Dow slides more than 300 points as Moody’s bank downgrade adds to August woes

 Stocks retreated Tuesday as an August sell-off was reignited by a downgrade of the banking sector by credit rating agency Moody’s.

The Dow Jones Industrial Average was down 342 points, or 1%, led by a decline in Goldman Sachs

. The S&P 500 dipped 1.1%, bringing its pullback from its late-July high to more than 3%. The benchmark is down more than 2.6% for August. The Nasdaq Composite pulled back by 1.5%.

Banks fell broadly after Moody’s downgraded the credit rating on several regional banks, including M&T Bank and Pinnacle Financial, citing deposit risk, a potential recession and struggling commercial real estate portfolios. The credit agency also placed Bank of N.Y. Mellon and State Street on review for a downgrade.

Goldman Sachs and JPMorgan Chase traded more than 3% and 2% lower, respectively, while the SPDR S&P Bank ETF (KBE) dropped more than 3%.

The SPDR S&P Regional Banking ETF (KRE) also slid more than 3%. M&T Bank also fell 3.5%. The regional bank ETF lost 28% in March amid the failure of Silicon Valley Bank.

“It’s not optional to have good credit ratings, because they need faith,” said Jay Hatfield, CEO of Infrastructure Capital Advisors, of regional banks. “Any sort of reduction of faith in the regional banking system is really terrible for market sentiment.”

Traders also parsed through the latest batch of earnings. UPS shares dropped more than 1% after the delivery giant reported weaker-than-expected revenue for the second quarter. The company also lowered its full-year revenue outlook.

The corporate earnings season has so far been better-than-anticipated. With 89% of S&P 500 stocks done reporting quarterly results, about four-fifths of them have beaten Wall Street’s expectations, according to FactSet. But it appears a lot of those results were already priced into the market, given the pullback the last two weeks.

Investors got a short respite from the selling on Monday with the 30-stock Dow posting its best day since June 15. But that comeback proved short-lived.

Second-quarter earnings season is nearing a close, with results out so far from 89% of the S&P 500

.

Of the nearly 450 companies that have reported results, 79% have topped earnings expectations while 63% have surpassed revenue estimates, according to Refinitiv.

For the period, earnings are expected to decline 3.8% from a year ago.

Some on Wall Street express cautious sentiments about the stock market.

Credit Suisse global equity strategist Andrew Garthwaite said he’s now more “incrementally more negative” on stocks. He also said a recession would likely hit next year.

Meanwhile, Bank of America’s Stephen Suttmeier said a tactical correct is already underway.

And Marko Kolanovic, JPMorgan’s top stock picker, recommended investors should stay underweight on equities, while noting people may be too optimistic about the state of the economy.

https://www.cnbc.com/2023/08/07/stock-market-today-live-updates.html

Novo Nordisk Nears LVMH as Europe’s Biggest Firm by Market Value

 In the race to be the biggest company by market value in Europe, a new contender is challenging the reign of luxury-goods behemoth LVMH.

Drugmaker Novo Nordisk A/S’s capitalization on Tuesday jumped $60 billion to about $423 billion, closing in on LVMH’s $442 billion, and consolidating its position as the second-largest company in Europe.

The Danish drugmaker, originally specialized in diabetes care, has further gained investors’ favor over the past three years thanks to obesity medicines including blockbuster Wegovy. Since the end of 2020, the stock has tripled, overtaking other European megacaps including Nestle SE and ASML NV.

Novo Nordisk on Tuesday jumped as much as 19%, its biggest intraday gain on record, after a highly anticipated study showed that Wegovy reduced the risk of heart attacks and strokes.

https://finance.yahoo.com/news/novo-nordisk-nears-lvmh-europe-145139605.html

Duchenne-focused Entrada: Q2 financials, update

 On track to dose first participant in ENTR-601-44 Phase 1 clinical trial in the United Kingdom in September 2023 –

– $377 million in cash, cash equivalents and marketable securities as of June 30, 2023 –

– Cash runway through 2025 –

Entrada Therapeutics, Inc. TRDA, a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today reported financial results for the second quarter ending June 30, 2023, and highlighted recent business updates.

"We are excited to transition into a clinical stage company with the initiation of our planned Phase 1 trial for our lead Duchenne product candidate, ENTR-601-44. There is a profound need for people living with Duchenne who are exon 44 skipping amenable and we look forward to dosing the first participant in the United Kingdom this September," said Dipal Doshi, President and Chief Executive Officer of Entrada Therapeutics. "Our fundamentals are strong and with the extension of our cash runway through the end of 2025, we believe we are well-positioned to advance our Duchenne franchise and introduce new indications outside of neuromuscular diseases, creating value for patients and shareholders alike."

Recent Corporate Highlights

Entrada received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its Clinical Trial of an Investigational Medicinal Product (CTIMP) for a Phase 1 clinical trial in healthy volunteers for ENTR-601-44, the Company's lead product candidate within its Duchenne franchise. This trial is an important part of the overall global clinical development of ENTR-601-44 and the Company believes it will provide clinical data to support the program's next steps, which include a global multiple ascending dose trial in patients with Duchenne who are exon 44 skipping amenable.

The Phase 1 clinical trial's primary objective is to evaluate the safety of a single dose of ENTR-601-44 in healthy volunteers, with a target enrollment of approximately 40 participants. It will also evaluate tolerability, pharmacokinetics and target engagement as measured by exon skipping in the skeletal muscle. The first participant is expected to be dosed in September of this year with data anticipated in the second half of 2024.

In parallel, Entrada is committed to resolving the clinical hold on its Investigational New Drug (IND) application for ENTR-601-44 with the U.S. Food and Drug Administration (FDA) and expects to provide an update in the fourth quarter of 2023.

https://www.benzinga.com/pressreleases/23/08/g33622240/entrada-therapeutics-reports-second-quarter-2023-financial-results

Madrigal Q2 and updates

 

• Resmetirom new drug application (NDA) submitted to the U.S. Food and Drug Administration
• NASH disease education and market development activities expand to support potential first-to-market launch in the U.S.

• Madrigal announced submission of the NDA seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis. The clinical development program for resmetirom is comprised of 18 clinical studies supporting the NDA: twelve Phase 1 studies, two Phase 2 studies, and four Phase 3 studies.
• Madrigal presented the Phase 3 MAESTRO-NASH primary results during the opening general session of the EASL Congress™. This first scientific presentation of detailed MAESTRO-NASH results confirmed achievement of the primary endpoints across multiple patient subgroups. Noninvasive imaging and biomarker data supported findings on liver biopsy and demonstrated broad treatment response to resmetirom. Further analyses of the results reinforced the resmetirom safety and tolerability profile.
• Madrigal highlighted its support for International NASH Day and announced expanded partnerships with patient advocacy groups focused on NASH disease education.
• Madrigal launched Taking on Fatty Liver and NASH, a new disease education campaign and website that is designed to educate, inform, and inspire people with NASH with liver fibrosis to find the right care team, understand their risk, and manage their liver health. It provides information about NASH disease progression, noninvasive testing options, and community resources from patient advocacy groups.
• The Institute for Clinical and Economic Review (ICER) published a Final Evidence Report for its value assessment of resmetirom and obeticholic acid. The Evidence Report indicates that resmetirom has the potential to be a cost-effective treatment for patients with at-risk NASH.

Financial Results for the Six Months Ended June 30, 2023

As of June 30, 2023, Madrigal had cash, cash equivalents and marketable securities of $298.4 million, compared to $358.8 million at December 31, 2022. The decrease in cash and marketable securities resulted primarily from cash used in operations of $159.4 million, partially offset by the capital raised under the Loan Facility (“Loan Facility”) with Hercules Capital, Inc. (“Hercules”) and our at-the-market sales agreement.

Operating expenses were $86.5 million and $164.8 million for the three month and six month periods ended June 30, 2023, compared to $70.3 million and $127.9 million in the comparable prior year periods.

Research and development expenses for the three and six month periods ended June 30, 2023 were $68.6 million and $130.8 million, compared to $58.5 million and $106.4 million in the comparable prior year periods. The increase is attributable primarily to additional activities related to the Phase 3 clinical trials, and an increase in head count.

General and administrative expenses for the three and six month periods ended June 30, 2023 were $17.8 million and $34.0 million, compared to $11.8 million and $21.4 million in the comparable prior year periods. The increase is due primarily to increases in commercial preparation activities, including an increase in headcount and an increase in non-cash stock compensation.

Interest income for the three and six month periods ended June 30, 2023 was $3.6 million and $7.3 million, compared to $0.3 million and $0.4 million in the comparable prior year periods. The increase in interest income was due primarily to a higher average interest rate in 2023.

Interest expense for the three and six month periods ended June 30, 2023 was $2.9 million and $5.2 million, compared to $0.8 million and $0.8 million in the comparable prior year periods. The increase in interest expense was as a result of the Loan Facility we entered with Hercules.

https://www.biospace.com/article/releases/madrigal-pharmaceuticals-provides-corporate-updates-and-reports-second-quarter-2023-financial-results/

Novo: Wegovy Protects Heart Health in Overweight, Obese Adults

 Novo Nordisk’s weight-loss medication Wegovy (semaglutide) met its primary efficacy endpoint in the Phase III SELECT trial, demonstrating strong protective effect on cardiovascular health in overweight and obese adults without diabetes, the company announced Tuesday.

At a 2.4-mg dose level, once-weekly Wegovy injections significantly reduced the occurrence of major adverse cardiovascular events (MACE) by 20% as compared with placebo. This treatment effect was statistically significant, according to Novo’s announcement. Wegovy’s safety profile in SELECT was also in line with what had been established in previous studies.

SELECT defined MACE as a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Wegovy reduced the frequency of all three MACE components in SELECT.

Novo was trading approximately 11% higher in pre-market Tuesday following the data drop.

The results from SELECT highlight the potential dual benefits of Wegovy for overweight and obese adults who suffer from a heightened risk of cardiovascular disease, but for whom there are no approved weight management medications that can also protect heart health, according to Martin Holst Lange, Novo’s executive vice president for development.

“SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated,” Lange said in a statement.

Novo will take these results to regulatory authorities and is planning to file for label expansions in the United States and EU this year. The company will also present more detailed data and analyses from SELECT at an upcoming congress.

Semaglutide is a therapeutic peptide that works by mimicking the GLP-1 hormone to activate its corresponding receptor. This in turn stimulates the pancreas to pump insulin into the blood in response to a high sugar concentration. The drug also moderates glucose production in the liver.

This mechanism of action has won semaglutide the FDA’s approval for weight loss and Type 2 diabetes, for which it is marketed under the brand names Wegovy and Ozempic, respectively.  

Joining Novo in the weight loss and diabetes space is Eli Lilly, which owns Mounjaro (tirzepatide), an injectable anti-diabetic medication that works similarly to semaglutide. Unlike Novo’s asset, however, Mounjaro has yet to be authorized as a weight-loss treatment, though Lilly has been building up a strong clinical case for a label expansion.

In July 2022, data from the Phase III SURMOUNT-1 study showed that Mounjaro could elicit strong and sustained weight loss in overweight and obese adults without Type 2 diabetes. The company followed this up in April 2023, posting data from SURMOUNT-2 demonstrating that the treatment also lowered body weight in patients with both diabetes and overweight or obese.

Lilly has also been beefing up its weight-loss business, dropping $1.9 billion last month to acquire Versanis and its lead asset bimagrumab, which is being developed as a treatment to cut fat mass without affecting muscle mass.

https://www.biospace.com/article/novo-s-wegovy-protects-heart-health-in-overweight-obese-adults/

Sensus: New $3 Million Share Repurchase Program

 Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces that its Board of Directors has authorized a new share repurchase program under which the Company may repurchase up to $3.0 million of its common stock.

“Given our optimism about the future of Sensus, we believe repurchasing our own stock is one of the best uses of our cash,” said Joe Sardano, chairman and chief executive officer of Sensus Healthcare.  “We will continue to deploy cash judiciously to fund initiatives that will provide the highest returns, and are fortunate to have a balance sheet that allows for multiple avenues for capital allocation.”

The timing and amount of any share repurchases under this program will be determined by Sensus Healthcare’s management at its discretion based upon its ongoing assessments of the capital needs of the business, the market price of Sensus’ common stock and general market conditions. Share repurchases under this program may be made through a variety of methods including open-market purchases, block trades, exchange transactions or any combination thereof. The program does not obligate Sensus to acquire any particular amount of its common stock, and the share repurchase program may be suspended or discontinued at any time at the company’s discretion.

https://finance.yahoo.com/news/sensus-healthcare-announces-3-million-123000116.html

bluebird Q2 results, updates

 Continued strong commercial launch for ZYNTEGLO® and SKYSONA®; 16 patient starts across both programs to date –

- Biologics License Application (BLA) for lovo-cel for sickle cell disease accepted for FDA priority review; PDUFA goal date December 20, 2023 -

- Ended quarter with $291M in cash, cash equivalents, marketable securities and restricted cash –

- Management to host conference call on Q2 earnings and commercial launch progress today August 8, 2023 at 8:00AM ET -

bluebird will hold a conference call to discuss second quarter financial results and commercial launch progress on Tuesday, August 8 at 8:00 am ET.

To access the call via telephone, please register at this link https://register.vevent.com/register/BI4fa1d86317c74333813f6827624e43ae to receive a dial in number and unique PIN to access the live conference call.

The live webcast of the call may be accessed by visiting the "Events & Presentations" page within the Investors & Media section of the bluebird website at http://investor.bluebirdbio.com. A replay of the webcast will be available on the bluebird website for 90 days following the event.

https://finance.yahoo.com/news/bluebird-bio-reports-second-quarter-110000706.html