Stock Markets
ORYZON Receives Intention to Grant Communication for Patent Relating to the Use of Vafidemstat in Borderline Personality Disorder
MADRID and CAMBRIDGE, Mass., Sept. 11, 2024 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the European Patent Office (EPO) has issued an intention to grant communication for Oryzon’s European patent application EP20712565.9 entitled Methods of treating borderline personality disorder related to vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for the treatment of psychiatric disorders like borderline personality disorder (BPD) and schizophrenia.
The intention to grant is a formal communication from the EPO in which it indicates that the patent application has reached the status where it is allowed for issuance as a patent. This European patent, once granted, will not expire until at least 2040, excluding any potential patent term extensions that may provide additional protection. Decision to grant communications have also recently been received in corresponding patent applications in Japan and Mexico, and patent applications are pending in other relevant markets.
We are delighted to have received this decision to grant from the EPO. This European patent application further strengthens the company’s patent portfolio for vafidemstat in CNS, and together with our European patent application allowed earlier this year covering the use of vafidemstat for the treatment of aggression and social withdrawal, will significantly prolong vafidemstat’s commercial life in Europe, said Neus Virgili, Oryzon’s Chief IP Officer.
About Oryzon
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS and iadademstat in oncology, in several Phase II clinical trials. The company has other pipeline assets directed against other epigenetic targets like HDAC-6 where a clinical candidate ORY-4001, has been nominated for its possible development in CMT and ALS. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit www.oryzon.com
About Vafidemstat
Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong, and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 and 12 months of treatment, and the pilot, small-scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, where anti-inflammatory activity has also been observed. Vafidemstat has also been tested in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Vafidemstat is being investigated in neuropsychiatric disorders in two double-blind, randomized, placebo-controlled Phase IIb trials: one in schizophrenia, named EVOLUTION (recruitment ongoing), and another one in Borderline Personality disorder (BPD), named PORTICO, finalized and with published topline data (final data will be presented at ECNP-2024 in September). Based on PORTICO’s results, the company has requested an End-of-Phase II meeting with the FDA to discuss options for a registrational Phase III trial in BPD. The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders and is preparing a clinical trial in Kabuki Syndrome patients. The company is also exploring the clinical development of vafidemstat in other neurodevelopmental syndromes.
FORWARD-LOOKING STATEMENTS
This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words expects, anticipates, believes, intends, estimates and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forwardlooking statements, whether as a result of new information, future events, or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.
Spain | Oryzon | IR, US | IR & Media, Europe |
Patricia Cobo/Mario Cordera | Emili Torrell | Ashley R. Robinson | Sandya von der Weid |
Atrevia | Chief Business Officer | LifeSci Advisors, LLC | LifeSci Advisors, LLC |
+34 91 564 07 25 +34 673 33 97 65 | +34 93 515 1313 | +1 617 430 7577 | +41 78 680 05 38 |
pcobo@atrevia.com mcordera@atrevia.com | etorrell@oryzon.com | arr@lifesciadvisors.com | svonderweid@lifesciadvisors.com |
Source: Oryzon Genomics, S.A.
Stock Markets
SUBARU ANNOUNCES PRICING ON 2025 SOLTERRA ELECTRIC SUV WITH SIGNIFICANT PRICE REDUCTION
- Starting price at $38,495 MSRP, $6,500 less than 2024 version, with same features
- 2025 Solterra Touring price reduced $7,000 compared to 2024 version
- Debut of Solterra Touring Onyx Edition with gloss black wheels, exterior and interior trim accents
- Standard Subaru (OTC:) ® Symmetrical All-Wheel Drive, best-in-class ground clearance of 8.3 inches
CAMDEN, N.J., Dec. 20, 2024 /PRNewswire/ — Subaru of America, Inc. announced pricing today on the 2025 Subaru Solterra all-electric SUV. One year after significant upgrades to charging performance, interior enhancements, and driver-assist technologies, the Solterra adds a new trim level and lower starting price for 2025. The 2025 Subaru Solterra will start at $38,495 MSRP — $6,500 less than the 2024 model — before applicable federal, state, and local tax credits, and arrive at retailers nationwide early next year.
The 2025 Subaru Solterra is available in Premium, Limited, Touring, and new Touring Onyx Edition trim levels. The 2025 Solterra will qualify for applicable federal tax credits of up to $7,500 for some consumers.
New for 2025, the Subaru Solterra adds a Touring Onyx Edition trim level that adds 20-inch aluminum-alloy gloss black wheels, black exterior and interior accents, including black badging. The Subaru Solterra Touring Onyx Edition will cost $45,495 MSRP.
All Solterras are equipped with Subaru’s Symmetrical All-Wheel Drive system and Subaru StarDrive ® Technology, which delivers smooth, linear output from dual electric motors placed on the front and rear axles that deliver 249 pound-feet of torque. All models feature Dual-Function X-MODE ® with Snow/Dirt and Deep Snow/Mud modes with Grip Control and Downhill Assist Control for confidence in low-grip or off-road capability. Every Solterra includes 8.3 inches of ground clearance for genuine off-road capability “ a Subaru hallmark and best in class among small electric SUVs “ and standard Active Cornering Assist and Vehicle Stability Control for better on-road handling.
The Solterra’s high-capacity lithium-ion battery pack includes ample usable daily range and can charge from 10% to 80% in as little as 35 minutes. New for 2024, an uprated battery conditioning system improved cold-weather charging performance in colder temperatures. With thousands of available public charging stations and DC-fast charging, replenishing the Solterra’s battery away from home can be quick and easy. At home, the Solterra offers affordable Level 1 or Level 2 charging compatibility.
All Subaru Solterras are equipped with a suite of standard EyeSight ® driver-assist technologies including Emergency Steering Assist, Intersection Collision Avoidance Support, Pre-Collision Brake Assist, Lane Departure Prevention, Dynamic Radar Cruise Control with Lane Tracing Assist, Hands-Free Low Speed Driving, DriverFocus ® Distraction Mitigation System, Emergency Driving Stop System, and more. In 2024, the Subaru Solterra was named a TOP SAFETY PICK+ by the Insurance Institute for Highway Safety, its highest honor, and the National Highway Transportation Safety Administration gave the Solterra a 5-Star Overall Vehicle Score.
For added convenience, the Solterra is available with a 12.3-inch high-resolution touchscreen for infotainment with wireless Apple (NASDAQ:) CarPlay ® and Android Auto™ compatibility. The 2025 Solterra includes five USB charge points: one USB-A and two USB-C connectors for front-seat occupants and two USB-C charge points for rear-seat riders. A wireless phone charger is included on Solterra Limited and higher trim levels.
2025 Subaru Solterra Premium
Starting at $38,495 MSRP, which is $6,500 less than the 2024 model, the 2025 Subaru Solterra Premium is well equipped with an impressive list of standard features for convenience and comfort. The Subaru Solterra Premium is equipped with standard roof rails with a 700-pound static load capacity (176 pounds dynamic load capacity), 18-inch aluminum-alloy wheels with black and silver aerodynamic wheel covers, an 8.0-inch touchscreen for infotainment with wireless Apple CarPlay ® and Android Auto™ compatibility, SiriusXM satellite radio (4-month free trial included), Bluetooth ® connectivity, and SUBARU SOLTERRA CONNECT™ vehicle services for safety, remote access, service, available cloud-based navigation, and Wi-Fi (30-day free trial or 3GB). The connected-vehicle services also include Remote Climate Control, Remote Lock/Unlock via smartphone, and more.
Inside, the Subaru Solterra Premium features heated front seats with auto setting, Dual-Zone Automatic Climate Control, rear seat reminder, S-Pedal Drive, electronic parking brake, a 7.0-inch LCD combination meter, windshield wiper de-icer, heated sideview mirrors, and LED headlights (multi-beam low and single-beam high).
2025 Subaru Solterra Limited
The 2025 Subaru Solterra Limited adds more comfort and convenience features to the Premium trim level’s roster of standard equipment and starts at $41,995 MSRP, which is $6,500 less than the outgoing version. Those include standard 20-inch alloy wheels with gray machine finish, 10-way power-adjustable driver’s seat, 8-way power-adjustable passenger’s seat, heated rear seats, power rear gate, rain-sensing wipers, wireless smartphone charger, LED fog lights, heated steering wheel, and StarTex ® trimmed interior upholstery.
A 12.3-inch high-resolution touchscreen with Apple CarPlay ® and Android Auto™ compatibility is standard and paired to a Harman Kardon ® 576 watt-equivalent premium audio system with 11 speakers. A 360-degree Panoramic View Monitor provides an overhead view for better maneuverability, and Advanced Park helps further with perpendicular or parallel parking assistance using the EV’s sensors and cameras.
2025 Subaru Solterra Touring
Building on the Solterra Limited’s impressive standard features, the 2025 Subaru Solterra Touring adds more comfort and convenience features for $44,995 MSRP, $7,000 lower than the 2024 model.
The Solterra Touring adds a panoramic glass moonroof with power sunshade, front and rear LED footwell lighting, standard heated and ventilated front seats, a digital rearview mirror with view position adjustment with Homelink ® and camera washer, and smart key access on all five doors.
2025 Subaru Solterra Touring Onyx Edition
New for 2025, the Subaru Solterra Touring Onyx Edition adds dynamic stylish features inside and out and starts at $45,495 MSRP.
On the exterior, the Subaru Solterra Touring Onyx Edition adds a high gloss black front underguard; 20-inch aluminum-alloy wheels finished in black; black roof pillars, shoulder line trim, door frame, rear quarter window and roof spoiler; and black badging. Two-tone exterior color options are exclusive to Touring Onyx Edition as well.
Inside, the Touring Onyx Edition features black trim accents on the front and rear doors, and black StarTex ® trimmed upholstery.
With the purchase or lease of a new 2025 Subaru Solterra, customers will also receive up to 10 days of Subaru Just Drive Rental at no charge from their participating Subaru retailer. The program allows owners to rent various Subaru vehicles through those retailers.
2025 Subaru Solterra | ||
Model/Trim | MSRP | MSRP plus Destination |
Solterra Premium | $38,495 | $39,915 |
Solterra Limited | $41,995 | $43,415 |
Solterra Touring | $44,995 | $46,415 |
Solterra Touring Onyx Edition | $45,495 | $46,915 |
i Destination & Delivery is $1,420 for Solterra and may vary in the following states: CT, HI, MA, ME, NH, NJ, NY, RI and VT. D&D is |
About Subaru of America, Inc.
Subaru of America, Inc. (SOA) is an indirect wholly owned subsidiary of Subaru Corporation of Japan. Headquartered in Camden, N.J., the company markets and distributes Subaru vehicles, parts, and accessories through a network of about 640 retailers across the United States. All Subaru products are manufactured in zero-landfill plants, including Subaru of Indiana Automotive, Inc., the only U.S. automobile manufacturing plant designated a backyard wildlife habitat by the National Wildlife Federation. SOA is guided by the Subaru Love Promise, which is the company’s vision to show love and respect to everyone and to support its communities and customers nationwide. Over the past 20 years, SOA and the SOA Foundation have donated more than $320 million to causes the Subaru family cares about, and its employees have logged over 100,000 volunteer hours. Subaru is dedicated to being More Than a Car Company ® and to making the world a better place. For additional information, visit media.subaru.com. Follow us on Facebook (NASDAQ:), Instagram, <a href="https://c212.net/c/link/?t=0&l=en&o=4329519-1&h=2088501060&u=https%3A%2F%2Furldefense.com%2Fv3%2Fhttps%3A%2Fwww.linkedin.com%2Fcompany%2Fsubaru-of-america%2F%3B!!P1uQfTJRew!RITC1tICLlR8tTdygLlH6eiHENIniru8XHdUVy0VTgQgkhmXIrEhDmg0rHqzgny7ey_ys_IlZvCI1TBBwUQ%24&a=LinkedIn” rel=”nofollow” target=”_blank”>LinkedIn, TikTok, and YouTube.
Dominick Infante
Director, Corporate Communications
856.488.8615
dinfante@subaru.com
Aaron Cole
Product Communications Manager
720.231.0809
acole1@subaru.com
Stock Markets
PBF Energy to Participate in the Goldman Sachs Energy, CleanTech & Utilities Conference
PARSIPPANY, N.J., Dec. 20, 2024 /PRNewswire/ — PBF Energy Inc. (NYSE:) today announced that members of its management team will participate in the Goldman Sachs Energy, CleanTech & Utilities Conference on January 6-8, 2025.
Any company presentation materials will be made available on the Investor Relations section of the PBF Energy website at www.pbfenergy.com.
About PBF Energy Inc.
PBF Energy Inc. (NYSE:PBF) is one of the largest independent refiners in North America, operating, through its subsidiaries, oil refineries and related facilities in California, Delaware, Louisiana, New Jersey and Ohio. Our mission is to operate our facilities in a safe, reliable and environmentally responsible manner, provide employees with a safe and rewarding workplace, become a positive influence in the communities where we do business, and provide superior returns to our investors.
PBF Energy is also a 50% partner in the St. Bernard Renewables joint venture focused on the production of next generation sustainable fuels.
Contacts:Colin Murray (investors)
ir@pbfenergy.com
Tel: 973.455.7578
Michael C. Karlovich (media)
mediarelations@pbfenergy.com
Tel: 973.455.8981
Stock Markets
Intensity Therapeutics Stock Hits 52-Week Low at $1.76
Intensity Therapeutics, Inc. (INTS) stock has reached a new 52-week low, trading at $1.76, marking a steep 80% decline from its 52-week high of $8.79. According to InvestingPro analysis, the company maintains a positive cash position despite challenging market conditions. This latest price point marks a significant downturn for the company, which has seen its stock value decrease by 69.09% over the past year. Investors are closely monitoring the biotech firm, known for its innovative cancer treatments, as it navigates through a challenging period. While analyst price targets range from $4 to $16, suggesting potential upside, InvestingPro data reveals weak financial health scores and unprofitable operations over the last twelve months. The 52-week low serves as a critical juncture for Intensity Therapeutics, as market watchers consider the company’s future prospects and potential for recovery.
In other recent news, Intensity Therapeutics secured approximately $3 million in gross proceeds from a stock offering and concurrent private placement. The company also reported promising results from its Phase 1/2 clinical trial of INT230-6, a treatment for various sarcomas, showcasing an improved median overall survival rate and a favorable safety profile. A global Phase 3 trial is currently underway to further evaluate the efficacy and safety of INT230-6.
In addition, Intensity Therapeutics granted stock options to its Chief Financial Officer, Joseph Talamo, and the Principal Accounting Officer, John Wesolowski, as part of the company’s 2021 Stock Incentive Plan. The company has also initiated a $15 million At-The-Market offering, facilitated by H.C. Wainwright & Co.
Furthermore, Brookline Capital Markets has given Intensity Therapeutics a Buy rating, highlighting the potential of their intratumoral drug delivery technology. The company is also preparing for a Phase 2/3 trial focusing on breast cancer.
Lastly, Intensity Therapeutics has elected two Class I directors and ratified EisnerAmper LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2024. The company is expecting the pathological complete response data from a partnered Phase 2 clinical trial in Europe in the second half of 2025. These are the recent developments concerning Intensity Therapeutics.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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