BOTHELL, Wash., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ:ATHA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today announced that it has changed its name to LeonaBio, Inc. The name change aligns with the Company's transformative acquisition of rights to develop and commercialize lasofoxifene, a promising late-stage clinical asset for the potential treatment of metastatic breast cancer, currently ...

Summary of Athira Pharma Conference Call - December 18, 2025 Company Overview - **Company**: Athira Pharma (NasdaqGS:ATHA) - **Focus**: Development of innovative therapies for diseases with unmet medical needs, specifically in oncology and neurology Key Points Discussed Transformative Acquisition - Athira announced the acquisition of rights to develop and commercialize **lasofoxifene**, a potential treatment for metastatic breast cancer, which diversifies its pipeline with a late-stage program [5][15][16] - The acquisition is expected to enhance Athira's mission to deliver transformative therapies for patients [5][14] Lasofoxifene Overview - Lasofoxifene is currently in a pivotal phase III clinical trial targeting **ER-positive HER2-negative metastatic breast cancer**, which represents about 70% of all breast cancer cases [15][16] - The global market for metastatic ER-positive HER2-negative breast cancer is projected to grow from **$10.9 billion in 2025 to over $15.9 billion by 2029** [15] - Lasofoxifene has shown promising clinical activity, achieving **13 months of progression-free survival (PFS)** in combination therapy during phase II trials [20][26] Clinical Data and Mechanism - Lasofoxifene demonstrated an **83% reduction in new-onset primary wild-type estrogen receptor-positive breast cancer** in previous studies [19] - It modulates the estrogen receptor rather than degrading it, providing tissue selectivity and sparing healthy estrogen receptors in critical tissues [19][21] - The drug has shown **significant efficacy against ESR1 mutations**, which occur in over 40% of patients and are a major mechanism of resistance in breast cancer treatments [20][21] ATH-1105 for ALS - Athira is also advancing **ATH-1105**, a potential treatment for **Amyotrophic Lateral Sclerosis (ALS)**, which affects approximately **33,000 patients in the U.S.** [37] - ATH-1105 modulates the hepatocyte growth factor (HGF) system, which is critical for neuronal health [38] - Preclinical studies have shown that ATH-1105 preserves motor function and reduces neurodegeneration in ALS models [39][40] Financial and Strategic Positioning - Athira raised **$90 million** to support its development programs, with the potential for an additional **$146 million** through warrants [46] - The financing positions the company to reach critical data readouts across both programs by the end of **2027** [46] - Athira aims to achieve peak annual U.S. sales for lasofoxifene approaching **$1 billion** if approved [35] Market Opportunity - The global breast cancer market is approximately **$55 billion**, with the second-line breast cancer segment in the U.S. exceeding **$5-$6 billion annually** [34] - Lasofoxifene's favorable tolerability profile and unique attributes position it as a potential leading therapy in this market [35][36] Conclusion - Athira is committed to advancing its promising development programs for lasofoxifene and ATH-1105, addressing significant unmet needs in metastatic breast cancer and ALS [45] - The company is optimistic about its future and the potential impact of its therapies on patient outcomes [47]

—Phase 2b BiRCh Study of Brensocatib in CRSsNP Did Not Meet Primary or Secondary Efficacy Endpoints; Safety Consistent with Previous Studies; Insmed Discontinues CRSsNP Program— —Company Acquires Phase 2 Ready Monoclonal Antibody for Potential Respiratory and Immunological & Inflammatory Indications— BRIDGEWATER, N.J., Dec. 17, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives ...

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company will host a conference call on December 17, 2025, to discuss its fiscal year 2025 financial results and provide a business update [1] Company Overview - Veru's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm combined with semaglutide led to greater fat loss and preservation of lean mass in older patients [4] - The upcoming Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [5] - The primary efficacy endpoint of the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5]

Vaxcyte (NasdaqGS:PCVX) FY Conference December 02, 2025 01:20 PM ET Company ParticipantsJames Wassil - COOAndrew Guggenhime - President and CFOModeratorSo, Andrew, I woke up Saturday and I had a text message from Vinay. I'm like, Vinay's texting me. What is going on? And I realized I was on some email chain. So I started reading it, and that's when I shot you an email on Saturday morning. Wow, what's going on here? So let's just start. Where are things standing on FDA? Because I feel like that's probably th ...

Core Insights - China's expanding pipeline of novel drug candidates is attracting global pharmaceutical companies and investors seeking licensing opportunities due to the country's clinical trial capacity now matching that of the US [1][3] Group 1: Clinical Trials in China - There is a growing interest from multinational corporations in conducting investigator-initiated trials for cell and gene therapies in China, as they can access patient data more quickly than in other markets [2] - As of 2024, China's clinical trial volumes have reached 80% of those in the US and are 10% higher than in Europe, indicating significant growth in the sector [3] - In 2024, China recorded 2,694 new clinical trials, a 13% increase from the previous year, with multinational companies accounting for 14.3% of these trials, reflecting a 7% compound annual growth rate since 2019 [4] Group 2: Market Dynamics and Future Outlook - Despite geopolitical tensions, multinational firms are not expected to slow down their clinical trials in China, as it remains the second-largest pharmaceutical market globally [5] - Chinese policymakers are anticipated to provide more targeted support for research and development and commercialization in the biomedical manufacturing sector, which could further enhance the growth of innovative clinical trials [5]

Neuralink Accomplishments & Current Status - Neuralink's N1 device, a wireless high-bandwidth brain-computer interface (BCI), is being used by at least 13 human patients [2] - Trial participants have accumulated over 15,000 hours of independent use of the BCI at home [2] - Patients are averaging around 50 hours per week of BCI usage, with peak usage exceeding 100 hours per week in some cases [7] - Neuralink received FDA approval for human trials in 2023, focusing on patients with paralysis and ALS [5] - The company has solved the thread retraction problem by updating brain signal decoding algorithms and shallower thread insertion [12] Expansion & Regulatory Approvals - Neuralink is now conducting studies in four countries: the United States, Canada, the UK, and the UAE [13][14] - International trials are a crucial step toward market readiness for treating paralysis, blindness, and other conditions [15] Future Products & Research - Neuralink plans to launch a thought-to-speech clinical trial in the US for patients who have lost the ability to speak [22] - Blind sight technology is expected to reach human trials next year, aiming to restore basic navigation and eventually full vision [25] - Neuralink is exploring hearing restoration and accessing deeper brain regions for helping with pain, mood, and memory regulation [26] - The company expects to work on helping with epilepsy and tinnitus in 2028 [27] Scaling & Technology - Engineers are working to increase electrode count from 1,000 channels to 10,000 and then 25,000 and beyond [28] - Neuralink aims to perform thousands of surgeries every month using the R1 surgical robot and dedicated clinics [29]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company announced the presentation of two abstracts at ObesityWeek 2025, highlighting its drug enobosarm's potential in weight management [1][2] Company Overview - Veru Inc. is developing two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making fat loss more tissue-selective while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass in older patients [4] - The study involved 168 older patients (≥60 years) and showed that while weight loss was similar across treatment groups, the preservation of lean mass is expected to enhance energy expenditure [4] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients initiating GLP-1 RA treatment [5][6] - The primary efficacy endpoint for the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5][7]

Core Insights - Arcutis Biotherapeutics shares surged nearly 30% following strong third-quarter earnings and an investor day presentation that provided positive guidance exceeding analyst expectations [1] Company Growth Plans - Management aims to establish Arcutis as a leader in medical dermatology through its Zoryve (roflimilast) portfolio, which includes FDA-approved treatments for plaque psoriasis, atopic dermatitis, and seborrheic dermatitis [2] - Zoryve is a selective phosphodiesterase-4 (PDE4) inhibitor, known for its anti-inflammatory effects [2] Regulatory Developments - Zoryve has been submitted for FDA approval for plaque psoriasis in children aged 2 to 5 and is undergoing phase 2 trials for vitiligo and hidradenitis suppurativa [3] Sales Projections - Management forecasts Zoryve sales could reach between $2.6 billion and $3.5 billion over time, with near-term sales estimates for 2026 projected at $455 million to $470 million, significantly above the $438 million anticipated by analysts [4] - The high end of the sales target for Zoryve exceeds the company's market cap of less than $3 billion, indicating strong growth potential [6] Market Outlook - The company is expected to experience over 30% sales growth in the coming years, supported by less risky clinical trials currently in progress [6] - The positive medium-term sales target for the Zoryve franchise has generated excitement among investors [8]

Financial Performance - Q3 2025 net product revenues reached $99.2 million, a 122% increase compared to Q3 2024[28,33] - Net product revenues increased by 22% quarter over quarter[28,33] - The company reported a net profit of $7.4 million in Q3 2025, a significant improvement from a net loss of $41.5 million in Q3 2024[33] - Cash, cash equivalents, and marketable securities totaled $191.4 million as of September 30, 2025[35] - The company projects product sales of $455-$470 million in 2026[138] ZORYVE Product and Market - Weekly TRx (Total Prescriptions) for the ZORYVE portfolio reached approximately 17,500 on a rolling 4-week basis[29] - TRx growth for ZORYVE showed a 13% increase compared to Q2 2025 and a 92% increase compared to Q3 2024[30] - The company estimates a total addressable market of 30 million patients across Psoriasis (PsO), Atopic Dermatitis (AD), and Seborrheic Dermatitis (SD)[50,84] - The serviceable obtainable market (SOM) is estimated at 8 million patients receiving topical prescriptions in dermatology[50] Growth Strategy - The company aims to expand ZORYVE into new markets and indications, including vitiligo and hidradenitis suppurativa (HS)[39,119] - Peak sales potential for current indications is estimated at $2.3 - $3.0 billion, with an additional $0.3 - $0.5 billion from label expansion and data generation[122]