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Ashvattha Therapeutics Presents Positive Interim Phase 2 Results for Subcutaneous Migaldendranib Treatment for DME and Wet-AMD at 2025 MaculArt Meeting
GlobeNewswire News Room· 2025-06-30 12:05
Monthly subcutaneous migaldendranib shows favorable safety with sustained efficacy through 24 weeks in patients with DME and wet-AMD Novel subcutaneous delivery may offer a more patient-friendly alternative to intravitreal injections, with the potential to significantly reduce treatment burden REDWOOD CITY, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively t ...
Quantum eMotion Expands Strategic Stake in Greybox Solutions to Capitalize on the Digital Therapeutics Surge
Newsfile· 2025-06-30 12:01
Core Insights - Quantum eMotion Corp. has converted $350,000 in debt into equity and made an additional investment of $350,000 in Greybox Solutions Inc., becoming the second-largest shareholder in the company [1][2] - This strategic investment reflects Quantum eMotion's confidence in Greybox's growth in the Remote Care Management and Digital Therapeutics sector, particularly following the launch of the TakeCareTM platform [2][4] - The digital therapeutics market is projected to grow at over 20% CAGR globally, indicating significant potential for both companies [4] Company Overview - Greybox Solutions is a Montreal-based health technology company focused on innovative software development aimed at improving patient care and addressing healthcare system challenges [5] - The TakeCareTM platform is designed to enhance the relationship between patients and healthcare teams, positioning Greybox as a leader in digital health [5] - Quantum eMotion specializes in cybersecurity solutions, leveraging its patented Quantum Random Number Generator technology to provide enhanced protection for critical systems [6][7] Strategic Partnership - The partnership between Quantum eMotion and Greybox Solutions is strengthened by Quantum's Sentry-Q cybersecurity platform, which secures the TakeCareTM platform [3][4] - The appointment of Quantum eMotion's CEO, Francis Bellido, to Greybox's Board of Directors is expected to enhance strategic alignment and access to a broader healthcare network [4] - This collaboration emphasizes the importance of building a trusted, quantum-safe infrastructure for the future of digital therapeutics [4]
Cidara Therapeutics Announces Inclusion in the Russell 2000® and Russell 3000® Indexes
GlobeNewswire News Room· 2025-06-30 12:00
Forward-Looking Statements This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward- looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "anticipates," ...
Pliant Therapeutics Provides Update on BEACON-IPF
Globenewswire· 2025-06-27 20:05
Bexotegrast development in IPF discontinued Clinical oncology program and early-stage programs continue Recent workforce and operational changes align with next steps SOUTH SAN FRANCISCO, Calif., June 27, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that following the review of data from the recently terminated BEACON-IPF Phase 2b/3 clinical trial, the Company has discontinued development of bexotegrast in idiopathic pulmonary fibrosis (IPF). BEACON-IPF Trial Update BEA ...
Clearmind Medicine Expands Global Clinical Trial Targeting Multibillion-Dollar Alcohol Use Disorder Market
Globenewswire· 2025-06-27 13:00
Vancouver, Canada, June 27, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the addition of Hadassah-University Medical Center, Jerusalem, Israel, as a new clinical site for its ongoing Phase I/IIa clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidat ...
Autonomix Medical, Inc. Granted New U.S. Patent for Innovative Catheter-Based Platform Technology
Globenewswire· 2025-06-27 12:00
Patent supports the Company’s broader mission to advance minimally invasive, nerve-focused treatments across high-need indications Strengthens strategic position in a multi-billion-dollar market opportunity and expands Autonomix’s growing global IP portfolio with over 80 issued patents THE WOODLANDS, TX, June 27, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced ...
PepGen Inc. Investors: Please contact the Portnoy Law Firm to recover your losses. August 8, 2025 Deadline to file Lead Plaintiff Motion.
GlobeNewswire News Room· 2025-06-26 22:35
Core Viewpoint - PepGen Inc. is facing a class action lawsuit due to allegations of misleading statements regarding the safety and efficacy of its lead product candidate, PGN-EDO51, and the adequacy of its clinical trials [3][4][5]. Company Overview - PepGen Inc. is a clinical-stage biotechnology company focused on developing oligonucleotide therapeutics for severe neuromuscular and neurologic diseases, with PGN-EDO51 targeting Duchenne muscular dystrophy (DMD) [3]. Allegations and Events - The class action lawsuit claims that PepGen made false statements about PGN-EDO51's safety and effectiveness, inadequately conducted the CONNECT2 clinical trial, and overstated the product's clinical and regulatory prospects [3]. - On July 30, 2024, PepGen reported "positive clinical data" from the CONNECT1 study, but the results were deemed disappointing by analysts, leading to a nearly 33% decline in stock price [4]. - On December 16, 2024, PepGen received a clinical hold notice from the FDA regarding the CONNECT2 study, causing further stock decline [5]. - On January 29, 2025, dosing in the CONNECT1 study was paused due to safety concerns, resulting in an approximate 22% drop in stock price [6]. - On March 4, 2025, PepGen announced a voluntary temporary pause of the CONNECT2 study, leading to another nearly 19% decline in stock price [7].
Cidara Announces Closing of Upsized Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares
Globenewswire· 2025-06-26 21:15
Group 1 - Cidara Therapeutics, Inc. closed its underwritten public offering of 9,147,727 shares at a price of $44.00 per share, raising gross proceeds of $402.5 million [1] - The offering included the full exercise of the underwriters' option to purchase an additional 1,193,181 shares [1] - The offering was conducted under a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [3] Group 2 - Cidara is utilizing its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 aimed at universal prevention of influenza [5] - CD388 received Fast Track Designation from the FDA in June 2023, and the Phase 2b NAVIGATE trial enrollment was completed in December 2024 [5] - Cidara has also developed additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received investigational new drug application clearance in July 2024 [5]
Whitehawk Therapeutics (AADI) Fireside Chat Transcript
2025-06-26 15:00
Summary of Whitehawk Therapeutics Fireside Chat - June 26, 2025 Company Overview - Whitehawk Therapeutics, formerly known as Adi Bioscience, underwent a transformation completed in Q1 2025, focusing on developing an advanced ADC (antibody-drug conjugate) portfolio after selling its mTOR inhibitor product to Kaken Pharmaceuticals for $100 million [3][4][15]. Pipeline and Technology - The company is developing a three-asset ADC portfolio targeting various cancers, including lung, ovarian, and gastrointestinal cancers, with a focus on established tumor biology and clinically validated tumor markers [4][5][14]. - All three programs are currently in preclinical stages, with IND (Investigational New Drug) filings anticipated by mid-2026 [6][13]. - The ADC platform utilizes a linker payload technology designed for greater stability, reduced off-target toxicity, and improved therapeutic index [5][12][13]. Key Programs 1. **HAWK 007 (PTK7-targeted ADC)** - PTK7 is broadly overexpressed in various solid tumors, with expression rates of 60-70% in cancer patients [20][21]. - The program aims to demonstrate differentiation from previous compounds, with a focus on lung cancer, ovarian cancer, and triple-negative breast cancer [24][26]. - Initial phase one trials will target patients with moderate to high expression of PTK7, aiming for a minimum response rate of 40% in lung cancer and 50% in ovarian cancer [56]. 2. **HAWK 016 (MUC16-targeted ADC)** - MUC16 is a circulating biomarker in ovarian cancer, with the approach focusing on targeting the membrane-bound portion to avoid complications from circulating biomarkers [60][63]. - The program will initially focus on gynecological cancers, with potential expansion into pancreatic and non-small cell lung cancers in the future [70]. 3. **HAWK 206 (SEZ6-targeted ADC)** - This program is in the early stages, with a biparatopic approach aimed at enhancing internalization and efficacy in neuroendocrine tumors and small cell lung cancer [71][78]. Competitive Landscape - The ADC market is competitive, with other companies like Zymeworks and Day One Pharmaceuticals developing next-generation ADCs. Whitehawk believes its platform offers superior optimization in terms of linker stability, hydrophilicity, and therapeutic index [36][46]. - The company aims to differentiate its products by demonstrating better efficacy and safety profiles compared to existing therapies [30][46]. Financial Position and Future Outlook - Whitehawk started Q2 2025 with approximately $185 million in cash, providing operational runway into early 2028 to generate clinical data before seeking additional funding [88][90]. - The company plans to release more preclinical data in 2026, focusing on a comprehensive view of its products' potential before public disclosures [89][90]. Conclusion - Whitehawk Therapeutics is positioned to make significant advancements in the ADC space with its innovative platform and targeted therapies. The upcoming IND filings and clinical trials will be critical in validating its approach and establishing its market presence.
Clearmind Medicine Enrolls First Patient in its Clinical Trial for Alcoholism Treatment
Globenewswire· 2025-06-25 11:48
Core Insights - Clearmind Medicine Inc. has initiated a Phase I/IIa clinical trial for CMND-100, a proprietary MEAI-based oral drug candidate aimed at treating Alcohol Use Disorder (AUD), which affects hundreds of millions globally [1][2] - The trial's primary focus is on evaluating the safety, tolerability, and pharmacokinetic profile of CMND-100, with preliminary efficacy assessments to determine its potential in reducing alcohol cravings and consumption [2] Company Overview - Clearmind is a clinical-stage biotech company dedicated to developing novel psychedelic-derived therapeutics to address significant health issues, including AUD [4] - The company has a robust intellectual property portfolio consisting of nineteen patent families and 31 granted patents, with plans to seek additional patents as necessary [5] Market Potential - The substance use disorder treatment market in the U.S. was valued at $35.1 billion in 2021 and is projected to grow to $60.2 billion by 2029, indicating a significant opportunity for innovative treatments like CMND-100 [3]