Clinical Trial Results of MRT-2359 - MRT-2359 combined with enzalutamide demonstrated a 100% PSA response rate in heavily pre-treated mCRPC patients with AR mutations[5, 38, 59] - Among the 4 patients with AR mutations, 2 patients showed PSA90 responses and 2 patients showed PSA50 responses[5, 38] - Two patients with AR mutations achieved RECIST partial responses (1 confirmed, 1 unconfirmed), and two had stable disease, resulting in a 100% disease control rate in the AR mutant population[5] - An overall disease control rate (DCR) of 64% was observed in 14 evaluable patients, including 5 patients without AR mutations who had stable disease[5, 59] Safety and Tolerability - The combination of MRT-2359 and enzalutamide was well-tolerated, with the most frequent adverse events (AEs) being mild or moderate manageable GI symptoms[5, 33, 59] - Treatment-related AEs occurring in >15% patients included fatigue (50%), diarrhea (45%), nausea (35%), arthralgia (30%), decreased appetite (30%), vomiting (30%), neutropenia (25%), and muscular weakness (20%)[31, 32] Future Plans - The company plans to initiate a signal-confirming 2-stage Phase 2 study (MODeFIRe-1) of MRT-2359 in combination with a 2nd generation AR inhibitor in 2026, targeting AR-mutated mCRPC[2, 56, 59] - Updated data from the Phase 1/2 study is expected to be presented at the ASCO Genitourinary Cancers Symposium in February 2026[59]

NEW YORK, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today announced that it is expected to be added to the Nasdaq Biotechnology Index (“NBI”) (Nasdaq: NBI). Immuneering’s addition will become effective prior to market open on Monday, December 22, 2025. The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market that are issued by c ...

MALVERN, Pa., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced it will host a corporate update webinar followed by a live Q&A session. The webinar will feature Maria Maccecchini, Ph.D., President and CEO, who will provide an overview of the Company’s recent progress, ongoing ...

Efficacy Results - The Phase 2b REZOLVE-AA study evaluated rezpegaldesleukin (REZPEG) for alopecia areata [1, 19] - The study achieved statistical significance for both treatment arms after excluding 4 patients with major study eligibility violations [36] - The mean percentage change in SALT score from baseline to week 36 was -30% in the REZPEG arms versus -6% in the placebo arm (p<0.05), after excluding 4 patients with major study eligibility violations [92] - 42% of REZPEG-treated patients achieved a best reduction in SALT score of 30% or greater [47] - 36% of REZPEG-treated patients achieved a best reduction in SALT score of 50% or greater [47] - 17% of REZPEG-treated patients achieved a best reduction in SALT score of 75% or greater [47] Safety and Tolerability - The study showed a consistent safety profile with previously reported studies, with nearly all adverse events (AEs) being mild to moderate in severity and self-resolved [31] - The discontinuation rate due to AEs was low at 1.4% for REZPEG-exposed patients [31] - The placebo-adjusted injection site reaction (ISR) rate was consistent with prior studies, with 87% being mild in severity [31] Market and Strategic Implications - The data supports a first-in-class Treg mechanism of action with fast onset of action in moderate-to-severe patients [9] - 54% of physicians report they would try patients on alternate therapies for AA before prescribing JAKi [10] - G7 market size for Alopecia Areata is projected to reach $4 billion by 2033 [7]

SUNNYVALE, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). The meeting was held in further preparation for formal clinical consultat ...

The registrational TACTI-004 Phase III has enrolled 289 patients globally, over 38% of the trial’s targeted enrolmentStrong operational progress continues globally with over 120 activated clinical sites and 27 countries having received full regulatory approvals including the United States Futility analysis remains on track for the first quarter of CY2026 and completion of patient enrolment in the third quarter of CY2026 SYDNEY, AUSTRALIA, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: ...

Veru Inc. (NASDAQ:VERU) will release earnings results for its fourth quarter before the opening bell on Wednesday, Dec. 17.Analysts expect the Miami, Florida-based company to report quarterly loss at 39 cents per share, versus a year-ago loss of 52 cents per share, according to Benzinga Pro.On Oct. 30, Veru announced pricing of $25 million public offering of 1.4 million shares of common stock at a price of $3.00 per unit.Shares of Veru fell 1.2% to close at $2.39 on Monday.Benzinga readers can access the la ...

Core Insights - Arch Biopartners Inc. has received ethics approval from the University Health Network Research Ethics Board for St. Michael's Hospital to participate in the Phase II trial of LSALT peptide aimed at preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI) [1][2] Company Overview - Arch Biopartners Inc. is a therapeutic biotech company focused on developing novel drugs for acute kidney injury (AKI) and chronic kidney diseases (CKD), with a pipeline targeting inflammation- and toxin-related kidney injury [17] Clinical Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study with a recruitment target of 240 patients, where subjects will receive either LSALT peptide (10mg IV twice daily for five days) or placebo [5] - The primary objective is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, as defined by KDIGO criteria [5][6] Current Status of the Trial - St. Michael's Hospital will be the ninth site activated globally and the fourth within a leading Canadian academic hospital network, with operational approvals and training underway before patient enrollment [2][4] - Other sites, including Toronto General Hospital and the University of Calgary, are actively enrolling patients, while Royal Columbian Hospital has received REB approval and is preparing for site initiation [4] Medical Context - CS-AKI is a common complication following cardiac surgery, affecting up to 30% of patients undergoing on-pump procedures, leading to serious complications and increased mortality [11][12] - There are currently no approved therapies for CS-AKI, highlighting a significant unmet medical need that LSALT peptide aims to address [12] Mechanism of Action - LSALT peptide is designed to prevent inflammation injury in the kidneys, lungs, and liver by binding to the dipeptidase-1 (DPEP1) enzyme, which plays a role in triggering organ inflammation [8] - Pre-clinical models have demonstrated LSALT's ability to prevent ischemia-reperfusion injury to the kidneys, supporting its therapeutic potential [8] Previous Research Findings - An earlier Phase II trial for acute lung inflammation showed that patients treated with LSALT peptide had significant reductions in inflammatory biomarkers, validating DPEP1 as a therapeutic target [9]

Core Viewpoint - Arch Biopartners Inc. has received ethics approval for St. Michael's Hospital to participate in a Phase II trial evaluating LSALT peptide for preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI) [1][2]. Company Overview - Arch Biopartners Inc. is a therapeutic biotech company focused on developing novel drugs for acute kidney injury (AKI) and chronic kidney diseases (CKD) [16]. - The company is advancing an integrated program targeting inflammation- and toxin-related kidney injury, with LSALT peptide as its lead drug candidate [16]. Clinical Trial Details - The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study with a recruitment target of 240 patients [5]. - Patients will be randomized to receive either LSALT peptide (10mg IV twice daily for five days) or placebo, with the primary objective being to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery [5][6]. Research and Development - The trial aims to address a significant unmet medical need, as up to 30% of patients undergoing on-pump cardiac surgery develop CS-AKI, which can lead to serious complications and increased mortality [11]. - LSALT peptide works by binding to the dipeptidase-1 (DPEP1) enzyme, inhibiting its role in triggering organ inflammation, and has shown promise in pre-clinical models for preventing ischemia-reperfusion injury to the kidneys [8][7]. Collaboration and Site Activation - St. Michael's Hospital will be the ninth site activated globally and the fourth within a leading Canadian academic hospital network [2]. - Other active sites include Toronto General Hospital and the University of Calgary, with additional sites being evaluated in Canada and the United States [4].

Core Insights - The State Street Health Care Select Sector SPDR ETF (XLV) is a passively managed ETF launched on December 16, 1998, providing broad exposure to the Healthcare - Broad segment of the equity market [1] - XLV is the largest ETF in its category, with assets exceeding $40.99 billion, and aims to match the performance of the Health Care Select Sector Index [3] Fund Details - The ETF has an annual operating expense ratio of 0.08%, making it the least expensive option in the healthcare ETF space, with a 12-month trailing dividend yield of 1.56% [5] - The fund is fully allocated to the healthcare sector, with top holdings including Eli Lilly + Co (12.97%), Johnson + Johnson, and Abbvie Inc, which together account for approximately 57.14% of total assets [6][7] Performance Metrics - As of December 16, 2025, XLV has returned approximately 14.79% year-to-date and 12.45% over the past year, with a trading range between $128.77 and $158.77 in the last 52 weeks [8] - The ETF has a beta of 0.61 and a standard deviation of 13.38% over the trailing three-year period, indicating a medium risk profile [8] Alternatives - Other healthcare ETFs include iShares Global Healthcare ETF (IXJ) with $4.52 billion in assets and Vanguard Health Care ETF (VHT) with $17.53 billion, each with different expense ratios [11]