Chewy (NYSE:CHWY) Stock, Quote.Headers.trade-ideas

Chewy

Chewy is the largest e-commerce pet care retailer in the US, generating $11.2 billion in 2023 sales across pet food, treats, hard goods, and pharmacy categories. The firm was founded in 2011, acquired by PetSmart in 2017, and tapped public markets as a stand-alone company in 2019 after spending a couple of years developing under the aegis of the pet superstore chain. The firm generates sales from pet food, treats, over-the-counter medications, medical prescription fulfillment, and hard goods, like crates, leashes, and bowls.

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10 large-cap stocks worst performers in last week: SMMT -23.61%, KSPI -21.66%, BMRN -16.74%, RIVN -13.26%, FDX -11.08%, BNTX -9.01%, AJG -7.17%, CHWY -6.97%, NVO -6.93%, MUSA -6.90%

Novo Nordisk, Chewy And FedEx Are Among Top 10 Large Cap Losers Last Week (Sept 15-Sept 21): Are The Others In Your Portfolio?

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Chewy shares are trading lower by 4.8% during Friday&#39;s session. The company announced the public offering of shares by a selling stockholder and a concurrent share repurchase.

Why Chewy (CHWY) Stock Is Trading Lower

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FedEx, Lennar And 3 Stocks To Watch Heading Into Friday

Chewy Inc

During times of turbulence and uncertainty in the markets, many investors turn to dividend-yielding stocks. These are often companies that have high free cash flows and reward shareholders with a<a href="https://www.benzinga.com/yield-investments"> high dividend payout</a>.
Benzinga readers can review the latest analyst takes on their favorite stocks by visiting <a href="https://www.benzinga.com/analyst-stock-ratings">Analyst Stock Ratings</a> page. Traders can sort through Benzinga's extensive database of analyst ratings, including <a href="https://www.benzinga.com/analyst-ratings/analyst-color/22/09/28888638/exclusive-study-finds-benzinga-analyst-ratings-data-yields-market-beating-strategie">by analyst accuracy</a>.
Below are the ratings of the most accurate analysts for three high-yielding stocks in the industrials sector.
<h3 class="wp-block-heading">ZIM Integrated Shipping Services Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ZIM#NYSE">ZIM</a>)</h3>
<ul>
<li>Dividend Yield: 5.78%</li>
<li>Jefferies analyst Omar Nokta maintained a Buy rating and raised the price target from $22 to $25 on Aug. 20. This analyst has an accuracy rate of 73%.</li>
<li>JP Morgan analyst Samuel Bland maintained a Neutral rating and cut the price target from $9.3 to $9.25 on March 22. This analyst has an accuracy rate of 75%.</li>
<li>Recent News: On Aug. 19, ZIM Integrated Shipping Services reported better-than-expected second-quarter financial results and raised its FY24 guidance.</li>
<li>Benzinga Pro's real-time newsfeed alerted to<a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"> latest ZIM news</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="905" height="845" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073915/image-174.png" alt="" class="wp-image-560853" style="width:669px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073915/image-174.png 905w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073915/image-174-300x280.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073915/image-174-768x717.png 768w" sizes="(max-width: 905px) 100vw, 905px" /></a></figure>
<h3 class="wp-block-heading">Genco Shipping &amp; Trading Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GNK#NYSE">GNK</a>)</h3>
<ul>
<li>Dividend Yield: 7.57%</li>
<li>B. Riley Securities analyst Liam Burke maintained a Buy rating and raised the price target from $27 to $30 on May 10. This analyst has an accuracy rate of 62%</li>
<li>Jefferies analyst Omar Nokta maintained a Buy rating and increased the price target from $26 to $27 on May 9. This analyst has an accuracy rate of 73%.</li>
<li>Recent News: On Sept. 10, Genco Shipping &amp; Trading enhanced Dividend Policy to increase cash distributable to shareholders.</li>
<li>Benzinga Pro&#8217;s charting tool helped identify the<a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"> trend in GNK stock</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="922" height="845" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073956/image-175.png" alt="" class="wp-image-560854" style="width:692px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073956/image-175.png 922w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073956/image-175-300x275.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073956/image-175-768x704.png 768w" sizes="(max-width: 922px) 100vw, 922px" /></a></figure>
<h3 class="wp-block-heading">Karat Packaging Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KRT#NASDAQ">KRT</a>)</h3>
<ul>
<li>Dividend Yield: 5.32%</li>
<li>Truist Securities analyst Jake Bartlett downgraded the stock from Buy to Hold and cut the price target from $34 to $28 on Aug. 9. This analyst has an accuracy rate of 75%.</li>
<li>Stifel analyst Michael Hoffman reiterated a Buy rating and raised the price target from $30 to $32 on March 15. This analyst has an accuracy rate of 82%.</li>
<li>Recent News: On Aug. 8, Karat Packaging reported worse-than-expected second-quarter financial results.</li>
<li>Benzinga Pro&#8217;s signals feature notified of a potential <a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1">breakout in KRT shares</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="888" height="842" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23074037/image-176.png" alt="" class="wp-image-560857" style="width:638px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23074037/image-176.png 888w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23074037/image-176-300x284.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23074037/image-176-768x728.png 768w" sizes="(max-width: 888px) 100vw, 888px" /></a></figure>
<figure class="wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio"> 
<div class="wp-block-embed__wrapper">
<iframe loading="lazy" title="How to Find Dividend Stocks: Scan, Analyze, and Capture with Benzinga Pro" width="500" height="281" src="https://www.youtube.com/embed/pVF0O2lsEH4?start=1&#038;feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
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</figure>
Read More:<a href="https://www.benzinga.com/markets/24/09/40962695/jim-cramer-viking-has-many-ships-coming-in"> </a>
<ul>
<li><a href="https://www.benzinga.com/markets/24/09/40962695/jim-cramer-viking-has-many-ships-coming-in">Jim Cramer: Viking Has &#8216;Many Ships Coming In&#8217;</a></li>
</ul>

Price Target

Analyst Ratings

Wall Street's Most Accurate Analysts Spotlight On 3 Industrials Stocks With Over 5% Dividend Yields

Baird analyst Colleen Kusy maintains Apellis Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APLS#NASDAQ">APLS</a>) with a Outperform and lowers the price target from $96 to $92.

APLS

Baird Maintains Outperform on Apellis Pharmaceuticals, Lowers Price Target to $92

Mativ Holdings, Inc. ("Mativ" or the "Company") (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MATV#NYSE">MATV</a>) today announced that it has commenced a private offering that is exempt from registration under the Securities Act of 1933, as amended (the "Securities Act"), subject to market and other conditions, of $400,000,000 in aggregate principal amount of senior notes due 2029 (the "Notes"). The Notes will be senior unsecured obligations of the Company and will be guaranteed by each of the Company's existing and future wholly owned subsidiaries that is a borrower under or that guarantees obligations under its credit agreement or that guarantees certain other indebtedness, subject to certain exceptions. The Company intends to use the net proceeds from the offering (i) to redeem its 6.875% Senior Notes due 2026 ("2026 Notes") and (ii) to repay approximately $43 million aggregate principal amount of outstanding borrowings under the term loan B facility under its credit agreement.
The Notes and the related guarantees will be offered only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and to non-U.S. persons outside the United States in reliance on Regulation S under the Securities Act. The Notes and the related guarantees have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from registration requirements under the Securities Act and any applicable securities laws of any other jurisdiction.

Offerings

MATV

Mativ Holdings To Raie $400M Via Proposed Private Offering of Senior Notes To Repay Debt

Alterity Therapeutics ((ASX: ATH, NASDAQ:<a href="https://www.benzinga.com/stock/ATHE#NASDAQ">ATHE</a>) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that multiple oral and poster presentations will be presented at the International Congress of Parkinson's Disease and Movement Disorders&#xAE; (MDS) taking place September 27 – October 1, 2024 in Philadelphia, PA.
"The MDS Congress promises to be an exceptional medical meeting for Alterity with multiple presentations showcasing our progress this year. Highlights for us include oral presentations on both of our Phase 2 clinical programs including the acceptance of our late-breaking interim data from our ATH434-202 trial in participants with advanced multiple system atrophy (MSA)," commented, David Stamler, M.D., Chief Executive Officer of Alterity Therapeutics.

Alterity Therapeutics Limited - American Depositary Shares

ATHE

Alterity Therapeutics to Present Key Phase 2 Data at Parkinson's Congress

Bowman Consulting Group Ltd. (the Company or Bowman) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BWMN#NASDAQ">BWMN</a>), a national engineering services firm delivering infrastructure design solutions and project management services to customers who own, develop and maintain the built environment, has been contracted by the Illinois Department of Transportation (IDOT) to provide corridor management and design services for a 15.6-mile corridor of I-55.
"We are excited to start working on the highly impactful and innovative I-55 corridor assignment," said Gary Bowman, chairman and CEO of Bowman. "This is one of several awards where we've been anticipating and planning for a final contract and notice to proceed for several months. We had the necessary resources for the assignment in place, so we were able to mobilize quickly and immediately commence work on the project. Our transportation practice has unparalleled experience with the complexities of large-scale infrastructure projects in Illinois, and we appreciate this opportunity to help IDOT improve and modernize one of the most heavily traveled expressways in the state for its constituents."
Corridor management is an innovative approach to transportation system management whereby public agencies and private contractors commit to working together to manage a transportation corridor holistically rather than the more traditional approach of managing individual assets discretely. This contract is one of a few design management corridor contracts to be released from IDOT and is a key component of the state's $45 billion Rebuild Illinois infrastructure investment program strategy.
Under this engagement, Bowman will manage all projects within the highly trafficked stretch of I-55, which connects Chicago to its southwest suburbs, a corridor that transits over 100,000 vehicles daily. Additionally, Bowman will prepare bridge repair plans for 16 bridges within the corridor, as well as develop roadway improvement plans of the expressway. These enhancements have been identified as key to improving safety, reducing congestion and extending the lifespan of Illinois' transportation infrastructure.

Government

Regulations

BWMN

Bowman Consulting Lands Major I-55 Corridor Management Contract with Illinois Department of Transportation (IDOT)

Aileron Therapeutics, Inc. ("Aileron") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALRN#NASDAQ">ALRN</a>), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced the completion of enrollment in Cohort 2 of the ongoing Phase 1b clinical trial of LTI-03 in IPF patients.
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The last patient was enrolled in mid-September, with a total of 24 patients enrolled in the trial. Eligible patients are randomly assigned (3:1) to receive either inhaled LTI-03 or placebo. The primary objective of the trial is to evaluate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.
"We are pleased to have completed enrollment in the high-dose cohort of our Phase 1b clinical trial and grateful to all participating patients and investigators," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "Following the positive trend observed in the low-dose cohort, we are excited to assess the safety, tolerability and biomarkers of 5 mg twice daily of inhaled LTI-03 and expect to report topline data in the near term."
In May 2024, the Company <a href="https://investors.aileronrx.com/news-releases/news-release-details/aileron-therapeutics-announces-positive-data-cohort-1-phase-1b">announced positive data</a> from Cohort 1 evaluating low-dose LTI-03 (2.5 mg BID). Following inhaled administration of low-dose LTI-03 in 12 patients, a positive trend was observed in seven out of eight biomarkers with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three biomarkers that was statistically significant, reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF.
About the Phase 1 Clinical Trial of LTI-03
The Phase 1b clinical trial of LTI-03 is a randomized, double-blind, placebo controlled, multi-center, dose escalation trial in patients recently diagnosed with IPF that have not received prior treatment with anti-fibrotic agents for at least two months (<a href="https://classic.clinicaltrials.gov/ct2/show/NCT05954988">NCT05954988</a>). Eligible patients are randomly assigned (3:1) to receive one of two doses of inhaled LTI-03 or placebo. The primary objective of the trial is to investigate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.

ALRN

Aileron Therapeutics Completes Enrollment for Phase 1b IPF Drug Trial, Topline Data Expected Soon

Elevation Oncology, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ELEV#NASDAQ">ELEV</a>), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.
"We are delighted to receive Fast Track designation for EO-3021, which marks an encouraging recognition of the unmet medical need in patients with Claudin 18.2-expressing tumors, as well as the potential for EO-3021 to deliver improved therapeutic outcomes," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "This designation is based on nonclinical and initial clinical data from our ongoing Phase 1 clinical trial. As we announced in August, early results showed a confirmed overall response rate of 42.8% in a Claudin 18.2-enriched subset of gastric and GEJ cancer. In addition, we observed differentiated tolerability, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia. We are grateful for the opportunity to potentially expedite the delivery of EO-3021 and look forward to advancing through monotherapy dose expansion and reporting additional data from our ongoing trial in the first half of 2025, and to initiating the combination portion of our study later this year."
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

ELEV

Elevation Oncology's EO-3021 Granted FDA Fast Track for Advanced Gastric Cancer Treatment

BioAtla, Inc. ("BioAtla") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCAB#NASDAQ">BCAB</a>), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic ("CAB") antibody therapeutics for the treatment of solid tumors, and Context Therapeutics Inc. ("Context") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNTX#NASDAQ">CNTX</a>), a biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, today announced that the companies have entered into an agreement under which Context has obtained from BioAtla an exclusive, worldwide license to develop, manufacture and commercialize BA3362, BioAtla's Nectin-4 x CD3 TCE. Context will assume and fund all&nbsp;development and commercialization activities.
"With the successful out-licensing of BA3362 to Context, we will continue to focus on execution of our lead clinical CAB programs, while ensuring the potential advancement of BA3362 under the leadership of a seasoned team," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla. "We believe this transaction marks the first of multiple collaborations, including a targeted collaboration for one of our Phase 2 assets over the coming months, thereby increasing shareholder value through non-dilutive means."
"This transaction is consistent with our focus on building a pipeline of TCE assets through strategic in-licensing or acquisition," said Martin Lehr, CEO of Context. "Nectin-4 is a priority target for Context given the target's high prevalence in solid tumors and the unmet need to address potential resistance to Nectin-4 antibody-drug conjugates. We identified BioAtla's Nectin-4 TCE antibody as a potentially best-in-class asset. BA3362 is built from BioAtla's compelling CAB platform technology that uses pH-dependency to drive selective Nectin-4 binding and T cell activation within the tumor microenvironment."
Under the terms of the agreement, BioAtla is eligible to receive up to $133.5 million in aggregate payments, including $15.0 million in upfront and near-term milestones with additional potential clinical, development and commercial milestones totaling $118.5 million, as well as tiered royalties on net sales.
Tungsten Advisors served as the exclusive financial advisor to BioAtla. Orrick, Herrington &amp; Sutcliffe LLP served as legal counsel to BioAtla. Piper Sandler served as sole financial advisor to Context. Goodwin Procter LLP served as legal counsel to Context.
About BA3362 (Nectin-4 x CD3 T cell engaging bispecific antibody) BA3362 targets Nectin cell adhesion protein 4 ("Nectin-4"), which is highly and frequently overexpressed in a variety of cancers. Nectin-4 is a clinically-validated target for cancer therapy using a traditional antibody-drug conjugate (ADC), but it is also associated with certain adverse events, including neuropathy and rash. BA3362 is a CAB T cell engager that is designed to be preferentially active within the tumor microenvironment.

BCAB

CNTX

Context Therapeutics Secures Global Rights to Develop and Commercialize BioAtla's Cancer Therapy BA3362

Rocket Lab USA, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RKLB#NASDAQ">RKLB</a>) shares are trading higher on premarket Monday. On Friday, the company successfully launched its 53rd Electron mission, deploying five satellites to Low Earth Orbit for the <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b40967932/rocket-lab-successfully-launches-53rd-electron-mission-deploys-another-five-satellites-for-kin-is" rel="noreferrer noopener">French Internet-of-Things (IoT) company </a><a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b40967932/rocket-lab-successfully-launches-53rd-electron-mission-deploys-another-five-satellites-for-kin-is" rel="noreferrer noopener">Kinéis</a>.
This was the second of five dedicated Electron launches for Kinéis, supported by private and public investors, including the French space agency CNES and CLS, aimed at enhancing global IoT connectivity.
The &#8220;Kinéis Killed the RadIOT Star&#8221; mission launched from Rocket Lab Launch Complex 1 in Mahia, New Zealand, at 11:01 a.m. NZST on September 21 (23:01 UTC, September 20), successfully deploying five satellites into a 643 km orbit.
Rocket Lab founder and CEO Sir Peter Beck stated, &#8220;Today&#8217;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.&#8221;
Related: <a target="_blank" href="https://www.benzinga.com/markets/equities/24/09/40940169/rocket-labs-nanosatellite-launch-for-kineis-mission-aborted-on-pad-future-launches-under-review" rel="noreferrer noopener">Rocket Lab&#8217;s Nanosatellite Launch For Kineis Mission Aborted On Pad, Future Launches Under Review</a>
This month, the company announced that Frank Klein will be its new Chief Operations Officer,<a target="_blank" href="https://www.benzinga.com/markets/equities/24/09/40816135/rocket-lab-usa-hires-rivian-veteran-frank-klein-as-new-coo-whats-going-on" rel="noreferrer noopener"> effective September 16th, 2024</a>.
According to&nbsp;<a target="_blank" href="https://pro.benzinga.com/?gspk=YWRhbWVja2VydDUzMzY&amp;gsxid=zBMR4PKmcgBw" rel="noreferrer noopener">Benzinga Pro</a>, RKLB stock has gained 71%&nbsp;in the past year. Investors can gain exposure to the stock via&nbsp;Procure Space ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UFO#NASDAQ">UFO</a>) and SPDR S&amp;P Kensho Final Frontiers ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ROKT#NYSE">ROKT</a>).
Price Action: RKLB shares are up 0.67% at $7.52 premarket at the last check Monday.
Photo via Company
Read Next:
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<li><a href="https://www.benzinga.com/general/space/24/09/40697380/bezos-vs-musk-battle-heads-to-space-how-amazon-founder-is-taking-tesla-ceo-on-more-directly" target="_blank" rel="noreferrer noopener">Bezos Vs. Musk Battle Heads To Space: How Amazon Founder Is Taking Tesla CEO On More Directly</a></li>
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Equities

RKLB

ROKT

Rocket Lab Launches 53rd Electron Mission, Deploying Five Satellites For Kinéis

Biohaven Ltd.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BHVN#NYSE">BHVN</a>) (Biohaven&nbsp;or the Company), today announced positive topline results from pivotal Study BHV4157-206-RWE (NCT06529146) demonstrating the efficacy of troriluzole on the mean change from baseline in the f-SARA after 3 years of treatment. The study achieved the primary endpoint and showed statistically significant improvements on the f-SARA at years 1 and 2 (Figure 1). SCA is a rare, progressively debilitating neurodegenerative disease that affects approximately 15,000 people in&nbsp;the United States and 24,000 in Europe and the United Kingdom. There are no FDA approved treatments for SCA.
<a href="https://mma.prnewswire.com/media/2512320/Biohaven_Figure_1_Troriluzole_vs_US_Natural_History_External_Control.html"><img src="https://mma.prnewswire.com/media/2512320/Biohaven_Figure_1_Troriluzole_vs_US_Natural_History_External_Control.jpg" alt="Figure 1: f-SARA Change from baseline demonstrating troriluzole reduced SCA disease progression vs US Natural History External Control" /></a>
Collectively, data across multiple analyses demonstrate a robust and clinically meaningful slowing of disease progression in SCA patients. These treatment benefits translate into a 50-70% slower rate of decline compared to untreated patients, representing 1.5-2.2 years delay in disease progression over the 3-year study period. Additionally, in a responder sensitivity analysis, disease progression when defined by a 2 point or greater worsening on the f-SARA at 3 years showed an odds ratio (OR) of 4.1 (95% CI: 2.1, 8.1) for the untreated external control arm versus troriluzole treated subjects (p &lt; 0.0001; pooled analysis).
Dr. Susan Perlman, Director of Ataxia Clinic and Neurogenetics Clinical Trials at the David Geffen School of Medicine at UCLA stated, "SCA is a debilitating, relentlessly progressive disease that destroys quality of life, leaving patients unable to care for themselves, walk, or speak. Troriluzole is the very first treatment to show a delay in disease progression that can give patients additional years of independence, where they can walk without assistance, continue to work, play with their children, and participate in daily activities. This is an exciting and hopeful moment for the SCA community."&nbsp;
Study BHV4157-206-RWE was designed, in discussion with the US Food and Drug Administration (FDA), to assess the effectiveness of troriluzole in SCA after 3 years of treatment as measured by the change from baseline in the f-SARA. The study utilized Phase 3 data and an external control of matched, untreated SCA subjects from the US Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) in accordance with FDA's Guidance on Real-World Evidence (RWE) of effectiveness. All endpoints were prespecified, and both the study protocol and statistical analysis plan were submitted to, and reviewed by, FDA prior to topline data analysis. The new analysis doubled the previously available 3 year data with 63 subjects now completing 3 years of treatment with troriluzole and matched to the external control arm. Propensity Score Matching (PSM) was used to ensure that untreated patients from the CRC-SCA study were rigorously matched to treated patients from Study BHV4157-206 on baseline characteristics.&nbsp; The primary objective was to examine the treatment effects of troriluzole for up to 3&nbsp;years, by comparing data on the f-SARA from patients treated with troriluzole in Study BHV4157-206 to untreated patients from the natural history study. Troriluzole-treated patients demonstrated statistically significant and sustained benefits at years 1, 2 and 3 on the f-SARA compared to a rigorously matched natural history control.
Additionally, prespecified analyses in the protocol employed a separate, independent natural history control from the European SCA natural history study (EUROSCA) for global regulatory purposes. Results using the EUROSCA patients, in addition to a pooled analysis using both CRC-SCA and EUROSCA patients, as the external controls were also statistically significant and consistent with the primary efficacy analysis at all timepoints (see Figure 2 and Figure 3). The addition of EUROSCA data increased the external control sample size and added to the robustness of the statistically significant treatment differences at years 1, 2, and 3, favoring troriluzole.
Jeremy Schmahmann, M.D., Professor of Neurology at Harvard Medical School and Founding Director of the Ataxia Center at Massachusetts General Hospital commented, "The stabilization of SCA symptoms as reflected by the topline data at 3 years along with the previously reported reductions in falls show the therapeutic potential of troriluzole. I cannot underscore enough the impact of a potential treatment that can slow SCA disease progression and the effect on patients and caregivers who have helplessly watched generations of family members deteriorate and die from SCA. These new data provide support for troriluzole as a safe and effective once daily treatment for patients with SCA."
Spinocerebellar ataxia is a group of dominantly inherited neurodegenerative disorders characterized by progressive loss of voluntary motor control and atrophy of the cerebellum, brainstem and spinal cord. Patients experience significant morbidity, including progression to a wheelchair, impaired gait leading to falls, inability to communicate due to speech impairment, difficulty swallowing, and premature death. While signs and symptoms can appear anytime from childhood to late adulthood, SCA typically presents in early adulthood and progresses over a number of years. Currently, there are no FDA-approved treatments and no cure for SCA.
Vlad Coric, M.D., Chief Executive Officer and Chairman of Biohaven stated, "Advancing new therapies for patients with rare diseases is often a multiyear process of collaboration across academic, patient advocacy, regulatory and industry partners. The Biohaven team has always been committed to rigorously following the science in this area, and through our partnership with the National Ataxia Foundation and collaboration with leading SCA experts across the globe, our SCA development program has provided the first evidence of a clinically meaningful treatment benefit as well as slowing disease progression in SCA patients. We were excited to receive the positive topline results from Study BHV4157-206-RWE, which was designed with FDA input and pursuant to the principles outlined in the FDA's guidance for the use of real-world evidence.&nbsp; The need for treatments for this deadly neurodegenerative disease is urgent. As a company, we remain committed to developing novel therapies for patients living with rare disorders with no approved therapies, like SCA. We look forward to interacting with regulatory agencies to bring troriluzole to patients with SCA."
Andrew Rosen, Chief Executive Officer of the National Ataxia Foundation (NAF), shared, "Biohaven was the first company to join NAF's Drug Development Collaborative (DDC), a group of pharmaceutical companies dedicated to bringing together advocates, clinicians, regulatory agencies, and the patient community to advance research and facilitate the development of therapies for ataxia. Today's topline results are the culmination of years dedicated to studying troriluzole as a treatment for SCA. Patients and families have been waiting for decades for a treatment that could slow disease progression in this devastating and relentlessly progressive disorder".
Based upon the topline data from Study BHV4157-206-RWE, and previous safety and efficacy data from the troriluzole development program in SCA, Biohaven plans to submit a New Drug Application (NDA) to the FDA in Q4 2024. The troriluzole development program has generated the largest clinical trial dataset in SCA and now has follow-up in some patients treated with troriluzole for over 5 years. &nbsp;Biohaven has previously received both Fast-Track and Orphan drug designation (ODD) from the FDA, and ODD from the European Medicines Agency, for troriluzole in SCA. An NDA with ODD is eligible for priority FDA review. Biohaven will be prepared to commercialize SCA in the US in 2025, if ultimately approved, based on potential priority review timelines.

BHVN

Biohaven Announces 3-Year Results for Troriluzole in Spinocerebellar Ataxia Treatment

Arrowhead Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>) today announced that it has filed for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-INHBE, the company's investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity. Arrowhead also plans to file for regulatory clearance before the end of 2024 to initiate a clinical trial for its second obesity candidate, ARO-ALK7.
"Arrowhead's two investigational RNAi therapies for the treatment of obesity, ARO-INHBE and ARO-ALK7, are both designed to intervene in the same pathway that signals the body to store fat in adipose tissue. We have generated very promising preclinical data that suggests inhibition of these targets reduces body mass and fat mass but spares lean muscle mass resulting in improved body composition," said James Hamilton, M.D., Chief of Discovery and Translational Medicine at Arrowhead. "We have designed the initial Phase 1/2 study to evaluate single and multiple doses of ARO-INHBE monotherapy in Part 1 which will enroll patients with obesity, and to evaluate multiple doses of ARO-INHBE in combination with tirzepatide in Part 2 which will enroll diabetic and non-diabetic patients with obesity. We believe new therapeutic strategies with novel mechanisms of action, like ARO-INHBE and ARO-ALK7, have the potential to make a significant impact on the way obesity is treated and we are eager to initiate clinical studies of these important new programs."
ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. INHBE is a promising genetically validated target in which loss-of-function INHBE variants in humans are associated with lower risk of obesity and metabolic diseases, such as type 2 diabetes. Activin E acts as a ligand in a pathway that regulates energy homeostasis in adipose tissue​. Intervening in this pathway with investigational ARO-INHBE treatment has the potential to increase lipolysis, and reduce adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance.
An application for approval to initiate the clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority for review by the Standing Committee on Therapeutic Trials. Pending clearance, Arrowhead intends to proceed with AROINHBE-1001, A Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE in up to 78 adult volunteers with obesity. Part 1 of the study is designed to assess single and multiple doses of ARO-INHBE monotherapy, and Part 2 of the study is designed to assess ARO-INHBE in combination with tirzepatide, a subcutaneously administered GLP-1/GIP receptor co-agonist that has been approved in the United States and the European Union for management type 2 diabetes mellitus since 2022 and weight management since 2023/2024 respectively.

ARWR

Arrowhead Pharmaceuticals Files for Phase 1/2a Trial of New Obesity Treatment, ARO-INHBE

The Federal Reserve slashed interest rates by half a percentage point on Wednesday, marking the first rate cut in years. The benchmark federal funds rate now ranges<a href="https://www.benzinga.com/economics/macro-economic-events/24/09/40926026/federal-reserve-delivers-bold-0-5-rate-cut-signals-further-easing-ahead"> between 4.75% and 5%</a>. While nearly half luxury home purchases are made in cash, that rate cut is poised to impact the high-end housing market. Industry experts anticipate a surge in confidence and activity across all property segments, with potential price increases in top-tier real estate.
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President and CEO of Berkshire Hathaway HomeServices EWM Realty in South Florida, Ron Shuffield, views the rate cut positively. "The drop in the Fed rate today is good news for everyone,&#8221; he told Mansion Global. "While high-end buyers often don't have a traditional home mortgage, everyone is impacted by changes in interest rates – whether in their home mortgage, their business financing, their personal life or in lines of credit they roll in and out of – all of which are based on interest rates," Shuffield said.
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Ian Slater, a New York City-based agent with Compass, noted the real estate community&#8217;s excitement about the rate cut. &#8220;Now that we know the Fed has cut a large amount, 0.5% rather than what some expected to be 0.25%, there is even more exuberance,&#8221; Slater said.
Despite the prevalence of cash purchases in the luxury market, Redfin reports that 44% of luxury home purchases were made with cash in the second quarter. The rate cut is expected to boost market sentiment. Slater predicts &#8220;a continued robust luxury market throughout the remainder of 2024 and potentially even more strength in 2025.&#8221;
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Lower mortgage rates&#8217; effects on buying power are more striking in high-priced metro areas. In California&#8217;s San Jose metro area, where the median listing price hit $1.4 million in August, a hypothetical drop in mortgage rates to 5.5% could increase buying power by $110,000, according to Realtor.com data cited by Mansion Global.
Matthew Lesser, senior partner at New York City brokerage Leslie Garfield, believes the rate cut will catalyze market activity. &#8220;Historically, this should lead to greater transaction volume and therefore push pricing because of the increased demand,&#8221; Lesser said.
Even for all-cash buyers at the top end of the market, the rate cut has indirect benefits. &#8220;These buyers use leverage in their daily lives, whether for their own businesses or investments,&#8221; Lesser said. Cheaper money will raise consumer confidence and provide greater opportunity to buy more real estate.
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44% Of Luxury Homes Bought With Cash – But This 0.5% Fed Rate Cut Could Raise Luxury Home Prices By $110k, Here's How

Piper Sandler analyst Clarke Jeffries upgrades Wix.com (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WIX#NASDAQ">WIX</a>) from Neutral to Overweight and raises the price target from $184 to $200.

Upgrades

Piper Sandler Upgrades Wix.com to Overweight, Raises Price Target to $200

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GDDY

Piper Sandler Downgrades GoDaddy to Neutral, Raises Price Target to $172

GE Aerospace's (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ge#NYSE">GE</a>) 52,000 employee workforce has a powerful new assistant, AI Wingmate, by their side as they work to enhance quality, serve customers, and invent the future of flight.&nbsp;&nbsp;GE Aerospace
GE Aerospace's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GE#NYSE">GE</a>) 52,000 employee workforce has a powerful new assistant, AI Wingmate, by their side as they work to enhance quality, serve customers, and invent the future of flight.&nbsp;&nbsp;
GE Aerospace technology leaders worked with one of its key partners in AI development, Microsoft, to use Azure AI, including Azure OpenAI Service, to bring enhanced security, compliance, and responsible AI inside GE Aerospace's own network. Employees now can securely collaborate with AI Wingmate in a human-like back-and-forth conversation on new ideas, new learnings, and new initiatives to propel air travel to new heights.&nbsp;
GE Aerospace employee engagement with the tool has been very strong since its launch in June. To date, the system has received:
<ul>
<li>~500,000 queries, searches, and other employee interactions; and</li>
<li>200,000+ pages processed for different AI chats.&nbsp;</li>
</ul>
"The launch of AI Wingmate will transform employee productivity, allowing our people to spend more time solving our customers' toughest problems," said David Burns, Chief Information Officer, GE Aerospace. "Generative AI is changing the way we all work, enabling us to be more productive with our daily work tasks than ever before. Ultimately, this will strengthen our ability to help the aerospace industry meet our highest objectives of enhanced safety, sustainability, and reducing supply chain constraints."&nbsp;
"Over 60,000 customers spanning industries and countries worldwide are applying the capabilities of Azure AIto deliver tangible results," said Nick Parker, President, Industry &amp; Partner Sales, Microsoft. "We are deeply committed to helping businesses like GE Aerospace implement multimodal AI-powered applications easily and securely. I'm thrilled to see the impact AI is already having at GE Aerospace as the company continues to infuse AI across the company and leverage its power to drive innovation and growth."&nbsp;
AI Wingmate is providing GE Aerospace employees with a secure, internal platform to engage and utilize the full suite of generative AI capabilities and infuse new data and information from employees over time to support the company's business requirements.&nbsp;
"As our workforce continues to become familiar with AI Wingmate, it will become an increasingly more valuable partner over time for GE Aerospace employees," added Burns. "We are particularly excited about plans to launch a new generative AI based module exclusively dedicated to FLIGHT DECK, our proprietary lean operating model that is the foundation of how we work. The generative AI platform will serve as a vehicle for employees to learn about FLIGHT DECK and its ten fundamentals."&nbsp;
&nbsp;
How it works&nbsp;
GE Aerospace employees are using AI Wingmate to enhance their productivity and work experience by having:&nbsp;&nbsp;
<ul>
<li>Instant access to information: Employees can quickly obtain information relevant to their tasks, reducing the time spent searching through documents or waiting for responses from colleagues.&nbsp;</li>
<li>Faster learning and discovery: Employees can use AI Wingmate to perform more advanced searches and queries to support their project work.&nbsp;</li>
<li>More advanced support tools: Employees can use AI Wingmate to draft more tailored communications for specific audiences, rapidly create documents, or ask questions to help understand a complex problem.&nbsp;</li>
</ul>
The launch of this new internal generative AI platform represents a key milestone in GE Aerospace's more than a decade's long journey successfully integrating AI across its business operations. Over this time, GE Aerospace has more than doubled its investment in AI technology, positioning the company as one of the top AI patent holders within the aviation industry.&nbsp;&nbsp;
Today, GE Aerospace is using AI to enhance everything from engine monitoring and part inspections to delivering insights for our airline customers to enable predictive maintenance measures and new ways to optimize fuel efficiency and safety. Click&nbsp;<a href="https://www.geaerospace.com/sites/default/files/ai-fact-sheet.pdf">here</a> to learn more about how GE Aerospace is using AI today and future applications under development.
"The integration of Azure AI platform capabilities including Azure OpenAI Service is delivering a step change in how GE Aerospace employees work and deliver for our customers," said Burns.&nbsp; "AI Wingmate is more than just a smart platform. It's a true catalyst for changing the way we work and what is possible for us to achieve in advancing the future of flight."&nbsp;

MSFT

GE Aerospace Teams Up with Microsoft to Power 52K Workers with AI Wingmate Platform

Kamada Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KMDA#NASDAQ">KMDA</a>, TASE: KMDA.TA)))), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced the expansion of its plasma collection operations with the opening of a new plasma collection center in Houston, TX. The new 12,000 square foot center is operated by Kamada's wholly owned subsidiary, Kamada Plasma, and is planned to support over 50 donor beds with an estimated total collection capacity of approximately 50,000 liters annually.
"We are extremely pleased to announce the opening of our new state-of-the-art plasma collection center in Houston," said Amir London, Chief Executive Officer of Kamada. "The opening of this center is an important milestone in Kamada's development and vertical integration, expanding the collection capacity of specialty plasma for our internal use beyond our existing site in Beaumont, TX. The new center in Houston is expected to be one of the largest sites for specialty plasma collection in the U.S. and will also collect normal source plasma to be sold to third parties. We are especially grateful for the skilled and experienced team of plasma collection experts we have hired to lead the development and operations of our new center."
Kamada intends to submit to the FDA a prior approval supplement to Kamada Plasma's existing Biologics License Application (BLA) for the approval of the Houston site, as well as a plasma master file (PMF) to the European Medicines Agency (EMA), during the first half of 2025. The FDA and EMA's regulatory process for obtaining approval for plasma collection centers includes onsite inspection. During the review process, the company is authorized to collect plasma donations at the center. Kamada currently anticipates approval decisions within 9-12 months of submissions.
In addition to the new Houston center, the company has begun construction of its third plasma collection site in San Antonio, TX, which is expected to open during the first half of 2025. Each collection center is expected to contribute annual revenues of $8 million to $10 million in sales of normal source plasma at its full capacity.

KMDA

Kamada Expands US Plasma Operations with Houston Center, Plans FDA Submission

YOSH

Yoshiharu Global  Filed For Offering Of Up To 400K Shares

Benchmark analyst Daniel Kurnos maintains Sinclair (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBGI#NASDAQ">SBGI</a>) with a Buy and raises the price target from $29 to $30.

SBGI

Benchmark Maintains Buy on Sinclair, Raises Price Target to $30

Leading private markets investment management firm Hamilton Lane (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HLNE#NASDAQ">HLNE</a>) announced that it has been named to the S&amp;P MidCap 400 by S&amp;P Dow Jones Indices, effective before the open of trading today, Monday, September 23, 2024.&nbsp;
For more than 30 years, Hamilton Lane has been dedicated exclusively to private markets investing, providing innovative solutions to institutional and private wealth investors around the world. As of June 30, 2024, the firm had more than $940 billion in assets under management and supervision, composed of nearly $130 billion in discretionary assets – representing 11% year-over-year growth – and more than $810 billion in non-discretionary assets.&nbsp;
Hamilton Lane Co-CEO <a href="https://www.hamiltonlane.com/en-us/about/our-team/erik-hirsch">Erik Hirsch</a> commented: "The addition of our firm to the S&amp;P MidCap 400 Index represents a significant milestone in Hamilton Lane's 33-year growth story – a story that continues to evolve but that has always been driven by our focus on delivering for our clients. &nbsp;We have an exciting path forward, as we continue to lean into our culture of integrity, innovation and the pursuit of excellence, while adapting to meet the evolving needs of private markets investors of all sizes with new technology, new markets and new regions across the globe."

HLNE

Hamilton Lane Joins S&P MidCap 400, Marks Major Growth Milestone in Private Markets

<a href="https://pr.report/2vaa">Alta Global Group</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MMA#NYSE">MMA</a>) ("Alta" or the "Company"), a pioneering technology company uniting passion and participation in global combat sports with a vision of converting 640 million fans to participants, announced its partnership with <a href="https://pr.report/2vab">UFC Gym Group</a> has the potential to deliver gross revenue of $7,000,000 per annum&#x2A; upon roll-out of UFC Gym's global gym footprint of over 150 gyms. The program will launch in California, scheduled to go on sale to members in September 2024. This represents Alta's first major enterprise partnership and will look to integrate Alta's innovative products and programs across UFC Gym's extensive network of global gyms.
&nbsp;
Nick Langton, Founder and CEO of Alta Global Group, commented, "This partnership with UFC Gym Group is a transformative milestone for Alta. By integrating our Warrior Training Program and mobile marketing platform into UFC Gym's global network, we're poised to significantly expand our reach while offering a unique pathway for UFC fans to experience the sport firsthand. UFC Gym is an ideal partner for us to deliver an unmatched training experience that not only elevates the gyms but also empowers participants. We're excited about the tremendous potential this collaboration holds for driving growth and deepening the connection between 640 million MMA fans and the sport."
Additional highlights of the partnership include:
Program Rollout: Alta will roll out its highly acclaimed 20-week Warrior Training Program across the United States and internationally. In the first year, these programs will be introduced in 15 locations across the US.
Revenue Opportunities: The Alta Warrior Training Program, which averages 24 participants per program, enables gyms to run up to two programs annually. Participants pay between $1,000 and $1,500 for the 20-week experience.
Mobile Marketing Platform: Furthermore, UFC Gym Group will utilize Alta's all-in-one mobile marketing platform, Hype, to enhance customer acquisition and retention across its network of over 150 gyms. Hype, powered by Alta, operates on a traditional Software-as-a-Service (SaaS) model.
Extensive opportunities for growth: Currently, UFC Gym Group boasts over 150 locations in 40 countries worldwide, including 80 in the United States, with hundreds of additional gyms in development.

Alta Global Partners With UFC Gym, Targets $7M Annual Revenue From Global Expansion

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