
NEW YORK (AP) — Free agent pitchers Luis Gabriel Moreno and Alejandro Crisostomo were suspended for 80 games each by Major League Baseball on Friday following positive tests for performance-enhancing substances under the minor league drug program. Moreno tested positive for Nandrolone, and Crisostomo tested positive for Boldenone and Nandrolone, the commissioner’s office said. A 26-year-old right-hander, Moreno was released by the New York Mets’ Class A Brooklyn Cyclones on Tuesday. He was 5-1 with a 5.33 ERA in 12 relief appearances this season for Brooklyn after spending 2016-23 in the San Francisco Giants organization. Crisostomo, a 24-year-old right-hander, was released by Minnesota on Aug. 24 after going 0-1 with a 7.13 ERA this year with the Florida Complex League Twins. He signed with Boston in 2017, spent 2018 in the Dominican Summer League with the Red Sox, then signed with Minnesota and spent 2023 with the Twins DSL team. Nineteen players have been suspended this year for positive drug tests, including eight under the minor league program and nine under the new program for minor league players assigned outside the United States and Canada. RELATED COVERAGE Royals acquire second baseman Jonathan India from Reds for right-hander Brady Singer Aaron Judge won’t be bothered if Juan Soto gets bigger contract from Yankees than his $360M deal Alyssa Nakken, first full-time female coach in MLB history, leaving Giants to join Guardians Two players have been suspended this year under the major league drug program. Noelvi Marté , a 22-year-old infielder who is the Cincinnati Reds’ top prospect, missed the first 80 games following a positive test for boldenone. Toronto Blue Jays infielder Orelvis Martínez was suspended for 80 games on June 23 following a positive test for the performance-enhancing drug clomiphene, an announcement made two days after his major league debut . ___ AP MLB: https://apnews.com/hub/mlbNEW YORK (AP) — Free agent pitchers Luis Gabriel Moreno and Alejandro Crisostomo were suspended for 80 games each by Major League Baseball on Friday following positive tests for performance-enhancing substances under the minor league drug program. Moreno tested positive for Nandrolone, and Crisostomo tested positive for Boldenone and Nandrolone, the commissioner’s office said. A 26-year-old right-hander, Moreno was released by the New York Mets’ Class A Brooklyn Cyclones on Tuesday. He was 5-1 with a 5.33 ERA in 12 relief appearances this season for Brooklyn after spending 2016-23 in the San Francisco Giants organization. Crisostomo, a 24-year-old right-hander, was released by Minnesota on Aug. 24 after going 0-1 with a 7.13 ERA this year with the Florida Complex League Twins. He signed with Boston in 2017, spent 2018 in the Dominican Summer League with the Red Sox, then signed with Minnesota and spent 2023 with the Twins DSL team. Nineteen players have been suspended this year for positive drug tests, including eight under the minor league program and nine under the new program for minor league players assigned outside the United States and Canada. Two players have been suspended this year under the major league drug program. , a 22-year-old infielder who is the Cincinnati Reds’ top prospect, missed the first 80 games following a positive test for boldenone. Toronto Blue Jays infielder was suspended for 80 games on June 23 following a positive test for the performance-enhancing drug clomiphene, an announcement made . AP MLB:
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Automatic Data Processing Inc. stock underperforms Friday when compared to competitors despite daily gainsSANTA CLARA, Calif., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Ambarella, Inc. (NASDAQ: AMBA), an edge AI semiconductor company, today announced financial results for its third quarter of fiscal year 2025 ended October 31, 2024. Total cash, cash equivalents and marketable debt securities on hand at the end of the third quarter of fiscal 2025 was $226.5 million, compared with $219.8 million at the end of the prior quarter and $222.3 million at the end of the same quarter a year ago. "Company specific factors are more than offsetting broad market weakness, and we are reporting 30% sequential revenue growth in fiscal Q3, above the high-end of our guidance range, with strength led again by our customers' new products, especially those incorporating our higher priced AI inference processors. Edge AI revenue represented about 70% of our total revenue, establishing a new record level, and this momentum is expected to enable growth in both our IoT and Auto markets in F2025 and F2026,” said Fermi Wang, President and CEO. "With the anticipated revenue growth, we intend to drive positive operating leverage and build upon our 15 consecutive fiscal years of positive free-cash-flow.” Quarterly Conference Call Ambarella plans to hold a conference call at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time today with Fermi Wang, President and Chief Executive Officer, and John Young, Chief Financial Officer, to discuss the third quarter of fiscal year 2025 results. A live and archived webcast of the call will be available on Ambarella's website at http://www.ambarella.com/ for up to 30 days after the call. About Ambarella Ambarella's products are used in a wide variety of human vision and edge AI applications, including video security, advanced driver assistance systems (ADAS), electronic mirror, drive recorder, driver/cabin monitoring, autonomous driving and robotics applications. Ambarella's low-power systems-on-chip (SoCs) offer high-resolution video compression, advanced image and radar processing, and powerful deep neural network processing to enable intelligent perception, fusion and planning. For more information, please visit www.ambarella.com . "Safe harbor" statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements that are not historical facts and often can be identified by terms such as "outlook,” "projected,” "intends,” "will,” "estimates,” "anticipates,” "expects,” "believes,” "could,” "should,” or similar expressions, including the guidance for the fourth quarter of fiscal year 2025 ending January 31, 2025, and the comments of our CEO relating to our expectation of future revenue growth, customer demand for our edge AI inference products, the growth potential of our new products, and our ability to generate positive free-cash flow in future periods. The achievement or success of the matters covered by such forward-looking statements involves risks, uncertainties and assumptions. Our actual results could differ materially from those predicted or implied and reported results should not be considered as an indication of our future performance. The risks and uncertainties referred to above include, but are not limited to, global economic and political conditions, including possible trade tariffs and restrictions; revenue being generated from new customers or design wins, neither of which is assured; the commercial success of our customers' products; our customers' ability to manage their inventory requirements; our growth strategy; our ability to anticipate future market demands and future needs of our customers, particularly for AI inference applications; our ability to introduce, and to generate revenue from, new and enhanced solutions; our ability to develop, and to generate revenue from, new advanced technologies, such as computer vision, AI functionality and advanced networks, including vision-language models and GenAI; our ability to retain and expand customer relationships and to achieve design wins; the expansion of our current markets and our ability to successfully enter new markets, such as the OEM automotive and robotics markets; anticipated trends and challenges, including competition, in the markets in which we operate; risks associated with global health conditions and associated risk mitigation measures; our ability to effectively manage growth; our ability to retain key employees; and the potential for intellectual property disputes or other litigation. Further information on these and other factors that could affect our financial results is included in the company's Annual Report on Form 10-K for our 2024 fiscal year, which is on file with the Securities and Exchange Commission. Additional information will also be set forth in the company's quarterly reports on Form 10-Q, annual reports on Form 10-K and other filings the company makes with the Securities and Exchange Commission from time to time, copies of which may be obtained by visiting the Investor Relations portion of our web site at www.ambarella.com or the SEC's web site at www.sec.gov . Undue reliance should not be placed on the forward-looking statements in this release, which are based on information available to us on the date hereof. The results we report in our Quarterly Report on Form 10-Q for the third fiscal quarter ended October 31, 2024 could differ from the preliminary results announced in this press release. Ambarella assumes no obligation and does not intend to update the forward-looking statements made in this press release, except as required by law. Non-GAAP Financial Measures The company has provided in this release non-GAAP financial information, including non-GAAP gross margin, net income (loss), and earnings (losses) per share, as a supplement to the condensed consolidated financial statements, which are prepared in accordance with generally accepted accounting principles ("GAAP"). Management uses these non-GAAP financial measures internally in analyzing the company's financial results to assess operational performance and liquidity. The company believes that both management and investors benefit from referring to these non-GAAP financial measures in assessing its performance and when planning, forecasting and analyzing future periods. Further, the company believes these non-GAAP financial measures are useful to investors because they allow for greater transparency with respect to key financial metrics that the company uses in making operating decisions and because the company believes that investors and analysts use them to help assess the health of its business and for comparison to other companies. Non-GAAP results are presented for supplemental informational purposes only for understanding the company's operating results. The non-GAAP information should not be considered a substitute for financial information presented in accordance with GAAP, and may be different from non-GAAP measures used by other companies. With respect to its financial results for the third quarter of fiscal year 2025, the company has provided below reconciliations of its non-GAAP financial measures to its most directly comparable GAAP financial measures. With respect to the company's expectations for the fourth quarter of fiscal year 2025, a reconciliation of non-GAAP gross margin and non-GAAP operating expenses guidance to the closest corresponding GAAP measure is not available without unreasonable efforts on a forward-looking basis due to the high variability and low visibility with respect to the charges excluded from these non-GAAP measures. We expect the variability of the above charges to have a significant, and potentially unpredictable, impact on our future GAAP financial results.
Palvella Therapeutics to debut on Nasdaq under the ticker symbol “PVLA” as a publicly traded rare disease biopharmaceutical company advancing a late clinical-stage pipeline and a platform for treating serious, rare genetic diseases Strong balance sheet with approximately $80.0 million of cash and cash equivalents, including proceeds from a PIPE financing co-led by BVF Partners, L.P. and Frazier Life Sciences Cash expected to fund operations into the second half of 2027, including through Phase 3 SELVA clinical trial of QTORINTM 3.9% rapamycin anhydrous gel (QTORINTM rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) and Phase 2 clinical trial in cutaneous venous malformations (cutaneous VMs) Microcystic LMs is a chronically debilitating and lifelong genetic disease affecting an estimated more than 30,000 diagnosed patients in the U.S. QTORINTM rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic LMs and cutaneous VMs WAYNE, Pa., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the completion of its previously announced merger with Pieris Pharmaceuticals, Inc. (Pieris). The combined company will operate under the name Palvella Therapeutics, Inc., and its shares are expected to begin trading on the Nasdaq Capital Market on December 16, 2024, under the ticker symbol "PVLA". Palvella will continue to be led by Wes Kaupinen, its Founder and Chief Executive Officer, and other members of the Palvella management team. The transaction was approved by Pieris stockholders at a special meeting held on December 11, 2024, and the transaction had been previously approved by Palvella stockholders. "With strong support from leading healthcare-dedicated investors, Palvella is well positioned to enter the public markets and pursue our vision of becoming the leading rare disease company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases," said Mr. Kaupinen. “This transaction will enable us to accelerate late-stage development of QTORINTM rapamycin, our lead product candidate, for microcystic LMs and cutaneous VMs while also further advancing additional novel product candidates from our QTORINTM platform." Concurrent with the merger, Palvella completed a previously announced oversubscribed $78.9 million private placement co-led by BVF Partners, L.P., an existing investor, and Frazier Life Sciences, a new investor, and with participation from a syndicate of leading healthcare-dedicated investors. Additional new investors include Blue Owl Healthcare Opportunities, Nantahala Capital, DAFNA Capital Management, ADAR1 Capital Management, and a healthcare dedicated fund. Existing investors Samsara BioCapital, Petrichor, CAM Capital, Ligand Pharmaceuticals, Integrated Finance Group (an AscellaHealth partner company), BioAdvance, and Gore Range Capital also participated in the financing. Palvella's cash and cash equivalents of approximately $80.0 million is expected to fund operations into the second half of 2027, including through results from the SELVA Phase 3 clinical trial of QTORINTM rapamycin for the treatment of microcystic LMs and Phase 2 clinical trial of QTORINTM rapamycin in cutaneous VMs. Palvella’s research team developed QTORINTM, a patented and versatile platform designed to generate novel topical therapies that penetrate the deep layers of the skin to locally treat a broad spectrum of serious, rare genetic skin diseases. Well-accepted mechanisms of action of rapamycin and other therapeutic agents represent potential therapies for rare genetic skin diseases. However, the adverse event profile of those agents through systemic exposure poses significant barriers to patient adoption. Palvella’s QTORINTM product candidates are designed for targeted, localized delivery of therapeutic agents to pathogenic tissue of interest while minimizing systemic absorption and thereby reducing the risk of unwanted adverse events associated with systemic therapy. Palvella's lead product candidate QTORINTM rapamycin is a novel, patented 3.9% rapamycin anhydrous gel currently under development for the treatment of microcystic LMs, cutaneous VMs, and other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway. QTORINTM rapamycin has received FDA Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation for microcystic LMs and is the recent recipient of up to a $2.6 million FDA Orphan Products Grant. QTORINTM rapamycin has also received Fast Track Designation for venous malformations. QTORINTM rapamycin is protected by issued composition patents covering anhydrous gel formulations of rapamycin, as well as methods of use, in the U.S., Japan, Australia, China and Israel and pending patent applications broadly covering anhydrous gel formulations of rapamycin, as well as methods of use, in the U.S. and other countries. In the third quarter of 2024, Palvella initiated SELVA, a 24-week, Phase 3, single-arm, baseline-controlled clinical trial of QTORINTM rapamycin administered once daily for the treatment of microcystic LMs. The primary efficacy endpoint is the change from baseline in the overall microcystic LM Investigator Global Assessment (mLM-IGA) at week 24. The Phase 3 study is enrolling approximately 40 subjects, age six or older, at leading vascular anomaly centers across the U.S. Transaction Details Based on the final exchange ratio of approximately 0.30946 shares of Pieris common stock for each share of Palvella common stock, at the closing of the merger, there are approximately 13.95 million shares of the combined company's common stock outstanding on a diluted basis, with prior Pieris stockholders owning approximately 11% on a diluted basis and prior Palvella stockholders (including investors in the private placement) holding approximately 89% of the combined company's outstanding common stock on a diluted basis. In connection with the closing of the merger, Pieris issued a non-transferable contingent value right (CVR) to Pieris shareholders of record immediately prior to the closing, which does not include the former holders of shares of Palvella or the private financing investors. Holders of the CVR will be entitled to receive payments from proceeds received by the combined company, if any, under Pieris' existing partnership agreements with Pfizer and Boston Pharmaceuticals, in addition to other potential licensing agreements involving certain of Pieris' legacy assets, as well as certain potential payments related to historical research and development tax credits, which may or may not be realized. TD Cowen served as lead placement agent and Cantor served as a placement agent for Palvella's concurrent financing. Troutman Pepper Hamilton Sanders LLP served as legal counsel to Palvella. Cooley LLP served as legal counsel to the placement agents. Stifel served as the exclusive financial advisor to Pieris and Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, P.C. served as legal counsel to Pieris. About Microcystic Lymphatic Malformations Microcystic LMs are a rare, chronically debilitating genetic disease caused by dysregulation of the phosphatidylinositol 3-kinase (PI3K)/mTOR pathway. The disease is characterized by malformed lymphatic vessels that protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections and cellulitis that can cause hospitalization. The natural history of microcystic LMs are persistent and progressive without spontaneous resolution, with symptoms generally worsening during life, including increases in the number and size of malformed vessels that lead to complications and lifetime morbidity. There are currently no FDA-approved treatments for the estimated more than 30,000 diagnosed patients with microcystic LMs in the United States. About Palvella Therapeutics Founded and led by rare drug disease drug development veterans, Palvella Therapeutics (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORINTM platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORINTM 3.9% rapamycin anhydrous gel (QTORINTM rapamycin), is currently in the Phase 3 SELVA clinical trial in microcystic lymphatic malformations (microcystic LMs) and a Phase 2 trial in cutaneous venous malformations. For more information, please visit www.palvellatx.com or follow the Company on LinkedIn. QTORINTM rapamycin is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency. This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella and Pieris, as well as assumptions made by, and information currently available to, management of Palvella and Pieris. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, the sufficiency of the combined company’s capital resources; the combined company’s cash runway; the expected timing of the closing of the proposed transactions; statements regarding the potential of, and expectations regarding, Palvella’s programs, including QTORINTM rapamycin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity; the expected timing of initiating, as well as the design of Palvella’s Phase 2 clinical trial of QTORINTM rapamycin in cutaneous venous malformations. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the limited operating history of each company; the significant net losses incurred since inception; the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORINTM rapamycin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of the global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella and Pieris to protect their respective intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Pieris’ most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC, as well as the registration statement on Form S-4 filed with the SEC by Pieris in connection with the merger. Palvella and Pieris can give no assurance that the conditions to the proposed transactions will be satisfied. Except as required by applicable law, Palvella and Pieris undertake no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. Palvella Therapeutics Contact Information Investors Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media Stephanie Jacobson Managing Director, Argot Partners palvella@argotpartners.com
Countries criticize Trump tariff plans, which could flout trade pactsShare Tweet Share Share Email Uber and WeRide have unveiled autonomous mobility services in Abu Dhabi. Takeaway Points Uber and WeRide unveiled autonomous mobility services in Abu Dhabi. The launch represents the first time autonomous vehicles (AVs) are available on the Uber platform outside of the United States. Tawasul Transport, a leading UAE national transport company, will act as the fleet operator. What did Uber and WeRide unveil? WeRide, the world’s first publicly listed Robotaxi company and a global leader in autonomous driving technology, on Friday announced the launch of their ride-hailing partnership with Uber Technologies, Inc., the world’s largest mobility and delivery technology platform, in Abu Dhabi, UAE. According to the report, the launch represents the first time autonomous vehicles (AVs) are available on the Uber platform other than the United States, as well as the largest commercial robotaxi service outside the U.S. and China. Noah Zych, Uber’s Global Head of Autonomous Mobility and Delivery Operations, said, “We’re thrilled to launch our partnership with WeRide, and receive the support of Abu Dhabi’s Integrated Transport Centre. As we take this next step in Abu Dhabi, we are excited to build on the strength of the Uber platform, helping our partners make autonomous vehicles a part of everyday life.” Jennifer Li, Chief Financial Officer and Head of International Business at WeRide, remarked, “WeRide prioritizes passenger and pedestrian safety through rigorously validated autonomous driving technology. As the first publicly listed Robotaxi company, WeRide has demonstrated its commitment to safety through over 1,800 days of public operational experience, setting new benchmarks for autonomous vehicle performance.” Which company is supporting the service? WeRide said that the service is supported by the Integrated Transport Centre (Abu Dhabi Mobility), and Tawasul Transport, a leading UAE national transport company, will act as the fleet operator. Availability Starting today, Uber riders in Abu Dhabi asking for UberX or Uber Comfort may be matched with a WeRide AV for qualifying trips. The service will be available in key areas, between Saadiyat Island, Yas Island, and routes to and from Zayed International Airport , with plans to expand the operating territory in the future, the company said in a statement. About Uber Uber’s mission is to create opportunity through movement. We started in 2010 to solve a simple problem: how do you get access to a ride at the touch of a button? More than 52 billion trips later, we’re building products to get people closer to where they want to be. By changing how people, food, and things move through cities, Uber is a platform that opens up the world to new possibilities. About WeRide WeRide is a global leader and a first mover in the autonomous driving industry, as well as the first publicly listed Robotaxi company. Empowered by the smart, versatile, cost-effective and highly adaptable WeRide One platform, WeRide provides autonomous driving products and services from L2 to L4, addressing a vast majority of transportation needs across a wide range of use cases on the open road, including in the mobility, logistics, and sanitation industries. WeRide earned a prestigious position among the top ten on Fortune Magazine’s “2023 Change the World” list and was named to Fortune Magazine’s 2024 “The Future 50” list. Related Items: Abu Dhabi , Uber , WeRide Share Tweet Share Share Email Recommended for you Dune Bashing: A Must-Try Desert Experience in Abu Dhabi Serve Robotics To Acquire Vebu Uber Updates Platform With EV Preference And Launches AI Chatbot For EV-curious Drivers Comments
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