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MaaT Pharma Schedules Pre-IND Meeting with FDA for MaaT034 in Solid Tumors

MaaT Pharma Schedules Pre-IND Meeting with FDA for MaaT034 in Solid Tumors

MaaT Pharma, a clinical-stage biotechnology company, has scheduled a Pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for October 2026. This meeting will focus on Chemistry, Manufacturing, and Controls (CMC) for MaaT034, a novel Microbiome Ecosystem Therapy (MET-C) candidate. MaaT034 is designed to be evaluated in combination with PD-(L)1 inhibitors for advanced solid tumors, including second-line advanced non-small cell lung cancer (NSCLC) and refractory advanced melanoma. The company aims to initiate a First-in-Human study in late 2027, pending regulatory clearance and funding. MaaT034 is the first candidate from MaaT Pharma's MET-C platform, which utilizes artificial intelligence and co-culture technology to produce functionally selected microbial ecosystems.

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

BriaCell Therapeutics Receives FDA Clearance for Prostate Cancer Clinical Trial, Advancing Off-the-Shelf Immunotherapy

BriaCell Therapeutics Receives FDA Clearance for Prostate Cancer Clinical Trial, Advancing Off-the-Shelf Immunotherapy

BriaCell Therapeutics Receives FDA Clearance for Prostate Cancer Clinical Trial, Advancing Off-the-Shelf Immunotherapy

Morgan Stanley flags Amgen's edge after heart-drug rival stumbles

Morgan Stanley flags Amgen's edge after heart-drug rival stumbles

A private meeting with Amgen management left Morgan Stanley with a very different read than the broader market's.

Beacon Therapeutics Prepares FDA Filing for XLRP Gene Therapy After Positive Phase 3 Results

Beacon Therapeutics Prepares FDA Filing for XLRP Gene Therapy After Positive Phase 3 Results

Beacon Therapeutics is preparing to submit a rolling Biologics License Application (BLA) to the FDA later this year for its gene therapy, laruparetigene zovaparvovec (laru-zova), which treats X-linked retinitis pigmentosa (XLRP). This decision follows positive results from the pivotal Phase 2/3 VISTA trial, where laru-zova met its primary endpoint with statistical significance. The trial demonstrated a significant improvement in low luminance visual acuity (LLVA) responder rates at 12 months compared to an untreated control group. Specifically, 31% of XLRP patients receiving a high dose and 24.1% receiving a low dose achieved an improvement of 15 letters or more on an eye chart, with no responders in the control group. The gene therapy also exhibited a favorable safety and tolerability profile consistent with previous studies.

RNA drug developer ADARx seeks $1.74 billion valuation in US IPO

RNA drug developer ADARx seeks $1.74 billion valuation in US IPO

Sept 21 (Reuters) - ADARx Pharmaceuticals is targeting a valuation of up to $1.74 billion in its US initial public offering, the company developing RNA drugs said on Monday. The ‌company is aiming to raise up to $371.9 million by offering 21.9 million shares priced between $15 and $17.

Cancer Research Advances in Detection and Treatment, Including Molecular Glues and Early Blood Tests

Cancer Research Advances in Detection and Treatment, Including Molecular Glues and Early Blood Tests

Significant advancements are emerging in cancer research, particularly in early detection and targeted therapies. Researchers are developing 'molecular glues' that can disrupt cancer-driving signals by attaching to proteins within growth systems or by bringing cellular machinery together. This approach aims to interrupt the pathways that fuel cancer growth. Concurrently, there is a strong emphasis on developing blood tests designed to detect cancer at its earliest stages. These tests seek to identify abnormal proteins, DNA fragments, and other signals released by tumors into the bloodstream, with the ultimate goal of not only detecting cancer but also pinpointing its origin. While this technology is in its nascent stages, it holds substantial promise for improving early diagnosis. These developments represent a shift from traditional treatments like surgery, radiation, and broad chemotherapy towards more selective and less toxic interventions. The focus is on therapies that deliver treatment directly to ma...

FDA Moves to Reduce Animal Testing Requirements for Drug Approval

FDA Moves to Reduce Animal Testing Requirements for Drug Approval

The U.S. Food and Drug Administration (FDA) has issued a direct final rule aimed at removing outdated references to animal testing in its drug and biologics regulations. This action is a significant step towards encouraging drug companies to utilize cutting-edge non-animal testing methods. Despite the FDA's public commitment to advancing non-animal test methods, existing regulations have often led companies to believe that animal testing is a mandatory requirement for drug approval. The new rule, which could become effective as early as February 4, 2027, directly responds to a 2024 legal petition filed by Humane World for Animals and Humane World Action Fund. These organizations advocated for the FDA to clarify that animal testing is not legally required. This initiative aligns with the FDA's stated goal of making animal tests "the exception rather than the norm" for preclinical safety and toxicity testing within the next three to five years.

Xenon Pharmaceuticals Halts Psychiatry Studies for Azetukalner Due to Psychosis Events

Xenon Pharmaceuticals Halts Psychiatry Studies for Azetukalner Due to Psychosis Events

Xenon Pharmaceuticals Halts Psychiatry Studies for Azetukalner Due to Psychosis Events

Mizuho Specialist Jared Holz States No Strong Link Between Biotech Sector and Interest Rates

Mizuho Specialist Jared Holz States No Strong Link Between Biotech Sector and Interest Rates

Mizuho Specialist Jared Holz States No Strong Link Between Biotech Sector and Interest Rates

Why Morgan Stanley likes Gilead's HIV prevention play

Why Morgan Stanley likes Gilead's HIV prevention play

After sessions with Gilead's leadership at Morgan Stanley's 2026 Global Healthcare Conference, the bank reaffirmed its Overweight rating, and one franchise stood out.

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics Reports Positive Phase 2 Results for Lavengratinib in Achondroplasia Treatment

Abbisko Therapeutics has announced positive preliminary efficacy results from its Phase II clinical study of lavengratinib (ABSK061), a selective orally available small-molecule FGFR2/3 inhibitor, for children with achondroplasia (ACH). In the initial and lowest dose cohort (0.064mg/kg QD), children aged 6 years and older with ACH who received lavengratinib for 27 weeks showed a mean increase of +2.4 cm/year in annualized height velocity (AHV) from baseline, achieving a 100% responder rate. The drug was well-tolerated, with no observed FGFR1 or FGFR2-associated adverse events. The ABSK061-202 study is a Phase II, multicenter, open-label, dose-escalation study evaluating the safety and efficacy of lavengratinib in children aged 3 to 12 years with ACH, with a planned treatment duration of 78 weeks. Preliminary safety evaluations for the first three dose cohorts have been successfully completed without identifying any safety concerns.