 (OTC:HRZSF) Stock, Quote.Headers.trade-ideas

<ul>
<li>– Exploratory long-term follow-up analysis of the Phase III POLARIX study indicated a positive trend in overall survival in favor of Polivy in combination with R-CHP for people with first-line diffuse large B-cell lymphoma (DLBCL) –</li>
<li>– Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems –</li>
<li>– These encouraging five-year results continue to highlight the potential of this Polivy combination to improve outcomes in first-line DLBCL, an area that previously had little advancement in nearly two decades –</li>
</ul>

News

RHHBF

RHHBY

RHHVF

Reported Sunday, Roche's Genentech Showcases Polivy's Transformative Impact On Frontline DLBCL Treatment: Five-Year POLARIX Trial Results Presented At ASH 2024

In anticipation of the year-end, investors are eyeing a potential rally in stocks and cryptocurrencies, driven by lower interest rates, decreasing inflation, and rising corporate profits. However, the upcoming release of&nbsp;the November consumer price index&nbsp;(CPI) data on Wednesday could significantly impact the Federal Reserve&#8217;s decision on a possible&nbsp;interest rate cut in December.
What Happened: The current economic environment is favorable for risk assets such as stocks and cryptocurrencies. Thomas Hainlin, senior investment strategist at U.S. Bank Asset Management Group, pointed out that the S&amp;P 500 Index and Nasdaq Composite reached record highs last week, while Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) surpassed $100,000 <a href="https://www.benzinga.com/markets/cryptocurrency/24/12/42367065/exclusive-bitcoin-briefly-tops-100000-but-where-do-benzinga-readers-predict-it-will-finish-2024">for the first time, </a>MarketWatch <a href="https://www.marketwatch.com/amp/story/stocks-and-crypto-could-rally-through-year-end-but-watch-for-this-last-wild-card-34509487">reported</a> on Monday.
Jay Hatfield, CEO of Infrastructure Capital Advisors, observed a shift in sentiment towards a<a href="https://www.benzinga.com/news/econ-s/24/12/42316647/interest-rate-cut-in-december-st-louis-feds-musalem-urges-patient-approach-in-last-mile-to-2"> December rate cut.</a> Fed fund futures traders are now pricing an 85% chance of a 25 basis point cut, up from 71% a day earlier. However, the CPI data could alter these expectations significantly.
See Also: <a href="https://www.benzinga.com/markets/equities/24/12/42356725/alex-karp-supports-doge-as-trump-taps-palantirs-shyam-shankar-for-border-security-role-cannot-have-a-better-person-than-musk?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Alex Karp Supports DOGE, As Trump Taps Palantir&#8217;s Shyam Shankar For Border Security Role: &#8216;Cannot Have A Better Person Than Musk&#8217;</a>
Gennadiy Goldberg from TD Securities stressed that a higher-than-expected core CPI reading might lead to a reassessment of the Fed&#8217;s December meeting plans, potentially reducing the likelihood of a rate cut.
Why It Matters: The University of Michigan&#8217;s Consumer Sentiment Index recently <a href="https://www.benzinga.com/news/econ-s/24/12/42366245/consumer-sentiment-hits-7-month-high-but-inflation-fears-divide-democrats-republicans">hit a seven-month high</a>, indicating improved economic conditions but also highlighting concerns over rising near-term inflation expectations. This sentiment could influence consumer behavior and spending, impacting the broader economy.
Additionally, economist Steve Hanke has dismissed <a href="https://www.benzinga.com/personal-finance/24/12/42362368/economist-steve-hanke-calls-inflation-fears-nonsense-as-fed-policies-take-the-wheel-in-2025">fears of inflation spiking</a>, attributing future inflation trends to Federal Reserve policies rather than political factors. He anticipates inflation to continue its downward trend, falling below the Fed&#8217;s 2% target by 2025, which could further affect market dynamics and the Fed&#8217;s policy decisions.
Meanwhile, as per <a href="https://pro.benzinga.com">Benzinga Pro</a>, the year-to-date(YTD) returns of SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) which tracks the S&amp;P 500 closely, has been 28.60% while the YTD returns of Invesco QQQ Trust, Series 1 (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>) has increased by 30.77%.
Read Next: 
<ul>
<li><a href="https://www.benzinga.com/24/12/42370333/happy-birthday-dogecoin-if-you-invested-100-in-meme-crypto-when-elon-musk-first-tweeted-about-it-heres-how-much-youd-have-today?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Happy Birthday Dogecoin! If You Invested $100 In Meme Crypto When Elon Musk First Tweeted About It, Here&#8217;</a></li>
</ul>
Disclaimer: This content was partially produced with the help of <a href="https://www.benzinga.com/author/benzinga-neuro" target="_blank" rel="noreferrer noopener">Benzinga Neuro</a> and was reviewed and published by Benzinga editors.
Image via Shutterstock

Analyst Color

Economics

Markets

General

$BTC

Stocks And Crypto Ride Optimism, But November CPI Could Be The Ultimate Market Test, Investors Warn

<ul>
<li>Stable production of anti-sickling adult hemoglobin (HBAT87Q) and elimination or significant reduction of vaso-occlusive events sustained through last follow-up for all evaluable patients (n=38), underscoring potentially transformative and durable clinical impact</li>
<li>Results from first and only focused analysis of patients with sickle cell disease with a history of overt or silent stroke (n=27) show no stroke recurrence through 9 years of follow-up (n=2)</li>
</ul>

BLUE

Reported Sunday, bluebird bio Highlights 9-Year Data For LYFGENIA Gene Therapy: Sustained Benefits In Sickle Cell Disease Patients At ASH 2024

The CNN Money Fear and Greed index showed a decline in the overall market sentiment, with the index in the &#8220;Neutral&#8221; zone on Friday.
U.S. stocks settled mixed on Friday, with the S&amp;P 500 and Nasdaq Composite hitting fresh records following the release of better-than-expected November jobs data.
The S&amp;P 500 and Nasdaq recorded gains for the third straight week, gaining 0.96% and 3.34%, respectively. However, the Dow lost 0.6% during the week.
Nonfarm payrolls rose by 227,000, sharply accelerating from the previous upwardly revised 36,000 and above the expected 200,000 as per TradingEconomics estimates. The unemployment rate rose from 4.1% to 4.2%, as expected. Average hourly earnings advanced at a 0.4% monthly pace, holding steady from October&#8217;s 0.4% increase and surpassing expectations of 0.3%.
DocuSign, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DOCU#NASDAQ">DOCU</a>) shares jumped around 28% on Friday after the company reported better-than-expected third-quarter financial results and issued FY25 revenue guidance above estimates. Asana, Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ASAN#NYSE">ASAN</a>) shares climbed over 43% after the company reported better-than-expected third-quarter financial results and issued FY25 guidance above estimates.
Lululemon Athletica Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LULU#NASDAQ">LULU</a>) shares jumped around 16% after the company reported better-than-expected third-quarter financial results and increased its share buyback program by $1 billion
Most sectors on the S&amp;P 500 closed on a negative note, with energy, utilities, and healthcare stocks recording the biggest losses on Friday. However, consumer discretionary and communication services stocks bucked the overall market trend, closing the session higher.
The Dow Jones closed lower by around 123 points to 44,642.52 on Friday. The S&amp;P 500 rose 0.25% to 6,090.27, while the Nasdaq Composite climbed 0.81% to close at 19,859.77 during Friday's session.
Investors are awaiting earnings results from Oracle Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ORCL#NYSE">ORCL</a>), Toll Brothers, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TOL#NYSE">TOL</a>), and Casey&#8217;s General Stores, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CASY#NASDAQ">CASY</a>) today.
What is CNN Business Fear &amp; Greed Index?
At a current reading of 53, the index moved to the &#8220;Neutral&#8221; zone on Friday, versus a prior reading of 54.5.
The Fear &amp; Greed Index is a measure of the current market sentiment. It is based on the premise that higher fear exerts pressure on stock prices, while higher greed has the opposite effect. The index is calculated based on seven equal-weighted indicators. The index ranges from 0 to 100, where 0 represents maximum fear and 100 signals maximum greediness.
Read Next: 
<ul>
<li><a href="https://www.benzinga.com/markets/24/12/42380712/how-to-earn-500-a-month-from-oracle-stock-ahead-of-q2-earnings">How To Earn $500 A Month From Oracle Stock Ahead Of Q2 Earnings</a></li>
</ul>
Photo courtesy: Shutterstock

Earnings

Pre-Market Outlook

Trading Ideas

ASAN

CASY

DOCU

LULU

ORCL

S&P 500, Nasdaq Hit Record Close As November Jobs Data Beats Expectations: Fear & Greed Index In 'Neutral' Zone

100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy

Reported Sunday, Johnson & Johnson Highlights TECVAYLI's Role In Advancing Frontline Multiple Myeloma Care With 100% MRD-Negative Results At ASH 2024

<ul>
<li>Data from long-term follow-up of patients in clinical trials further demonstrate durability of the transformative benefits of CASGEVY&#x2122; -</li>
<li>- Safety profile consistent with busulfan conditioning and autologous hematopoietic stem cell transplant -</li>
<li>- Vertex provides update on progress in bringing CASGEVY to patients -</li>
</ul>

VRTX

Reported Sunday, Vertex Highlights Long-Term Benefits Of CASGEVY For Sickle Cell Disease And Beta Thalassemia At ASH 2024

<ul>
<li>NHP Data Showed CD117 Monoclonal Antibody (mAb) Conditioning Successfully Achieved Long-term Engraftment of Base-edited Hematopoietic Stem Cells and Induced Robust Levels of&nbsp;Hemoglobin F</li>
<li>mAb Dosing Well Tolerated Without Need for Supportive Care</li>
<li>Beam on Track to Initiate Phase 1-enabling Studies by End of 2024</li>
</ul>

BEAM

Reported Sunday, Beam Therapeutics Showcases Proof-Of-Concept Non-Human Primate Data For ESCAPE, A Non-Genotoxic Antibody-Based Conditioning Strategy For Sickle Cell Disease, At ASH 2024

<ul>
<li>Data presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH)</li>
</ul>

ABBV

Reported Saturday, AbbVie Unveils Phase 1b/2 EPCORE NHL-2 Trial Results: Epcoritamab Plus R2 Achieves 96% Overall Response Rate In Relapsed/Refractory Follicular Lymphoma

-New insights show Black, Hispanic, and Asian patients have more negative emotional experiences and outlooks with their chronic lymphocytic&nbsp;leukemia (CLL) diagnosis and treatment journeys -CLL is one of the most common leukemias among adults affecting more than 200,000 people in the U.S.1,2

Reported Sunday, AbbVie's Emotional Impact Report Reveals Mental Health Challenges Faced By Diverse CLL Patient Populations At ASH 2024

With U.S. stock futures trading slightly lower this morning on Monday, some of the stocks that may grab investor focus today are as follows:
<ul>
<li>Wall Street expects Toll Brothers, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TOL#NYSE">TOL</a>) to report quarterly earnings at $4.33 per share on revenue of $3.17 billion after the closing bell, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>. Toll Brothers shares rose 0.6% to $155.00 in after-hours trading.</li>
<li>Analysts are expecting Casey&#8217;s General Stores, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CASY#NASDAQ">CASY</a>) to post quarterly earnings at $4.29 per share on revenue of $4.02 billion. The company will release earnings after the markets close. Casey&#8217;s shares climbed 0.5% to close at $422.27 on Friday.</li>
<li>Super Micro Computer Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMCI#NASDAQ">SMCI</a>) shares climbed in after-market hours trading on Friday after the company received an extension from Nasdaq to file its overdue annual and quarterly reports by Feb. 25. Super Micro Computer shares surged 8.7% to $47.75 in the after-hours trading session.</li>
</ul>
Check out our <a href="https://www.benzinga.com/premarket/">premarket coverage here</a>
<ul>
<li>After the markets close, MongoDB, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MDB#NASDAQ">MDB</a>) is projected to post quarterly earnings at 69 cents per share on revenue of $497.76 million. MongoDB shares gained 0.8% to $345.99 in the after-hours trading session.</li>
<li>Analysts expect Oracle Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ORCL#NYSE">ORCL</a>) to post quarterly earnings at $1.48 per share on revenue of $14.11 billion after the closing bell. Oracle shares gained 0.9% to $193.35 in after-hours trading.</li>
</ul>
Check This Out:
<ul>
<li> <a href="https://www.benzinga.com/markets/24/12/42380712/how-to-earn-500-a-month-from-oracle-stock-ahead-of-q2-earnings">How To Earn $500 A Month From Oracle Stock Ahead Of Q2 Earnings</a></li>
</ul>
Photo courtesy: Shutterstock

Long Ideas

SMCI

Toll Brothers, Oracle And 3 Stocks To Watch Heading Into Monday

<ul>
<li>Demonstrated durable hematologic response across all patient subgroups, regardless of baseline transfusion status and concomitant JAK inhibitor therapy</li>
<li>Phase 2 study in MF anemia has been initiated, enrolling a broad range of patient types</li>
</ul>

IRON

Reported Sunday, Disc Medicine Shares Phase 1b Results For DISC-0974 In Myelofibrosis Patients At ASH 2024, Starts Phase 2 Trial

-- Preliminary results from 86 patients enrolled in the Phase 2 pivotal iMMagine-1 study of anito-cel demonstrated 97% ORR and 62% CR/sCR at a median follow-up of 9.5 months --
-- No delayed neurotoxicities have been observed to date with anito-cel, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome in more than 150 patients dosed across the Phase 1 and iMMagine-1 studies --
-- 30.2-month median progression-free survival with a median follow-up of 38.1 months in the Phase 1 study of anito-cel; median overall survival not reached --
-- Company highlights additional presentations during the ASH Annual Meeting --

ACLX

Reported Sunday, Arcellx Unveiled New Data From Immagine-1 Study In Relapsed/Refractory Multiple Myeloma At The 66th ASH Annual Meeting And Exposition

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fpuretechhealth.com%2F&amp;esheet=54163549&amp;newsitemid=20241208030033&amp;lan=en-US&amp;anchor=PureTech+Health+plc&amp;index=1&amp;md5=b1f34df05794f55066bb0d7455bf5c26">PureTech Health plc</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTC#NASDAQ">PRTC</a>, LSE: PRTC))) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, presented data from the dose escalation phase of its ongoing Phase 1b trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego, California.
LYT-200 is currently being evaluated both as a monotherapy and in combination with the standard-of-care venetoclax and hypomethylating agents (HMA) for patients whose disease is relapsed/refractory to at least one line of prior treatment. It targets galectin-9, a glycan-binding protein that is significantly upregulated in AML and MDS and plays a key role in disease development, progression, immune interference and drug resistance. Initial results show a favorable safety profile across both arms and all dose levels with no dose limiting toxicities, as well as evidence of response, hematological improvement and sustained disease management.
"Relapsed/refractory acute myeloid leukemia is one of the most dire cancer diagnoses, with 50% of patients non-responsive to or relapsing after initial treatment and a median survival time of less than six months,2" said Luba Greenwood, J.D., Entrepreneur-in-Residence at PureTech who is leading the Gallop Oncology work. "We are encouraged to see that LYT-200 achieved responses as well as long-term disease stabilization in heavily pre-treated patients, and we look forward to progressing LYT-200 as a critical therapeutic option with the potential to treat most AML patients."
In the monotherapy arm, patients received LYT-200 at five dose levels (2.0 mg/kg to 16.0 mg/kg). Across all dose levels, LYT-200 induced clinical benefit and responses in heavily pre-treated, relapsed/refractory AML/MDS patients, even in those with complex cytogenetics and mutations such as KRAS, NRAS, BRAF as well as patients previously fully refractory to standard of care. Out of 22 evaluable patients who received monotherapy, 59% achieved stable disease or better with two partial responses. The mean duration on treatment is greater than two months, which exceeds the standard overall survival of approximately 1.7 months in venetoclax/HMA-refractory patients.3
When administered in combination with venetoclax/HMA, results demonstrate that LYT-200 may enhance the efficacy of standard-of-care therapies, even in relapsed or refractory patients. In the combination arm, patients received LYT-200 across three dose levels (4.0 mg/kg to 12.0 mg/kg) with venetoclax/HMA. Out of 15 evaluable patients who received combination therapy, 80% achieved stable disease or better, with two experiencing complete responses and one patient achieving a morphologic leukemia free state (MLFS).1 The combination regimen has also demonstrated clinical benefit in patients with KRAS/NRAS mutations and the mean duration on treatment up until the point of data cut-off is greater than two months.

PRTC

PureTech Health Presents Promising Data on LYT-200 for Treating Relapsed Leukemia and Blood Disorders at 2024 ASH Annual Meeting

Key Highlights for November 2024:
<ul>
<li>Bitcoin Production: HIVE mined 103 BTC, bringing its HODL portfolio to 2,713 BTC, a 67% increase year-over-year.</li>
<li>Mining Capacity: Maintained an average mining capacity of 5.3 Exahash per Second ("EH/s") with fleet efficiency at 22.3 Joules per Terahash ("J/TH"), reaching a peak hashrate of 5.7 EH/s.</li>
<li>Operational Efficiency: Achieved an average daily production rate of 3.42 BTC, equivalent to 19.3 Bitcoin per Exahash.</li>
<li>Bitcoin Valuation: HIVE's Bitcoin holdings were valued at over $261 million as of November 30, 2024, based on a BTC closing price of approximately $96,400.</li>
</ul>

Coverage of Bitcoin, Etherum, Ripple and all the latest digital currencies.

Cryptocurrency

HIVE

HIVE Digital November 2024 Production Results: Bitcoin Holdings Values At $261M, Mining Capacity Reaches 5.3 EH/s

<a href="https://www.globenewswire.com/Tracker?data=AqfvHp3-Z_Vxi-A4D-uv1FjI6HBmWssLmlKuTd0X8ZTLm6yMmMN0uXGUuwc8yG57nVqDxFLXQmthERBOs9WGf-j6XvyRGzYbJ_8UudWcyOPX242p-Th79Bfk-UVGaz1qLDiRWUvjUlA0IkivDYspiua-bBerxW1jZZJ4C_DiPScIur6V5Sj0VejM3QGJCnXN4aD2ITyXA_Pe0kHjNa4Ei1E2Gt3vUEPuspu9_0DYq9oQhqM_pSkxxDipSJJx-Pt0ph1xnnawsL-WI0R9u1C-OYpZ5lt2Dkrmlu8TXo0_nwfrIWybITI2xGAfGwFyMoY86llCqF48JLOv6wlmtsS9oqwc9hReZgBNK2H7humQABjh08Em7s4lrCSY6w-iPuYW">MaxCyte, Inc.</a>, (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MXCT#NASDAQ">MXCT</a>, LSE: MXCT))), a leading cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, today announced the completion of an internal operational review, initiated earlier this year following the appointment of Maher Masoud as President and Chief Executive Officer. This "bottom-up" review focused on optimizing new product development, manufacturing, commercial execution, and capital allocation to enhance efficiency and align resources with strategic priorities. As part of an effort to streamline operations, the company made adjustments to its workforce which affected 21 positions, reflecting approximately 15% of its personnel globally, including both directly employed individuals and those engaged through third-party employer-of-record (EOR) arrangements. This adjustment is designed to improve accountability, better align personnel resources with the company's goals, and position MaxCyte for long-term growth.
Anticipated cost savings in 2025 as a result of this action are expected to be about $5.8 million. These savings will help accelerate new strategic initiatives addressing customer needs in cell engineering and manufacturing adjacent to electroporation in the cell therapy manufacturing process. Following this adjustment, combined with other personnel decisions made throughout the year, MaxCyte expects to end the year with 116 employees, compared with 143 employees at the end of 2023 (in each case, inclusive of individuals employed through EOR arrangements).
Reflecting the company's strengthened operational foundation and continued strong performance, MaxCyte is raising its full-year 2024 core revenue guidance to project 6% to 8% growth compared to 2023.
"2024 has been a good year for MaxCyte. We signed six SPL agreements, added a cell therapy industry veteran to the board and outperformed our financial commitments to the investment community. Throughout the year, we have implemented a more focused, and accountable, operating philosophy at MaxCyte, taking important and necessary steps to drive innovation and growth in a capital efficient manner," said Maher Masoud, President and CEO at MaxCyte. "I would like to thank the employees impacted by today's announcement for their contributions to MaxCyte. Core business momentum remains strong as we exit 2024, resulting in an increase to our core revenue growth guidance. I am incredibly optimistic about the future of MaxCyte and am excited about the opportunities ahead to drive the cell therapy industry forward."
2024 Revenue Guidance
MaxCyte increases 2024 revenue guidance for core business revenue and affirms SPL Program-related revenue guidance.
MaxCyte now expects full year 2024 core business revenue of 6% to 8% growth compared to 2023. SPL Program-related revenue is expected to be approximately $6 million. The outlook for the full year does not include SPL Program-related revenue from Vertex/CRISPR's CASGEVY&#x2122;.
MaxCyte continues to expect to end 2024 with approximately $185 million in cash, cash equivalents and investments.

Guidance

MXCT

MaxCyte expects FY24: Core Revenue Growth Of 6%-8% (Prior At Least 5%) YoY; Reiterated SPL Revenue ~$6M, To Let Go Of 21 Employees To Save $5.8M In Costs For 2025

<ul>
<li>Findings reveal promising early signs that lacutamab may help alleviate some of the most distressing symptoms of cutaneous T cell lymphomas</li>
</ul>

IPHA

Innate Pharma's TELLOMAK Phase 2 Trial: Lacutamab Demonstrates Significant Symptom Relief and Quality-of-Life Improvements In Advanced CTCL, Presented At ASH 2024

Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>).
The U.S. Food and Drug Administration (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat serious conditions and address significant unmet medical needs. The medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.
The FDA granted this BTD based on data from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT04484142%3Fterm%3Dtropion-lung05%26rank%3D1&amp;esheet=54163228&amp;newsitemid=20241206314659&amp;lan=en-US&amp;anchor=TROPION-Lung05&amp;index=1&amp;md5=bfb7eb5703ca3e73e32cb6f616580ed8">TROPION-Lung05</a> phase 2 trial with supporting data from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04656652&amp;esheet=54163228&amp;newsitemid=20241206314659&amp;lan=en-US&amp;anchor=TROPION-Lung01&amp;index=2&amp;md5=10ce6b41534181dc3781ed4177a115e8">TROPION-Lung01</a> phase 3 trial. Results from a pooled analysis of patients with previously treated EGFR-mutated NSCLC in these studies were <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202412%2F20241206_E.pdf&amp;esheet=54163228&amp;newsitemid=20241206314659&amp;lan=en-US&amp;anchor=presented&amp;index=3&amp;md5=6b0b3b2dfbe52c68b2743eeff561dd40">presented</a> this month at the European Society of Medical Oncology (ESMO) Asia 2024 Congress. This is the first BTD for datopotamab deruxtecan and the twelfth BTD across Daiichi Sankyo's oncology pipeline.

Government

Regulations

Datopotamab Deruxtecan Receives FDA Breakthrough Therapy Designation for EGFR-Mutated Lung Cancer

Summary of the Transaction
<ul>
<li>Boliden has entered into a definitive agreement to acquire the mines Somincor-Sociedade Mineira de Neves-Corvo, S.A. ("Neves-Corvo") and Zinkgruvan Mining Aktiebolag ("Zinkgruvan") for an upfront cash consideration corresponding to USD 1,300 m plus a contingent payment up to USD 150 m, on a cash and debt-free basis (the "Transaction").</li>
<li>The Transaction has a strong industrial logic and strategic fit, complementing current&nbsp;Boliden operations with two well-invested mines. Following the Transaction, zinc and copper concentrate production will increase from 35% to 70% of zinc smelting capacity and 30% to 40% of copper smelting capacity.</li>
<li>The Transaction will lead to a significant increase in production of metals in concentrate in Business Area Mines, by 95% for zinc and 43% for copper, based on 2023 production figures.</li>
<li>The Transaction is expected to be immediately accretive to&nbsp;Boliden's earnings per share from completion of the Transaction and contribute with &gt;10% to Cash EPS1).</li>
<li>The EBITDA contribution from the&nbsp;Neves-Corvo and Zinkgruvan mines over the next five years is estimated to amount to USD 300-350 m annually, assuming consensus prices and terms.</li>
<li>The upfront cash consideration will be fully financed through a bridge loan, which is expected to be refinanced through a share issue corresponding to approximately half of the bridge loan (the "Share Issue"), and the remaining amount in medium and long-term debt financing. The Share Issue will be based on an authorization from a general meeting or subject to approval by a general meeting. Boliden intends to explore options to conduct the Share Issue either as a directed share issue or as a fully underwritten rights issue. The Share Issue is expected to be carried out during the first half of 2025; however no decision has been taken at this time and the timing of the Share Issue is subject to, among other, prevailing market conditions at the time of the Share Issue.</li>
<li>Completion of the Transaction is expected during mid-2025, subject to regulatory approvals, including merger control filings and approvals and other customary closing conditions.</li>
</ul>

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The company is also expanding the coed Apple Foundation Program to enhance learning opportunities for more students at the Apple Developer Academy
Apple&#xAE; today announced plans to expand in the Kingdom of Saudi Arabia, starting with the launch of the Apple Store&#xAE; online in summer 2025. The online store will bring customers across Saudi Arabia new ways to shop Apple's full range of products, with exceptional service and support directly from Apple in Arabic for the very first time.
Starting in 2026, Apple will begin opening the first of several flagship Apple Store locations in Saudi Arabia. These retail stores will offer customers in the country even more ways to connect with Apple's knowledgable team members and find the perfect products and services. As part of this expansion, Apple is in the initial stages of planning an iconic retail store coming to Diriyah, a UNESCO World Heritage site.

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Reported Earlier, Apple Expands In Saudi Arabia: Flagship Stores, Developer Training, And Economic Growth

Renowned stock picker and founder of asset management giant Ark Invest, Cathie Wood, deemed Bitcoin's (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) breach of the $100,000 mark a "big deal" on Sunday, hailing the leading cryptocurrency's rising prominence in the world of finance and investing.
What happened: In a video shared on X,&nbsp; Wood recalled how Ark Invest published a Bitcoin whitepaper back in 2015 when the asset was valued at just around $250.
Wood remembered her early lessons from renowned economist Arthur Laffer in collaboration with whom Ark released the whitepaper.&nbsp;
"I said to Arthur that sounds like a big idea. How big could it be? And he said at that time, ‘Well, how big is the U.S. monetary base? That's the reserve currency of the world. This seems to be the new reserve currency of the world.'"
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">Bitcoin hit $100K this week. Its emergence signals a shift in the foundation of financial tech. <a href="https://twitter.com/CathieDWood?ref_src=twsrc%5Etfw">@CathieDWood</a> explores its rise and how tech-driven deflation could transform the economy in "In The Know." Past performance does not guarantee future results.<a href="https://t.co/Qqcnc7AyFl">https://t.co/Qqcnc7AyFl</a>
&mdash; ARK Invest (@ARKInvest) <a href="https://twitter.com/ARKInvest/status/1865910532277989559?ref_src=twsrc%5Etfw">December 9, 2024</a></blockquote>
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Wood emphasized that, in addition to being perceived as the next reserve currency, Bitcoin might be viewed in a variety of different ways.
See Also: <a href="https://www.benzinga.com/markets/cryptocurrency/24/12/42331483/michael-saylors-bitcoin-strategy-drives-microstrategys-490-surge-hedge-fund-cio-says-its-an-extreme-example-of-volatility-monetization">Michael Saylor&#8217;s Bitcoin Strategy Drives MicroStrategy&#8217;s 490% Surge, Hedge Fund CIO Says It&#8217;s An &#8216;Extreme Example&#8217; Of Volatility Monetization</a>
"It&#8217;s a substitute for gold, a store of value," Wood stated. She also called the asset an "insurance policy" in emerging markets for populations who are used to corruption, collapses in currencies, and outright confiscation of wealth or capital controls.
Wood viewed Bitcoin as an ideal hedge against any form of uncertainty that could affect high-net-worth individuals.
"All fiduciaries have to look at this new asset class, and so we think it could become, you know, 2 to 5 or 6% of portfolios," the veteran investor added.
Why It Matters: CEO Wood has previously <a href="https://www.benzinga.com/startups/24/07/39865003/bitcoin-could-soar-5-837-by-2030-according-to-cathie-wood-why-that-is-a-bold-prediction">expressed bullish sentiments about Bitcoin</a>, predicting a potential surge to a per-unit price of $3.8 million by 2030. Although not impossible, it's unlikely for BTC to achieve these numbers any time soon.
Wood has also joined the call for a<a href="https://www.benzinga.com/markets/cryptocurrency/24/11/41799045/ark-invests-cathie-wood-joins-call-for-strategic-bitcoin-reserve-gives-thumbs-up-to-cynthi"> strategic Bitcoin reserve</a>, which President-elect Donald Trump advocated for during his campaign trail.
Ark Invest was among the handful of players that launched a spot Bitcoin exchange-traded fund, namely ARK 21Shares Bitcoin ETF (BATS:<a class="ticker" href="https://www.benzinga.com/stock/ARKB#BATS">ARKB</a>), earlier this year. As per SoSo Value, it was the <a href="https://sosovalue.com/assets/etf/us-btc-spot">fourth-largest</a> Bitcoin fund as of this writing.
Price Action: As of this writing, Bitcoin was trading at $99,438.47, down 0.16% in the last 24 hours, according to <a href="https://pro.benzinga.com/dashboard?_gl=1&#x2A;380nj0&#x2A;_ga&#x2A;MTEyOTAyOTcxMy4xNzEzMzY0NTYy&#x2A;_ga_V7ZK73W7N0&#x2A;MTcxNDk4MzIzMi42LjEuMTcxNDk4OTE0Ni4wLjAuMA..">data from Benzinga Pro</a>.
Read Next:&nbsp;
<ul>
<li><a href="https://www.benzinga.com/24/12/42356727/peter-schiff-challenges-jim-cramers-bullish-bitcoin-take-says-such-statements-are-made-at-market-tops">Peter Schiff Questions Jim Cramer&#8217;s Bullish Bitcoin Take As It Slumps From $100K: These Are Statements &#8216;Made At Market Tops</a></li>
</ul>

ARK 21Shares Bitcoin ETF ARK 21Shares Bitcoin ETF

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