, and Florian Krammer, Ph.D, the platform uses a Newcastle disease virus (NDV) as a transporter to display other proteins native to viruses of concern, including the virus that causes COVID-19. The hope is that this method could be replicated with a bevy of problem proteins to develop vaccines for current and future infectious diseases.

NDV itself is part of the avian paramyxovirus family and not harmful to humans, making itself an ideal decoy that can display other disease-causing proteins. The researchers say this platform has already been used to develop intranasal and intramuscular vaccines targeting new COVID-19 variants, including omicron. The nasal spray version is currently being evaluated for its ability to “induce mucosal immunity," something scientists say could help blunt transmission of the virus. As the virus has continued to mutate, the efficacy against infection of the currently authorized or approved vaccines in the U.S. has dropped dramatically, while protection against severe illness has persisted. 

Mount Sinai reports that interim results from a placebo-controlled, phase 1/2 study of the technology in Thailand found that the nasal vaccine induced higher neutralizing antibodies against the Wuhan strain than the available COVID-19 shots in the U.S.

Interim results of a booster study of the nasal spray conducted at Mount Sinai are expected in the fourth quarter, according to CastleVax CEO Matt Stober. The vaccine technology has been transferred to manufacturers in Brazil, Mexico, Vietnam and Thailand, which together could produce more than a billion doses a year. 

CastleVax also has contingency plans should humans develop immunogenicity to the benign NDV virus In that event, the company would replace the NDV glycoproteins in the vaccine with ones from other members of the avian paramyxovirus family. 

Given the tantalizing—albeit early—data on the intranasal vaccine and the manufacturing capabilities, the potential public health and global equity benefits are clear. But recent history would also suggest there’s an economic upside. Most notably, Moderna and BioNTech both ascended last year from budding biotechs to top 20 pharma off the back of their own vaccine platforms and COVID-19 jabs.

“COVID-19 is the first step for our platform development,” said Stober in a release. “We aim to engineer vaccines to fight a broad range of future respiratory pandemic threats that experts in the field foresee as inevitable.”  

https://www.fiercebiotech.com/biotech/mount-sinai-spins-out-new-vaccine-castle-preparing-lay-siege-infectious-diseases

Florida to restart two-dose regimens of monkeypox vaccine

 The Florida Department of Health is allowing two doses of the Jynneos monkeypox vaccine to be administered to residents again.  

After cases doubled over the past week, state health officials began to ration the state’s supply of monkeypox vaccines — only allowing the first of a two-dose regimen to be given.   

But days after the Food and Drug Administration approved a different method of administering the vaccine, Florida health officials told Changing America that it will start to re-administer second doses and reschedule previously canceled vaccination appointments made by residents. 

“Preventing the spread of monkeypox is a priority for the Department of Health,” said health department spokesperson Jeremy Redfern.  

“We will continue to make adjustments as more supplies are made available from the federal government.” 

Following a rising number of monkeypox cases, Florida initially announced earlier this week that it will administer one dose of the two-dose regimen to ration its supply of the vaccine.  

But on Tuesday, the Biden administration authorized a new federal monkeypox vaccine distribution plan to potentially vaccinate up to five times as many people.  

Now, instead of delivering the monkeypox vaccine subcutaneously, or into the fatty tissue under the skin, the inoculation can be injected intradermally, or just beneath a person’s first layer of skin.  

This approach requires a smaller amount of the vaccine but can cause the skin where the vaccine was administered to bubble and potentially scar, according to The Washington Post.  

By doing this, health officials hope to expand the country’s limited stockpile of monkeypox vaccines from 441,000 doses up to 2.2 million, according to ˚NY1 

Monkeypox is a poxvirus similar to smallpox or cowpox, and is spread by skin-to-skin contact, according to the U.S. Centers for Disease Control and Prevention. 

 Symptoms of the disease are usually a rash formed by small blisters around the genitals, hands, feet, chest or face and flu-like symptoms including fever, chills and fatigue, according to the CDC.  

The Florida Department of Health has reported at least 1,085 cases of the virus across the state as of Thursday. Two weeks ago, there were 350 cases of the illness.  

Florida is not the only place in the country that decided to try to stretch out its monkeypox vaccine supply.  

Last month, the Washington, D.C., health department announced it would postpone administering second doses of the monkeypox vaccine to residents due to a rapid increase in cases.  

“Given the rapid increase in monkeypox cases, and the very limited supply of vaccine, DC Health has decided the most urgent priority is providing first doses of vaccine to high-risk residents,” the health department said in a message to residents.  

https://thehill.com/changing-america/well-being/prevention-cures/3598399-florida-resuming-two-dose-regimen-of-monkeypox-vaccine/

Peloton must face lawsuit over availability of fitness classes

 A U.S. judge on Thursday said Peloton Interactive must face a proposed class action lawsuit accusing the bike and treadmill maker of misleading customers about the "ever-growing" size of its library of on-demand fitness classes.

The lawsuit stemmed from Peloton's March 2019 decision to purge more than half of its estimated 12,000 on-demand classes, after music publishers sued the New York-based company for streaming songs in its workout videos without proper licensing.

Customers said Peloton knew this could happen, yet kept charging full price for bicycles and monthly subscriptions that carried copyrighted songs from artists including Adele, Beyoncé, Luke Bryan, Drake, Ariana Grande, Madonna, Justin Timberlake and Jay Z.

In a 40-page decision, U.S. District Judge Lewis Liman in Manhattan said customers in New York from April 2018 to March 2019 could try to prove they overpaid because Peloton was silent about the "imminent" removal of much of its digital library.

Liman called it reasonable to infer from Peloton's claim of an "ever-growing" library that "there would be value associated with the products that resulted in an increased price when that value was not actually there."

Peloton did not immediately respond to requests for comment.

In a joint statement, the plaintiffs' lawyers said they were "pleased with Judge Liman's categoric denial of Peloton's latest dismissal motion and we look forward to prosecuting our clients' and the other class members' claims through trial."

Peloton settled the licensing lawsuit by the National Music Publishers' Association and 14 of its members in February 2020.

Ticker	Security	Last	Change	Change %
PTON	PELOTON INTERACTIVE INC.	13.59	+1.68	+14.13%
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More recently, the 10-year-old company has struggled with waning demand, losing $757.1 million in the quarter ending March 31 as more people resumed pre-pandemic activities.

Peloton expects to report fiscal fourth-quarter and full-year results on Aug. 25.

The case is Passman et al v Peloton Interactive Inc, U.S. District Court, Southern District of New York, No. 19-11711.

https://www.foxbusiness.com/lifestyle/peloton-must-face-lawsuit-over-availability-of-fitness-classes

Advent to sell Bioduro stake, eyes valuation over $1 bln

 Buyout firm Advent International plans to sell a majority stake in U.S.-based Bioduro-Sundia in a deal that could value the drug development and manufacturing outsourcing provider at over $1 billion, said three people with knowledge of the matter.

Boston-headquartered Advent had tapped JPMorgan (JPM.N) to advise on the potential sale of its stake, said two of the people, adding that the bank had contacted potential buyers to gauge interest.

A formal sale process, however, may not kick off until next year, said one of those two sources.

Bioduro-Sundia operates in the United States and China, with more than 2,000 employees and 10 facilities, providing contract research, development and manufacturing outsourcing services, according to Advent’s website.

Advent is looking to sell its stake in Bioduro-Sundia at a company valuation of more than 20 times annual earnings before interest, tax, depreciation and amortisation, said the second source. The valuation would be more than $1 billion, that person said.

The seller could be seeking a valuation as high as $1.5 billion, said the third source.

All the sources declined to be identified, because the information was confidential. Advent, Bioduro-Sundia and JPMorgan declined to comment.

Advent bought a majority stake in San Diego, California-based Bioduro in 2019 and a year later merged the company with peer Sundia. Financial details of those two transactions have not been disclosed, nor has the exact size of Advent’s holding.

Bioduro-Sundia has provided drug research services for major pharmaceutical firms in China, including Shanghai Fosun Pharmaceutical Group and InnoCare Pharma, Bioduro-Sundia says on its website.

It has also worked with Pfizer to develop a drug-making compound called AISF, the company says.

https://www.pharmalive.com/advent-to-sell-bioduro-stake-eyes-valuation-over-1-bln-sources/