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Acadia Stock Up 59% in a Year — Is a $51 Million New Stake a Bet on a Bigger Rebound?
The Motley Fool· 2025-12-04 00:12
One fund is quietly buying into ACADIA — just as the company posts one of its strongest quarters in years.Connecticut-based fund Braidwell established a new position in ACADIA Pharmaceuticals (ACAD +1.77%), adding nearly 2.4 million shares, a stake valued at about $50.8 million as of September 30.What HappenedAccording to a filing with the U.S. Securities and Exchange Commission dated November 14, Braidwell disclosed a new stake in ACADIA Pharmaceuticals, acquiring nearly 2.4 million shares valued at approx ...
CASI Pharmaceuticals Receives and Appeals Delisting Determination from NASDAQ
Accessnewswire· 2025-11-10 21:05
Core Viewpoint - CASI Pharmaceuticals has received a delisting determination from Nasdaq due to its market value of listed securities falling below the minimum requirement of $35 million for 30 consecutive trading days, and the company has appealed this decision to regain compliance [2][3]. Company Update - CASI Pharmaceuticals, Inc. is focused on developing CID-103, an anti-CD38 monoclonal antibody aimed at treating organ transplant rejection and autoimmune diseases [5][6]. - The company was notified on May 5, 2025, that it did not comply with Nasdaq Listing Rule 5550(b)(2) due to its market value falling below the required threshold [2]. - CASI has appealed the delisting determination and requested a hearing to present a plan for regaining compliance, which will temporarily stay the suspension of its securities [3][4]. Product Development - CID-103 is a fully human IgG1 monoclonal antibody that has shown promising pre-clinical efficacy and clinical safety compared to other anti-CD38 monoclonal antibodies [6]. - The company has received FDA IND clearance to conduct a Phase 1 study in the U.S. for renal allograft antibody-mediated rejection, with plans to enroll the first patient in the first quarter of 2026 [6]. - CASI is also actively recruiting patients for an ongoing Phase 1 study in immune thrombocytopenia (ITP) and is exploring technologies for developing a stable, high concentration protein solution for subcutaneous injection [6].
Lilly announces two new Executive Committee members and expansion of leadership roles to prepare for next wave of growth
Prnewswire· 2025-11-06 21:05
Core Insights - Eli Lilly and Company has announced the appointment of two new Executive Committee members and the expansion of existing leaders' roles to enhance its ambitious pipeline and improve patient access to medicines [1][6]. Leadership Changes - Carole Ho, M.D., has been appointed as executive vice president and president of Lilly Neuroscience, bringing over 20 years of biopharmaceutical experience [2]. - Adrienne Brown has been promoted to executive vice president and president of Lilly Immunology, having held various leadership roles at Lilly for over 20 years [3]. - Daniel Skovronsky, M.D., Ph.D., will expand his role as chief scientific and product officer, overseeing research and development for Cardiometabolic Health, Immunology, and Neuroscience [4]. - Jacob Van Naarden will also take on an expanded role, incorporating corporate business development under his leadership [5]. Strategic Vision - The company aims to leverage its transformed research engine and expanded production capacity to enhance access to care and affordability, with a focus on driving growth and improving patient outcomes [6].
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) Surpasses Earnings and Revenue Estimates
Financial Modeling Prep· 2025-11-05 06:10
Core Insights - Aurinia Pharmaceuticals Inc. is focused on developing therapies for autoimmune diseases and is part of the Zacks Medical - Drugs industry [1] - RBC Capital set a price target of $15 for AUPH, indicating a potential upside of approximately 5.12% from its current trading price of $14.27 [1] Financial Performance - Aurinia reported earnings of $0.23 per share for Q3 2025, surpassing the Zacks Consensus Estimate of $0.16, representing a positive surprise of 43.75% and an increase from $0.10 per share in the same quarter last year [2][6] - The company's revenue for the quarter ending September 2025 was $73.47 million, exceeding the Zacks Consensus Estimate by 7.31% and marking an increase from $67.77 million in the same period last year [3][6] - Aurinia has consistently surpassed consensus earnings and revenue estimates in each of the last four quarters, showcasing strong financial performance and growth trajectory [2][3] Stock Performance - AUPH's stock price has increased by 8.35%, currently priced at $14.27, with a fluctuation range between a low of $13.50 and a high of $16.20 today [4][6] - The stock's highest price over the past year was $16.20, while the lowest was $6.55, indicating significant volatility [4] - The company has a market capitalization of approximately $1.88 billion, with a trading volume of 4,972,046 shares today [5]
Inhibrx Announces Participation in Upcoming Scientific Conferences
Prnewswire· 2025-11-04 21:01
Core Insights - Inhibrx Biosciences, Inc. is set to present clinical data on its DR5 Agonist at multiple upcoming scientific conferences, highlighting its focus on novel biologic therapeutic candidates [1][2][3] Conference Presentations - The company will present at the 21st Annual Industry/Academia Precision Oncology & Radmed Symposium on November 5, 2025, discussing DR5 Agonist clinical data in various cancers [1] - At the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting from November 12-15, 2025, Inhibrx will present results from the Phase 2 ChonDRAgon Study on ozekibart (INBRX-109) in conventional chondrosarcoma [2] - The Society for NeuroOncology (SNO) 2025 Annual Meeting from November 19-23, 2025, will feature a poster presentation on the anti-tumor activity of ozekibart in GBM models [3] Company Overview - Inhibrx Biosciences is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates, utilizing diverse protein engineering methods [4] - The company was incorporated in January 2024 and has a current clinical pipeline that includes ozekibart and INBRX-106, both employing multivalent formats for optimized agonist function [4]
Vanda Pharmaceuticals to Announce Third Quarter 2025 Financial Results on October 29, 2025
Prnewswire· 2025-10-22 20:30
Core Viewpoint - Vanda Pharmaceuticals Inc. is set to release its third quarter 2025 financial results on October 29, 2025, after market close, followed by a conference call to discuss the results and corporate activities [1][2]. Financial Results Announcement - The financial results for Q3 2025 will be announced on October 29, 2025, after the market closes [1]. - A conference call will be held at 4:30 PM ET on the same day to discuss the results [2]. Conference Call Details - Participants can join the conference call by dialing 1-888-596-4144 for domestic calls or 1-646-968-2525 for international calls, using passcode 8728050 [2]. - The call will be broadcast live and archived on Vanda's website, with a recommendation for investors to register at least 15 minutes early [3]. Replay Information - A replay of the conference call will be available starting at 8:30 PM ET on October 29, 2025, until November 5, 2025, at 11:59 PM ET [4]. - The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers, with the same passcode [4]. Company Overview - Vanda Pharmaceuticals Inc. is a global biopharmaceutical company focused on developing and commercializing innovative therapies to meet high unmet medical needs [5].
Inhibrx To Host Webcast Presentation of Topline Results from its Registrational Trial of Ozekibart (INBRX-109) in Chondrosarcoma and to Provide Updates on Colorectal Cancer and Ewing Sarcoma Expansion Cohorts
Prnewswire· 2025-10-22 20:01
Core Insights - Inhibrx Biosciences, Inc. will host a live webcast on October 23, 2025, to present topline results from the ChonDRAgon study of ozekibart (INBRX-109) for advanced chondrosarcoma [1] - The company will also provide updates on ongoing trials of ozekibart in combination therapies for colorectal cancer and Ewing sarcoma [1] Company Overview - Inhibrx is a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases [1][5] - The company utilizes diverse protein engineering methods to create novel biologic therapeutic candidates [5] Product Information - Ozekibart (INBRX-109) is a tetravalent death receptor 5 (DR5) agonist antibody designed to induce tumor-biased cell death [3] - The FDA granted Fast Track designation for ozekibart in January 2021 and orphan drug designation in November 2021 for chondrosarcoma [3] Clinical Trials - A Phase 2 trial of ozekibart in metastatic, unresectable conventional chondrosarcoma was initiated in June 2021 [4] - Ongoing Phase 1/2 trials are investigating ozekibart in combination with FOLFIRI for colorectal cancer and with irinotecan/temozolomide for Ewing sarcoma [4]
Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics' Global Phase 3 Trials of Dotinurad for the Treatment of Gout
Globenewswire· 2025-10-21 12:30
Core Insights - Urica Therapeutics, a subsidiary of Fortress Biotech, has initiated Phase 3 trials for dotinurad, a new oral treatment for gout, marking a significant advancement in its clinical development program [1][3] Group 1: Clinical Trials - The RUBY study will evaluate dotinurad's safety and efficacy in approximately 500 patients with hyperuricemia associated with gout, with participants receiving the drug once daily for up to 64 weeks [4] - The TOPAZ study will assess dotinurad in about 250 patients with tophaceous gout, with a treatment duration of up to 76 weeks [5] Group 2: Market Context - Gout is a prevalent form of inflammatory arthritis caused by excess uric acid, leading to severe pain and inflammation, with a significant treatment gap for patients not responding to first-line therapies [6] - There are currently no suitable second-line treatment options available in the U.S. or E.U., highlighting a critical unmet need in the market [6] Group 3: Company Developments - Fortress Biotech has achieved significant milestones, including two FDA approvals and a substantial acquisition, enhancing its portfolio and potential revenue streams [3] - Urica holds a minority equity position in Crystalys and is entitled to a 3% royalty on future net sales of dotinurad, indicating a strategic financial interest in the drug's success [3]
Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout
Globenewswire· 2025-10-21 12:30
Core Viewpoint - Urica Therapeutics, a subsidiary of Fortress Biotech, has initiated two Phase 3 clinical trials for dotinurad, a new oral treatment for gout, which could address significant unmet medical needs in this area [1][3]. Clinical Trials - The RUBY study will evaluate dotinurad's safety and efficacy in approximately 500 patients with hyperuricemia associated with gout, with participants receiving the drug once daily for up to 64 weeks [4]. - The TOPAZ study will assess dotinurad in about 250 patients with tophaceous gout, with a treatment duration of up to 76 weeks [5]. Company Developments - Fortress Biotech's Executive Chairman highlighted the initiation of these trials as a major milestone, building on recent successes including two FDA approvals and a significant acquisition [3]. - Fortress received approximately $28 million upfront from the acquisition of Checkpoint Therapeutics by Sun Pharma, with potential future payments and royalties [3]. Market Context - Gout is characterized by painful inflammation due to excess uric acid, and there is a notable treatment gap for patients who do not respond to first-line therapies [6]. - Current treatment options in the U.S. and E.U. are limited, indicating a critical need for new therapies like dotinurad [6]. Company Overview - Fortress Biotech focuses on acquiring and advancing biopharmaceutical assets to enhance shareholder value through various revenue streams [7]. - The company has a diverse portfolio, including eight marketed products and multiple development programs across therapeutic areas such as oncology and rare diseases [8].
Palisade Bio Announces Closing of Upsized $138 Million Public Offering of Common Stock and Including Full Exercise of Over-Allotment Option
Globenewswire· 2025-10-02 20:05
Core Insights - Palisade Bio, Inc. has successfully closed an underwritten public offering, raising approximately $138 million to support the Phase 2 clinical development of PALI-2108 for Ulcerative Colitis [1][2] Group 1: Offering Details - The offering consisted of 197,154,844 shares of common stock priced at $0.70 per share [3] - The offering was led by B Group Capital and Columbia Threadneedle Investments, with participation from several notable investors [1] Group 2: Use of Proceeds - Proceeds from the offering will be utilized to advance the clinical development program for PALI-2108, which targets significant unmet medical needs in inflammatory bowel disease (IBD) [2] Group 3: Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases [6]