Latest news for  (OTC:HEPZF) Stock

Stifel foresees a significant market downturn by the end of 2024. Chief equity strategist Barry Bannister <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40701071/market-bull-warns-of-up-to-10-september-pullback-urges-caution-but-stresses-be-read">warned the S&amp;P 500 could fall by 12% in the fourth quarter</a>.
What Happened: Bannister highlighted various concerns, including high valuations and speculative investor behavior. &#8220;Our instruments tell us to expect an S&amp;P 500 correction to the very low 5,000s by 4Q24,&#8221; he stated, <a href="https://markets.businessinsider.com/news/stocks/stock-market-outlook-strategist-warns-correction-soon-tech-bubble-risk-2024-9">reported</a> Business Insider.
He noted that current stock market valuations are nearing a &#8220;near three-generation high&#8221; with the S&amp;P 500&#8217;s price-to-earnings multiple around 24x. Additionally, the outperformance of large-cap growth stocks relative to value stocks is reminiscent of peaks seen in February 2000 and August 2020, which preceded bear markets.
Bannister also pointed out that rising labor supply from increased immigration has bolstered economic growth, but overall labor demand is waning. &#8220;Fading labor demand is now symbolic of recession risk,&#8221; he said, mentioning that the non-farm payroll 6-month diffusion index has dipped below a &#8220;recession trigger level.&#8221;
He further explained that the typical &#8220;pre-election juice&#8221; for the economy might diminish towards year-end, impacting stock performance. Lastly, Bannister warned of a potential bubble in technology stocks, comparing it to the dot-com bubble of the 1990s.
See Also: <a href="https://www.benzinga.com/news/24/09/40969895/support-for-taylor-swifts-get-out-the-vote-efforts-have-dropped-15-points-since-february-amid-super?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Support For Taylor Swift&#8217;s Get-Out-The-Vote Efforts Have Dropped 15 Points Since February Amid Super Bowl Conspiracy Theory</a>
Why It Matters: The warning from Stifel comes on the heels of several significant market events. 
Additionally, in early September, equity strategist Tom Lee warned of a <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40701071/market-bull-warns-of-up-to-10-september-pullback-urges-caution-but-stresses-be-read">potential 7%-10% market pullback</a>, attributing this to historical trends showing September as the weakest month for stocks. Lee urged caution but also advised investors to be ready to &#8220;buy that dip.&#8221; 
More recently, the Federal Reserve&#8217;s decision to cut interest rates by 0.5% <a href="https://www.benzinga.com/news/24/09/40969943/fed-rate-cut-fuels-market-rally-amidst-valuation-fears">triggered a market rally</a>, despite concerns over inflated valuations. This move led to a significant surge in U.S. stocks and commodities, while reducing bond market volatility.
The rate cut also influenced investor behavior, with a shift away from money market funds and into <a href="https://www.benzinga.com/economics/24/09/40965570/fed-rate-cut-may-drive-investors-away-from-money-markets-says-portfolio-manager">longer-duration bonds</a>, as noted by fixed-income portfolio manager Timothy Ng.
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<li><a href="https://www.benzinga.com/markets/equities/24/09/40951546/big-short-fame-investor-drops-previous-prediction-of-trump-victory-the-market-is-going-straight-?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">&#8216;Big Short&#8217; Fame Investor Drops Previous Prediction Of Trump Victory: &#8216;The Market Is Going Straight Down&#8217; If Kamala Harris Wins White House And Democrats Sweep Congress</a></li>
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Image via Unsplash
This story was generated using <a href="https://www.benzinga.com/author/benzinga-neuro">Benzinga Neuro</a> and edited by <a href="https://www.benzinga.com/topic/Kaustubh-Bagalkote" target="_blank" rel="noreferrer noopener">Kaustubh Bagalkote</a>

Equities

News

Global

Economics

Markets

Stifel Warns Of 12% Market Drop By End Of 2024 As S&P 500 Faces High Valuations And Speculative Risks

Apple Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AAPL#NASDAQ">AAPL</a>) <a href="https://www.benzinga.com/news/24/09/40680904/7-products-apple-will-likely-discontinue-next-week-after-iphone-16-launch">has discontinued</a>&nbsp;the iPhone 15 Pro, iPhone&nbsp;15 Pro Max, and iPhone 13 models, along with other products,&nbsp;as part of its annual&nbsp;product streamlining.
What Happened: Apple has stopped production of several products, but these models can still be found in stock at online and third-party retail stores for a limited time.
Apple&#8217;s annual product discontinuation is a routine practice, making way for newer items. This year,&nbsp;the oldest iPhone still in&nbsp;production, the iPhone 13, was also dropped, <a href="https://appleinsider.com/articles/24/09/22/in-with-the-new-out-with-the-old-apple-discontinues-the-iphone-15-pro-iphone-13">reported</a> AppleInsider.
See Also:&nbsp;<a href="https://www.benzinga.com/news/24/09/40911877/jeff-bezos-had-a-habit-of-keeping-an-empty-chair-for-the-most-important-person-in-the-room-at-compan?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Jeff Bezos Had A Habit Of Keeping An Empty Chair For The Most Important Person In The Room At Company Meetings: This Strategy Helped The Amazon Founder Build The E-Commerce Giant We Know Today</a>
The current iPhone lineup now includes the iPhone 14 and iPhone 14 Plus, iPhone 15 and&nbsp;iPhone 15 Plus, the four <a href="https://www.benzinga.com/news/24/09/40780100/apple-intelligence-ready-iphone-16-with-faster-processor-dedicated-camera-button-announced-check-pri">new&nbsp;iPhone 16 models</a>, and the&nbsp;third-generation iPhone SE from 2022.
Other discontinued products include the AirPods Max, replaced by nearly identical models with new colors and a USB-C port.
The regular AirPods&nbsp;2 and AirPods 3 have&nbsp;also been replaced with two&nbsp;new models of AirPods 4.&nbsp;After the introduction of&nbsp;the Apple Watch Series 10,&nbsp;the Apple Watch Series 9 was also discontinued.
Apple&nbsp;also dropped its line of FineWoven iPhone cases due to negative customer feedback, the report noted.
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Why It Matters: The discontinuation of these models comes amid mixed reports about the demand for the new iPhone 16.&nbsp;T-Mobile US Inc. CEO Mike Sievert&nbsp;said that the iPhone 16 is selling at a <a href="https://www.benzinga.com/markets/equities/24/09/40932937/apple-iphone-16-selling-at-a-greater-rate-than-last-year-says-t-mobile-ceo-amid-reports-of-lower">greater rate than last year&#8217;s model</a>.
However,&nbsp;<a href="https://www.benzinga.com/tech/24/09/40930388/apple-iphone-16-pre-orders-show-possible-low-demand-one-sign-could-point-to-company-breaking-this-em">analysts predicted weak demand</a>&nbsp;for the iPhone 16 due to a lack of reasons for existing iPhone owners to upgrade to the latest model.
JPMorgan analyst Samik Chatterjee&nbsp;has noted that the <a href="https://www.benzinga.com/news/24/09/40882969/iphone-16-pro-demand-lags-longer-wait-times-globally-china-shows-smaller-gap-analyst">lead times of the iPhone 16 series</a> across critical markets, including the U.S., China, Germany, and the U.K., indicate in-line demand for the iPhone 15 series during the first week.
Previously, it was reported that the iPhone 16 series launch also <a href="https://www.benzinga.com/news/24/09/40785959/iphone-16-fails-to-sway-some-chinese-buyers-im-going-to-buy-huaweis-tri-fold-phone-missing-ai-featur">failed to impress some Chinese buyers</a> due to its lack of AI features.
Photo courtesy: Apple
Check out more of Benzinga's Consumer Tech coverage by&nbsp;<a href="https://www.benzinga.com/topic/consumer-tech" target="_blank" rel="noreferrer noopener">following this link</a>.
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</ul>
Disclaimer:&nbsp;This content was partially produced with the help of&nbsp;<a href="https://www.benzinga.com/author/benzinga-neuro" target="_blank" rel="noreferrer noopener">Benzinga Neuro</a>&nbsp;and was reviewed and published by Benzinga editors.

Tech

Media

AAPL

iPhone 15 Pro Models and iPhone 13 Discontinued By Apple: Here's Why

Biohaven Ltd.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BHVN#NYSE">BHVN</a>) (Biohaven), today announced that it will host a conference call to discuss topline data from Study BHV4157-206-RWE (NCT06529146), a study designed in discussion with the US Food and Drug Administration (FDA), to assess the effectiveness of troriluzole in Spinocerebellar Ataxia.
&nbsp;
 Biohaven will hold a live conference call and webcast Monday, September 23, 2024, at&nbsp;8:30 a.m. Eastern Time. The live event may be accessed via the Investor Relations portion of Biohaven's website at&nbsp;<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4260062-1&amp;h=3860713886&amp;u=https%3A%2F%2Fir.biohaven.com%2Fevents-presentations%2Fevents&amp;a=https%3A%2F%2Fir.biohaven.com%2Fevents-presentations%2Fevents">https://ir.biohaven.com/events-presentations/events</a>.&nbsp;To participate in the live conference call via telephone, please register&nbsp;<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4260062-1&amp;h=3868013617&amp;u=https%3A%2F%2Fregister.vevent.com%2Fregister%2FBI8f49496d1a3a4b51a653f73b99957cfb&amp;a=here">here</a>. Upon registering, a dial-in number and unique PIN will be provided to join the conference call.

BHVN

Reported Friday, Biohaven to Announce Topline Data for Troriluzole Spinocerebellar Ataxia Study, Conference Call Set for Sept 23

China&#8217;s central bank has taken significant steps to support the economy by reducing a key short-term interest rate and <a href="https://www.benzinga.com/markets/asia/24/09/40951221/bank-of-japan-leaves-interest-rate-at-0-25-diverging-from-feds-50-basis-point-cut">injecting substantial liquidity into the financial system</a>.
What Happened: The People's Bank of China cut the 14-day reverse repurchase interest rate by 10 basis points to 1.85% and injected 74.5 billion yuan ($10.6 billion) of liquidity via this policy tool, according to its website.
Additionally, the central bank injected 160.1 billion yuan (&nbsp;$10.6 billion) through 7-day reverse repo agreements, maintaining the interest rate at 1.7%, the bank stated on Monday.
Last week, the PBOC unexpectedly kept its benchmark lending rates steady, despite rising expectations for easing following the U.S. Federal Reserve&#8217;s rate cut.
See Also: <a href="https://www.benzinga.com/government/24/09/40923879/chinas-ymtc-makes-strides-in-chip-production-substitutes-asml-lam-research-tech-as-us-sanctions-bite?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">China&#8217;s YMTC Makes Strides in Chip Production; Substitutes ASML, Lam Research Tech As US Sanctions Bite: Report</a>
Why It Matters: The recent actions by the People's Bank of China come amid a global trend of monetary policy adjustments. On Thursday, the Bank of Japan opted to maintain its <a href="https://www.benzinga.com/markets/asia/24/09/40951221/bank-of-japan-leaves-interest-rate-at-0-25-diverging-from-feds-50-basis-point-cut">benchmark interest rate at 0.25%</a>, diverging from the U.S. Federal Reserve&#8217;s 50 basis point cut. 
On Friday, a portfolio manager noted that the Federal Reserve's rate cut could drive <a href="https://www.benzinga.com/economics/24/09/40965570/fed-rate-cut-may-drive-investors-away-from-money-markets-says-portfolio-manager">investors away from money market</a> funds and into longer duration bonds.
Additionally, Federal Reserve Governor Michelle W. Bowman defended her decision to <a href="https://www.benzinga.com/etfs/broad-u-s-equity-etfs/24/09/40965082/feds-historic-dissenter-bowman-says-smaller-interest-rate-cut-was-justified-we-have-no">support a smaller 25-basis-point rate cut</a>, citing ongoing inflation concerns. This marked a historic moment as it was the first time since 2005 that a Fed governor openly disagreed with a rate decision.
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</ul>
Image Via Shutterstock 
This story was generated using <a href="https://www.benzinga.com/author/benzinga-neuro">Benzinga Neuro</a> and edited by <a href="https://www.benzinga.com/topic/Kaustubh-Bagalkote" target="_blank" rel="noreferrer noopener">Kaustubh Bagalkote</a>

Asia

China's Central Bank Follows Fed's Dovish Move, Cuts Key Short-Term Rates, Injects Over $10B To Boost Economy

CLVT

Clarivate Announced A Strategic Partnership With Relatable Healthcare, A Technology Company Delivering Product Relationship Management (PRM) Software To Leading Medtech Companies To Drive Revenue And Workflow Efficiency

NDAQ

Nasdaq Announced It Has Expanded Its Digital Bank Financial Technology Presence In Latin America, Having Agreed To Provide Its AxiomSL Regulatory Reporting Solution To Nubank

Empire Petroleum Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EP#NYSE">EP</a>) ("Empire" or the "Company"), an oil and gas company with current producing assets in New Mexico, North Dakota, Montana, Texas, and Louisiana, announced today that its Board of Directors has fixed the close of business on September 30, 2024 as the record date (the "Record Date") for a subscription rights offering ("Rights Offering") pursuant to which it intends to raise gross proceeds of up to approximately $10 million. The Company will distribute at no charge to holders of its common stock, par value $0.001 per share ("Common Stock"), as of the close of business on the Record Date one subscription right for each share of Common Stock held. Each subscription right will entitle the holder to purchase 0.063 shares of Common Stock at a subscription price of $5.05 per share. If fully subscribed, this would result in the issuance of an aggregate of approximately 1.98 million shares of Common Stock. The subscription rights are non-transferable, and will not be listed for trading on any stock exchange or market. In addition, holders of subscription rights who fully exercise their subscription rights will be entitled to over-subscribe for additional shares of Common Stock, subject to proration.
The Rights Offering is expected to expire at 5:00 p.m., Eastern Time, on October 16, 2024 ("Expiration Date"), subject to extension or earlier termination.

Offerings

Reported Friday, Empire Petroleum Announces $10M Rights Offering, Record Date Set for September 30

Mobile-health Network Solutions (NASDAQ:<a href="https://www.benzinga.com/stock/MNDR#NASDAQ">MNDR</a>) ("MaNaDr" or "the Company"), a leading Asia-Pacific telehealth provider, today announced that it received a notice dated September 18, 2024, from the Listings Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that the minimum bid price per share of its Class A ordinary shares ("Class A Ordinary Shares") was below $1.00 for a period of 30 consecutive business days and that the Company did not meet the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Rule"). The Nasdaq notification letter does not result in the immediate delisting of the Company's Class A Ordinary Shares, and the shares will continue to trade uninterrupted under the symbol "MNDR." &nbsp;
Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of one hundred eighty (180) calendar days, or until March 17, 2025 (the "Compliance Period"), to regain compliance with Nasdaq's minimum bid price requirement. If at any time during the Compliance Period, the closing bid price per share of the Company's Class A Ordinary Shares is at least $1.00 for a minimum of ten (10) consecutive business days, Nasdaq will provide the Company a written confirmation of compliance, and the matter will be closed.
In the event the Company does not regain compliance by March 17, 2025, the Company may be eligible for an additional 180 calendar day grace period. To qualify, the Company will be required to meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, including by effecting a reverse stock split, if necessary. If the Company chooses to implement a reverse stock split, it must complete the split no later than ten (10) business days prior to March 17, 2025, or the expiration of the second compliance period if granted.

Government

Regulations

MNDR

Reported Friday, MaNaDr Receives Nasdaq Notice for Minimum Bid Price Rule Violation, Has Until March 2025 to Comply

Saba Capital Income &amp; Opportunities Fund II (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SABA#NYSE">SABA</a>) (the "Fund"), a registered closed-end management investment company listed on the New York Stock Exchange, today announced that its Board of Trustees has renewed its share repurchase authorization for the Fund to repurchase up to 10% of its total common shares for the fiscal year ending October 31, 2025.
The share repurchase program is intended to increase the Fund's net asset value ("NAV") to the benefit of all shareholders and help create further value for shareholders by reducing the Fund's discount to NAV.
The Fund may repurchase shares through open market transactions, at the discretion of the Fund's investment adviser. In exercising its discretion consistent with its portfolio management responsibilities, the investment adviser will take into account various factors, including, but not limited to, timing, the quantity of repurchases, the level of the discount, the Fund's performance, portfolio holdings, dividend history and objectives, market conditions, cash on hand, the availability of other attractive investments, and whether the sale of certain portfolio securities would be undesirable because of liquidity concerns or because the sale might subject the Fund to adverse tax consequences. Any repurchases would be made on a national securities exchange at the prevailing market price, subject to exchange requirements, federal securities laws and rules that restrict repurchases.
There is no assurance that the market price of the Fund's shares, either absolutely or relative to net asset value, will increase as a result of any share repurchases, or that the program will enhance shareholder value. Investment return and principal value of an investment in the Fund will fluctuate. Shares, when sold, may be worth more or less than their original cost. Investors should consider the investment objective, risks and expenses carefully. You can obtain the Fund's most recent periodic reports and filings by visiting <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.sec.gov%2Fedgar%2Fbrowse%2F%3FCIK%3D828803%26owner%3Dexclude&amp;esheet=54125321&amp;newsitemid=20240920050661&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.sec.gov%2Fedgar%2Fbrowse%2F%3FCIK%3D828803%26amp%3Bowner%3Dexclude&amp;index=1&amp;md5=6ea55a096c339655a4603de599e135e0">https://www.sec.gov/edgar/browse/?CIK=828803&amp;owner=exclude</a>.

Buybacks

SABA

Reported Friday, Saba Capital Fund II Announces 10% Share Buyback Plan, Targets NAV Improvement

Rocket Lab USA, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RKLB#NASDAQ">RKLB</a>) ("Rocket Lab" or "the Company"), a global leader in launch services and space systems, today successfully launched its 53rd Electron mission and deployed five satellites to Low Earth Orbit for French Internet-of-Things (IoT) company Kinéis.
&nbsp;
&nbsp;
Rocket Lab's Electron takes to the skies for its 53rd launch out of Mahia, NZ, for return French Internet-of-Things customer, Kinéis. Photo Credit: Rocket Lab
The ‘Kinéis Killed the RadIOT Star' lifted off from Rocket Lab Launch Complex 1 in Mahia, New Zealand, at 11:01 a.m. on 21 September NZST (23:01, 20 September UTC), successfully deploying five satellites to a 643 km orbit. The mission was the second of five dedicated Electron launches for Kinéis, a company backed by private and public investors including the French government's space agency CNES (Centre National d'Études Spatiales) and CLS (Collecte Localisation Satellites), an international space-based solutions provider, to improve global IoT connectivity. The Kinéis constellation is designed to make it possible to connect and locate any connected object anywhere in the world, enabling data transmission to users in near-real time, at low bit rates and with very low energy consumption. By enabling internet connection to the Earth's most remote locations, Kinéis constellation can support forest fire detection, water resource management, infrastructure and energy network monitoring, transport and logistics tracking, and much more.
Rocket Lab founder and CEO Sir Peter Beck said: "Today's successful launch marks another milestone for Rocket Lab as we continue to enable innovative companies like Kinéis to push the boundaries of global IoT connectivity. With each mission, we are bringing the world closer together, allowing vital data to be transmitted from the remotest corners of the Earth."
Across 53 launches Rocket Lab has now deployed 197 satellites for a diverse range of customers and missions, including NASA missions to the Moon, the National Reconnaissance Office and Space Force missions supporting national security and defense, scientific research to combat climate change, and commercial constellations providing vital data and services to millions of people on Earth.

RKLB

Reported Friday, Rocket Lab Successfully Launches 53rd Mission, Deploys Satellites for French IoT Company Kinéis

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today presented data informing clinical strategies for switching patients to UZEDY&#xAE;, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, from a once-monthly subcutaneous injection of Perseris&#xAE; (RBP-7000). The results were presented during the 37th Annual European College of Neuropsychopharmacology (ECNP) Congress taking place between September 21-24, 2024, in Milan, Italy.
Schizophrenia is a complex medical condition that may require switching from an oral option or between different long-acting injectable options during the patient treatment journey. These data further clinical understanding of optimal treatment strategies when switching to UZEDY from Perseris&#xAE;.
"Schizophrenia patients and healthcare providers rely on evidence-based studies that can help inform their treatment decisions. That is why Teva is dedicated to building on our commitment to neuroscience and schizophrenia and helps provide these clinical insights on UZEDY switching strategies, along with its role in long-acting treatment options," said Eric Hughes, MD, PhD, Executive Vice President of Global R&amp;D and Chief Medical Officer at Teva. "Up to 80% of schizophrenia patients experience multiple relapses in the first five years, making switching treatments a common experience in the search for optimal treatment. With UZEDY, Teva is building a robust portfolio of research that can help determine if and when it may be the right long-acting option."
In a population pharmacokinetic (PopPK) analysis, simulations were conducted to predict pharmacokinetic (PK) exposures when switching to UZEDY 4-6 weeks after the last injection of once-monthly RBP-7000. The simulation models indicated that switching to UZEDY 4 weeks after the last dose of once-monthly RBP-7000 resulted in comparable PK properties of UZEDY at both the initial exposure and steady state. Comparable doses included UZEDY at 100 mg (once-monthly dosing) or 200 mg (once-every-two-months dosing) to 120 mg of once-monthly RBP-7000.1
Any switching strategy should be determined by clinicians on an individual patient basis, considering factors such as patient preference, scheduling convenience and potential tolerability issues or risk of symptom breakthrough.
"Every person living with schizophrenia has unique treatment needs and preferences that may also evolve over time. For my patients, I encourage discussion around key factors like treatment adherence, dosing frequency, symptom control, and rate of relapse which inform what treatment option may be the most appropriate," said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY. "For healthcare providers, there is also a significant knowledge gap in the available clinical data on switching patients between the various LAI treatment options, which have differing pharmacokinetic properties and dosing considerations. Insights from studies like these are crucial for researchers and clinicians like myself, as they help us become more informed and better serve our patients."
Additional key data being presented at ECNP 2024 included new quantitative results from the ADVANCE (Attitudes Driving Regional Differences in LAI Antipsychotic Utilization for Schizophrenia Among HCPs, Patients and Caregivers) surveys, including:
<ul>
<li>Among 447 people living with schizophrenia and 375 caregivers, most common patient-reported reasons for accepting an LAI (n=331) were improvement of symptoms/condition with LAIs (68%, n=224), recommendation by their HCP (65%, n=214) and ease of using LAIs versus oral antipsychotics (57%, n=189).1</li>
<li>Patients also reported using LAIs due to fewer side effects versus oral antipsychotics (38%, n=127) and to help prevent hospitalization (20%, n=67).1</li>
<li>Caregivers (n=229) reported that patients accepted LAIs based on ease of use versus oral antipsychotics (78%, n=178), to help prevent hospitalization (62%, n=143) and perception that LAIs would work better for improving condition/symptoms (62%, n=143).1</li>
<li>Among a sample of 791 HCPs from 8 different countries, most HCPs reported that the primary reason for recommending an LAI to a patient was nonadherence to oral medication, with the exception of South Korea where the most common reason was that an LAI would be more efficacious than oral.1</li>
<li>The primary reasons cited for not recommending an LAI were patient clinical characteristics and the lack of an available LAI formulation of the patient's current oral treatment, except for China and South Korea, where the primary reasons were LAI cost to patient and LAI product not marketed, respectively.</li>
</ul>

TEVA

Reported Saturday, Teva Unveils Data on UZEDY Injection Switching Strategy for Schizophrenia Treatment at ECNP

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new positive efficacy, safety and tolerability results for Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients diagnosed with schizophrenia. In the study, TEV-‘749 met the primary endpoint, demonstrating significant improvements in the Positive and Negative Syndrome Scale (PANSS)&nbsp;total score from baseline to week 8, as well as key secondary endpoints with improvements in both the Clinical Global Impression-Severity (CGI-S) scale and the Personal and Social Performance (PSP) scale score, compared to placebo at week 8. Additionally, SOLARIS (Period 1) and Phase 1 safety results demonstrated no incidence of post-injection delirium/sedation syndrome (PDSS) in participants taking TEV-‘749 to date.1 The overall safety profile was consistent with other oral acting olanzapine options. These data were presented during the 37th Annual European College of Neuropsychopharmacology (ECNP) Congress taking place between September 21-24, 2024, in Milan, Italy.
Schizophrenia is a complex medical condition that may require switching from oral options or between different long-acting injectable (LAI) options during the patient treatment journey. These data demonstrate the potential role of TEV-‘749 as an LAI treatment option for schizophrenia patients taking daily oral olanzapine or other antipsychotic medications. Currently, the only long-acting olanzapine treatment option for schizophrenia carries a risk for PDSS, the sudden and unexpected onset of delirium or sedation when medication is released too quickly into the blood after receiving an intramuscular injection of long-acting olanzapine.1
"Teva is dedicated to building on its commitment to neuroscience by developing new long-acting injectable treatment options like TEV-‘749 that may help address unmet needs in schizophrenia for patients and healthcare providers," said Eric Hughes, MD, PhD, Executive Vice President of Global R&amp;D and Chief Medical Officer at Teva. "PDSS is a major barrier to the utilization of intramuscular olanzapine LAIs that exists today, and our SOLARIS findings fuel the continued development of TEV-‘749."
With nearly 30 years of clinical and real-world use, olanzapine is one of the most commonly prescribed 2nd generation oral antipsychotics for schizophrenia around the world. Its efficacy and safety profiles are well established.
"Developing a long-acting olanzapine formulation that poses potentially no risk of PDSS is crucial in preventing these dangerous episodes that otherwise limit the use of olanzapine to daily oral options," said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY. "With no PDSS observed in the SOLARIS trial to date, these data add to the growing body of evidence that TEV-‘749 may one day serve as an important treatment option for patients and healthcare providers who rely on olanzapine and also have needs or preferences that require a long-acting option."
Period 1 of the SOLARIS study is an 8-week, randomized, double-blind, placebo-controlled trial in patients aged 18-64 years diagnosed with schizophrenia, followed by an open-label safety period of up to 48 weeks (Period 2). Efficacy results from Period 1 of the SOLARIS study show that by week 8:
<ul>
<li>TEV-‘749 met its primary endpoint across all three dosing groups, with statistically significant mean differences in the change in PANSS total scores from baseline to week 8 of -9.71 points, -11.25 points, and -9.69 points versus placebo for the high (531 mg, corresponding to 20 mg/day of oral olanzapine), medium (425 mg, corresponding to 15 mg/day of oral olanzapine), and low (318 mg, corresponding to 10 mg/day of oral olanzapine) dose groups, respectively (all P&lt;0.0001).1</li>
<li>TEV-‘749 treatment significantly improved CGI-S scale scores across all three dosing groups, with reductions of -0.47 points (high), -0.61 points (medium), and -0.53 points (low) versus placebo from baseline to week 8 (all P&lt;0.0001).1</li>
<li>TEV-‘749 treatment significantly improved PSP scale scores across all three dosing groups, with increases of 4.93 points (high), 3.15 points (medium), and 4.63 points (low) versus placebo from baseline to week 8 (all P&lt;0.02).1 &nbsp;</li>
</ul>
The systemic safety profile of TEV-‘749 was consistent with other approved formulations of olanzapine, with no new safety signals identified. Additional safety and tolerability results from Period 1 (917 active injections) through week 8 of the SOLARIS study show that:
<ul>
<li>There were no reported cases of PDSS.1</li>
<li>Treatment-emergent adverse events that occurred more often in patients receiving TEV-‘749 versus placebo included weight increase (35% [173/500] versus 8% [13/167]), injection site induration (13% [64/500] versus 2% [4/167]), injection site pain (10% [50/500] versus 4% [7/167]) and injection site erythema (10% [48/500] versus 1% [1/167]).1</li>
<li>Serious adverse events and discontinuations due to adverse events were reported in 1% (7/500) and 3% (16/500) of patients treated with TEV-‘749, respectively, and in 2% (3/167) and 3% (5/167) of patients treated with placebo, respectively.1 &nbsp;</li>
</ul>
Also presented at ECNP 2024, results from the Phase 1 study of TEV-'749 show similar safety and tolerability results, including no reports of PDSS events. Additionally, a presented pre-clinical study suggests that the subcutaneous route of administration and formulation characteristics of TEV-'749 appear to greatly reduce the hypothesized risk of PDSS occurrence for patients receiving the treatment.
The long-term safety of TEV-‘749 and incidence of PDSS are also being evaluated in the SOLARIS open-label study (Period 2), with safety data topline readout expected in the first half of 2025.
TEV-‘749 utilizes SteadyTeq&#x2122;, a copolymer technology proprietary to Medincell that provides a controlled steady release of olanzapine.
TEV-‘749 is an investigational once-monthly subcutaneous LAI of the 2nd generation antipsychotic olanzapine and is not approved by any regulatory authority for any use, and its safety and efficacy are not established.

Reported Saturday, Teva's New Schizophrenia Treatment TEV-749 Meets Key Endpoints in Phase 3 Study

IDEAYA Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IDYA#NASDAQ">IDYA</a>), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the company plans to issue a pre-market press release and conduct an investor webcast on&nbsp;Monday, September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from FDA Type C meeting in neoadjuvant uveal melanoma (UM). Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM.
&nbsp;
The investor webcast presentation agenda to review the interim Phase 2 clinical data and regulatory update for darovasertib in neoadjuvant UM will be the following:
<ul>
<li>Market introduction: annual incidence of UM</li>
<li>Registrational trial design based on FDA Type C meeting guidance</li>
<li>Phase 2 clinical data update
<ul>
<li>Baseline characteristics</li>
<li>AE profile</li>
<li>Clinical efficacy from Phase 2 company-sponsored and&nbsp;IST</li>
</ul>
</li>
</ul>
The investor webcast and conference call will include participation from a key opinion leader. IDEAYA management, Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences, and Darrin Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences, will also serve as presenters. The link to the investor webcast will be available on the&nbsp;<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4260191-1&amp;h=3377453956&amp;u=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaZNKgmjyzMiSsMV9B-Z278MGSBmp7QT7selVCYln7cme2BlMujELVbZsAvmEnglHhEEP1UAiAlw0tD0KLcJ62HpJpBtsaRzd339TU33692AfxZb1oqzMHlryeai5G-mo&amp;a=Investor">Investor</a> Relations&nbsp;Events section of the Company's website at: <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4260191-1&amp;h=1643450813&amp;u=https%3A%2F%2Fir.ideayabio.com%2Fevents&amp;a=https%3A%2F%2Fir.ideayabio.com%2Fevents">https://ir.ideayabio.com/events</a>. Registration is available at <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4260191-1&amp;h=1643450813&amp;u=https%3A%2F%2Fir.ideayabio.com%2Fevents&amp;a=https%3A%2F%2Fir.ideayabio.com%2Fevents">https://ir.ideayabio.com/events</a> or <a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4260191-1&amp;h=1935289296&amp;u=https%3A%2F%2Flifescievents.com%2Fevent%2Fideaya-3%2F&amp;a=https%3A%2F%2Flifescievents.com%2Fevent%2Fideaya-3%2F">https://lifescievents.com/event/ideaya-3/</a> in advance of the event.

IDYA

Reported Sunday, IDEAYA Biosciences to Announce Interim Phase 2 Data for Darovasertib in Uveal Melanoma

Pedro Azagra, CEO of Avangrid, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AGR#NYSE">AGR</a>), a leading sustainable energy company and member of the Iberdrola Group, today issued the following statement at the start of Climate Week NYC. "Under the leadership of Iberdrola's Executive Chairman Ignacio Galán, Avangrid has embarked on a journey to purposefully and confidently lead the clean energy transition in the United States. We recognize that we stand at a pivotal moment in our history, as we mark the beginning of Climate Week NYC, where the urgency to fight climate change has never been greater. Every devastating storm, heat wave, or drought – likely made more extreme due to our changing climate – demonstrates the need for immediate action. In keeping with this year's theme, it's time to accelerate progress. With a growing portfolio of over 9 Gigawatts of clean energy installed, and with America's first large-scale offshore wind farm currently under construction, we aren't just promising a greener future, we are building it today. Along the way, we are making record investments in our networks to help our millions of power customers weather the next extreme event fueled by climate change. The demand for safe, clean, affordable electricity to power our homes and businesses will keep growing. Together with our global partners, Avangrid has been at the forefront of the energy transition and will continue forging ahead to achieve our common goal of creating a healthier tomorrow that will ensure the well-being of generations to come."

Reported Sunday, Avangrid CEO Pedro Azagra Urges Climate Action, Highlights Clean Energy Progress at Climate Week NYC

While the first day of fall was ushered in across the Gulf Coast region at 7:43&nbsp;a.m. central time Sunday, there are still several more weeks remaining in the 2024 hurricane season. That is why CenterPoint Energy has been closely monitoring weather forecasts in the Gulf of Mexico this weekend and following its standard preparedness protocols. Greater clarity on the weather situation is expected from the National Hurricane Center in the coming days, but CenterPoint and its frontline electric and gas crews remain ready.
<a href="https://mma.prnewswire.com/media/95201/centerpoint_energy_logo.html"><img src="https://mma.prnewswire.com/media/95201/centerpoint_energy_logo.jpg" alt="CenterPoint Energy logo. (PRNewsFoto)" /></a>
In preparation for potential severe weather across the Gulf Coast, CenterPoint will continue to monitor and prepare as the situation evolves. In the event it is needed, the company will begin the process of securing work sites, preparing crews and equipment, and securing additional frontline resources from mutual assistance companies, as necessary. And while autumn days may be on everyone's minds, the company wants to remind customers and the public to develop an emergency plan and assemble or restock a <a href="https://youtu.be/oshsLHzUEOg">storm preparedness kit</a> that includes essential items such as nonperishable food, water, flashlights, batteries, a first aid kit, any necessary medications, a battery-powered radio, and a portable charger for mobile devices.&nbsp;
"It's important to be mindful of the weather and plan ahead," said Darin Carroll, Senior Vice President, Electric Business. "Although schools are back in class and football games highlight our weekends, we have to keep an eye on the Gulf and be prepared to act quickly, if necessary. We want our customers and communities to know that we are constantly monitoring the weather and refining and updating our preparations and plans."
Carroll added, "Since Hurricane Beryl we've made significant improvements to our electric system as part of the Greater Houston Resiliency Initiative. We believe our actions since Beryl will help improve the resiliency and reliability of the electric grid and better meet our customers' expectations."
Greater Houston Resiliency Initiative
Across Greater Houston, CenterPoint is taking action now to improve resiliency and help reduce the risk of outages this hurricane season.&nbsp;
As part of the first phase of its Greater Houston Resiliency Initiative, throughout August CenterPoint crews and contractors installed more than 1,100 stronger and more resilient fiberglass poles, trimmed vegetation along more than 2,000 miles of power lines and installed more than 300 automation devices in neighborhoods all over Houston. The company's next step is taking the boldest series of resiliency actions in its nearly 160-year history, including additional system hardening, strategic undergrounding, self-healing grid technology, and further enhancements to its outage tracker.
Call to Action: Power Alert Service
Customers should remember that a storm is a powerful force of nature that can cause significant damage and widespread lengthy electricity outages. Conditions can also change unexpectedly and for the worse.
Customers are encouraged to enroll in <a href="https://www.centerpointenergy.com/en-us/residential/services/electric-utility/outage-center/power-alert-service?sa=ho&amp;WT.mc_id=VanURL_PAS_On">Power Alert Service&#xAE;</a> to receive outage details, estimated restoration times as available or determined, and customer-specific restoration updates in the event of severe weather. With the option to receive updates via phone call, text or email, Power Alert Service&#xAE; helps keep customers informed of restoration progress during an outage event. Customers can also find additional resources at <a href="https://www.centerpointenergy.com/en-us/residential/safety/weather-storm-center?sa=ho">CenterPointEnergy.com/StormCenter</a>.&nbsp;
New and Improved Outage Tracker with Greater Web Resiliency
CenterPoint's new and improved <a href="http://centerpointenergy.com/OutageTracker#sthash.5KkUvaRI.dpuf">Outage Tracker</a> can be used to update individual customers on their expected restoration date as soon as possible after restoration expectations are determined.&nbsp;
To learn more about Outage Tracker's new features and functionality, watch the demonstration&nbsp;<a href="https://www.youtube.com/watch?v=UY40X8UFq5E">video</a>.
For an in-depth, step-by-step guide to using the Outage Tracker,&nbsp;<a href="https://www.centerpointenergy.com/en-us/Documents/Outage_Tracker_Walkthrough.pdf">click here</a>.&nbsp;&nbsp;
Customers with Critical Needs
Because CenterPoint Energy cannot guarantee an uninterrupted, regular or continuous power supply during a severe weather event, customers who depend on electricity for life-sustaining equipment are encouraged to make alternate arrangements for on-site backup capabilities or other alternatives in the event of loss of electric service.&nbsp;
During pre-storm preparations and post-storm recovery efforts, CenterPoint urges customers to stay informed of weather conditions and warnings or advisories issued by local authorities by paying close attention to announcements from local news outlets for important information regarding ongoing conditions and recovery efforts. The company also recommends that customers follow these important natural gas and electric safety tips:&nbsp;

Reported Sunday, CenterPoint Energy Prepares for Hurricane Season, Urges Customers to Stay Ready

FFIE

Faraday Future Announced It Delivered An FF 91 2.0 Futurist Alliance To Born Leaders Entertainment In The Famous Warwick Club In Hollywood On September 20

IPHA

Innate Pharma Announced That The US FDA Has Cleared Its Investigational New Drug (IND) Application To Initiate A Phase 1 Clinical Study Of IPH4502, A Nectin-4 ADC To Be Developed In Solid Tumors

<a href="https://www.globenewswire.com/Tracker?data=4qPy0caPR_MD2ZH_btFsxurCYUBnsieYZfcpBfbj_y1uh1qAF_Gp0uHf71uFje-4L3liTH4Ck9e75tC9zBDn7w==">Acronis</a>, a global leader in <a href="https://www.globenewswire.com/Tracker?data=yw_TI8F-_ILezlPytFRE3x7pwtcOwSbAb6P3fAZp0PW4T5jIm4Ot8CM5-ZdfNLk56KK8R-hR5aK-S4y0FObRi0y6XZHzWrb40BxPboGLWG23k-IeBkRTj1_RQZk935V6">cybersecurity</a> and <a href="https://www.globenewswire.com/Tracker?data=JBSvRUTEWeaLaIra4D2jWRfL7WaeYd4wWiNah8FbgWQp2KHKab73ky42mDD7yYufYQakvDLErLRJTPw_0kmzN16al293OOuimL589aoY-F73hNDvnUXsRNrsJEks9oRM">data protection</a>, is excited to announce its latest Acronis #TeamUp Partner, FC Bayern Munich Basketball. In partnership with TD SYNNEX Germany, a leading global distributor and aggregator of solutions for the IT ecosystem, the German Basketball champion will leverage Acronis' solutions to uplevel its IT infrastructure and capabilities. &nbsp;
"We are proud to join forces with Bayern Munich and TD SYNNEX," said Markus Fritz, General Manager DACH at Acronis. "At Acronis, our focus is on delivering comprehensive cyber protection solutions. With an emphasis on expanding our presence in Germany, partnering with FC Bayern Basketball, a team renowned for its excellence and achievements, aligns perfectly with our goal to #TeamUp with champions and make a positive impact in the region. This collaboration merges top-tier technology and sports excellence, and we look forward to a successful and impactful partnership."
Bayern Munich is a prominent force in German basketball, with six German championships and five German Cup victories to their name. Most recently, the team secured the national championship for the 2023-2024 season. But FC Bayern Basketball's excellence extends beyond domestic success. Three players from Bayern Munich were key members of the German national team that won the World Cup in 2023, showcasing their talent on the global stage. Plus, three Bayern players represented Germany in the Men's Olympic Basketball Tournament in Paris 2024. These achievements highlight the growing popularity of basketball in Germany and affirm the team's influential role in the sport's development within the country and beyond.
"Partnering with Acronis and TD SYNNEX represents a significant milestone for our club," said Marko Pesic, CEO of FC Bayern Basketball. "This collaboration underscores our commitment to innovation and excellence both on and off the court. We are thrilled to work with two industry leaders in technology to bring together new opportunities that will strengthen our organization."
TD SYNNEX is the exclusive Acronis #CyberFit Partner for the DACH region. As the Acronis #CyberFit Partner for FC Bayern Basketball, TD SYNNEX will leverage Acronis solutions to enhance the basketball team's IT infrastructure. This joint venture will offer a range of benefits, including invitations to high-profile club events and membership in the club's Business Circle. From corporate events to behind-the-scenes tours, this collaboration comes with a wide array of perks for all parties involved.
"At TD SYNNEX, we are committed to empowering organizations through robust IT infrastructure," said Maximilian Wieser, Business Unit Manager Data &amp; Applications der TD SYNNEX. "By providing the tools that drive innovation, we aim to enhance Bayern Basketball's technological capabilities with Acronis solutions. This fuels our mission to empower organizations and supporting the growth of basketball in Germany is an added benefit. Together, we bring a strong foundation for future success."
Service providers are invited to join the Acronis #TeamUp Program to deliver Acronis Cyber Protection solutions to world-class and global professional sports teams.

Acronis Teams Up with FC Bayern Basketball and TD SYNNEX to Boost IT Infrastructure

Reported Earlier, Teva Pharmaceutical Disclosed That A New Analysis Revealed That Deutetrabenazine Treatment Of Patients With Tardive Dyskinesia (TD) Was Associated With Long Term Improvement Of TD Symptoms

It is with regret that Caledonia Mining Corporation Plc ("Caledonia")&nbsp;(NYSE:<a href="https://www.benzinga.com/stock/CMCL#NYSE">CMCL</a>, AIM: CMCL, VFEX: CMCL)))&nbsp;reports that an accident took place on September 21, 2024 at the Blanket Mine in Zimbabwe, where an employee was hit by a fall of rock while drilling in a development area and as a result has sadly died. &nbsp;
Management at Blanket Mine are assisting the relevant authorities in their enquiry into this accident.
Caledonia expresses its condolences to the family and colleagues of the deceased.

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