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Monday, September 18, 2023

MRNA Insider Activity

 

Number of Insider Trades

INSIDER TRADE3 MONTHS12 MONTHS
Number of Open Market Buys00
Number of Sells22166
Total Insider Trades22166

Number of Insider Shares Traded

INSIDER TRADE3 MONTHS12 MONTHS
Number of Shares Bought00
Number of Shares Sold300,1033,813,326
Total Shares Traded300,1033,813,326
Net Activity(300,103)(3,813,326)
  
KLINGER SHANNON THYMEOfficer09/08/2023SellDirect557$107.227,215
KLINGER SHANNON THYMEOfficer09/07/2023Option ExecuteDirect1,1387,772
GARAY ARPAOfficer09/06/2023SellDirect574$108.403,113
AFEYAN NOUBARDirector09/06/2023Automatic SellDirect15,000$107.271,982,209
HOGE STEPHENOfficer09/05/2023SellDirect320$111.441,589,187
KLINGER SHANNON THYMEOfficer09/05/2023SellDirect115$111.446,634
GARAY ARPAOfficer09/05/2023Option ExecuteDirect1,1403,687
HOGE STEPHENOfficer09/01/2023Option ExecuteDirect6521,589,507
KLINGER SHANNON THYMEOfficer09/01/2023Option ExecuteDirect2336,749
AFEYAN NOUBARDirector08/30/2023Automatic SellDirect15,000$114.641,997,209
HOGE STEPHENOfficer08/29/2023SellDirect1,135$115.011,588,855
HOGE STEPHENOfficer08/28/2023Option ExecuteDirect2,4111,589,990
AFEYAN NOUBARDirector08/23/2023Automatic SellDirect15,000$112.612,012,209
HOGE STEPHENOfficer08/17/2023Automatic SellDirect15,000$100.001,587,579
AFEYAN NOUBARDirector08/16/2023Automatic SellDirect10,000$95.702,027,209

Eloxx: Independent Confirmation of Positive Biopsy Results in All Patients in Phase 2 Alport Study

 Highly regarded renal pathologist and transmission electron microscopy (TEM) expert independently confirms previously reported qualitative assessment by Mayo Clinic of TEM biopsy scans

All three patients treated with ELX-02 showed a visual improvement in podocyte foot process effacement post-treatment in kidney biopsies demonstrating the disease modifying effect of ELX-02

Podocyte foot process effacement is a hallmark of Alport syndrome

Eloxx intends to gain alignment with U.S. Food and Drug Administration (FDA) on design of pivotal trial and potential for seeking Breakthrough Therapy Designation

https://finance.yahoo.com/news/eloxx-pharmaceuticals-reports-independent-confirmation-110000183.html

UAW strike: Ford, GM to lay off workers due to ripple effects

 UAW president Shawn Fain appeared on the Sunday talk show circuit, criticizing the automakers and warning negotiations were dragging.

“Progress is slow,” Fain said on MSNBC’s “The Sunday Show with Jonathan Capehart,” adding, “I don’t really want to say we’re closer.” Fain also declined to elaborate on plans for the possibility of a second wave of plant strikes.

Around 12,700 UAW workers have walked off and remain on strike as part of a coordinated plan that affected three separate plants. The UAW is asking for wage hikes of nearly 40%, COLA (cost of living adjustments) built into a future contract, end of wage “tiers,” and a defined benefit pension plan, among other things.

The ripple effects of the current stand up strikes — at GM's Wentzville, Mo., plant (which assembles midsize trucks and full-size vans), Stellantis' Toledo Assembly (Jeep Wrangler and Gladiator), and Ford's Michigan Assembly Plant in Wayne (Ranger midsize pickup and Bronco SUV) — are starting to be felt on both sides.

Following the walk-offs at strike locations, Ford said it was laying off 600 workers in a different part of the Michigan Assembly plant, due to the striking workers in the paint and assembly division of that plant.

“This layoff is a consequence of the strike at Michigan Assembly Plant’s final assembly and paint departments, because the components built by these 600 employees use materials that must be e-coated for protection. E-coating is completed in the paint department, which is on strike," Ford said in a statement.

In addition, GM said the strike at the Wentzville Assembly plant in Missouri was affecting production at its Fairfax, Kansas factory, meaning 2,000 workers at the Fairfax location could be laid off by the end of the week. GM’s Fairfax plant assembles the Cadillac XT4 crossover, and the Chevrolet Malibu sedan.

"[The layoffs are] due to a shortage of critical stampings supplied by Wentzville's stamping operations to Fairfax," GM said in a statement. "We are working under an expired agreement at Fairfax. Unfortunately, there are no provisions that allow for company-provided SUB-pay in this circumstance."

https://finance.yahoo.com/news/uaw-strike-stellantis-ups-offer-ford-gm-to-lay-off-workers-due-to-ripple-effects-154134129.html

AbbVie: Positive Topline in Second Phase 3 of BOTOX for Platysma Prominence

 All primary and secondary endpoints were met for second Phase 3 study (M21-310) and results were consistent with findings from first Phase 3 study (M21-309).

Results support onabotulinumtoxinA as a potential treatment option for moderate to severe platysma prominence.
Data will be included as part of an upcoming U.S. Food and Drug Administration regulatory submission expected near the end of the year. If approved, onabotulinumtoxinA will be the first and only neurotoxin for this indication.

'Morgan Stanley kicks off generative AI era on Wall Street with assistant for financial advisors'

 Morgan Stanley

 has officially kicked off the generative AI era on Wall Street.

The bank plans to announce Monday that the assistant it created with OpenAI’s latest generative AI software is “fully live” for all financial advisors and their support staff, according to a memo obtained by CNBC.

“Financial advisors will always be the center of Morgan Stanley wealth management’s universe,” Morgan Stanley co-President Andy Saperstein said in the memo. “We also believe that generative AI will revolutionize client interactions, bring new efficiencies to advisor practices, and ultimately help free up time to do what you do best: serve your clients.”

Morgan Stanley, a top investment bank and wealth management juggernaut, made waves in March when it announced that it had been working on an assistant based on OpenAI’s GPT-4. Competitors including Goldman Sachs and JPMorgan Chase have announced projects based on generative AI technology. But Morgan Stanley is the first major Wall Street firm to put a bespoke solution based on GPT-4 in employees’ hands, according to Jeff McMillan, head of analytics, data and innovation at Morgan Stanley wealth management.

Called the AI @ Morgan Stanley Assistant, the tool gives financial advisors speedy access to the bank’s “intellectual capital,” a database of about 100,000 research reports and documents, McMillan said in a recent interview.

By saving advisors and customer service employees time when it comes to questions about markets, recommendations and internal processes, the assistant frees them to engage more with clients, he said.

Human speech

The tool, a simple window of text, belies the difficulty in making sure the program would produce quality responses, according to McMillan. The bank spent months curating documents and using human experts to test responses, he said.

One adjustment for advisors is that they’ll need to phrase questions in full sentences as though they were speaking to a human, instead of leaning on keywords as they would with a search engine query, said McMillan.

“No different than how I would ask you a question, that’s how you talk to this machine,” he said. “People are not accustomed to that.”

It’s just the first in a series of solutions based on generative AI planned by the bank, according to McMillan. The firm is piloting a tool called Debrief that automatically summarizes the content of client meetings and generates follow-up emails.

‘Completely disruptive’

Using OpenAI software required a fundamentally different approach than with previous technology efforts, he said. OpenAI’s ChatGPT uses large language models, or LLMs, to create human-sounding responses to questions.

“The traditional way in which you would solve those things is you would write code,” McMillan said. “In the new world, you give examples of what ‘good’ looks like, and the system learns what good is. It’s actually able to ‘reason’ and apply logic that a human would apply.”

Excitement over AI has bolstered the stock market this year and forced entire industries to contend with its implications, leading some experts to declare it the next foundational technology.

“I’ve never seen anything like this in my career, and I’ve been doing artificial intelligence for 20 years,” McMillan said. “We saw a window of opportunity that was just completely disruptive, and I think as an organization, we didn’t want to get left behind.”

https://www.cnbc.com/2023/09/18/morgan-stanley-chatgpt-financial-advisors.html

Pfizer forecasts 24% COVID vaccination rate in US this year

 Pfizer expects 24% vaccination rate for COVID-19 shots in the United States this year, Chief Financial Officer David Denton said at a conference on Monday, which equates to roughly 82 million people.

The U.S. Food and Drug Administration has authorized updated COVID-19 vaccines from Pfizer and its partner BioNTech as well as from Moderna as the country prepares to start a fall vaccination campaign. A third vaccine from Novavax is also under review.

During the last re-vaccination campaign, when most Americans had either already had the COVID virus or been previously vaccinated, only around 56.5 million people got the updated booster shots, according to federal data.

But last week, a Reuters/Ipos poll showed that about half of Americans are interested in getting an updated COVID-19 vaccine.

Rival Moderna has also said it expects U.S. demand for the shots to reach 50 million-100 million doses in the fall season.

Demand for COVID vaccines has dropped sharply since 2021, when they first became available.

Pfizer had said in August it will launch a cost-cutting program if its COVID-19 vaccine and antiviral treatment keep underperforming expectations in the coming months due to plunging demand.

At the J.P. Morgan U.S. All Stars Conference, Denton said Pfizer will provide more details on its cost-cutting measures in the second half of the year.

"We want to make sure that we're investing appropriately based on our R&D pipeline and the investments that we're making and bets that we made ... are aligned to the revenue performance of the company long term," said Denton.

https://finance.yahoo.com/news/2-pfizer-forecasts-24-covid-112252700.html

DOJ, Chamber of Commerce Tussle in Court Over IRA’s Drug Price Negotiations

 Lawyers for the Department of Justice and the U.S. Chamber of Commerce sparred on Friday in the first hearing in federal court in Ohio over the Inflation Reduction Act’s Drug Price Negotiation Program, as reported by Politico.

The Chamber of Commerce has asked for a preliminary injunction to halt the program before Oct. 1, the deadline for pharma companies to agree to Medicare negotiations on pricing for the first 10 drugs.

At the heart of the debate on Friday in the U.S. District Court for the Southern District of Ohio were two issues, according to STAT News. The first was whether the negotiation program was merely a price control program—thereby violating companies’ rights—and the second was whether the Chamber's members would incur damages sufficient to file a complaint against the law.

Jeffrey Bucholtz from the law firm King & Spalding argued for the Chamber and other industry groups, asking that Judge Michael Newman release his ruling on the motion for a preliminary injunction by Oct. 1. Under the program, drugmakers have until that date to signify if they will participate in the first round of negotiations.

In its request for an injunction, the Chamber contends that the IRA has and will continue to cause its members “unrecoverable economic losses.”

However, DOJ countered that the Chamber doesn’t have legal standing to challenge the Drug Price Negotiation Program and the court should throw out the case given that any financial injury to drugmakers wouldn’t happen until 2026, when the negotiated prices take effect.

Judge Newman on Friday said he would issue a decision “as quickly as we can” while praising the “zealous advocacy” of attorneys in making their arguments, according to Pink Sheet.

Last month, the Centers for Medicare and Medicaid Services (CMS) named the first 10 drugs that would be a part of the initial price negotiations. The list included some of the most widely prescribed medications, such as BMS’ blood thinner Eliquis (apixaban), Lilly’s diabetes drug Jardiance (empagliflozin) and AbbVie’s and J&J’s blood cancer therapy Imbruvica (ibrutinib).

In crafting its initial list, the CMS looked at medicines with the highest gross Medicare Part D coverage, paying particular attention to those without generic or biosimilar competition. Taken together, these treatments cost the government around $50 billion between June 2022 and May 2023, according to a CMS factsheet.

Under the negotiation program, CMS would be able to negotiate the prices for these drugs with the goal of generating $25 billion in cost savings over the next eight years.

Ever since President Joe Biden signed the IRA into law in August 2022, pharma companies and industry groups have strongly opposed the measure. Several lawsuits have already been filed seeking to stop the negotiation program. Industry powerhouses such as MerckBMSJ&J and AstraZeneca have all filed separate complaints against the program.

Similar to the Chamber of Commerce, the companies claim that the IRA’s Drug Price Negotiation Program is unconstitutional as it effectively is a forced taking of their property without just compensation. The program also compels drugmakers to agree that CMS’ prices are fair, according to their respective legal complaints, thereby violating their First Amendment rights.

https://www.biospace.com/article/doj-chamber-of-commerce-tussle-in-court-over-ira-s-drug-price-negotiation-program/