Gossamer Bio PROSERA Phase 3 Top Line Results Call Summary Company Overview - **Company**: Gossamer Bio, Inc. - **Focus**: Development of seralutinib for the treatment of pulmonary arterial hypertension (PAH) Key Industry and Company Insights Phase 3 Study Results - **Study Name**: PROSERA - **Objective**: Evaluate the efficacy of seralutinib in patients with PAH - **Primary Endpoint**: Change in six-minute walk distance at week 24 - **Results**: - Seralutinib showed a numerical improvement of approximately 13.3 meters compared to placebo (p-value = 0.032) - Did not meet the pre-specified statistical significance threshold of 0.025, thus considered not statistically significant [4][12][28] Subgroup Analysis - **Intermediate and High-Risk Subgroup**: - 234 patients defined by REVEAL Lite 2 risk score - Demonstrated a clinically meaningful improvement of 20 meters in six-minute walk distance (p-value = 0.0207) [5][17] - 3 out of 4 key secondary endpoints favored seralutinib with p-values below 0.0125 [5] Placebo Response - **Unexpected High Placebo Response**: - The placebo group showed a larger improvement than typically seen in PAH studies, which diluted the treatment effect [12][15] - Geographic differences noted, with North America showing more typical placebo responses compared to Latin America, where the placebo response was significantly higher [16][68] Safety Profile - **Adverse Events**: - Treatment-emergent adverse events (TEAEs) reported in 86.5% of seralutinib patients vs. 80.5% in placebo [24] - Most common TEAE was cough (37% in seralutinib vs. 13.7% in placebo) [25] - Liver enzyme elevations were noted, with 13% of seralutinib patients experiencing elevations ≥3 times the upper limit of normal [26][107] Strategic Decisions - **Enrollment Pause**: - Gossamer Bio decided to pause enrollment in the SERANATA Phase 3 study to focus resources on the PROSERA dataset and engage with the FDA [9][30] - **Next Steps**: - Further analysis of PROSERA data and discussions with regulators regarding the implications of the results [31] Commercial Opportunity - **Market Potential**: - Seralutinib is viewed as a meaningful opportunity in the PAH market, particularly for high-risk patients who face significant morbidity and mortality [30] Regulatory Considerations - **FDA Engagement**: - Gossamer Bio plans to present the PROSERA results to the FDA, emphasizing the unmet medical need in the high-risk population [56][100] Additional Important Insights - **Long-Term Efficacy**: - Data suggests that seralutinib may show improved efficacy over time, particularly in patients with more severe disease [15][70] - **Comparative Analysis**: - The treatment effect of seralutinib aligns well with other approved PAH therapies, especially in patients with higher baseline disease severity [20][21] This summary encapsulates the critical findings and strategic directions from the Gossamer Bio PROSERA Phase 3 results call, highlighting both the challenges and opportunities in the development of seralutinib for PAH treatment.

GRAIL Inc. (NASDAQ:GRAL) shares are down during Monday's premarket session following the release of results from the NHS-Galleri trial, which evaluated the effectiveness of the Galleri test in reducing late-stage cancer diagnoses.NHS-Galleri Trial ResultsThe NHS-Galleri trial results showed a favorable trend in reducing Stage IV cancer diagnoses, although the primary endpoint was not met. On Friday, GRAIL stock closed almost 51% lower.The trial evaluated annual multi-cancer screening with the Galleri test i ...

Core Insights - The article discusses the promising results of the Phase 2 S-OLARIS trial for sonelokimab, indicating its potential as an effective treatment for axial spondyloarthritis [2][3] - MoonLake Immunotherapeutics has a strong cash position, which is expected to support its operations into the second half of 2027 [4] - The stock of MoonLake is currently experiencing short-term weakness but has a Buy Rating from analysts with varying price targets [6][8] Clinical Trial Results - In the S-OLARIS trial, 81% of patients treated with sonelokimab achieved a clinically meaningful response at Week 12, showing significant improvement in disease parameters [2] - The trial confirmed sonelokimab's ability to reduce inflammation and osteoblast activity, suggesting a rapid onset of action [2] - Biomarker-controlled data indicated a reduction in key inflammatory mediators in patients, with a consistent safety profile compared to previous trials [3] Financial Position - MoonLake ended Q4 with $394 million in cash and equivalents, alongside $75 million from a recent equity raise, providing a cash runway into H2 2027 [4] - The company amended its debt facility with Hercules Capital, allowing for a drawdown of $25 million and up to $400 million in non-dilutive funds for future needs [4] Stock Performance and Analyst Consensus - The stock is trading 9.8% below its 20-day SMA and 4.1% below its 100-day SMA, indicating short-term weakness [6] - The stock is currently 67.2% below its 52-week high, with key resistance at $20.00 and support at $15.00 [8] - Analysts have a Buy Rating on the stock with an average price target of $40.00, with recent price actions showing a 9.70% increase to $20.59 in premarket trading [8]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 increased 65% year-over-year to $196 million, and for the full year increased 66% to $639 million [6][12] - Net product sales of Auvelity for Q4 were $155.1 million, up 68% compared to the prior year, and total sales for Auvelity reached $507.1 million, representing a 74% year-over-year increase [12][13] - Net loss for Q4 was $28.6 million, or $0.56 per share, compared to a net loss of $74.9 million, or $1.54 per share for Q4 2024 [16] - Net loss for the full year was $183.2 million, or $3.68 per share, compared to a net loss of $287.2 million, or $5.99 per share for 2024 [17] Business Line Data and Key Metrics Changes - Auvelity achieved sales of over $500 million in its third full year of launch, with significant growth in prescriptions [6][19] - Sunosi generated net product revenue of $36.7 million for Q4, a 40% increase compared to Q4 2024, and $124.8 million for the full year, representing a 32% increase [13] - Symbravo generated $4.1 million in net sales for Q4 and $6.6 million for the full year, following its second full quarter of launch [13] Market Data and Key Metrics Changes - Auvelity prescriptions grew by 42% year-over-year, with over 225,000 prescriptions written in Q4 [19] - Payer coverage for Auvelity increased from 75% to 78%, bringing total coverage to 86% of all lives across channels [20] - Symbravo's overall payer coverage is approximately 52% at the start of the year [22] Company Strategy and Development Direction - The company is advancing a broad CNS pipeline with 5 novel product candidates across 9 high-impact indications [6] - Plans to conduct two Phase 3 trials in ADHD, one in children and one in adolescents, are on track for initiation in the first half of the year [9] - The company aims to expand its sales force to approximately 600 representatives to support growth in MDD and potential launch in Alzheimer's disease agitation [21][59] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver new treatment options for patients living with CNS disorders, supported by a scalable commercial platform [6][11] - The company anticipates that its current cash balance is sufficient to fund operations into cash flow positivity based on the current operating plan [17] - Management is optimistic about the potential impact of the upcoming launch for Alzheimer's disease agitation, with preparations underway [69] Other Important Information - The company has made significant progress with its NDA package for AXS-12 in narcolepsy and expects to submit that imminently [8] - The acquisition of AZD7325, a novel oral GABA A alpha-2/3 receptor positive allosteric modulator, is planned for evaluation in epilepsy [10] Q&A Session Summary Question: Implications of the new FDA publication on the one trial policy - Management is assessing the implications and will continue to vet clinical plans with the FDA [28] Question: Development plan for AXS-17 in epilepsy - The product has been studied in various indications, and the focus is currently on preparing for Phase II readiness [33] Question: Coverage evolution for Auvelity post-ADA label approval - Existing coverage should generally apply to the new indication, but there may be additional efforts needed for Medicare coverage [36] Question: Growth drivers for Sunosi - Growth is driven by both volume and improved access across OSA and narcolepsy markets [44] Question: Sales force expansion rationale - The expansion aims to accelerate growth in MDD and prepare for potential Alzheimer's agitation indication [59] Question: Coverage evolution for Symbravo - The secured contract with a third large GPO allows for active negotiation with payers, with optimism for increased coverage [63]

Core Viewpoint - Arcellx's stock surged approximately 80% following Gilead Sciences' announcement to acquire the cancer-therapy developer for $7.8 billion in an all-cash deal, with a definitive buyout price set at $115 per share [1]. Deal Structure - Gilead will pay $115 per share in cash, plus a contingent value right (CVR) worth an additional $5 per share if Arcellx's lead therapy, anito-cel, achieves at least $6 billion in cumulative global net sales by the end of 2029 [1]. - The total offer represents a premium of about 87% over Arcellx's previous closing price, prompting immediate trading activity towards the buyout price [1]. - The transaction is structured as a tender offer followed by a second-step merger, already approved by both companies' boards [1]. Strategic Importance - Gilead is acquiring anitocabtagene autoleucel (anito-cel), a CAR-T therapy for relapsed or refractory multiple myeloma, which presents a significant commercial opportunity despite intense competition from established products like Johnson & Johnson's Carvykti [1]. - Analysts have previously noted supportive data for anito-cel's potential, with comparisons to Carvykti as the datasets have matured [1]. - The FDA is expected to make a decision on anito-cel by December 23, 2026, which positions the acquisition within a near-launch timeframe rather than a distant research phase [1]. Historical Context - Gilead and Arcellx have collaborated in cell therapy since 2022, making this acquisition a consolidation of a program that Gilead is already familiar with [1].

CAMBRIDGE, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced that Paul Bolno, MD, MBA, President and Chief Executive Officer, is scheduled to participate in an analyst-led fireside chat at the virtual Oppenheimer 36th Annual Healthcare Life Sciences Conference on Thursday, February 26, 2026 at 2:40 p.m. ET. A live webcast of the presentatio ...

SOUTH SAN FRANCISCO, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced its participation at the 16th World ADC London Summit, taking place in London, UK, February 23-26, 2026. Plenary/Panel Discussion Details: Panel Discussion: ADC Licensing, Partnering & Investment Session Sutro Participant: Hans-Peter Gerber, Ph.D.Date/Time: Febru ...

Enhanced board oversight aligns subsidiary with disciplined capital allocation and strategic evaluation framework KUALA LUMPUR, Malaysia, Feb. 23, 2026 (GLOBE NEWSWIRE) -- BioNexus Gene Lab Corp. (Nasdaq: BGLC) (“BioNexus” or the “Company”), today announced the completion of a governance restructuring of its wholly owned subsidiary, Chemrex Corporation Sdn. Bhd. (“Chemrex”). As part of this restructuring, Chemrex’s board has been streamlined to two directors: Matthew L. Barsing, ChairmanAngeline Chong, Chie ...

Core Viewpoint - TransCode Therapeutics has published a manuscript detailing a novel tumor-selective immunotherapy approach that activates innate immune signaling specifically within cancer cells, enhancing drug delivery imaging capabilities [1]. Group 1: Research and Development - The published study in the journal Molecular Imaging and Biology describes a template-driven RIG-I agonist strategy that selectively activates RIG-I signaling in tumor cells by utilizing overexpressed oncogenic microRNAs, such as miRNA-21, as assembly templates [1]. - This new approach aims to address challenges associated with RIG-I agonists, including off-target immune activation and inefficient systemic delivery [1]. - The findings suggest a method to engage innate immune pathways directly within tumor cells while minimizing systemic toxicity, potentially advancing RIG-I-based immunotherapy towards clinical relevance [1]. Group 2: Clinical Trials and Therapeutic Candidates - TransCode's TTX delivery platform, which is currently under evaluation in clinical trials, is expected to enhance the translational feasibility of this immunotherapy approach [1]. - The company's lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a well-documented biomarker of metastasis [1]. - TransCode's portfolio includes other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells [1].

Core Insights - Celldex announced multiple presentations of Phase 2 clinical trials for barzolvolimab at the 2026 AAAAI Annual Meeting, focusing on chronic spontaneous urticaria (CSU), cold urticaria (ColdU), and symptomatic dermographism (SD) [1][2] Group 1: Clinical Trial Presentations - New data from the Phase 2 ColdU and SD Open Label Extension (OLE) will be presented, indicating that retreatment with barzolvolimab results in rapid improvement in urticaria control after symptom recurrence [2] - The presentations include: - **Phase 2 ColdU and SD Study**: "Treatment with Barzolvolimab Improves Urticaria Control and Quality of Life in Patients with Chronic Inducible Urticaria" on February 27, 2026 [2] - **Phase 2 CSU Study**: "Prolonged Off-Treatment Efficacy of Barzolvolimab in Chronic Spontaneous Urticaria" on February 27, 2026 [2] - **Phase 2 ColdU and SD Study**: "Retreatment with Barzolvolimab Leads to Rapid Improvement in Urticaria Control After Symptom Recurrence in Chronic Inducible Urticaria" on March 1, 2026 [2] Group 2: Barzolvolimab Overview - Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action targeting mast cells by binding to a unique part of the KIT receptor, which is critical for mast cell function and survival [3] - The drug shows significant potential as a first-in-class treatment for CSU, ColdU, and SD, based on data from robust Phase 2 studies [3] - Barzolvolimab is currently undergoing Phase 3 studies for CSU and ColdU/SD, as well as Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD) [3] Group 3: Company Background - Celldex is focused on pioneering new therapies in immunology, particularly antibody-based treatments that engage the human immune system to address allergic, inflammatory, and autoimmune disorders [4]