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The broad market exchange-traded fund SPDR S&P 500 ETF Trust was up 0.1% and the actively traded Invesco QQQ Trust was 0.2% higher in Wednesday's premarket activity, as investors weighed the size of the Federal Reserve's potential interest rate cut later in the day.
US stock futures were also higher, with S&P 500 Index futures up 0.1%, Dow Jones Industrial Average futures advancing 0.2%, and Nasdaq futures gaining 0.2% before the start of regular trading.
US mortgage applications rose 14.2% for the week ended Sept. 13, driven by declining mortgage rates, with refinancing up 24% and new home applications rising 5%, according to Mortgage Bankers Association data released Wednesday. The average rate for 30-year fixed mortgages dropped to 6.15%, the lowest since September 2022.
The housing starts and permits data for August will be released at 8:30 am ET. This month's Atlanta Fed Business Inflation Expectations report releases at 10 am ET, followed by the weekly domestic petroleum inventories report at 10:30 am ET.
The US Federal Reserve is slated to announce its rate decision at 2 pm ET, with Chair Jerome Powell to hold a press conference at 2:30 pm ET.
In premarket action, bitcoin was down by 0.1% and the cryptocurrency fund ProShares Bitcoin Strategy ETF was 0.4% lower.
Power Play:
Industrial
Industrial Select Sector SPDR Fund was 0.3% higher while the Vanguard Industrials Index Fund and the iShares US Industrials ETF were inactive.
Intuitive Machines shares were up more than 49% before the opening bell after the company said late Tuesday that the US National Aeronautics and Space Administration has awarded the firm a Near Space Network contract with a maximum potential value of $4.82 billion.
Winners and Losers:
Health Care
The Health Care Select Sector SPDR Fund was flat. The Vanguard Health Care Index Fund , the iShares US Healthcare ETF , and the iShares Biotechnology ETF were inactive.
MannKind shares were up 2.1% premarket after the company said it received clearance from Japan's Pharmaceuticals and Medical Devices Agency to begin the phase 3 trial of its Clofazimine Inhalation Suspension treatment for lung disease.
Consumer
The Consumer Staples Select Sector SPDR Fund was flat, while the Vanguard Consumer Staples Fund was inactive. The iShares US Consumer Staples ETF was inactive, and the Consumer Discretionary Select Sector SPDR Fund gained 0.1%. The VanEck Retail ETF was inactive, while the SPDR S&P Retail ETF was up 0.1%.
General Mills was down 1.4% pre-bell after the company reported lower fiscal Q1 adjusted earnings and net sales.
Energy
The iShares US Energy ETF was up nearly 1.5%, while the Energy Select Sector SPDR Fund was down by 0.3%.
Crown LNG Holdings shares were 1% higher before Wednesday's opening bell. The company said it received a Nasdaq notification for failing to meet the minimum bid price requirement for continued listing, with its shares closing below $1 for 30 consecutive business days.
Technology
Technology Select Sector SPDR Fund was flat, and the iShares US Technology ETF was 0.9% higher, while the iShares Expanded Tech Sector ETF was up 0.5%. Among semiconductor ETFs, SPDR S&P Semiconductor ETF was inactive, while the iShares Semiconductor ETF rose by 0.1%.
Clarivate was up 1% in recent Wednesday premarket activity after the company said it had launched a generative AI-powered academic research tool dubbed Primo Research Assistant.
Financial
Financial Select Sector SPDR Fund gained 0.1%. Direxion Daily Financial Bull 3X Shares was up 0.4%, while its bearish counterpart Direxion Daily Financial Bear 3X Shares was 0.1% lower.
Commodities
Front-month US West Texas Intermediate crude oil retreated 0.9% to $70.57 per barrel on the New York Mercantile Exchange. Natural gas was up nearly 1% at $2.35 per 1 million British Thermal Units. United States Oil Fund fell by 1%, while the United States Natural Gas Fund advanced by 1.1%.
Gold futures for December were up 0.5% at $2,606.20 an ounce on the Comex, while silver futures slipped 0.1% at $31.02 an ounce. SPDR Gold Shares gained 0.4%, and iShares Silver Trust was 0.1% lower.
DANBURY, Conn., Sept. 18, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to initiate the Phase 3 study (ICoN-1) of Clofazimine Inhalation Suspension for the treatment of NTM lung disease. The global study is now cleared by health authorities to proceed in four countries (U.S., Japan, South Korea and Australia) with a fifth (Taiwan) expected in 4Q 2024.
“We are pleased to initiate the ICoN-1 study in Japan in an effort to further develop potential therapy for those living with serious NTM lung infections,” said Dr. Kozo Morimoto, lead principal investigator for ICoN-1 in Japan, Chief Doctor for the Respiratory Disease Center at Fukujuji Hospital and Japan Anti-Tuberculosis Association. “Patients living with NTM infections deserve safe, well-tolerated, convenient, and effective options to treat this serious respiratory disease that is on the rise in Japan, as well as globally.”
The ICoN-1 study was initiated in the United States in June 2024 and had its first patient randomized in September. In all, approximately 230 eligible participants will be enrolled and randomized at more than 100 sites across the U.S. and globally to ensure a minimum of 180 participants are evaluable for efficacy. Details of the ICoN-1 study and sites can be found at: ClinicalTrials.gov (NCT06418711).
About the ICoN-1 Clinical TrialThe ongoing ICoN-1 trial is a multi-national, randomized, double-blind, placebo-controlled, Phase 3 registrational study to evaluate the efficacy and safety of Clofazimine Inhalation Suspension when added to guideline-based therapy in adults with refractory NTM lung disease caused by mycobacterium avium complex (MAC), followed by an open-label extension. The co-primary endpoints in the U.S. are sputum culture conversion (negative for NTM) from baseline to end of Month 6 and change in quality of life (QoL) during the same timeframe. Outside the-U.S., the primary endpoint is sputum culture conversion.
In May 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Clofazimine Inhalation Suspension (MNKD-101) for the treatment of NTM lung disease. The FDA also previously designated Clofazimine Inhalation Suspension as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. A drug that receives orphan drug exclusivity receives seven years of exclusivity, and one that also earns QIDP designation, may receive an additional five years of market exclusivity.
Clofazimine Inhalation Suspension was granted a patent (No. 11,793,808) by the United States Patent and Trademark Office covering compositions of clofazimine and methods for treating lung infections. The patent is not due to expire until June 8, 2039. A corresponding clofazimine patent was granted in Japan (7377259), and patent applications are pending in other major markets.
About NTM – A Global Health Concern Pulmonary NTM infection is a rare disease with a global health impact due to its rising prevalence worldwide and association with shortened life span, high morbidity, and significant impact on patients’ quality of life. NTM is a group of bacteria naturally found in our environment, including water and soil, that can lead to cough, fatigue, a reduction in lung function, and poor quality of life among other debilitating symptoms. While most people are exposed to NTM daily, the organisms generally do no harm. Individuals with underlying conditions such as COPD, asthma, and bronchiectasis are at increased risk of NTM getting established in the lungs creating an infection and progressive worsening of lung function.
There are nearly 200 species of NTM; the most common is MAC, which accounts for about 80% of all NTM lung disease cases in the United States. While not everyone is at risk of contracting NTM from MAC, for those who are, it can cause serious lung damage. NTM lung disease is more common in women over the age of 65. Estimated 2022 NTM disease prevalence is more than 100,000 in the U.S. and over 150,000 in Japan. Approximately 15-20% of NTM patients are refractory. The prevalence rate of NTM is increasing globally – within the U.S. alone claims-based studies suggest an annual rise of 7.5%. To learn more about NTM, please visit LearnAboutNTM.com.
About MannKindMannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.
We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram.
Forward-Looking StatementsThis press release contains forward-looking statements about the regulatory clearance to proceed with a clinical study that involve risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that continued testing of an investigational drug product may not yield successful results or results that are consistent with earlier testing, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
MNKD-101 is an investigational product that is not approved for any use in any country.
MANNKIND is a registered trademark of MannKind Corporation.
This press release was published by a CLEAR® Verified individual.
MannKind Contacts: Christie Iacangelo Corporate Communications (818) 292-3500 media@mannkindcorp.com Investor Relations (818) 661-5000 ir@mannkindcorp.com
Shares of Intuitive Machines, Inc. rose sharply in today's pre-market trading after the company announced it was awarded a NASA Near Space Network contract for communication and navigation services, with a maximum potential value of $4.82 billion.
Intuitive Machines shares jumped 41.1% to $7.62 in the pre-market trading.
Here are some other stocks moving in pre-market trading.
Gainers
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