Stockwinners Market Radar for June 14, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:50 EDT Salarius Pharmaceuticals trading halted, news pending

19:50 EDT Star Equity Holdings Inc trading halted, news pending

17:21 EDT General Dynamics awarded $202.73M Navy contract - General Dynamics was awarded a $202.73M cost-plus-award-fee contract, for DDG 51 Class Planning Yard. This contract includes options which, if exercised, would bring the cumulative value of this contract to $1.13B. Work will be performed in Bath, Maine, and is expected to be completed by July 31, 2029. FY24 operation and maintenance funds in the amount of $5.99M and FY24 other procurement funds in the amount of $7.22M, will be obligated at time of award, of which $5.99M will expire at the end of the current fiscal year. This contract was not competitively procured in accordance with 10 U.S. Code 2304(c)(1). Naval Sea Systems Command is the contracting activity.

16:43 EDT Northfield Bancorp announces new $10M share repurchase plan - In a regulatory filing, Northfield Bancorp disclosed that on June 14, the Board of Directors of the company approved a new $10M stock repurchase program. The company anticipates conducting such repurchases beginning on June 18 in accordance with a Rule 10b5-1 trading plan.

16:22 EDT Amgen says FDA approves BLINCYTO - Amgen announced the U.S. Food and Drug Administration has approved BLINCYTO for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase, regardless of measurable residual disease status. "B-ALL is an aggressive blood cancer with enduring high unmet need. BLINCYTO has helped thousands of patients with B-ALL over the last 10 years. Today's approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager therapy," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. The approval marks the third indication for BLINCYTO and is based primarily on the Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group that studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that BLINCYTO added to multiphase consolidation chemotherapy showed superior overall survival versus chemotherapy alone. The 3-year OS was 84.8% in the BLINCYTO plus chemotherapy arm and 69% in the chemotherapy arm, with the hazard ratio for OS of 0.42. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm and 62.5% in the chemotherapy arm.

16:09 EDT AbbVie recommends shareholders reject Tutanota's 'mini-tender' offer - AbbVie has been notified that Tutanota LLC has commenced an unsolicited "mini-tender" offer, dated May 28, 2024, to purchase up to 250,000 shares of AbbVie common stock at $165.00 per share in cash. This offer is conditioned on, among other things, the closing price per share of AbbVie's common stock exceeding the Offer Price on the last full trading day prior to the expiration date of the offer. Tutanota also states in its offer documents that it expects to extend the offer for successive periods of 45 to 180 days until the market price of AbbVie's common stock exceeds the Offer Price. This means that AbbVie shareholders who tender their shares in the offer will receive a below-market price if the offer conditions are satisfied and their shares are accepted in the offer. There is no guarantee that the conditions of the offer will be satisfied. AbbVie does not endorse Tutanota's offer and is not associated in any way with Tutanota, its offer, or the offer documents. AbbVie recommends that AbbVie shareholders do not tender their shares in response to this unsolicited offer. AbbVie shareholders who have already tendered may withdraw their shares by providing the written notice described in the Tutanota offer documents prior to the expiration of the offer, which is currently scheduled at 5:00 p.m. New York City time on June 28, 2024.

16:07 EDT Shift4 Payments CEO Isaacman sells 14,486 class A shares - In a regulatory filing, Shift4 Payments chairman and CEO Jared Isaacman disclosed the sale of 14,486 class A common shares of the company on June 14 at a price of $69.3987 per share.

15:51 EDT RCP Eagle reports 8.36% stake in New York Community Bancorp - RCP Eagle Holdings disclosed an 8.36% stake in New York Community Bancorp, which represents over 88.1M shares. On March 7, New York Community entered into an investment agreement with RCP Eagle.

14:37 EDT Disc Medicine jumps 18% to $46.15 after data update, share offering

14:07 EDT Novavax submits application to FDA for updated COVID-19 vaccine formula - Novavax announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration for its updated JN.1 COVID-19 vaccine for individuals aged 12 and older. The submission is in line with guidance from the U.S. FDA, European Medicines Agency and the World Health Organization to target the JN.1 lineage this fall. Novavax's JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants. As discussed at the recent FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to target JN.1, the parent strain of the most common currently circulating variants. "Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates," said John C. Jacobs, President and Chief Executive Officer, Novavax.

13:36 EDT NightHawk Biosciences Inc trading halted, news pending

13:05 EDT MultiSensor AI enters Strategic Channel Partner relationship with Denali - MultiSensor AI Holdings has entered into a formal Strategic Channel Partner relationship with Denali Advanced Integration. MSAI and Denali have worked together closely for many years, particularly serving customers in MSAI's core Distribution & Logistics and Manufacturing verticals. By formalizing their relationship, Denali makes it easier for its customers to purchase MSAI's multi-sensor solutions directly, and sets the stage for accelerated commercial rollout of these solutions into a large existing customer base. Denali's distinctive logistics and implementation capabilities accelerate MSAI's geographic growth, particularly in Europe and APAC. Both companies' strong relationships with Amazon Web Services create additional strategic and commercial opportunities. Finally, and most important, MSAI's sensor technologies and software complement Denali's proprietary development of innovative automation solutions across multiple industry verticals.

13:00 EDT Baker Hughes reports U.S. rig count down 4 to 590 rigs

12:24 EDT Kyverna: KYV-101 demonstrates 'promising' outcomes across multiple indications - On June 14, Kyverna Therapeutics hosted an industry symposium at EULAR in Vienna with a data update on KYV-101, its lead CAR T-cell therapy candidate. In the data presentation, Kyverna said early KYV-101 data demonstrate "promising" outcomes across multiple indications. In the KYV-101 CAR safety and efficacy experience from hematology, the company said CAR demonstrated an improved safety profile in a 20-patient study without compromising efficacy and that data supported dose-selection for the autoimmune disease setting. In myasthenia gravis, within 60 days of infusion, improved symptoms and mobility were observed, Kyverna says.

12:09 EDT Denali Capital Acquisition Corp trading halted, volatility trading pause

12:03 EDT Li-Cycle rises 10.1% - Li-Cycle is up 10.1%, or 36c to $3.94.

12:01 EDT MSC Industrial falls -9.4% - MSC Industrial is down -9.4%, or -$8.00 to $76.66.

12:00 EDT RH falls -17.8% - RH is down -17.8%, or -$49.22 to $227.84.

10:32 EDT Fluor team awarded NNSA's Pantex plant management and operating contract - Fluor Corporation (FLR) announced that the U.S. Department of Energy's National Nuclear Security Administration selected PanTeXas Deterrence LLC - a joint venture led by a BWX Technologies (BWXT) subsidiary, together with Fluor; SOC, a Day & Zimmermann Company; and The Texas A&M University System - for the management and operations of the Pantex Plant located outside of Amarillo, Texas. Following an initial term of five years, NNSA has the ability to award three additional five-year option periods. If all contract options are exercised, the contract will span 20 years at a funding level of approximately $30B. "We have supported our nation's security since 1944 and are looking forward to delivering on the NNSA's mission at the Pantex Plant," said Tom D'Agostino, Group President of Fluor's Mission Solutions business. "With the purpose of supporting the Nuclear Security Enterprise, we are committed to helping NNSA revitalize America's national security while building a culture of safety, production delivery and program excellence." Pantex represents a key nuclear production capability and is responsible for maintaining the safety, security and effectiveness of the nation's nuclear weapons stockpile. Work performed at Pantex includes support of the nuclear weapons life extension programs; nuclear weapons surveillance, assembly and dismantlement; and the development, testing and fabrication of high explosive components.

10:14 EDT Snap One announces completion of acquisition by Resideo - Snap One (SNPO) announced that its acquisition by Resideo Technologies (REZI) was completed today. The acquisition was effectuated by the merger of a wholly-owned subsidiary of Resideo with and into the company, with the company surviving the merger and becoming a wholly-owned subsidiary of Resideo.

10:04 EDT Havertys rises 5.5% - Havertys is up 5.5%, or $1.39 to $26.67.

10:02 EDT Tutor Perini rises 8.9% - Tutor Perini is up 8.9%, or $1.71 to $20.91.

10:00 EDT MSC Industrial falls -7.9% - MSC Industrial is down -7.9%, or -$6.67 to $77.99.

09:59 EDT La Rosa Holdings trading halted, news pending

09:51 EDT MSC Industrial falls -5.5% - MSC Industrial is down -5.5%, or -$4.62 to $80.04.

09:49 EDT RH falls -14.6% - RH is down -14.6%, or -$40.55 to $236.50.

09:48 EDT ZKH Group rises 6.3% - ZKH Group is up 6.3%, or 26c to $4.37.

09:41 EDT QXO Inc trading resumes

09:37 EDT Feutune Light Acquisition Corp trading resumes

09:34 EDT Kyverna Therapeutics Inc trading halted, volatility trading pause

09:32 EDT Co-Diagnostics submits FDA 510(k) application for Co-Dx PCR Pro platform - Co-Diagnostics announced that the Company has completed its first U.S. Food and Drug Administration application for 510(k) clearance for the Co-Dx PCR Pro instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter use. Co-Diagnostics completed the submission via the FDA's electronic Submissions Template And Resource system, and have received the acknowledgement from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed for 510(k) submission preparation.

09:08 EDT JetBlue to launch new daily jet service between BOS, PQI - JetBlue announced it will launch new daily jet service between Boston Logan International Airport, or BOS, and Presque Isle International Airport, or PQI, starting September 5, with tickets now available for sale. This new route not only offers residents of northern Maine and New Brunswick convenient access to the city of Boston and dozens of other JetBlue and partner airline destinations around the globe, but it also opens up the beauty of the Crown of Maine and the region to travelers from around the world.

09:06 EDT BWX Technologies-led team awarded $30B contract from DOE/NNSA - BWX Technologies announced a contract award from the U.S. Department of Energy, National Nuclear Security Administration, or DOE/NNSA, for management and operations of the Pantex Plant. Following an initial term of five years, NNSA has the ability to award three additional five-year option periods. If all contract options are exercised, the contract will span 20 years at a funding level of approximately $30B. The NNSA announced the contract was awarded to PanTeXas Deterrence, or PXD. PXD is a joint venture led by a BWX Technologies subsidiary - it also includes Fluor; SOC, A Day & Zimmermann Company; and The Texas A&M University System.

09:04 EDT Entravision to sell digital advertising representation business to Aleph Group - Entravision announced that it has entered into an agreement to sell its digital advertising representation business to Aleph Group. The transaction has been approved by the Entravision board of directors and is expected to close by the end of June.

09:03 EDT Clover Health announces CMS improved star ratings to 3.5 - Clover Health Investments announced that the Centers for Medicare and Medicaid Services, CMS, has recalculated the 2024 Star Ratings of Clover Health's PPO Medicare Advantage plans for the 2025 payment year, and has increased the rating by 0.5 Stars, to a revised rating of 3.5 Stars, from the original rating of 3 Stars. Currently, over 95% of Clover's Medicare Advantage membership is served through its PPO plans. "We had previously communicated and planned to operate with a 3.0 Star rating for our PPO plans for 2025. This recalculation to 3.5 Stars significantly improves our financial outlook for next year. We believe the improvement provides us with the opportunity to accelerate our membership growth while maintaining and growing profitability," said Peter Kuipers, Chief Financial Officer of Clover Health.

09:01 EDT CBAK Energy Technology unit secures ~$7M order from European Client - CBAK Energy Technology announced that its subsidiary, Dalian CBAK Power Battery Co., has secured an order valued at almost $7M from a renowned European client. Founded in Europe, the Partner has been sourcing cylindrical batteries from CBAK Energy for orders valued close to $55M.

08:51 EDT Charles Schwab reports May activity report - Charles Schwab released its monthly activity report. Company highlights for the month of May include: Core net new assets brought to the company by new and existing clients totaled $31.1B. Total client assets were $9.21T as of month-end May, up 20% from May 2023 and up 4% compared to April. New brokerage accounts were 314,000 in May, flat year-over-year and down 13% compared to April.

08:47 EDT Safe and Green Development announces agreement with Trio Residential - Safe and Green Development is pleased to announce a strategic agreement with Trio Residential. This collaboration adds Trio's innovative home financing solutions into SGD's Xene Home AI Platform, with the goal of making homebuying more achievable for more customers. By adding Trio's, lease-to-own and seller financing programs into SGD's Xene, the collaboration aims to empower customers from diverse backgrounds to achieve their dream of homeownership. Trio's home financing solutions will expand the range of options available to consumers, offering additional pathways to realize their real estate goals. Xene customers will gain access to Trio's various down- payment assistance products, including their lease-to-own program. Trio's unique "Link Home Loan" and "Convertible Lease" provide borrowers with challenging financial backgrounds an opportunity to overcome barriers presented by traditional mortgage products and fulfill their aspirations of becoming homeowners.

08:46 EDT Co-Diagnostics completes first FDA 510(k) application for Co-Dx PCR Pro - Co-Diagnostics announced that the company has completed its first Food and Drug Administration application for 510(k) clearance for the Co-Dx PCR Pro instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter use. The Co-Dx PCR platform "has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories," the company said in a statement. Co-Diagnostics is also preparing to shortly pursue clearance for the Co-Dx PCR COVID-19 test on the new instrument, to be used for point-of-care testing.

08:35 EDT Chijet subsidiary entered into cooperation agreement with Sayyed Karimov - Chijet Motor Company announced that on May 29, Chijet's majority-owned subsidiary FAW Jilin Automobile entered into a framework cooperation agreement with Sayyed Karimov, the economic governor of Tashkent Region of Uzbekistan, on behalf of TANK AUTO, a Uzbekistan local auto distributor. TANK AUTO will carry out automotive sales and after-sales services, as a distribution and sales agent of FAW in Uzbekistan in the next three years.

08:34 EDT CLPS receives Nasdaq notice of non-compliance - CLPS announced that it received a written notice from The Nasdaq Stock Market dated June 10, 2024, indicating that the company's closing bid price for its common shares fell below $1.00 per share for 30 consecutive trading days, which is not in compliance with Nasdaq Listing Rule 5450(a)(1). The Nasdaq notification does not affect CLPS's current listing or trading of the company's securities on the Nasdaq Global Market. Pursuant to the Nasdaq Listing Rule 5810(c)(3)(A), the company has been granted a 180-calendar day compliance period, until December 9, 2024, to regain compliance with the minimum bid price requirement. To regain compliance, CLPS's common shares must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. If the company achieves this within the compliance period, Nasdaq will provide written confirmation of compliance and the matter will be closed.

08:34 EDT TriplePoint Venture CFO Christopher Mathieu to retire - TriplePoint Venture announced that Christopher Mathieu plans to retire as the CFO of TPVG effective as of the close of business on August 9 and will continue to serve as an advisor through December 31 to provide a smooth transition. Mathieu has served as CFO of TPVG since July 2019. The company has initiated a search for a successor to Mathieu and engaged an executive search firm.

08:33 EDT Peoples Financial, FNCB Bancorp approved for merger - Peoples Financial Services (PFIS) and FNCB Bancorp (FNCB) announced receipt of all required regulatory approvals or waivers necessary to complete the previously announced merger of FNCB with and into Peoples, with Peoples as the surviving corporation, pursuant to the Agreement and Plan of Merger, dated as of September 27, 2023, by and between Peoples and FNCB. The merger is expected to close on July 1, 2024, pending satisfaction of customary closing conditions.

08:32 EDT Phillips 66 to sell 25% interest in REX to Tallgrass Energy for $1.275B - Phillips 66 announced it has agreed to sell its 25% non-operated common equity interest in Rockies Express Pipeline, or REX, to a subsidiary of Tallgrass Energy for an enterprise value of approximately $1.275B. TGE is the operator of REX and will own 100% of the common equity interest in REX following the transaction. This transaction generates pre-tax cash proceeds of $685M to Phillips 66 after adjustments for Phillips 66's allocation of REX's debt and preferred equity balances. The expected proceeds will support Phillips 66's strategic priorities, including returns to shareholders. REX, a 1,714-mile pipeline system, is one of the largest natural gas pipelines in the United States and provides over 5 billion cubic feet per day of bi-directional natural gas transportation service between the Rockies, Appalachia and the northeastern United States. The transaction is expected to close today.

08:13 EDT Takeda enters exclusive license agreement for olverembatinib with Ascentage - Takeda announced the signing of an option agreement with Ascentage Pharma to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia, or CML, and other hematological cancers. If exercised, the option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia. As part of the agreement, Ascentage Pharma will continue to be solely responsible for all clinical development of olverembatinib prior to potential exercise of the option to license. Olverembatinib is currently approved and marketed in China for the treatment of adult patients with TKI-resistant chronic-phase CML or accelerated-phase CML harboring the T315I mutation and in adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs. Under the terms of this agreement, Ascentage Pharma will receive an option payment of $100M upon signing of the exclusive option to license agreement and will be eligible for an option exercise fee and additional potential milestone and royalty payments if Takeda exercises the option to license olverembatinib, with the exercise of the option being subject to customary regulatory approvals. Additionally, Ascentage Pharma will receive a minority equity investment from Takeda.

08:06 EDT Ameriserve Financial enters cooperation, settlement agreement with Driver - AmeriServ Financial announced that it has reached a cooperation and settlement agreement with Driver Opportunity Partners I LP. Pursuant to the cooperation agreement, Driver has agreed to withdraw its notice of nomination of director candidates for election to the company's board of directors, along with other shareholder proposals, at the 2024 annual meeting of shareholders and to voluntarily dismiss all outstanding litigation against AmeriServ. Further, Driver has agreed to a perpetual standstill which provides that from and at all times after the effective date of the cooperation agreement, Driver will not attempt to nominate director candidates at AmeriServ or bring litigation against the company, among other provisions. AmeriServ and Driver have also executed a stock purchase agreement under which the company will acquire the approximately 628,000 AmeriServ shares held by Driver for a price equal to the five-day trailing average stock price prior to the effective date of the stock purchase agreement. Since these Driver shares will be acquired at a price below tangible book value, this stock repurchase will be accretive to AmeriServ shareholders. AmeriServ expects that approximately 68% of the remaining costs of $1.76M associated with the cooperation agreement will be covered by directors and officers liability insurance policies held by the company.

08:06 EDT Moleculin Biotech reports data from Phase 1B/2 (MB-106) clinical trial - Moleculin Biotech reported additional efficacy findings from the company's ongoing Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of subjects with acute myeloid leukemia. The preliminary data was presented at the European Hematology Association 2024 Hybrid Congress. The company also hosted a data presentation to leading AML experts as part of a KOL meeting held in conjunction with EHA 2024 Congress. To date, a total of 22 subjects have been enrolled, 20 of whom have completed efficacy evaluations with 9 subjects achieving a composite complete remission, consisting of 8 subjects with complete remission and one subject with complete remission with an incomplete recovery of peripheral blood counts, following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects are pending. Of the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting, 5 achieved a CR (50%) and 6 achieved a CRc (60%). Of the 13 subjects in the ITT evaluable population that were 1st or 2nd line treatment, 7 achieved a CR (54%) and 8 achieved a CRc (62%). The mDOR for the 9 subjects who achieved a CRc is approximately 6 months and climbing. Additionally, the median overall survival in the 2nd line subjects is approximately 6 months and increasing. Additionally, 89% of the subjects included in the CRc group had cytogenetics and/or mutations generally considered to contribute to a poor prognosis. These include FLT3, IDH2, ASXL1, KMT2A and others. While not yet statistically relevant, the company believes such cytogenetic and mutation data are informative to clinicians. "We continue to be highly encouraged by the positive growing body of preliminary clinical data demonstrated by Annamycin in the treatment of patients with AML," commented Walter Klemp, Chairman and CEO of Moleculin. "While still preliminary, we believe the efficacy to date including the climbing durability of response demonstrated by AnnAraC in 2nd line patients continues to significantly exceed the performance reported by any drug currently approved for use in 2nd line AML. We are incredibly pleased with the progress of the trial and the data and continue to advance our preparations for an End of Phase 2 meeting with FDA."

08:05 EDT GRI Bio announces 1-for-13 reverse stock split - GRI Bio announced that the board of directors of the Company approved a 1-for-13 reverse stock split of the Company's common stock. The Reverse Split was approved by the stockholders of the Company at a special meeting of the Company held on June 7, 2024. The Company's common stock will open for trading under a new CUSIP number 3622AW 304 on The Nasdaq Capital Market on June 18, 2024, on a split-adjusted basis under the current ticker symbol "GRI." The Reverse Split is intended to increase the per share trading price of the Company's common stock to enable the Company to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.

08:04 EDT Strattec Security appoints Slater as President, CEO, board member - The Board of Directors Strattec Security (STRT) announce the appointment of Jennifer Slater as the Company's President and Chief Executive Officer and Board member, each effective July 1, 2024. Slater is a senior executive at Sensata Technologies (ST) with over 25 years of experience as a leader and a manager. Her experience includes general management, engineering, finance, sales and strategy. She has delivered results for owners across a diverse set of enterprises that include publicly traded companies, privately held firms, and private equity owners.

08:03 EDT Strattec Security Sensata appoints Slater as President, CEO, board member - The Board of Directors Strattec Security announce the appointment of Jennifer Slater as the Company's President and Chief Executive Officer and Board member, each effective July 1, 2024. Slater is a senior executive at Sensata Technologies (ST) with over 25 years of experience as a leader and a manager. Her experience includes general management, engineering, finance, sales and strategy. She has delivered results for owners across a diverse set of enterprises that include publicly traded companies, privately held firms, and private equity owners.

08:02 EDT Johnson & Johnson reports long-term data from Phase 1/2 MonumenTAL-1 study - Johnson & Johnson announced that long-term data from the Phase 1/2 MonumenTAL-1 study showed that with 20 to 30 months of median follow-up, triple-class-exposed patients with relapsed or refractory multiple myeloma who were treated with TALVEY maintained high overall response rates and durable responses, irrespective of whether they had received prior T-cell redirection therapy. These data, featured in a poster presentation at the 2024 European Hematology Association Congress demonstrate the efficacy and durability of TALVEY when used before or after chimeric antigen receptor T-cell therapy or bispecific antibody therapies in triple-class-exposed patients with RRMM. "Results from the MonumenTAL-1 study continue to show deeper response levels and a longer duration of response in patients treated with either of the approved dose options of talquetamab, while the median overall survival has yet to be reached at two years," said Dr. Leo Rasche, attending physician on the myeloma service, University Hospital of Wurzburg.* "It is encouraging to see no notable increases in treatment-related discontinuations with this longer follow-up across cohorts."

07:56 EDT Treasure Global appoints Thow as new CEO after Teo resigned from position - Treasure Global (TGL) announced the appointment of Carlson Thow as its new Chief Executive Officer, succeeding Sam Teo, who has resigned from his position. Thow, previously the Group Chief Legal Officer of Nasdaq-listed VCI Global Limited (VCIG), brings extensive expertise in corporate leadership, business strategy, and driving successful business transformations.

07:37 EDT Disc Medicine presents clinical data across portfolio at EHA 2024 Congress - Disc Medicine announced additional data for bitopertin in erythropoietic protoporphyria, including additional analyses of AURORA data that further demonstrated the clinical activity of bitopertin and highlighted meaningful improvements in light tolerance, phototoxic reactions, and quality of life. Additionally, Disc shared updated data from a Phase 1b trial of DISC-0974 in MF anemia which demonstrated durable increases in hemoglobin and reduced transfusion burden in a majority of evaluable patients. Disc also shared initial SAD data from a Phase 1 healthy volunteer trial of DISC-3405 that provided proof of mechanism, showing that the drug has the potential to provide deep and sustained increases in hepcidin and reductions in iron. The data were presented at the European Hematology Association 2024 Congress.

07:32 EDT Aptose Biosciences announces poster presentation, e-poster at EHA - Aptose Biosciences announced a clinical poster presentation and a preclinical e-poster at the European Hematology Association, EHA, 2024 Hybrid Congress in Madrid, Spain. TITLE: Safety and Efficacy of Tuspetinib as Monotherapy and Combined with Venetoclax in a Phase 1/2 Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia, CONCLUSIONS: Extensive dose exploration with TUS and TUS+VEN in highly treatment experienced R/R AML patients. TUS monotherapy: Complete remissions achieved at 40, 80, 120, and 160 mg with no DLT; 42% CRc and 50% ORR was observed in VEN naive and FLT3-mutation harboring patients. TUS+VEN Doublet: Remains safe and well tolerated; Achieves bone marrow blast reductions and responses among diverse R/R AML patients with adverse mutations and prior failure of VEN. TUS targets known VEN resistance mechanisms in vitro and is clinically active in both FLT3MUT & FLT3WT R/R AML populations even after prior VEN exposure. AML 1L UNMET NEED AND TUS+VEN+HMA TRIPLET: Significant Unmet Medical Need in Frontline Newly Diagnosed AML. Progress made with VEN+HMA in 1L therapy but 1/3 do not respond and median OS less than15 months with less than25% alive at 3-years. Response rates and OS need improvement, especially in adverse genetic subgroups. Emergence of VEN resistance via RAS/MAPK, TP53, and FLT3 clonal expansion, among other mechanisms, compromises salvage therapies in R/R setting.

07:11 EDT VersaBank receives final U.S. approval for Stearns Holdingford acquisition - VersaBank announced that it has received approval from the Office of the Comptroller of the Currency to proceed with its proposed acquisition of Minnesota-based Stearns Bank Holdingford N.A. Stearns Holdingford is an independent OCC-chartered national bank with $79M in assets located in Holdingford, Minnesota that is wholly owned by Stearns Financial Services. The OCC approval is the second and final U.S. regulatory approval required for VersaBank to proceed with the Stearns Holdingford acquisition. VersaBank will now seek approval for the Stearns Holdingford acquisition from its Canadian regulator, the Office of the Superintendent of Financial Institutions. Upon VersaBank's receipt of OSFI approval, it will proceed to close the Stearns Holdingford acquisition as soon as possible.

07:08 EDT Syndax reports new data from AUGMENT-102 trial - The company announced a poster presentation featuring updated data from the AUGMENT-102 trial of revumenib in combination with fludarabine/cytarabine in a predominantly pediatric population of patients with relapsed/refractory mNPM1, NUP98-rearranged or KMT2Ar AML titled "Safety and Activity of Revumenib in Combination with Fludarabine/Cytarabine in Patients with Relapsed/Refractory Acute Leukemias." As of the data cutoff date of January 15, 2024, 27 patients received revumenib plus FLA, including 9 patients treated at 113 mg q12h and 18 treated at 163 mg q12h. The patients enrolled had a median age of 6 years and had received a median of 3 prior lines of therapy. Eighteen patients had prior FLA containing regimens while 11 patients had prior HSCT. Five patients treated at the 113 mg q12h dose and nine patients treated at the 163 mg q12h achieved a CRc. Most patients who achieved a CRc and had evaluable data achieved negative status and 7 patients underwent HSCT while in remission following treatment. Overall, revumenib was tolerable in heavily pretreated patients with KMT2Ar, NUP98r, or NPM1m acute leukemias without increased frequency or severity of AEs compared with historic FLA data or revumenib monotherapy. One DLT occurred at the 163 mg q12h dose that was a Grade 4 decreased neutrophil count in a patient with multiple prior transplants. Grade 3 and above adverse events in over 40% of patients included decreased platelet count, anemia and febrile neutropenia. Lower rates of cytopenias were reported at the 163 mg q12h dose than the 113 mg q12h dose, consistent with faster remission at the higher dose. Lower rates of nonhematologic adverse events were also observed at the higher dose level, which further suggests that the adverse event profile was not driven by revumenib. There was one adverse event leading to death not related to revumenib. There were no cases of differentiation syndrome in the trial. This study supports the selection of revumenib 163 mg q12h combined with FLA and a strong cytochrome P450 inhibitor as the RP2D, in line with the dose of revumenib under FDA review as a monotherapy agent.

07:07 EDT Gravity announces Ragnarok: Dawn receives ISBN by Chinese Government - GRAVITY announced that Ragnarok: Dawn, Tentative English Title, a fantasy action MMORPG game, received an ISBN by Chinese government disclosed on June 5, 2024. The game is co-developed by Guangdong Xinghui Teamtop Interactive Entertainment, a game developer and publisher in China. Gravity entered into an agreement with Teamtop Interactive granting them the right to use the Ragnarok IP to develop and distribute the game in China. Ragnarok: Dawn marks the second issued ISBN in 2024 as Ragnarok title following Ragnarok Online in February 2024. Also, Ragnarok Origin and Ragnarok X: Next Generation received ISBNs in August 2023 and in December 2023, respectively.

07:06 EDT BlackRock announces Glass Lewis support of board nominees - BlackRock Advisors announced that independent proxy advisory firm Glass Lewis has issued recommendations for the reelection of ALL of BlackRock's board nominees and against all proposals put forth by dissident shareholder Saba Capital at the upcoming contested meetings for ten closed-end funds advised by BlackRock. "We applaud Glass Lewis for backing our incumbent Board nominees and rejecting every Saba proposal to terminate BlackRock as investment manager. These recommendations, along with the strong support we received from ISS, highlight the strength of our Board members, the quality of our portfolio management team and our continued legacy of delivering for all shareholders," said R. Glenn Hubbard, chair of the boards of BlackRock Closed-End Funds.

07:05 EDT Syndax reports new data from BEAT AML trial of revumenib/venetoclax/azacitidine - Syndax Pharmaceuticals announced updated data from multiple combination trials of revumenib, the company's potent, selective, small molecule menin inhibitor, in patients with acute leukemias. The updated data are being presented at the European Hematology Association 2024 Congress, being held June 13-16 in Madrid, Spain and virtually. The company announced updated data from the BEAT AML trial of revumenib in combination with venetoclax/azacitidine in newly diagnosed mutant nucleophosmin or KMT2A-rearranged acute myeloid leukemia patients aged 60 years or older in an oral presentation titled "Phase 1b Study of Azacitidine, Venetoclax and Revumenib in Newly Diagnosed Older Adults with NPM1 Mutated or KMT2A Rearranged AML: Interim Results of Dose Escalation from the BeatAML Consortium." The dose escalation phase of the trial tested revumenib at doses of 113 mg and 163 mg q12h in combination with a strong CYP3A4 inhibitor beginning on day 1 of a 28-day cycle in combination with on label doses of venetoclax and azacitidine. As of the data cutoff date of May 1, 2024, 26 newly diagnosed mNPM1 or KMT2Ar AML patients were enrolled. In the efficacy evaluable population, the composite complete remission rate was 96% and 92% of patients also attained minimal residual disease negative status as determined by central flow cytometry. Three patients proceeded to hematopoietic stem cell transplant (HSCT). The first cohort of patients treated in the trial, at 113 mg, had extended follow-up and an estimated 12-month survival of 100%. Revumenib was dosed safely at both the 113 mg and 163 mg q12h dose in combination with venetoclax and azacitidine. 15% of patients experienced differentiation syndrome with one Grade 3 event. 46% of patients experienced QTc prolongation with three Grade 3 events. All DS and QTc prolongations were self-limiting and resolved without complication or the need for revumenib dose reductions. Venetoclax was dosed in accordance with its label and an analysis of the onset and extent of hematologic toxicities suggest a similar experience to what has been reported for the venetoclax/azacytidine doublet. Overall, there were no new or increased safety signals observed when revumenib was added to this triplet combination. An expansion cohort is ongoing at both dose levels to establish the recommended dose for future trials. The company plans to initiate a pivotal trial with this combination in front-line newly diagnosed patients by year-end 2024.

07:04 EDT First Interstate CEO Kevin Riley to retire - First Interstate announced the upcoming retirement of president and CEO Kevin Riley and has initiated a search for his successor. Riley will continue to serve in his role as president and CEO until a successor is appointed. Riley joined First Interstate in 2013 as executive VP and the CFO before becoming president and CEO in 2015.

07:03 EDT Bio-Path presents data from ongoing Phase 2 combination study of prexigebersen - Bio-Path Holdings presented interim results from the Company's Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia in a poster presentation at 2024 European Hematology Association Congress, on June 14, 2024 in Madrid, Spain. Jorge Cortes, M.D., Director of the Georgia Cancer Center, presented data showing prexigebersen continues to be well-tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy. In Cohort 1, 31 newly diagnosed patients were enrolled; 20 evaluable patients with a median age of 75 years, treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk or secondary AML evolved from myelodysplastic syndromes, chronic myelomonocytic leukemia or treatment-related AML. Fifteen patients achieved complete remission, CRh, or CRi; two patients achieved partial remission and two patients achieved stable disease. In Cohort 2, 38 relapsed/refractory patients were enrolled; 23 evaluable patients with a median age of 63 years, treated with at least one cycle of prexigebersen, decitabine and venetoclax, had adverse-risk or sAML. Twelve patients achieved CR/CRi/CRh; one patient achieved PR, eight patients achieved SD and one patient had treatment failure. Among the evaluable patients of both cohorts, adverse events were consistent with those expected with decitabine and venetoclax and/or AML, including fatigue, anemia and neutropenia, while the most frequent severe adverse events were febrile neutropenia and sepsis. Given these promising interim results, Bio-Path expects to continue enrollment of up to 98 and 54 evaluable patients for Cohorts 1 and 2, respectively.

07:01 EDT TScan Therapeutics appoints Nicholson to board of directors, Biggar as Chair - TScan Therapeutics announced changes to its Board of Directors. Garry Nicholson has been appointed to the Company's Board of Directors. In addition, Timothy Barberich has retired as a Member and Chair of the Board of Directors. Current board member Stephen Biggar, M.D., Ph.D., will assume the role of Chair of the Board of Directors.

06:29 EDT Samsung showcases AI-era vision, latest technologies at SFF 2024 - Samsung Electronics unveiled its latest foundry innovations and outlined its vision for the AI era during Samsung Foundry Forum, SFF, U.S., an annual event held at the company's Device Solutions America headquarters in San Jose, California. Under the theme "Empowering the AI Revolution," Samsung announced its reinforced process technology roadmap, including two new cutting-edge nodes - SF2Z and SF4U - as well as its integrated Samsung AI Solutions platform. The company's latest 2nm process, SF2Z, incorporates optimized backside power delivery network technology, which places power rails on the backside of the wafer to eliminate bottlenecks between the power and signal lines. Mass production of SF2Z is slated for 2027. SF4U, on the other hand, is a high-value 4nm variant that offers PPA improvements by incorporating optical shrink, with mass production scheduled for 2025. Samsung reaffirmed that its preparations for SF1.4 are progressing smoothly, with performance and yield targets on track for mass production in 2027. Entering its third year of mass production, Samsung's GAA process is consistently demonstrating continuous maturity in both yield and performance. Samsung's GAA production has been steadily increasing since 2022 and is poised to substantially expand in the coming years. Another highlight was the unveiling of Samsung AI Solutions, a turnkey AI platform resulting from collaborative efforts across the company's Foundry, Memory and AVP businesses.

06:08 EDT Manchester United to invest GBP50M in Carrington Training facility - Manchester United will commence work to modernize the men's first team building at Carrington Training Complex next week, with a focus on creating a high-performance collaborative environment for players and staff. The GBP50M project will result in all areas of the building being refurbished to deliver a world-class football facility with a positive culture to support future success. The renovation work will begin on Monday and is expected to last for the duration of the 2024/25 season. The initial focus will be on the gym, medical, nutrition, and recovery areas, with a design emphasis on creating more space for collaboration and innovation among players and staff.

06:03 EDT Shattuck Labs reports 'positive' interim data from Phase 1B trial of SL-172154 - Shattuck Labs announced updated interim data from the Phase 1B dose expansion clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients. These data are to be featured in a poster presentation on June 14, 2024 at 18:00 CEST, during the European Hematology Association 2024 Congress. "We are pleased to present additional data from our Phase 1B dose expansion clinical trial, which further supports our differentiated mechanism of action and underscores SL-172154's emergence as the leading CD47 inhibitor in hematologic malignancies," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "This update shows that the rate of complete remission has improved since our last data release in December, with additional patients in both cohorts who continue to improve on therapy. As a result of these encouraging data, and our expectation of rapid enrollment and progress in our ongoing randomized, controlled cohort in HR-MDS, we are focusing our efforts on our opportunity in HR-MDS and TP53m AML. These are indications with high unmet need, limited competition, and potential for accelerated paths to approval." Dr. Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck added, "We are encouraged by the maturing data that continues to underscore the therapeutic potential, and manageable safety profile, of SL-172154 for patients with previously untreated HR-MDS and TP53m AML. Accumulating clinical evidence now shows the pharmacodynamic contribution of CD40 activation in the peripheral blood, and an emerging correlation between clinical remission and CD40 mediated induction of certain cytokines. The TP53m AML and HR-MDS patients we have treated represent a high-risk group with short duration of complete remission and overall survival when treated with azacitidine alone. Median overall survival and duration of remission have not yet been achieved, and we look forward to sharing additional durability data later this year. Enrollment is now underway for our randomized, controlled expansion cohort in frontline HR-MDS patients, and we expect to engage in regulatory discussions later this year regarding the registrational strategy for SL-172154."

06:02 EDT Zura Bio presents data for tibulizumab program at EULAR 2024 - Zura Bio shared supportive data from a Phase 1 study evaluating its lead candidate, tibulizumab (ZB-106), for the treatment of Sjogren's syndrome. These data, along with preclinical data supporting further development of tibulizumab in rheumatoid arthritis, were presented at the Annual European Congress of Rheumatology 2024 in Vienna. "Collectively, these data add to early-phase evidence demonstrating that dual-inhibition of both IL-17A and BAFF could be a breakthrough approach for autoimmune and inflammatory diseases in which single-pathway inhibition is the standard of care," stated Robert Lisicki, CEO. "The results in Sjogren's syndrome demonstrate that tibulizumab achieved robust target engagement, nearing maximum serum levels following single, well-tolerated subcutaneous doses at four-week intervals. Further, the preclinical results suggest dual-pathway inhibition may warrant clinical exploration in RA and other autoimmune diseases, adding to the breadth of potential we see with tibulizumab." The randomized, double-blind, placebo-controlled Phase 1 study evaluated four ascending doses of tibulizumab in 25 participants with Sjogren's syndrome. Twenty-one participants in the 12-week study received greater than or equal to1 dose of tibulizumab (30mg Q4W, 100mg Q4W, 300mg Q4W, 300mg Q2W), with four receiving placebo. Treatment with tibulizumab was generally well tolerated in patients with Sjogren's syndrome. Serum levels of total IL-17A and BAFF increased following tibulizumab administration, reflecting target engagement. At doses of 100 mg Q4W and higher, the total IL-17A and BAFF concentrations appeared to plateau, suggesting the targets were engaged nearly to maximum levels. Throughout the study, total B cell counts were dose-dependently reduced in all participants, while administration of tibulizumab was associated with lower levels of Th1 cells. Tibulizumab was also shown to modulate inflammatory mediators, including serum amyloid A, interleukins 5 and 10, as well as basic fibroblast growth factor. These reductions suggest tibulizumab has treatment potential for additional autoimmune conditions.

05:45 EDT WISeKey CFO Peter Ward to retire, John O'Hara to succeed - WISeKey (WKEY) announced the retirement of Peter Ward as its CFO, effective June 30. The company appoints John O'Hara as its new CFO, effective July 1. Following his retirement, Ward will remain a member of the board of directors of WISeKey. Ward joined the company in 2008 and has served as its CFO since 2015. O'Hara, who currently serves as the CFO of SEALSQ Corp. (LAES), a subsidiary of the company, has been part of the WISeKey team since 2018, serving as International Financial Controller. Prior to joining WISeKey, O'Hara served as the global financial controller for Jesuit Worldwide Learning and as Finance Director at Deloitte, where he led the strategic and operational finance functions of the Tax Service Line.

05:38 EDT Cabaletta Bio reports clinical data from first two patients dosed with CABA-201 - Cabaletta Bio reported initial clinical data from each of the first two patients dosed with CABA-201 in the Phase 1/2 RESET-Myositis and RESET-SLE trials. These data will be presented at 8:15 a.m. CEST at a EULAR European Congress of Rheumatology 2024 Industry Symposia session titled "Immune Reset: The Potential of CAR T Cell Therapy to Transform the Treatment of Patients with Autoimmune Disease" in Vienna, Austria. Cabaletta designed CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to deeply and transiently deplete CD19-positive B cells following a one-time infusion that may enable a reset of the immune system with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is advancing four Phase 1/2 RESET trials evaluating CABA-201 within a total of ten cohorts with six patients in each cohort. All cohorts are evaluating the same single, weight-based dose of 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide consistent with the dosing regimen used in the academic experience, without a dose escalation requirement. As of May 28, the data cut-off date, one patient treated in the immune-mediated necrotizing myopathy cohort in the RESET-Myositis trial had completed three months of follow-up and one patient enrolled in the systemic lupus erythematosus non-renal cohort in the RESET-SLE trial had completed one month of follow-up. The patient with IMNM is a 33-year-old male with a two-year history of disease, positive for anti-SRP antibody and who had prior disease-specific therapy that included IVIg, rituximab, methotrexate and glucocorticoids. The patient with SLE is a 26-year-old male with a six-year history of disease, positive for anti-dsDNA antibody and who had prior disease specific therapy that included cyclophosphamide, voclosporin, belimumab, tacrolimus, mycophenolate mofetil, hydroxychloroquine and glucocorticoids. Both patients were administered a one-time infusion of CABA-201 at 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide. The primary endpoint of each trial is safety and tolerability within 28 days of infusion. Secondary endpoints include translational assessments and clinical outcomes. CABA-201 was administered during a four-day hospital stay, as currently required by the protocol, and was generally well-tolerated with no serious adverse events reported for either patient through the follow-up period. No evidence of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome of any grade was observed for either patient through the follow-up period. Tocilizumab was not administered for either patient. No infections were observed for either patient through the follow-up period. All chronic maintenance therapy or concomitant medications were discontinued for both patients through the follow-up period, other than a planned prednisone taper for the SLE patient. Complete B cell depletion was observed within 15 days post-infusion with CABA-201 in both patients. Both patients had early, transient leukopenia, as expected with the preconditioning regimen. CAR T cell expansion associated with CABA-201 reached its peak magnitude at day 15 post-infusion in both patients and the magnitude of expansion was consistent with the academic experience with a similar 4-1BB CD19-CAR T construct. At week 12 of follow-up for the IMNM patient, the data show a decline in creatinine kinase from 617 at infusion to 308 and a total improvement score of 30, which is consistent with the clinically meaningful improvement seen in the academic experience of a similar 4-1BB CD19-CAR T construct that also recently reported data from an IMNM patient. At week 4 of follow-up for the SLE patient, the data demonstrated an improvement in the SLEDAI-2K score from 26 at baseline to 10. B cell repopulation was observed in the IMNM patient at week 8 with immature, naive B cell phenotypes as demonstrated by flow cytometry, suggesting potential immune system reset with confirmatory analyses ongoing.

05:29 EDT Editas Medicine announces new safety, efficacy data from EdiTHAL trial - Editas Medicine announced new safety and efficacy data in seven patients with transfusion-dependent beta thalassemia, or TDT, treated with renizgamglogene autogedtemcel in the Phase 1/2 EdiTHAL clinical trial. Reni-cel, the first investigational AsCas12a gene-edited cell therapy medicine, is being studied in the EdiTHAL trial as a potential one-time, durable gene editing medicine for people living with TDT. The data will be presented in a poster presentation at the European Hematology Association, or EHA, Hybrid Congress in Madrid, Spain, on Friday, June 14. In the EdiTHAL trial to date, reni-cel was well-tolerated and continues to demonstrate a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by all patients. Following treatment with reni-cel, all EdiTHAL patients had early and robust increase of total hemoglobin and fetal hemoglobin and remain transfusion-free at last follow-up for a range of 4.1 to 12.8 months. All patients in the EdiTHAL trial underwent 1.0 apheresis and mobilization cycle. In the EdiTHAL trial, patients demonstrated early and robust total Hb and HbF increases, with total Hb rising above the transfusion independence threshold of 9.0 g/dL. For patients with six months follow-up, the mean total Hb and HbF concentrations at month six were 12.1 g/dL and 10.9 g/dL, respectively, which were sustained at or above the transfusion threshold from six months through subsequent follow-ups. All patients have been transfusion free for a range of 4.1 to 12.8 months after receiving the last red blood cell transfusion at 0.5-2.2 months post-reni-cel infusion. All patients in the EdiTHAL trial showed sustained high levels of editing in the HBG1 and HBG2 promoter regions. Reni-cel was well-tolerated and demonstrated a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by all evaluated EdiTHAL trial patients. After reni-cel infusion, all patients demonstrated successful neutrophil and platelet engraftment. Neutrophil engraftment occurred at a median of 23 days, and platelet engraftment occurred at a median of 38 days. No serious adverse events related to reni-cel treatment in the EdiTHAL trial have been reported.

05:19 EDT Beam Therapeutics reports data from BEAM-101 trial - Beam Therapeutics reported data highlighting its optimized, closed and automated manufacturing process for its base-edited CD34+ hematopoietic stem and progenitor cell, or HSPC, genetic medicines in a poster presentation at the European Hematology Association, or EHA, Hybrid Congress. The optimized process is deployed for the manufacturing of BEAM-101 in the BEACON Phase 1/2 clinical trial in patients with severe sickle cell disease, or SCD, and the data include both preclinical and GMP clinical manufacturing experience to date. Beam designed its automated CD34+ HSPC process for manufacturing of BEAM-101 to have the flexibility for a wide range of patient-starting material and variable cell numbers, while maintaining robust cell yield and high drug product quality suitable for use in the BEACON Phase 1/2 clinical trial. The data highlight the following: The integration of key technologies has led to robust and improved process performance. Automation improved manufacturing execution, including increased cumulative yield and process consistency, and provided an up to three-fold increase in process capacity while reducing process duration, contamination risk and operator variability. Drug product reproducibly met the high viability threshold across 14 development runs using healthy and sickle cell trait donor cells and nine GMP clinical runs using SCD patient cells. The use of base editing in an optimized, closed and automated process produced clinical drug product with consistently high CD34+ purity ranging from 84% to 95% and an editing rate ranging from 88% to 94%.

05:10 EDT Vertex Pharmaceuticals presents long-term Casgevy trial data - Vertex Pharmaceuticals announced longer-term data for Casgevy from global clinical trials in people with severe sickle cell disease, or SCD, or transfusion-dependent beta thalassemia, or TDT. The results, presented at the annual European Hematology Association, or EHA, Congress, confirm the transformative, consistent and durable clinical benefits of Casgevy over time. Casgevy is the first and only approved CRISPR-based gene-editing therapy. The data being presented are from more than 100 patients treated with exa-cel in clinical trials, with the longest follow-up now extending more than five years. The efficacy results are consistent with the previously reported primary and key secondary endpoints analyses from these exa-cel studies and continue to demonstrate transformative clinical benefit with durable and stable levels of fetal hemoglobin and allelic editing. In SCD 36/39 evaluable patients were free from vaso-occlusive crises, or VOCs, for at least 12 consecutive months, consistent with the previously reported primary endpoint data. Mean duration of VOC-free was 27.9 months, with a maximum of 54.8 months. 38/39 patients with at least 16 months of follow-up were free from hospitalizations related to VOCs for at least 12 consecutive months, consistent with the previously reported key secondary endpoint data. In TDT 49/52 evaluable patients were transfusion-independent for at least 12 consecutive months with a mean weighted hemoglobin of at least 9 g/dL, consistent with the previously reported primary endpoint data. Mean duration of transfusion independence was 31 months, with a maximum of 59.4 months. All TDT patients dosed with at least 16 months of follow up are transfusion free. Two of the three patients who did not achieve TI12 in CLIMB-111 achieved TI12 in the long-term follow-up study, CLIMB-131, and have been transfusion independent for over one year. The third has been transfusion free for 3.4 months. Both SCD and TDT patients reported sustained and clinically meaningful improvements in their quality of life, including physical, emotional, social/family and functional well-being, and overall health status. In both SCD and TDT patients, edited levels of BCL11A alleles were stable over time in bone marrow and peripheral blood indicating successful editing in the long-term hematopoietic stem cells. All patients engrafted neutrophils and platelets after exa-cel infusion. The safety profile of exa-cel was generally consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant.