Stockwinners Market Radar for June 19, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:50 EDT Arcellx announces clinical hold for iMMagine-1 Phase 2 clinical program - Arcellx announced that it has received notification from the U.S. Food and Drug Administration that a clinical hold has been placed on its CART-ddBCMA investigational new drug for the treatment of patients with relapsed or refractory multiple myeloma, or rrMM. The clinical hold was received on June 16, following a recent patient death. The company believes limitations on bridging therapy are a contributing factor and is working with FDA to amend the protocol to expand options for patients that are consistent with current clinical practice. The FDA has provided clearance to Arcellx to continue to dose patients who have undergone lymphodepletion.

17:03 EDT Preformed Line Products Co announces 20c quarterly dividend - The Board of Directors of Preformed Line Products on June 13, 2023, declared a regular quarterly dividend in the amount of 20c per share on the company's common shares, payable July 20, 2023, to shareholders of record at the close of business on July 3, 2023.

16:51 EDT Avanos Medical announces agreement to acquire Diros Technology - Avanos Medical announced it has entered into a definitive agreement to acquire Diros Technology, a manufacturer of innovative radiofrequency products used to treat chronic pain conditions. The addition of Diros' unique RF Trident technology is expected to further enhance Avanos' pain management treatment options and complement its premium COOLIEF Cooled Radiofrequency product offering. The transaction is expected to close in the third quarter of 2023, subject to customary closing conditions. Avanos will finance the acquisition through a combination of funds from its existing credit facility and available cash. The company estimates that the new business will be immediately accretive to revenue growth, gross margins, operating margins and EPS.

16:44 EDT BorgWarner to acquire Eldor's EHS business segment for EUR 75M - BorgWarner and Eldor Corporation S.p.A. announced that they have entered into a Share Purchase Agreement under which BorgWarner has agreed to acquire the Electric Hybrid Systems, or EHS, business segment of Eldor for EUR 75M at closing with a potential additional amount due subject to an earnout. Headquartered in Italy, Eldor's EHS segment includes on-board chargers, DC/DC converters, and integrated high voltage boxes, all of which are expected to complement BorgWarner's existing product portfolio. The acquisition is expected to enhance BorgWarner's capabilities in engineering compact and efficient 400V and 800V on-board chargers that are compatible with the variety of regional grid configurations found globally while also bringing innovative and cost-effective high-frequency DC/DC converter technology to the portfolio. BorgWarner expects that Eldor's EHS business will generate EUR 25M of revenue for the full year 2023. Relative to its Charging Forward 2027 targets, BorgWarner expects that revenues will be approximately EUR 250M in 2027. The transaction is subject to satisfaction of closing conditions and is expected to close in the third quarter of 2023.

16:38 EDT Brown-Forman announces sale of Finlandia vodka for $220M - Brown-Forman (BF.A; BF.B)announced that it has reached an agreement to sell its Finlandia vodka brand to Coca-Cola HBC AG (CCHGY) for $220M, subject to the customary closing process. The purchase is expected to close in the second half of the 2023 calendar year.

11:11 EDT Pratt & Whitney selected by Volaris to power added 64 Airbus A321neo aircraft - Pratt & Whitney, an RTX business, and Volaris announced that the airline has selected GTF engines to power an additional 64 A321neo aircraft. "Pratt & Whitney will also provide Volaris with engine maintenance through an EngineWise Maintenance long-term agreement. This brings Volaris' total commitment to 217 GTF-powered purchased and leased aircraft including the airline's previous selection of GTF engines for 153 A320neo family aircraft," the companies stated.

10:27 EDT Boeing, CAE to collaborate on pilot training - Boeing (BA) and CAE (CAE) announced that they have signed an agreement through which CAE will become a Boeing Authorized Training Provider and the first to offer Boeing's Competency-Based Training and Assessment curriculum. "With this arrangement, Boeing and CAE will expand accessibility to high-quality, innovative flight training to commercial aviation customers worldwide," the companies stated. "This partnership expands our competency-based flight-training capacity to better meet the needs of our customers worldwide. By sharing data, leveraging digital capabilities, and providing greater accessibility and affordability, Boeing and CAE are enhancing global aviation safety," said Stephanie Pope, president and CEO, Boeing Global Services.

10:20 EDT Polestar enters into strategic joint venture to accelerate growth in China - A subsidiary of Polestar Automotive is entering into a strategic joint venture for the China market with the technology company Xingji Meizu Group. "The joint venture is expected to strengthen Polestar's offer in the Chinese EV market by bringing together Polestar's capabilities within design and performance with the software and consumer electronics hardware development expertise of Xingji Meizu," the company said. The joint venture will develop Xingji Meizu's existing technology platform, Flyme Auto, into a seamless operating system for Polestar cars sold in China, including in-car apps, streaming services, and intelligent vehicle software. This will be complemented by mobile and augmented reality devices and customer apps, creating a seamless digital ecosystem. Polestar expects to transfer around 130 commercial staff in China to the new company, which will be the sole authorised Polestar sales and service entity in China. Polestar will own 49% of the joint venture company equity, with the remaining 51% to be owned by Xingji Meizu, who will be taking responsibility for arranging the joint venture's future financing beyond the initial capital provided by Polestar and Xingji Meizu.

10:13 EDT ACI Worldwide launches ACI Instant Pay for merchants in Europe, U.K. - ACI Worldwide announced it has launched ACI Instant Pay - a real-time payments solution that enables merchants to accept instant online, mobile and in-store payments via a simple API integration with ACI Payments Orchestration Platform - in Europe and the U.K. The move comes against the backdrop of a regulatory push in Europe. Banks across the Eurozone must comply with a proposed European Commission law, mandating financial institutions across the Single Euro Payments Area countries to offer instant payments under the SEPA Instant Credit Transfer scheme, at the same cost or lower-than-standard credit transfers. The new regulation is aimed at unlocking the benefits of instant payments for European economies.

10:08 EDT United Airlines selects Pratt & Whitney GTF engines to Power 120 Airbus - Pratt & Whitney, an RTX business (RTX), announced that United Airlines (UAL) has selected the GTF engine to power 70 Airbus (EADSY) A321neo and 50 A321XLR firm aircraft orders, the first of which is expected to be delivered this year.

10:04 EDT Ascendis Pharma presents one-year data from Phase 3 trial of TransCon PTH - Ascendis Pharma reported one-year data from its ongoing Phase 3 PaTHway Trial of TransCon PTH in adults with hypoparathyroidism. The data showed that treatment with TransCon PTH resulted in sustained improvements through Week 52, as well as safety and tolerability similar to that reported for the initial 26-week blinded portion of the trial. PaTHway is a Phase 3 trial of TransCon PTH with a placebo-controlled 26-week blinded portion and a 156-week open-label extension portion, designed to evaluate the long-term efficacy and safety of TransCon PTH as a potential hormone therapy for those diagnosed with hypoparathyroidism. Results through Week 52 were reported at ENDO 2023. Of the 82 study participants dosed, 79 completed blinded treatment and entered the OLE, and 78 completed Week 52. 95% of patients in the OLE achieved independence from conventional therapy, and none required active vitamin D. At Week 52, 81% of participants treated with TransCon PTH achieved both normal serum calcium and independence from conventional therapy. With TransCon PTH treatment, mean albumin-adjusted serum calcium levels were maintained within the normal range through Week 52 of the OLE. Patient-reported scores on the Hypoparathyroidism Patient Experience Scale and SF-36 Health Survey showed sustained improvements in disease-related physical and cognitive symptoms, as well as physical functioning and daily life, starting at the first scheduled follow up after randomization or switching from placebo and sustained through Week 52. Bone mineral density Z-scores continued to trend toward age- and sex-matched norms with 52 weeks of TransCon PTH treatment. TransCon PTH normalized 24-hour urine calcium through Week 52, regardless of initial randomization . TransCon PTH continued to be well-tolerated in the Phase 3 open-label extension, with no new safety signal identified.

09:58 EDT Seres Therapeutics, Nestle Health Science present late-breaking data on VOWST - Seres Therapeutics and Nestle Health Science announced the presentation of a post-hoc analysis from the Phase 3 development program for VOWST, the first and only U.S. Food and Drug Administration-approved orally administered microbiota-based therapeutic to prevent recurrence of C. difficile infection in adults following antibacterial treatment for recurrent CDI. The analysis was featured as a late-breaker Emerging Science presentation at American Society of Microbiology Microbe 2023 being held in Houston, TX. The presentation highlighted post-hoc gastrointestinal microbiome analyses of recurrent C. diff patients enrolled in the ECOSPOR III and ECOSPOR IV Phase 3 studies, including those with a first recurrence and multiple recurrences. Results showed that at baseline, individuals experiencing a first recurrence or multiple recurrences exhibited a similarly low degree of gut microbiome diversity. Following treatment with VOWST, both first recurrence and multiple recurrence patient groups had a significant increase in microbiome diversity as well as increased levels of secondary bile acids, a metabolites shown to inhibit growth of C. difficile bacteria. Recurrent CDI represents significant unmet need and is a leading cause of hospital-acquired infection that can result in severe illness and death. Based on data from the U.S. Centers for Disease Control and Prevention, the companies estimate 156,000 episodes in the U.S. in 2023. VOWST is indicated to prevent the recurrence of Clostridioides difficile infection in individuals 18 years of age and older following antibacterial treatment for recurrent CDI. VOWST is not indicated for treatment of CDI.

09:51 EDT Vera Therapeutics announces efficacy, safety results Phase 2b ORIGIN trial - Vera Therapeutics announced the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36. Atacicept is the company's potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator and a proliferation-inducing ligand. ORIGIN is a multinational, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite available ACEi or ARB therapy. At week 36 in the prespecified per-protocol analysis, the atacicept 150 mg dose group showed a 43% placebo-adjusted reduction from baseline in proteinuria, compared to 35% in the intent-to-treat analysis, as shown in Figure 1 below. In the ITT analysis of all randomized patients, patients receiving placebo had an expected decline in kidney function as measured by eGFR, while patients receiving atacicept 150 mg had stable eGFR through week 36, as shown in Figure 2. This difference in eGFR was statistically significant and clinically significant. In addition, the atacicept 150 mg group achieved a 64% reduction from baseline at week 36 in Gd-IgA1. Safety results indicated that atacicept was generally well-tolerated and were consistent with the previously observed safety profile of atacicept, with no increased rate of infections compared to placebo, a low rate of serious adverse events overall, and no drug discontinuations or interruptions due to hypogammaglobulinemia. Serious treatment-emergent adverse events were observed in 3% of patients receiving atacicept 150 mg and in 9% of placebo patients. These results build upon the prior integrated analysis of atacicept in randomized, double-blind, placebo-controlled clinical trials in over 1,500 patients to date across different indications - in which atacicept was well-tolerated.

08:42 EDT Bristol-Myers announces primary analysis results from TRANSCEND trials - Bristol Myers Squibb announced the first disclosure of primary analysis results from two pivotal studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi in patients with relapsed or refractory follicular lymphoma and the relapsed or refractory mantle cell lymphoma cohort of TRANSCEND NHL 001, an open-label, multicenter, Phase 1, single-arm, seamless-design study evaluating Breyanzi. TRANSCEND FL, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL, enrolled adults with relapsed or refractory disease treated with Breyanzi in the second-line and third-line plus setting. Patients received treatment with Breyanzi at a target dose of 100 x 106 CAR-positive viable T cells. In efficacy evaluable patients with relapsed or refractory FL treated with Breyanzi in the third-line plus setting, the overall response rate was 97%, with 94% of patients achieving a complete response. Responses were durable with a median duration of response not reached at a median follow-up of 16.6 months. At 12 months, 81.9% of responders had an ongoing response. Median progression-free survival was also not reached at a median follow-up of 17.5 months, with 12-month PFS achieved in 80.7% of patients. With a median on-study follow-up of 18.9 months in the safety set, which included patients treated in the second-line plus setting, Breyanzi exhibited a manageable safety profile, with no new safety signals observed and low rates of severe cytokine release syndrome and neurologic events. Any grade CRS occurred in 58% of patients, with Grade 3 CRS occurring in 1% of patients and no Grade 4/5 CRS reported. Any grade NEs were reported in 15% of patients, with Grade 3 NEs occurring in 2% of patients and no Grade 4/5 NEs reported. Historically, outcomes are poor for patients with relapsed or refractory FL. Despite high initial response rates to front-line treatment, the majority of patients experience multiple relapses and prognosis often worsens with subsequent relapses. Additionally, the durability of response with available treatment options decreases with each subsequent line of therapy. There are currently no curative options. The MCL cohort of TRANSCEND NHL 001 enrolled adults with relapsed or refractory disease after two or more prior lines of therapy, including a BTK inhibitor. These patients were treated with Breyanzi at dose levels of either 50 x 106 or 100 x 106 CAR-positive viable T cells. With a median on-study follow-up of 16.1 months, the ORR in patients evaluated for efficacy in the primary analysis set was 86.5%, with 74.3% of patients achieving a CR. In the safety set, Breyanzi was well-tolerated and no new safety signals were observed. Any grade CRS occurred in 61% of patients, with Grade 3/4 CRS occurring in 1% of patients and no Grade 5 CRS reported. Any grade NEs were reported in 31% of patients, with Grade 3/4 NEs occurring in 9% of patients and no Grade 5 NEs reported.