iShares iBonds Dec 2029 Term Corporate ETF (ARCA: IBDU)

iShares iBonds Dec 2029 Term Corporate ETF (ARCA:IBDU), Quote.Headers.trade-ideas

The Fund will invest at least 80% of its assets in the component instruments of the Underlying Index, and (except during the last twelve months of the Funds operations) the Fund will invest at least 90% of its assets in fixed income securities of the types included in the Underlying Index that BFA believes will help the Fund track the Underlying Index. The Fund will invest no more than 10% of its assets in futures, options and swaps contracts that BFA believes will help the Fund track the Underlying Index as well as in fixed income securities other than the types included in the Underlying Index, but which BFA believes will help the Fund track the Underlying Index

iShares iBonds Dec 2029 Term Corporate ETF

WIIM

Wheels Up shares are trading higher after the company announced that approximately 97.2% of lead investor shares will remain subject to a lock-up restriction until September 20, 2025.

Baird analyst Peter Arment maintains Kratos Defense &amp; Security (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KTOS#NASDAQ">KTOS</a>) with a Outperform and raises the price target from $22 to $35.

News

Price Target

Analyst Ratings

KTOS

Baird Maintains Outperform on Kratos Defense & Security, Raises Price Target to $35

BDTX

Black Diamond Therapeutics shares are trading higher after the company announced initial Phase 2 data demonstrating encouraging clinical responses and durability of BDTX-1535 in patients with relapsed/refractory epidermal growth factor receptor-mutant non-small cell lung cancer.

In a recent turn of events, the United States has directly cautioned Israel against escalating hostilities with Hezbollah, as the two sides engage in intense cross-border exchanges. The U.S. has urged Israel to seek diplomatic solutions, emphasizing the potential risks of a full-scale land war.
What Happened: On Sunday, Israeli forces and Hezbollah militants clashed in some of the most severe confrontations since Oct. 7, Financial Times <a href="https://www.ft.com/content/2bb03f05-c3d5-4f3f-99e3-56f541f51769">reported</a> on Monday. The escalating violence has raised concerns about the situation spiraling into a full-scale war.
John Kirby, a spokesperson for the U.S. National Security Council, cautioned Israel against escalating the conflict. He stated that there are &#8220;better ways&#8221; to ensure the safety of Israeli citizens than through war or further escalation. President Joe Biden assured that his administration would do everything possible to prevent a wider war.
Despite international calls for de-escalation, Israeli Prime Minister Benjamin Netanyahu has pledged to maintain military pressure on Hezbollah. The situation has become increasingly tense, with the recent hostilities resulting in a significant rise in casualties.
See Also: <a href="https://www.benzinga.com/news/24/09/40970828/data-scientists-election-prediction-kamala-harris-receives-historic-endorsement-from-magazine-elon-m?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Data Scientist&#8217;s Election Prediction, Kamala Harris Receives Historic Endorsement From Magazine, Elon Musk Suggests Warren Buffett Is Preparing For A Harris Win And More: Top Political Update This Week</a>
On Monday, Israeli airstrikes in Lebanon led to 30 deaths and over 300 injuries, as per CNN. This escalation follows a series of events, including Hezbollah&#8217;s rocket attacks on Israel and the detonation of the group&#8217;s communication devices, which Hezbollah blames on Israel. The recent violence has led to fears of a potential full-scale war.
Why It Matters: The recent violence adds to the <a href="https://www.benzinga.com/news/24/09/40924166/hezbollah-hit-in-new-round-of-explosions-across-lebanon-casualties-climb">already tense situation</a> in the region. Just last week, Lebanon experienced a second wave of deadly explosions targeting Hezbollah operatives, following a massive wave of pager explosions that killed 12 people and injured nearly 2,800 more. The second round of explosions killed at least nine people and injured over 300, further exacerbating the situation in Lebanon.
Meanwhile, U.S. Senator Lindsey Graham has called for a new <a href="https://www.benzinga.com/news/24/09/40973072/lindsey-graham-says-either-saudi-arabia-recogonizes-israel-or-tel-aviv-targets-tehran-we-need-game-c">approach to Middle East policy,</a> advocating for either a &#8220;game-changing peace&#8221; or a &#8220;game-changing military strategy.&#8221; Graham suggested that a significant shift in strategy is needed, either through Saudi Arabia recognizing Israel, or Israel taking military action against Iran.
Did You Know?
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<li>Congress Is Making Huge Investments.&nbsp;<a href="https://www.benzinga.com/gov-trades" target="_blank" rel="noreferrer noopener">Get Tips On What They Bought And Sold Ahead Of The 2024 Election With Our Easy-to-Use Tool</a></li>
</ul>
Photo by Ilin Sergey on 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/Pooja-Rajkumari" target="_blank" rel="noreferrer noopener">Pooja Rajkumari</a>

Politics

Global

General

US Warns Israel Against Opening A Full-Blown War Against Hezbollah As Air Strikes Kill 30 In Lebanon

Monday, AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) released high-level results from the TROPION-Breast01 Phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to the investigator&#8217;s choice of chemotherapy.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/datopotamab-deruxtecan-final-overall-survival-results-reported-in-patients-with-metastatic-hr-positive-her2-low-or-negative-breast-cancer-in-tropion-breast01-phase-iii-trial.html" rel="noreferrer noopener">study</a> did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
The study previously met the dual primary endpoint of progression-free survival.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40793946/astrazeneca-ceo-pascal-soriot-updates-on-chinese-compliance-probe-and-lung-cancer-drug-trial-resu" rel="noreferrer noopener">AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results</a>.
An improvement in patient-reported outcomes was also seen.
The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis, including lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns were identified.
All-grade interstitial lung disease (ILD) rates remained low, and no new Grade 3 or higher ILD events were observed.
With multiple antibody-drug conjugates (ADCs) approved during the trial, including&nbsp;Enhertu (trastuzumab deruxtecan), subsequent treatment following patients&#8217; disease progression or treatment discontinuation is likely to have affected survival results.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd ADC discovered by Daiichi Sankyo Ltd&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) and being jointly developed by AstraZeneca and Daiichi Sankyo.
Earlier this month, AstraZeneca&nbsp;shared detailed results from the TROPION-Lung01 Phase 3 of datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with at least&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40791315/astrazenecas-investigational-cancer-drug-disappoints-in-late-stage-lung-cancer-trial" rel="noreferrer noopener">one prior line of therapy</a>.
In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel (12.9 vs. 11.8 months) but did not reach statistical significance.
Friday, the FDA <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html" rel="noreferrer noopener">approved</a> AstraZeneca&#8217;s FluMist as the only self-administered influenza vaccine.&nbsp;
FluMist, a needle-free nasal spray, was approved for self-administration by adults up to 49 years of age or for parent/caregiver administration to individuals 2-17 years of age.
Once available, individuals 18 and older can have FluMist delivered directly to their homes via FluMist Home.
Price Action: AZN stock is down 1.86% at $76.92 during the premarket session at last check Monday.
Read Next:
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<li><a href="https://www.benzinga.com/news/large-cap/24/09/40964870/us-federal-trade-commission-sues-cvs-health-cigna-unitedhealths-pharmacy-benefit-managers-for-infl" target="_blank" rel="noreferrer noopener">US Federal Trade Commission Sues CVS Health, Cigna, UnitedHealth&#8217;s Pharmacy Benefit Managers For Inflating Insulin Prices</a>.</li>
</ul>
Image by Robert Way via Shutterstock

Biotech

Large Cap

Health Care

Movers

DSKYF

DSNKY

Latest Trial Setback For AstraZeneca's Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients

Baird analyst Ben Kallo maintains Ameresco (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AMRC#NYSE">AMRC</a>) with a Outperform and raises the price target from $32 to $42.

AMRC

Baird Maintains Outperform on Ameresco, Raises Price Target to $42

BHVN

Biohaven shares are trading higher after the company announced its study of Troriluzole for the treatment of spinocerebellar ataxia in achieved the primary endpoint.

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>
</div>
</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>

Pre-Market Outlook

Markets

Trading Ideas

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.
&nbsp;
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
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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RKLB

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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.

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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According to Freddie Mac, mortgage rates have already declined, reaching 6.2% as of Sept. 12, the lowest since February 2023. This downward trend will likely continue in response to the Fed&#8217;s decision.
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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.

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