Stockwinners Market Radar for November 27, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:50 EST Silexion Therapeutics Corp trading halted, news pending

19:37 EST Eisai, Biogen launch Leqembi in South Korea - Eisai (ESAIY) and Biogen (BIIB) announced that the humanized anti-soluble aggregated amyloid-beta, or Abeta, monoclonal antibody Leqembi has been launched in South Korea. Leqembi received the Ministry of Food and Drug Safety, or MFDS, approval in May for treatment in adult patients with mild cognitive impairment due to Alzheimer's disease, or AD, or mild AD dementia.

18:29 EST Enerflex provides update on Kurdistan natural gas processing facility - Enerflex provided an update of a modularized cryogenic natural gas processing facility in Kurdistan. As previously announced, during the second quarter of 2024, Enerflex suspended activity at the EH Cryo project, demobilized its personnel and provided its customer with notice of Force Majeure following a fatal drone attack at an adjacent facility. Due to the continuing Force Majeure and circumstances that make it impossible for Enerflex to fulfill its obligations under the EH Cryo project contract, Enerflex provided its customer with formal notice of termination. As previously announced, Enerflex's customer has commenced arbitration proceedings against the Company, asserting certain baseless and unsubstantiated claims. Enerflex is disputing these claims and, following today's termination, Enerflex will seek to recover amounts owing in connection with the EH Cryo project. At the end of Q3, the net asset position associated with the EH Cryo project was $161M. Approximately $75M of work associated with the EH Cryo project was included in the company's Engineered Systems, or ES", backlog at the end of Q3. With the termination of the EH Cryo project, Enerflex expects to reverse this amount during the fourth quarter of 2024. The future ES revenue associated with the EH Cryo project was expected to contribute minimal gross margin. Since inception of the EH Cryo project, Enerflex has maintained a $31M letter of credit to support its obligations under the EH Cryo project contract. Enerflex would view any drawing of this financial security in the prevailing circumstances as improper and would increase the amount owing by the customer. Any drawing of the financial security would not have a material impact on the company's financial position or liquidity. At the end of Q3, Enerflex had $588M available for future drawings, which reflects the $31M letter of credit funded with the company's revolving credit facility.

17:37 EST Rivian Automotive Chairman Scaringe sells $938K in company shares - Rivian Automotive Chairman Robert Scaringe disclosed the sale of 83,334 shares of company stock on November 25, at $11.25 per share for a total transation amount of $937,508.

17:28 EST Primis Financial receives Nasdaq noncompliance notice - Primis Financial received, as the company expected, a notice from Nasdaq indicating that the company remains noncompliant with Nasdaq Listing Rule 5250(c) because the company has not filed its Quarterly Report on Form 10-Q for the quarters ended June 30 and September 30. The additional notice also required that the company submit an update to the Nasdaq Hearings Panel no later than November 28. The company has filed the previously delayed 2023 Form 10-K and the 2024 Q1 Form 10-Q and plans to file the Form 10-Qs as promptly as practicable. As with the prior notices, the additional notice has no immediate effect on the listing of the Company's common stock on the Nasdaq Global Select Market and the company currently expects to regain compliance in the near future.

17:19 EST Lockheed Martin awarded $579M Missile Defense Agency contract modification - Lockheed Martin was awarded a contract modification with an estimated value of $579M under Foreign Military Sales, or FMS, Case JA-P-NCO with the Japan Ministry of Defense. Under this modification, the contractor will continue to develop, test and integrate equipment, material, software and hardware end items in support of the Aegis System Equipped Vessel, or ASEV, and deliver the system to Japan. The work will be performed in Moorestown, New Jersey. The period of performance for this action is from Dec. 1 through Aug. 31, 2026. The total value of the contract is increased from $963.97M to $1.54B. FMS funds in the amount of $196.43M are being obligated at the time of modification award. The Missile Defense Agency is the contracting activity.

17:04 EST Primech Holdings receives noncompliance notification from Nasdaq - Primech Holdings announced that it received a letter from Nasdaq, notifying the company that it is eligible for an additional 180 calendar day period, or until May 12, 2025, to regain compliance with the Nasdaq's minimum $1 bid price per share requirement.

17:02 EST Gilead announces PURPOSE 2 trial data published in NEJM - Gilead announced The New England Journal of Medicine, or NEJM, published the full results from the company's pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. The study found that twice-yearly lenacapavir for pre-exposure prophylaxis, or PrEP, was highly efficacious at reducing HIV infections, reducing them by 96% compared to background HIV incidence. There were two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir for PrEP also demonstrated superiority to once-daily Truvada for PrEP and was generally well-tolerated, with no significant or new safety concerns identified. The efficacy and tolerability of lenacapavir are consistent with previous results from the PURPOSE 1 trial, which demonstrated zero infections and 100% efficacy for the investigational use of lenacapavir for PrEP in cisgender women in sub-Saharan Africa. The NEJM publication of the full PURPOSE 2 results follows a data presentation during an oral abstract session at the International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland earlier this month, the unblinding of the trial at interim analysis in September, and a presentation of additional efficacy and safety data in October at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 1 data were also published by NEJM in conjunction with the full data presentation at the 25th International AIDS Conference in Munich, Germany.

16:44 EST Applied Therapeutics down 84% after receiving CRL from FDA on NDA for govorestat - In after-hours trading, shares are down 84% to $1.34.

16:40 EST Applied Therapeutics trading resumes

16:32 EST Charles & Colvard receives non-compliance letter from Nasdaq - Charles & Colvard received a letter from the Nasdaq Listing Qualifications Department notifying the company that it was not in compliance with Nasdaq Listing Rule 5250(c), which requires the timely filing of all required periodic reports, as a result of not having timely filed its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024, and because the company remains delinquent in filing its Form 10-K for the fiscal year ended June 30, 2024. The company filed a Notification of Late Filing on Form 12b-25 with the SEC on November 15, 2024. The notice has no immediate effect on the listing or trading of the company's common stock on Nasdaq. The company has until December 17 to regain compliance with the Listing Rule or to submit to Nasdaq a plan to regain compliance with the Listing Rule. If Nasdaq accepts the plan, then Nasdaq may grant the company until April 14, 2025 to file its Form 10-K and Form 10-Q and regain compliance. The company is working to complete its Form 10-K and Form 10-Q and plans to file its Form 10-K and Form 10-Q as promptly as practicable.

16:19 EST Urban-Gro receives non-compliance notification from Nasdaq - Urban-gro received a notice from Nasdaq on September 21 stating that because the company had not yet filed its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024, the company continues to not be in compliance with Nasdaq listing rules. This notification has no immediate effect on the listing of the company's common stock on the Nasdaq Capital Market. The company's audit committee concluded that, as a result of inadvertent errors in the accounting for deferred tax liabilities associated with historical share-purchase acquisitions made by the company, it is appropriate to restate the company's previously issued financial statements as of and for FY22 and FY23 and interim financial statements for seven fiscal periods. Given the scope of the process for preparing the Amended Form 10-K and Amended Form 10-Q, the company was unable to complete and file the Form 10-Q by the required due date of November 14, 2024. On November 15, the company filed a Form 12b-25 Notification of Late Filing with the SEC related to the Form 10-Q. On September 27, the company submitted a plan to regain compliance with Rule 5250(c) with Nasdaq. On November 8, 2024, Nasdaq notified the company that the company must file all of its delinquent filings, including the Form 15, on or before January 31, 2025. The company would have the opportunity to appeal the delisting determination to a hearings panel.

16:16 EST Coinbase Chief People Officer sells $4.74M of shares - Coinbase Chief People Officer Lawrence Brock disclosed the sale of 15,858 shares at an average price of $298.98, for a total value of $4.74M. Brock continues to own 21,019 shares of Coinbase.

16:10 EST Four Corners Property acquires five Outback Steakhouse properties for $19.7M - Four Corners Property Trust is pleased to announce the acquisition of five Outback Steakhouse properties for $19.7M from the same Seller as that of the Bloomin' Brands 19-property portfolio the company closed in August 2024. The properties are located in strong retail corridors across Texas, Florida , and Missouri and are corporate operated under long-term net leases. The transaction was priced at a cap rate in range with previous FCPT transactions.

16:10 EST Four Corners Property acquires five Outback Steakhouse properties for $19.7M - Four Corners Property Trust is pleased to announce the acquisition of five Outback Steakhouse properties for $19.7M from the same Seller as that of the Bloomin' Brands 19-property portfolio the company closed in August 2024. The properties are located in strong retail corridors across Texas, Florida , and Missouri and are corporate operated under long-term net leases. The transaction was priced at a cap rate in range with previous FCPT transactions.

16:07 EST Titan Pharmaceuticals receives Nasdaq notice of non-compliance - Titan Pharmaceuticals reported that it received a notice on November 22 from the Listing Qualifications Department of The Nasdaq Stock Market advising the company that it was not in compliance with Nasdaq's continued listing requirements under the Nasdaq Listing Rule 5250(c)(1) as a result of its failure to file its Quarterly Report on Form 10-Q for the quarter ended September 30 in a timely manner. In response to the Notice, the company is working to file the Q3 Form 10-Q as soon as possible in order to regain compliance with the Listing Rule. However, if the company does not submit the Q3 Form 10-Q by January 21, 2025, the company will submit a plan by such date to Nasdaq that outlines, as definitively as possible, the steps the company will take to promptly file the Q3 Form 10-Q.

15:56 EST Janssen treatment of multiple myeloma granted FDA orphan status - Janssen Research & Development was granted FDA orphan designation for a treatment of multiple myeloma, according to a post to the agency's website. Reference Link

14:20 EST North American rail traffic up 19.1% for the week ending November 23 - The Association of American Railroads, AAR, reported U.S. rail traffic for the week ending November 23. For this week, total U.S. weekly rail traffic was 520,798 carloads and intermodal units, up 25.6% compared with the same week last year. Total carloads for the week ending November 23 were 230,036 carloads, up 17.6% compared with the same week in 2023, while U.S. weekly intermodal volume was 290,762 containers and trailers, up 32.8% compared to 2023. Nine of the 10 carload commodity groups posted an increase compared with the same week in 2023. They included nonmetallic minerals, up 8,383 carloads, to 29,904; chemicals, up 6,228 carloads, to 33,785; and grain, up 5,705 carloads, to 23,647. One commodity group posted a decrease compared with the same week in 2023: coal, down 2,934 carloads, to 58,189...North American rail volume for the week ending November 23 on 9 reporting U.S., Canadian and Mexican railroads totaled 338,963 carloads, up 13.2% compared with the same week last year, and 372,927 intermodal units, up 25.1% compared with last year. Total combined weekly rail traffic in North America was 711,890 carloads and intermodal units, up 19.1% North American rail volume for the first 47 weeks of 2024 was 31,571,661 carloads and intermodal units, up 2.5% compared with 2023. Publicly traded companies in the space include CN (CNI), CSX (CSX), Canadian Pacific Kansas City (CP), Norfolk Southern (NSC), Union Pacific (UNP), Greenbrier (GBX), FreightCar America (RAIL), L.B. Foster (FSTR), Wabtec (WAB), GATX (GATX) and Rail Vision (RVSN). Reference Link

13:38 EST Direct Line says Board 'unanimously rejected' Aviva's 'opportunistic' offer - In a notice to the London Stock Exchange, Direct Line (DIISY) stated: The Board of Direct Line Group notes the recent announcement made by Aviva plc regarding a possible offer for the Company and confirms that on 19 November 2024 it received an unsolicited, indicative and conditional cash and share proposal from Aviva to acquire the entire issued and to be issued share capital of Direct Line Group. As set out in the Aviva announcement, the terms of the Proposal comprised 112.5 pence in cash and 0.282 new Aviva shares for every Direct Line Group share. The Proposal implied a value of 250 pence per Direct Line Group share (based on the closing price of Aviva shares on 18 November 2024). The Board considered the Proposal with its advisers and concluded that it was highly opportunistic and substantially undervalued the Company. The Board has considerable conviction in the capabilities of our newly established leadership team and stands firmly behind their delivery of our strategy. Under this strategy, the Company continues to make early progress towards our financial targets, and expects to deliver attractive growth in profitability, capital generation and shareholder returns. As such, the Board considered the Proposal to not reflect the standalone value that can be delivered by the Company, and hence considered the possible offer highly opportunistic in nature. Accordingly, the Board unanimously rejected the Proposal on 26 November 2024. There can be no certainty that any firm offer will be made and, save as set out in the Aviva announcement dated 27 November 2024, nor as to the terms on which any offer will be made. In accordance with Rule 2.6(a) of the Code, Aviva is required, by not later than 5.00 p.m. on 25 December 2024, to either announce a firm intention to make an offer for the Company in accordance with Rule 2.7 of the Code or announce that it does not intend to make an offer for the Company, in which case the announcement will be treated as a statement to which Rule 2.8 of the Code applies. This deadline can be extended with the consent of the Panel on Takeovers and Mergers in accordance with Rule 2.6(c) of the Code. For the purposes of Rule 2.5(a) of the Code, this announcement is not being made with the approval of Aviva. As a consequence of this announcement, an 'offer period' has now commenced in respect of the Company in accordance with the rules of the Code and the attention of shareholders is drawn to the disclosure requirements of Rule 8 of the Code."

13:19 EST Grifols says 'not feasible' for transaction with Brookfield to move forward - In a notice to the Spanish National Securities Market Commission, Grifols stated: "Grifols announces that its Board of Directors held an extraordinary meeting this afternoon in which it was informed of the content of a letter sent today by Brookfield Capital Partners Limited to the Transaction Committee of the Board of Directors. As explained by the Transaction Committee to the Board, the letter stated that, under the current circumstances, Brookfield is not in a position to proceed with a potential offer for Grifols. The Board of Directors concurs that, given the current circumstances, it is not feasible for the Transaction to move forward. The Board of Directors appreciates the efforts made, although they have not been sufficient, and remains focused on enhancing the Company's long-term value."

12:59 EST Lionsgate discloses filing of amended Form S-4 registration statement with SEC - Lionsgate on Wednesday disclosed the public filing of an amended Form S-4 registration statement with the U.S. Securities and Exchange Commission around the separation of its studios business, to be called Lionsgate Studios Corp., and its media networks business, mainly Starz. The SEC filing calls for LG Studios to formally split from Starz to produce two separately traded public companies. The first, LGEC, will be renamed Starz Entertainment Corp., and New Lionsgate will be called Lionsgate Studios Corp. After the closing of the planned formal separation, pre-transaction shareholders of Lionsgate, the Hollywood studio, will own the shares in the two separately traded public companies. The transactions, involving a complex share exchange structure for shareholders, aim to be "generally tax-free for U.S. federal income tax purposes" for shareholders of LGEC and LG Studios common shares. The Lionsgate board of directors recommends that the Lionsgate shareholders vote "FOR" each of the proposals to be considered at the Lionsgate Annual General and Special Meeting. The LG Studios board of directors recommends that LG Studios shareholders vote "FOR" each of the proposals to be considered at the LG Studios Special Meeting.

12:50 EST Blue Bird JV Micro Bird to establish facility in New York State - Blue Bird Corporation announced the U.S. expansion of Micro Bird's manufacturing operations to build small and midsize buses in New York State. Micro Bird, a 50/50 joint venture of Blue Bird Corporation and Girardin, has confirmed the purchase of the Nova Bus facility in Plattsburgh, NY, and plans to begin production in mid-2025. The investment will enable Micro Bird to double its production capacity to better meet the sustained and growing demand for its full line of school buses, school activity buses, multi-purpose vehicles and commercial buses, the company said in a statement. Micro Bird is poised to create more than 350 full-time jobs over the next several years at its Plattsburgh facility. This project is supported by the Empire State Development with nearly $10M in performance-based Excelsior Jobs Program tax credits and a $2.5M capital grant from the North Country Regional Economic Development Council. "We are thrilled to expand our leadership in Type A small and midsize buses with Micro Bird's U.S. manufacturing capacity expansion in the great state of New York," said Phil Horlock, President and CEO of Blue Bird Corporation. "Once fully operational, the new facility will double our Micro Bird production capacity and represents a significant step in our long-term profitable growth journey."

12:22 EST Foxx Development Holdings Inc trading resumes

12:02 EST FDA investigating serious risk of hematologic malignancy following Skysona - The FDA stated: "Since approval, the Food and Drug Administration has received additional reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome and acute myeloid leukemia, following treatment of early, active cerebral adrenoleukodystrophy - CALD- patients with Skysona, or elivaldogene autotemcel, an autologous hematopoietic stem cell-based gene therapy. The reported cases appear to be related to treatment with Skysona. Reports were received from clinical trials, with cases diagnosed between 14 to 92 months post-treatment. FDA is investigating the known risk of hematologic malignancies with serious outcomes, including those such as hospitalization, the requirement for allogeneic hematopoietic stem cell transplantation, and death, and is evaluating the need for further regulatory action." Skysona is marketed by Bluebird Bio. Reference Link

12:00 EST Archer Aviation rises 16.7% - Archer Aviation is up 16.7%, or $1.21 to $8.43.

12:00 EST Nordstrom falls -11.1% - Nordstrom is down -11.1%, or -$2.73 to $21.89.

12:00 EST Dell Technologies falls -12.9% - Dell Technologies is down -12.9%, or -$18.23 to $123.51.

11:16 EST VeriSign rallies after reaching renewal agreement with ICANN - VeriSign and the Internet Corporation for Assigned Names and Numbers, or ICANN, entered into the renewal of the .com registry agreement, which amends and restates in its entirety the .com registry agreement, dated December 1, 2012, as amended on October 20, 2016, March 27, 2019, and March 27, 2020. The agreement is effective as of December 1, 2024. "The agreement includes certain new provisions to better align the agreement with ICANN's Base Registry Agreement, including permissible increases based on the U.S. Consumer Price Index in the domain name transaction fees that the Company pays to ICANN, obligations related to mitigation of Domain Name System abuse, and service level requirements for the Registration Data Access Protocol. The Agreement also contains new commitments to enhance the security, stability and resiliency of the .com Top-Level Domain, including new security incident reporting commitments and obligations for the parties to discuss business continuity. There are no changes to the provision governing the price that the Company charges for .com domain names," VeriSign disclosed earlier. The stock in morning trading is up 4% to $192.65.

10:31 EST JBT Corp. receives all regulatory clearances for Marel acquisition - JBT Corporation (JBT) announced receipt of all remaining regulatory clearances required to complete its proposal to acquire all issued and outstanding shares of Marel (MRRLF). On November 26, 2024, the European Commission adopted a clearance decision at the end of its Phase 1 review period. Additionally, on November 22, 2024, JBT received formal confirmation that the Australian Competition and Consumer Commission does not oppose the transaction. JBT's voluntary takeover offer will expire on December 20, 2024, at 12:00 GMT, unless such offer period is further extended in accordance with applicable laws and the terms of the definitive agreement between JBT and Marel. Provided JBT achieves a threshold acceptance by Marel shareholders, representing at least 90 percent of all Marel shares, JBT will settle the offer consideration to Marel shareholders within 5 Icelandic business days from the expiration date of the offer. The settlement of the transaction is therefore expected to close no later than January 3, 2025, taking into account all bank holidays in the Icelandic market.

10:00 EST Hims & Hers rises 14.0% - Hims & Hers is up 14.0%, or $4.29 to $34.97.

10:00 EST HP Inc. falls -9.5% - HP Inc. is down -9.5%, or -$3.71 to $35.38.

10:00 EST Tango Therapeutics treatment of pancreatic cancer granted orphan designation - Tango Therapeutics' treatment of pancreatic cancer was granted FDA orphan designation, according to a post to the agency's website. Reference Link

09:58 EST SmartKem Inc trading resumes

09:49 EST Archer Aviation rises 10.5% - Archer Aviation is up 10.5%, or 76c to $7.98.

09:48 EST SOS Limited rises 47.2% - SOS Limited is up 47.2%, or $3.28 to $10.23.

09:47 EST Guess falls -11.5% - Guess is down -11.5%, or -$2.00 to $15.33.

09:39 EST Quantum Corp trading resumes

09:38 EST Primega Group Holdings Ltd trading resumes

09:34 EST Quantum Corp trading halted, volatility trading pause

09:33 EST Primega Group Holdings Ltd trading halted, volatility trading pause

09:28 EST Haoxi Health Technology awarded RMB30M framework contract - Haoxi Health Technology announced the Company's wholly owned subsidiary Beijing Haoxi Digital Technology was awarded a Recharge Service Framework Contract to provide comprehensive digital advertising services with a budget of RMB30M for Tengyuan Media Advertising and its clients. Pursuant to the Contract, Tengyuan has authorized Beijing Haoxi to produce customized internet marketing services through its network of media platforms that align with Tengyuan's unique business needs. Over the next year, Beijing Haoxi will also utilize its marketing expertise to help promote and enhance competitiveness for Tengyuan and its clients, according to the Contract.

09:12 EST Vedanta signs MOU with Saudi Arabia in its Vision 2030 initiative - Vedanta Copper International, a 100% subsidiary of Vedanta Limited has signed a Memorandum of Understanding MoU with the Ministry of Investment and Ministry of Industries & Mineral Resources of the Kingdom of Saudi Arabia. This collaboration aims to invest $2B in significant copper projects, encompassing a 400 KTPA greenfield copper smelter and refinery and a 300 KTPA copper rod project, which are set to be established in Ras Al Khair Industrial City within the Kingdom...Chris Griffith, Chief Executive Officer - Base Metals, Vedanta Limited, remarked, "We are thrilled and truly honoured to collaborate with the Kingdom of Saudi Arabia in its Vision 2030 initiative. Our projects will enhance the Kingdom's self-reliance in the copper supply chain edanta plans to commence operations in the Kingdom with a 125 KTPA copper rod mill project, which requires an investment of ~$30 million. Commercial production is expected to start in full swing by Q4 FY 2025-26. The global annual demand for copper is expected to increase by 40% by 2040 driven by the global energy transition and the move towards a sustainable future.

09:03 EST MultiSensor AI appoints Stuart Flavin as interim CEO - MultiSensor AI Holdings announced a leadership transition as MultiSensor AI evolves into its goal of being a SaaS leader in Predictive Maintenance and to position the Company for its next phase of growth. The Board of Directors is pleased to announce that, consistent with its succession plans, it has appointed fellow Board member Stuart Flavin, III "Trip" to also serve as Interim CEO. Trip succeeds Gary Strahan who has stepped down as CEO to focus on the next phase of his professional career.

09:02 EST Rising Dragon Acquisition announces separate trading of ordinary shares, rights - Rising Dragon Acquisition announced that, commencing December 2, 2024, holders of the units sold in the Company's initial public offering completed on October 15, 2024 may elect to separately trade the ordinary shares of the Company, and the rights included in such units on The Nasdaq Capital Market. The ordinary shares and rights that are separated will trade on Nasdaq under the symbols "RDAC" and "RDACR," respectively. Those units not separated will continue to trade on Nasdaq under the symbol "RDACU." Holders of units will need to have their brokers contact Continental Stock Transfer & Trust Company, the Company's transfer agent, in order to separate the units into ordinary shares and rights.

09:02 EST Fat Brands announces opening of second Chicago area location - FAT announces the opening of Fatburger and Buffalo's Express in Chicago in the Chatham community, in partnership with franchisee Jackie Jackson, a well-known business figure throughout the Chicago area who was recently named Small Business Administration's Illinois small-business person of the year. "We are pleased to continue our growth throughout Illinois with an experienced small business owner like Jackie Jackson," said Jake Berchtold, COO of FAT Brands' Fast Casual Division. "There was strong demand to get a taste of Fatburger's iconic, made-to-order burgers when we opened in Orland Park last year and we look forward to introducing sister brand, Buffalo's Express, to the Chatham community, providing them with award-winning wings to pair their burgers, shakes and fries with."

08:53 EST Zentek to add ZenGUARD Enhanced Air Filters under existing MDEL - Zentek announces its decision that its ZenGUARD Enhanced Air Filters will be added under the company's existing medical device establishment licence, similar to ZenGUARD Surgical Masks. Initial test work and validation began on ZenGUARD Enhanced Air Filters in early 2021, culminating in the award of an Innovative Solutions Canada Testing Stream. The purpose of the ISC Testing Stream - The Government of Canada contract awarded in 2021 - was to determine whether ZenGUARD Enhanced Air Filters could achieve a significant net reduction in airborne respiratory pathogens, thereby validating it as an effective device to mitigate the transmission of disease. Independent proof-of-concept testing and validation was completed by the National Research Council of Canada in their unique bioaerosol facility, a purpose-built modular room intended to simulate the risk of infection in a real-world classroom environment. LMS Technologies Inc. was subsequently contracted to test ZenGUARD Enhanced Air Filter finished products and reported an average viral filtration efficiency enhancement of ~66% compared to an untreated filter, or an average ~67% VFE under simulated operating conditions over 6 months with negligible change in pressure drop. This extensive testing program was conducted over the course of approximately two years and successfully demonstrated that ZenGUARD Enhanced Air Filters can achieve a significant reduction in airborne respiratory pathogens to help mitigate the transmission of disease indoors. To further validate this, the Company completed a study with ParticleOne, a RWDI Ventures company. ParticleOne's computational model showcased ZenGUARD Enhanced Air Filter's viral filtration action, effectively reducing the spread of viral pathogens and enhancing indoor safety. It also demonstrated potential cost savings from absenteeism related to poor indoor air quality. Prior to distributing and selling an additional medical device in Canada, certain testing, process updates and additional documentation related to the Company's supply chain will be required to qualify ZenGUARD Enhanced Air Filters as a medical device under its MDEL and ensure compliance with its ISO 13485:2016 Quality Management System. While this process will take additional time and resources, the Company expects it to be significantly less than that required under the previous pathway to market being pursued.

08:49 EST Sellas Life Sciences announces data from preclinical studies of SLS009 - SELLAS Life Sciences announced data from preclinical studies identifying ASXL1 mutation as key predictor of SLS009, a highly selective CDK9 inhibitor, response in solid cancers. Based on elucidated biology of ASXL1 mutations, results from SELLAS' clinical trials in acute myeloid leukemia, and reports of common occurrence of ASXL1 mutations in some solid cancers, the Company performed experiments and analyses to explore the following: The frequency of ASXL1 mutations in certain solid cancers, including colorectal carcinomas with high level microsatellite instability and non-small cell lung cancer; Whether ASXL1 mutations in solid cancers may predict as high SLS009 efficacy as the efficacy exhibited in AML where ASXL1 and similar mutations demonstrated high response rates in SELLAS' clinical trials. SELLAS performed experiments in patient derived cell lines exposing them to SLS009 at various concentrations and determining the inhibitory concentration for each cell line. All cell lines were analyzed for presence of ASXL1 mutations and other genetic markers. High efficacy was prespecified as IC50 less than 100 nM, significantly lower than the standard threshold definition for an effective compound. This threshold was chosen based on the observed long-lasting concentrations of SLS009 observed in patients, which were ~400 nM. Negative controls consisted of untreated cell lines, while active negative control varying concentrations of revumenib. Positive controls involved cell lines treated with staurosporine at different concentrations. The results were as follows: In CRC MSI-H, ASXL1 mutations were observed in 7/12 of PDCs, aligning with predicted frequency of ~55%. In NSCLC, ASXL1 mutations occurred in 2/6 studied cell lines, higher than predicted 2.6%. Overall, in 18 studied solid cancer cell lines, ASXL1 mutations were recorded in 9 cell lines and no ASXL1 mutations were recorded in 9 cell lines which were designated as control. In ASXL1 mutated cell lines, high SLS009 efficacy was observed in 6/9 solid cancer cell lines and in non-ASXL1 mutated cancer high SLS009 efficacy was observed in 0/9 of studied solid cancer cell lines. In CRC MSI-H, high efficacy was observed in 4/7 of ASXL1 mutated cell lines and in 0/5 of non-ASXL1 mutated cell lines. In NSCLC, high efficacy was observed in 2/2 of ASXL1 mutated cell lines and in 0/4 of non-ASXL1 mutated cell lines. No activity was observed in any of the studied cell lines with revumenib at any concentration. Staurosporine activity was confirmed, but interestingly and importantly, SLS009 outperformed positive control staurosporine in 5/9 cell lines.

08:42 EST enVVeno launches recap website highlighting VEITH Symposium participation - enVVeno Medical announced the launch of a recap website which highlights the Company's participation at the recently held 51st Annual Vascular and Endovascular, Techniques and Horizons Symposium. Materials accessible on the recap website include interviews with two patients and two Principal Investigators who participated in the VenoValve U.S. Pivotal Trial as well as data presented at the symposium. "While our data is compelling, we think it is equally important to hear the stories behind the data from both physicians and patients who have first-hand experience with the VenoValve," said Robert Berman, CEO. "It is physicians and patients that will ultimately drive our commercial success following FDA approval. This is the second group of patients and third group of primary investigators whose perspectives we have made available. It takes an organic network of physician and patient advocates for a new device to succeed and anyone who takes the time to engage with these materials will recognize the strong foundation we've established."

08:39 EST LQR House announces share acquisition by MeiFang Group - LQR House announced a step forward under the guidance of activist investor David Lazar. Mr. Lazar has entered into a Securities Purchase Agreement with both MeiFang Group & Winz Technology Co., signaling a strategic alignment aimed at advancing LQR House's market position and fostering sustainable growth. As part of the agreement, MeiFang Group acquired 821,818 shares of common stock from Mr. Lazar for $1,300,000, representing a valuation of $1.58 per share. Similarly, Winz Technology Co. is set to acquire 280,000 shares of common stock from Mr. Lazar for $800,000, reflecting a valuation of $2.85 per share. LQR House also announced the nomination of two candidates Yilin Lu and Hong Chun Yeung, to its Board of Directors. These appointments are pending shareholder approval. Lu has served as the Founder and CEO of Senchi Morgan Capital Market and Senchi Morgan Asset Management. Hong Chun Yeung, a practicing member of the Hong Kong Institute of Certified Public Accountants, has around 13 years of experience in auditing, M&A advisory, and pre-listing consultation. As a Director of Zhonghui Anda CPA since 2014, Mr. Yeung has provided strategic oversight to companies in manufacturing, mining, logistics, and engineering.

08:35 EST Global Water board increases quarterly dividend 1% to 2.533c per share - Global Water Resources has increased its dividend by 1% and declared under its dividend policy an increased monthly cash dividend in the amount of $0.02533 per common share. The increased monthly distribution represents a new annualized dividend rate of $0.30396 per share, an increase of $0.003 per share from the previous annual rate of $0.30096 per share. The dividend will be payable on December 30, 2024, to holders of record at the close of business on December 16, 2024.

08:33 EST Jeffs' Brands entered into LOI with Deliverz.AI - Jeffs' Brands announced that it has entered into a binding Letter of Intent, LOI, with Deliverz.AI. The LOI outlines a plan to establish a joint venture to operate exclusively in the United States, combining the strengths of both companies to introduce AI-powered fully autonomous robotic solutions for healthcare logistics in the United States

08:31 EST Nova to acquire Sentronics Metrology for $60M in cash - Nova announced that it has entered into a definitive agreement to acquire Sentronics Metrology GmbH, a privately held company headquartered in Mannheim Germany, in an all-cash transaction valued at approximately $60M. The acquisition is subject to customary closing and regulatory conditions and approvals and is expected to close within the first quarter of 2025. The company expects the acquisition to be accretive on a non-GAAP basis within 12 months of closing. Sentronics Metrology GmbH is a global provider of wafer metrology tools for backend semiconductor fabrication. The company develops flexible and modular metrology tools equipped with multiple metrology sensors for a variety of critical dimension applications, including thickness, roughness, and topography.

08:09 EST CMC Metals announces new MRE for Silver Hart Project - CMC Metals announced a new Mineral Resource Estimate for its silver-lead-zinc Silver Hart Project, in Yukon, Canada. The new MRE totals an Inferred resource of 8.820 Moz @ 145.2 g/t silver equivalent. in 1,889,000 tonnes utilizing a cut-off grade of 50 g/t AgEq. This MRE has been prepared in accordance with the Canadian Securities Administrators' National Instrument 43-101 - Standards of Disclosure for Mineral Projects. Kevin Brewer, CEO, noted, "We have a conceptual development plan that suits the size and grade of the resource estimate and the nature of the mineralization that starts at surface. The mineralization at Silver hart comprises of high-grade veins and mantos that are potentially amenable to open pit mining. Our plan is to fully evaluate developing these resources for a seasonal, small scale open pit operation developing each of the known mineralized areas. We plan to evaluate the potential ways to minimize project risk that will include the possible utilization of an ore sorter to enhance ore grades with the concentrate material then trucked to a processing facility. The closest potential mill may be at the Silvertip project owned by Coeur Mining, which would entail a trucking distance of approximately 100 kilometers from Silver Hart. CMC also hopes to establish a partnership arrangement with local First Nations to undertake this project and will be commencing discussions in the very near future. Our next steps are to engage discussions with First Nations and conduct the first round or metallurgical testing and ore sorting capabilities which we hope to commence in the near future, subject to financing."

08:07 EST Radiopharm Theranostics achieves Nasdaq listing of ADSs - Radiopharm announced that American Depositary Shares representing its ordinary shares will commence trading on the Nasdaq Capital Market on Wednesday morning, 27 November 2024 US time, under the ticker symbol "RADX". Each ADS represents 300 ordinary shares of the Company. The listing on Nasdaq follows the declaration of effectiveness by the U.S. Securities and Exchange Commission of the Company's registration statement on Form 20-F and formal approval from Nasdaq upon meeting its listing requirements. The Nasdaq listing is a secondary listing and complements the Company's existing primary listing of ordinary shares on the ASX. The Company completed the Nasdaq listing without an associated capital raise in the United States. Therefore, initial trading of ADSs may be limited due to the time it takes for existing shareholders to deposit their RAD ordinary shares into the ADR program and receive ADSs for trading on Nasdaq. Deutsche Bank Trust Company Americas has been appointed depositary, custodian, and registrar for the Company's American Depositary Receipt program.

08:06 EST Rallybio publishes RLYB212 data - Rallybio announced the publication of a manuscript titled, "Informing Pregnancy Dose via Target-Mediated Drug Disposition Modeling and Simulations for a Recombinant Human Monoclonal Antibody," in a special pregnancy themed issue of Clinical Pharmacology and Therapeutics: Pharmacometrics & Systems Pharmacology. The manuscript details the target-mediated drug disposition, or TMDD, model, which simultaneously characterized the pharmacokinetics of RLYB212 and introduces a novel parameter to describe the pharmacodynamics of HPA-1a-positive platelet elimination. Prior to performing dose regimen simulations, additional model parameters related to clearance, volume and intercompartmental transfer rates were incorporated into the TMDD model to account for dynamic physiological changes associated with pregnancy. The model was then used to perform simulations to inform the dosing regimen for the RLYB212 Phase 2 dose confirmation trial in pregnant women at higher risk of HPA-1a alloimmunization and FNAIT. The complete article can be accessed here. Rallybio is developing RLYB212, a novel human monoclonal anti-HPA-1a antibody, to prevent alloimmunization in pregnant women and thereby eliminate the risk of FNAIT and its potentially devastating consequences in their fetuses and newborns. Rallybio recently announced the initiation of screening in its Phase 2 dose confirmation trial in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT. The company is also conducting a non-interventional FNAIT natural history study that is designed to provide a contemporary dataset for HPA-1a alloimmunization frequency in a racially and ethnically diverse population. As of November 1, more than 13,000 pregnant women had been screened in this ongoing study.

08:05 EST WORK Medical subsidiary showcases products at MEDICA Trade Fair 2024 - WORK Medical Technology announced that its subsidiary, Hangzhou Shanyou Medical Equipment, participated in the MEDICA Trade Fair 2024, held in Dusseldorf, Germany, from November 11 to November 14, 2024. The Event provided a platform through which Hangzhou Shanyou's products could garner interest and attention from international customers. This milestone underscores WORK Medical's strategic commitment to enhancing its global brand visibility and competing internationally in the low- and medium-value medical devices and consumables sectors.

08:04 EST Information Services announces ticker symbol change on TSX - Information Services announced that the Company's stock ticker symbol on the Toronto Stock Exchange will change from "ISV" to "ISC" effective as of market open on Monday, December 2, 2024. As a result of this change, "ISC" will now be the ticker symbol for Information Services Corporation's common shares listed on the TSX. The change allows for improved and synchronized brand alignment for the stock and the Company. No action is required by ISC's shareholders in connection with the ticker symbol change. The CUSIP number for ISC's Class A Limited Voting Shares remains unchanged, and no steps need to be taken with respect to previously issued share certificates, as these are not affected by the symbol change.

07:44 EST Idaho Strategic sees election as 'pivotal turning point' for country - Idaho Strategic Resources provided a President's Letter to stakeholders, which read in part, "I have stated publicly that Idaho Strategic's business plan, in general, was built around what keeps me up at night, and as a fellow investor the opportunity such dislocations may provide. This statement rings as true today as it did when I first got involved with Idaho Strategic, then New Jersey Mining Company, in 2013. Beyond my belief that the Golden Chest Mine and New Jersey Mill were undervalued/under-owned assets with a lot of upside potential, there was the developing backdrop of the cracks that had the potential to form over the longer term in the foundation of American hegemony. As a student of history, local economies and commodities, I am keenly aware of the role that human nature plays in decision making and the tendencies for humans to unknowingly sow the seeds of failure during times of great success. It has been a pattern that has repeated itself a number of times throughout history at the individual and societal level. And until recently, I was admittedly fearful that America was following the same path while simultaneously losing its ability to course-correct. As Ayn Rand once famously said, 'You can ignore reality, but you can't ignore the consequences of ignoring reality'. For me, the recent presidential election was a pivotal turning point for our country. And to be clear, it wasn't as much the political result of the election that I am referring to, but rather what the result of the election says about the condition and resiliency of the American people. It is my opinion that the election of President Trump sends a clear message that American's are not only willing to change, but they are willing to own the challenges of bringing about change. At IDR, we have built a business around paying attention to the consequences of other's choosing to ignore reality, many of which have come to pass and are better known today; such as the rise of the BRICS Nations Alliance, America's dependence on foreign sources for critical minerals, our country's compounding national debt and subsequent inflation, and a global mindset that is shifting away from the US dollar as the world's reserve currency. We see an eventual investment horizon in which the commodity cycle and domestication is fully realized and that exposure to gold as a 'hedge' is seen more as yesterday's speculative rationale, with critical minerals and stores of value comprising a much larger portion of investor's more permanent portfolios. Furthermore, I believe that one of the best indications for how to address the global 'shake-up' is to take cues from the fact that the primary gold bulls of today aren't individual investors - it's the guys running the fiat printers. This is an insider buy signal at a global scale. These are up and coming central banks with a new reserve policy, and it appears to heavily favor gold. And I remain hopeful that, post-election, the U.S. will adjust and lead the way into this new era of multiple competitive global currencies. All of the above said, and to paraphrase Toby Keith's 'Never apologize for being proud of your country' ringing in my head, I am heading into this Thanksgiving cautiously optimistic about the rekindling of American Patriotism, feeling fortunate that gold is trading above $2,700 an ounce, and knowing our folks at the mine and mill are ceding the high ground to no one. And while I don't know the future and I certainly cannot change it; I know we will do our best to put Idaho Strategic in a position to benefit from whatever comes our way."

07:38 EST Interactive Strength announces compliance letter for continued Nasdaq listing - Interactive Strength announced that the Company received a letter confirming demonstrated compliance with Listing Rule 5550(b)(1) of The Nasdaq Stock Market, which successfully concludes the Hearings Panel appeal process that began in May.

07:35 EST StoneX Financial achieves GCM status with European Commodity Clearing - StoneX Group announced that its wholly owned subsidiary, StoneX Financial, has been awarded General Clearing Member status by European Commodity Clearing. This achievement underscores StoneX Financial's commitment to expanding its capabilities and providing enhanced services to its energy and commodities sector clients.

07:32 EST Kronos Bio announces workforce reduction of 83% by year-end - The company announced a workforce reduction of approximately 83 percent by year end as part of its previously announced plan to implement cost reduction strategies while exploring options, including possible business combinations and/or divestiture of its remaining internally developed preclinical assets, in an effort to maximize stockholder value.

07:29 EST Electrovaya provides update on EXIM loan, Jamestown expansion - EXIM Direct Loan Update: The Export-Import Bank of the United States on November 14, 2024 approved a direct loan of $50.8 million to Electrovaya to support its lithium ion battery manufacturing expansion in Jamestown, New York. Electrovaya is currently in the process of finalizing documentation with an anticipated funding date in CY Q1 2025. The EXIM facility is expected to have a term of six years with an expected interest rate of 4.25%, subject to any changes in the Federal interest rate prior to closing and annual fees of less than2%. The EXIM facility will cover all equipment, engineering and construction costs for the Jamestown battery manufacturing site. Other Jamestown NY Expansion Updates: Electrovaya is in the process of updating disbursement schedules from Empire State Development to reflect the anticipated Jamestown battery manufacturing project start. ESD has provided commitments of $6.5 million of incentives including $2.0 million in grants and $4.5 million in refundable tax credits. Jamestown battery operations are expected to commence in the first half of CY 2026, coinciding with several ongoing OEM production programs reaching maturity which is expected to further bolster demand and revenue. Verticals & Market Interest for Mission Critical Applications: Electrovaya's core market for material handling electric vehicles and robots is witnessing increasing demand from the Company's current largest end users. Furthermore, a new leasing promotion in partnership with an OEM partner appears to be generating new sales opportunities. Electrovaya continues to make strides in growing interest from the defense industry. Recently, a global aerospace and defense company issued follow on orders for high voltage battery systems following intensive testing. The Company is expecting to ship its first battery modules to a global Japanese headquartered construction equipment OEM in CY Q1 2025. These initial shipments will be exported to Japan. The Company has begun development of battery systems specifically targeting the data center energy storage/back-up power market. Due to inherent advantages in safety and longevity, we believe that the Company can retain premium pricing in this fast growing energy storage segment. Solid State Battery Research: progress continues in developing lithium ion conducting ceramics along with a composite separator. Pouch cell testing is ongoing.

07:27 EST FCC grants SpaceX approval for coverage from space with T-Mobile - The Federal Communications Commission granted SpaceX's application, as amended, authorizing SpaceX to provide supplemental coverage from space in earth-to-space and space-to-Earth bands in the United States pursuant to a lease arrangement with T-Mobile (TMUS) and to operate its satellites in the mobile-satellite service ( in certain sub-bands for the purpose of direct-to-cell operations outside the United States. SpaceX has permission to use T-Mobile's cellular frequencies on up to 7,500 Gen2 Starlink satellites to provide supplemental coverage from space, provided it does not interfere with other networks. Reference Link

07:22 EST Codere Online sees FY24 net gaming revenue in upper part of EUR 205M - EUR 215M - Oscar Iglesias, CFO of Codere Online, stated, "Beyond the significant top line growth, we also generated EUR 1.5 million of Adjusted EBITDA and EUR 3.5 million of cash in the quarter. This is now the third consecutive quarter of positive Adjusted EBITDA and brings the year-to-date total to EUR 4.5 million. With regards to our existing outlook for 2024, we expect to finish the year in the upper part of the range with respect to both our net gaming revenue and Adjusted EBITDA guidance."

07:17 EST Camtek awarded $50M initial orders for its new Hawk product - Camtek announced that it has received over $50M in initial orders from several customers for its new Hawk product, with additional orders in the pipeline. These orders will be delivered throughout 2025. The Hawk, based on a groundbreaking new platform, addresses high-end Advanced Packaging technologies including capabilities for inspection and 3D measurements of wafers with 500 million micro bumps and Hybrid Bonding technology. Offering significantly enhanced capabilities beyond the Eagle product line, the Hawk expands Camtek's total addressable market, or TAM. The Hawk will be officially launched in February 2025 at Semicon Korea.

07:11 EST Lithium Ionic secures LOI from EXIM for $266M - Lithium Ionic announce the receipt of a non-binding Letter of Interest, LOI, from the Export-Import Bank of the United State, EXIM, to provide up to $266M in debt financing for its 100%-owned flagship Bandeira Lithium Project, located in Minas Gerais, Brazil. This funding represents 100% of the capital expenditure outlined in the May 2024 Feasibility Study, marking a pivotal milestone as the Company accelerates toward construction and production within the next 2 years.

07:09 EST Computer Modelling Group appoints Herman Nieuwoudt as president, Bluware - Computer Modelling Group announces the appointment of Herman Nieuwoudt as President of Bluware, a CMG company. He joins Bluware from a successful career at Baker Hughes where he spent almost two decades in various positions, most recently as Vice President, Saudi Arabia

07:06 EST Enthusiast Gaming appoints Macdonald as CFO - Enthusiast Gaming announced that Felicia DellaFortuna has tendered her resignation as Chief Financial Officer of the Company, CFO, to pursue a new opportunity. Alex Macdonald, who had served as CFO of Enthusiast Gaming from its inception until November 2023, has agreed to return as CFO of the Company. His appointment by the Board of Directors will become effective December 31, 2024, concurrently with DellaFortuna's resignation.

07:05 EST PTC Therapeutics to sell Priority Review Voucher for $150M - PTC Therapeutics announced that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher for $150M upon the closing of the transaction. PTC was granted the PRV on November 13 along with the U.S. FDA approval of KEBILIDI for the treatment of children and adults with AADC deficiency, including the full spectrum of disease severity. The transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino Antitrust Improvements Act.

07:05 EST Laser Photonics opens pre-orders for CleanTech Industrial Roughening Laser 3060 - Laser Photonics announced that pre-orders are open for its soon to be launched CleanTech Industrial Roughening Laser 3060. This versatile surface treatment system can function as a standalone unit or be integrated into a CleanTech Robotic Cell for an AI ready automated solution.

07:04 EST SolarEdge to cease all Energy Storage division activities to focus on core solar - SolarEdge Technologies announced that as part of its focus on its core solar activities, it will cease all activities of its Energy Storage division. This decision will result in a workforce reduction of approximately 500 employees, most of whom are in South Korea. The expected quarterly operating expenses savings due to the closure are approximately $7.5 million with the full run rate expected to be achieved by the second half of 2025. The Company intends to sell the assets related to the storage division activities including its manufacturing facilities for battery cells and packs. This does not impact the solar business sale of batteries for residential and C&I markets. Ronen Faier, Interim Chief Executive Officer of SolarEdge, said: "The decision to close our Energy Storage division was the result of a thoughtful analysis of our portfolio of businesses and product lines, industry trends, and the competitive environment. The measures also represent continued execution of two of our main priorities: financial stability through cost reduction, return to cash flow positivity and profitability; and focus on our core business lines of solar, PV-attached storage and energy management capabilities. I wish to thank our Energy Storage division employees for all of their efforts in building this business."

07:03 EST WeightWatchers appoints DellaFortuna as CFO - WW International (WW) announced the appointment of Felicia DellaFortuna as Chief Financial Officer, CFO, effective January 1, 2025. She succeeds Heather Stark, who will remain with the Company through December 27, 2024. DellaFortuna was previously CFO of Enthusiast Gaming (EGLXF)

07:02 EST CervoMed announces ODD granted to neflamapimod by U.S. FDA - CervoMed announced that its oral investigational drug neflamapimod has been granted Orphan Drug Designation, ODD, by the U.S. Food and Drug Administration, FDA, for the treatment of frontotemporal dementia, FTD. "We are pleased to have received Orphan Drug Designation as it implicitly recognizes the scientific rationale and potential for neflamapimod to treat this debilitating condition. Patients diagnosed with frontotemporal dementia have no available treatment options, and this rare condition is extremely burdensome to patients and caregivers alike," said John Alam, MD, Chief Executive Officer of CervoMed. "Within this year, there have been multiple scientific presentations and publications that indicate neflamapimod targets specific pathogenic mechanisms associated with FTD. We are in active discussions with clinical thought leaders regarding the design of a proof-of-principle study in FTD, while continuing to prepare to advance neflamapimod into a Phase 3 trial in DLB in mid-2025."

06:53 EST Outlook Therapeutics reports preliminary results from Norse Eight trials - Outlook Therapeutics announced preliminary topline results of Norse Eight, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients. Upon the completion of analysis of the final results of NORSE EIGHT, Outlook Therapeutics plans to resubmit the Biologics License Application, or BLA, application for ONS-5010 in the Q1 of FY25. In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment, or SPA, with the FDA. However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010. Analysis of the data is ongoing as the month 3 data from NORSE EIGHT is being collected, which is expected to be available in January 2025. Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics plans to resubmit the BLA application for ONS-5010 in the first quarter of calendar 2025. In addition, plans for a potential 2025 launch in the UK and Germany are ongoing, where LYTENAVA has received European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics remains confident that ONS-5010/ LYTENAVA is an important therapy for the treatment of wet AMD in place of off-label repackaged bevacizumab that has not received regulatory approval for use in ophthalmology. The pre-specified non-inferiority endpoint at week 8 set forth in the SPA with the FDA was measured by mean change in best corrected visual acuity, or BCVA, from baseline to week 8. The difference in the means between the ONS-5010 and ranibizumab in the NORSE EIGHT trial was -2.257 BCVA letters with a 95% confidence interval of while the lower bound of the pre-specified non-inferiority margin in the SPA was -3.5 at a 95% confidence interval; the hypothesis of noninferiority was not met. In the intent-to-treat, or ITT, primary dataset, NORSE EIGHT demonstrated a mean +4.2 letter improvement in BCVA in the ONS-5010 arm and +6.3 letter improvement in BCVA in the ranibizumab arm.

06:14 EST Novartis announces EC approved Kisqali in combination with an inhibitor - Novartis announced that the European Commission, EC, has approved Kisqali in combination with an aromatase inhibitor, AI, for the adjuvant treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2, HER2, -negative early breast cancer, EBC, at high risk of recurrence. The approval is based on results from the pivotal Phase III NATALEE trial, which included a broad patient population with HR+/HER2- stage II and III EBC, including those with node-negative disease2. The trial showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence with adjuvant Kisqali plus endocrine therapy compared to ET alone. The invasive disease-free survival benefit was consistently observed across all patient subgroups. Regulatory review of Kisqali in EBC is ongoing worldwide. Following recent data announcements at ESMO 20246, Novartis will continue to evaluate NATALEE patients for longer-term outcomes, including overall survival.

06:01 EST Samsung names Young Hyun Jun as head of memory chip unit, co-CEO - Samsung Electronics announced new leadership for the next phase of the company's growth and to strengthen its future competitiveness, focusing on the semiconductor business. Young Hyun Jun, Vice Chairman and Head of Device Solutions Division, was named CEO and will also become the Head of Memory Business and Samsung Advanced Institute of Technology. Jinman Han was promoted to President and will become the Head of Foundry Business, while Seok Woo Nam will become Chief Technology Officer of Foundry Business, a newly-created position. JH Han, Vice Chairman, CEO and Head of Device eXperience Division, will also lead a newly-created committee that will focus on strengthening product quality across the company. Reference Link

05:24 EST Jack in the Box COO Tony Darden to depart - Jack in the Box announced a strategic leadership restructure as Tony Darden, SVP, COO, will depart from his role. Darden has been a member of the Jack in the Box executive team since June 2021. Darden's departure is consistent with a planned restructure that includes Ryan Ostrom, currently serving as EVP, chief marketing and digital officer, assuming responsibility for Jack Operations in addition to his current function. Ostrom has been named chief customer and digital officer, effective December 6.

05:10 EST Nokia awarded over 3,000 sites by Deutsche Telekom - Nokia announced that it has been awarded more than 3,000 sites by Deutsche Telekom to support the operator's multi-vendor Open RAN network scale-up in Germany. The deal, which includes Fujitsu, covers a mass rollout of O-RAN-compliant technology with commercial deployment already underway in the Neubrandenburg area of Northern Germany. The new deal formally marks Nokia's return as a supplier to Europe's largest network and will see Nokia replace the incumbent vendor in the area covered in the agreement. Under the deal, Nokia will supply equipment from its O-RAN-compliant 5G AirScale portfolio powered by its energy-efficient ReefShark System-on-Chip technology, including modular baseband solutions and Habrok Massive MIMO radios for coverage and capacity. Nokia will also deploy its intelligent AI-powered MantaRay NM solution for improved network monitoring and management and will provide AI-based services, including digital deployment, optimization, and technical support.