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ProMIS Neurosciences to Showcase Protein-Misfolding Drug Discovery Platform & PRECISE-AD Trial Design at the 2025 Alzheimer’s Association International Conference
Globenewswire· 2025-07-29 12:00
Core Insights - ProMIS Neurosciences Inc. is advancing its Phase 1b clinical trial, PRECISE-AD, for PMN310, a therapeutic candidate targeting toxic oligomers in Alzheimer's Disease (AD) [2][6] - The company has received Fast Track designation from the FDA for PMN310, indicating its potential to address unmet medical needs in AD [2][10] - The ongoing trial has enrolled over 50% of the planned 128 patients, reflecting a swift enrollment process [2][7] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including AD, ALS, and PD [8] - The company's proprietary platform, EpiSelect, identifies toxic misfolded proteins, enabling the design of selective therapeutic antibodies [3][8] Clinical Trial Details - The PRECISE-AD trial is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and pharmacokinetics of PMN310 at multiple ascending doses [7] - The trial aims to evaluate the effects of PMN310 on biomarkers associated with AD pathology and clinical outcomes, with a primary focus on safety [6][7] - Interim data from the trial is expected to be reported in Q2 2026, with topline results anticipated by Q4 2026 [2][10] Presentation and Conference Participation - ProMIS Neurosciences will present its findings at the Alzheimer's Association International Conference 2025, highlighting the PRECISE-AD trial and the EpiSelect platform [1][4] - Key presentations will include discussions on the design and validation of the EpiSelect platform and the ongoing clinical trial [4][5]
These 2 Stocks Could More Than Double Your Money, According to Wall Street. Is It Time to Buy?
The Motley Fool· 2025-07-20 08:48
Core Viewpoint - The biotechnology industry presents significant investment opportunities, particularly in pre-revenue companies with high price targets set by analysts, indicating potential for dramatic gains in a short time [1][4]. Group 1: Compass Pathways - Compass Pathways is developing a treatment for depression using synthetic psilocybin, with a current market cap of approximately $363 million, down from a peak of over $2 billion during the COVID-19 pandemic [5][10]. - Analysts have set a consensus price target of $15.78 for Compass Pathways, suggesting a potential gain of over 300% from current prices [5]. - The company reported positive results from the COMP005 trial for treatment-resistant depression (TRD), showing a 3.6-point improvement on the Montgomery-Asberg Depression Rating Scale (MADRS) compared to the placebo group [8][9]. - The upcoming COMP006 study will further evaluate the efficacy of COMP360, with expectations that stronger results could significantly increase the stock's value [10]. Group 2: Viking Therapeutics - Viking Therapeutics, another clinical-stage drugmaker, has seen its market cap drop to approximately $3.6 billion from a peak of over $9 billion, with analysts projecting a price target of $90.26, indicating a potential increase of 181% [12]. - The company's lead candidate, VK2735, has shown promising results in weight loss, achieving a placebo-adjusted weight loss of 13% after 13 weeks of treatment [13]. - Viking Therapeutics is positioned to compete with established products like Zepbound, which generated $9.3 billion in annualized sales in the first quarter of this year [14]. - The company is currently conducting a phase 3 study to support a new drug application, which carries risks if tolerability issues arise [15].
My 3 Top Stocks to Buy in a Market That's Highly Volatile (Again)
The Motley Fool· 2025-07-14 08:44
Group 1: Market Overview - Stock market turbulence has returned, primarily due to tariffs, leading to increased volatility [1] - Investors are advised to be cautious but can still find opportunities in the current market [2] Group 2: Dominion Energy - Dominion Energy is highlighted as a strong utility stock, benefiting from stable revenue streams and regulated monopoly status [4] - The company serves 3.6 million customers in Virginia, North Carolina, and South Carolina, and provides natural gas to around 500,000 customers in South Carolina [5] - Dominion Energy has a forward dividend yield of 4.64%, making it attractive for income-focused investors [6] - The company operates in fast-growing markets, particularly in Virginia, which is a hub for data centers, enhancing its growth prospects [7] Group 3: Enbridge - Enbridge is noted for its stability following recent acquisitions, making it the largest natural gas utility in North America by volume [9] - The company maintains a utility-like business profile and offers a dividend yield of 6.11% [10] - Concerns about tariffs on Canadian imports affecting Enbridge are mitigated by the lower tariff rate on energy imports and the U.S. demand for Canadian fuels [11] Group 4: Vertex Pharmaceuticals - Vertex Pharmaceuticals specializes in therapies for cystic fibrosis, with a strong market position due to its unique offerings [12] - The company is expected to strengthen its CF business with the introduction of a new therapy, Alyftrek, which has a more convenient dosage [13] - Vertex has launched Journavx, a new class of pain medication, which is anticipated to become a blockbuster due to its non-opioid nature [14] - The company's pipeline includes promising candidates like povetacicept, targeting a larger patient population than cystic fibrosis [15]
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]
Cidara Announces Pricing of Upsized Public Offering of Common Stock
Globenewswire· 2025-06-25 00:00
Core Viewpoint - Cidara Therapeutics, Inc. has announced a public offering of 7,954,546 shares of its common stock priced at $44.00 per share, aiming to raise approximately $350 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on June 26, 2025, subject to customary closing conditions [2]. - Cidara has granted underwriters a 30-day option to purchase an additional 1,193,181 shares at the public offering price [2]. - J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor are acting as joint book-running managers for the offering [3]. Group 2: Regulatory Information - The offering is made pursuant to a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [4]. Group 3: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 aimed at universal prevention of influenza [6]. - CD388 received Fast Track Designation from the FDA in June 2023, and the company completed enrollment for its Phase 2b NAVIGATE trial in December 2024 [6]. - Cidara is also developing additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors [6].
Cidara Announces Proposed Public Offering of Common Stock
Globenewswire· 2025-06-23 20:15
Core Viewpoint - Cidara Therapeutics, Inc. plans to initiate an underwritten public offering to sell $250 million of its common stock, with a potential additional 15% option for underwriters [1][2] Group 1: Offering Details - The public offering is subject to market conditions and other factors, with no assurance on completion or terms [1] - The offering is made under a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [3] - Joint book-running managers for the offering include J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor Fitzgerald [2] Group 2: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with a focus on antiviral and oncology applications [5] - The lead DFC candidate, CD388, aims for universal prevention of seasonal and pandemic influenza and received Fast Track Designation from the FDA in June 2023 [5] - Cidara completed enrollment for its Phase 2b NAVIGATE trial in December 2024 and received investigational new drug application clearance for CBO421 targeting solid tumors in July 2024 [5]
Defence Therapeutics Receives USPTO Allowance for Patent Application Covering Next-Gen ADC Technology
Newsfile· 2025-06-09 07:15
Core Insights - Defence Therapeutics Inc. has received a Notice of Allowance from the USPTO for its U.S. patent application covering next-generation antibody-drug conjugate (ADC) technology, which includes broad composition-of-matter claims for therapeutically active ADCs [1][2] - The allowed patent application (no. 18/351,291) will potentially grant the company market exclusivity for its proprietary second-generation Accum®-based ADCs until 2043 [2][4] - The company has an established patent portfolio for its Accum® technology, with granted patents in the U.S., Japan, Australia, and Israel, and pending applications in Canada and Europe [3][4] Company Overview - Defence Therapeutics is a clinical-stage biotechnology company focused on developing next-generation ADC products using its proprietary Accum® technology, which enhances the precision delivery of ADCs to target cells [5] - The Accum® technology aims to increase the efficacy and potency of cancer treatments [5]
Bio-Path Holdings Provides Clinical and Operational Update
Globenewswire· 2025-06-03 11:00
Core Insights - Bio-Path Holdings, Inc. is advancing its proprietary DNAbilize platform to develop targeted nucleic acid drugs for cancer and obesity, with a focus on licensing opportunities for commercialization [1][2] Clinical Program Overview - The Phase 2 clinical trial for Prexigebersen in treating Acute Myeloid Leukemia (AML) includes three patient cohorts, with promising results showing two patients in complete remission after over 15 treatment cycles [3][4] - A Phase 1/1b trial for BP1001-A in advanced solid tumors is ongoing, with a patient showing a 15% reduction in tumor size after ten treatment cycles, indicating potential for improved quality of life [5][6] - The Phase 1/1b trial for BP1002 targets relapsed/refractory AML patients, with no dose-limiting toxicities observed in initial cohorts, reflecting a strong demand for new treatment options [7][8] Drug Development and Applications - BP1001-A has shown potential as a treatment for obesity in Type 2 diabetes patients by downregulating Grb2 expression, with preclinical studies confirming its efficacy [9] - The company plans to file an Investigational New Drug (IND) application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide [10] Intellectual Property Protection - Bio-Path holds a robust patent portfolio, including composition of matter patents that protect its proprietary products and allow for the application of its technology to new protein targets [10][13]
Bio-Path Holdings to Host Corporate Update Conference Call on May 29, 2025
Globenewswire· 2025-05-22 20:30
Company Overview - Bio-Path Holdings, Inc. is a biotechnology company focused on developing targeted nucleic acid cancer and obesity drugs using its proprietary DNAbilize antisense RNAi nanoparticle technology [1][3] - The company has a pipeline of RNAi nanoparticle drugs that can be administered via intravenous infusion [3] Product Pipeline - The lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 study for blood cancers [3] - BP1001-A, a modified version of prexigebersen, is in a Phase 1/1b study for solid tumors and is also being evaluated for obesity and related metabolic diseases in Type 2 diabetes patients [3] - The second product, BP1002, targets the Bcl-2 protein and is being evaluated for blood cancers and solid tumors, including acute myeloid leukemia [3] - An IND application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide, is expected to be filed [3] Upcoming Events - The company will host a live conference call and audio webcast on May 29, 2025, at 8:30 a.m. ET to provide a comprehensive business overview [1]
Bio-Path Holdings Achieves Third Pre-Clinical Milestone Confirming Potential of BP1001-A as Treatment for Obesity in Type 2 Diabetes Patients
Globenewswire· 2025-05-01 11:00
Core Insights - Bio-Path Holdings, Inc. has reported promising preclinical results for BP1001-A, indicating its potential to prevent insulin resistance in cells, particularly in the context of obesity and Type 2 diabetes [1][3][5] Group 1: BP1001-A Development - BP1001-A has shown the ability to rescue the decrease in AKT activity in liver cells, which is associated with palmitic acid treatment, suggesting its effectiveness in preventing insulin resistance [1][3] - The drug downregulates Grb2 expression, which is linked to improved insulin signaling in both muscle and liver cell models [3][5] - Bio-Path plans to conduct further preclinical testing using a mouse model to evaluate BP1001-A's impact on weight, insulin sensitivity, and glucose tolerance [4] Group 2: Mechanism of Action - BP1001-A targets the Grb2 protein to enhance insulin sensitivity and lower blood glucose levels in Type 2 diabetes patients [5] - The drug has demonstrated the ability to restore insulin signaling in C2C12 myoblasts, myotubes, and HepG2 liver cells treated with palmitic acid [3][5] Group 3: Future Plans - If preclinical testing is successful, Bio-Path anticipates filing an Investigational New Drug (IND) application in 2025 to initiate a Phase 1 clinical trial [4] - The company is also advancing other product candidates, including BP1002 and BP1003, targeting different proteins for various cancers and metabolic diseases [6]