This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news from Praxis Precision Medicines, Rezolute and Geron, as well as updates from Rhythm Pharmaceuticals and Centessa Pharmaceuticals that you may have missed. Praxis Precision Medicines on Thursday announced plans to, sometime early next year, submit an experimental seizure drug for U.S. approval. Researchers have been evaluating the ...

Core Viewpoint - The discussion around "celebrity rejuvenation" highlights the ongoing advancements in the global biomedical field, which are bringing humanity closer to extending lifespan through various innovative therapies and technologies [1][2]. Group 1: Advances in Biomedical Technology - Continuous breakthroughs in life sciences are making the ancient human desire for longevity increasingly attainable, pending large-scale commercialization and official endorsement [1]. - Technologies such as stem cells, mitochondrial transplants, and induced pluripotent stem cells (iPSC) are at the forefront of research aimed at extending human life [1][14]. - The approval of the first mesenchymal stem cell product for treating children with steroid-refractory acute graft-versus-host disease (SR-aGVHD) in the U.S. marks a significant milestone in stem cell therapy [23]. Group 2: Market Dynamics and Commercialization - The commercial pathways for longevity-related drugs and therapies are becoming clearer, with a growing demand driving initial implementations in aging delay and specific disease treatments [2]. - The pricing of stem cell therapies in China is significantly lower than similar products in the U.S., making them more accessible [25]. Group 3: Ethical and Social Considerations - There are substantial ethical concerns regarding the commercialization of longevity treatments, particularly the potential for creating a divide where only the wealthy can afford life-extending therapies [22][30]. - The pursuit of longevity by the elite raises questions about the implications for societal dynamics and the potential emergence of a "blood-hunting" class [22][30]. Group 4: Historical Context and Future Outlook - Historical attempts at achieving immortality, from ancient practices to modern biomedical research, reflect a long-standing human fascination with life extension [30]. - The future of longevity research may focus more on treating prevalent diseases rather than solely extending life for a select few, emphasizing the importance of quality of life over mere lifespan [29][30].

Summary of Geron Corporation Conference Call Company Overview - **Company**: Geron Corporation - **Core Asset**: Imetelstat (commercial name: Rytelo), the first approved telomerase inhibitor for lower-risk myelodysplastic syndromes (MDS) [2][5] Key Points Company and Product Positioning - Geron is a commercial-stage hematology company with an approved product, Rytelo, launched in the US and approved in Europe [2][5] - The company aims to help patients in the relapse, lower-risk MDS population, which has limited treatment options [2][5] Leadership and Experience - Harout Semerjian, the new CEO, has over 30 years of experience in biopharma, particularly in oncology and hematology [4][5] - The CEO's previous experience includes launching multiple oncology drugs, which aligns with Geron's current needs [4][5] Market Performance and Challenges - Rytelo's growth has stalled, with net revenue around $50 million, despite strong phase 3 data [6][9] - The disconnect between the drug's efficacy and sales performance is attributed to: - Initial patient selection being primarily late-line patients, who are harder to treat [8][9] - Limited clinical experience among US hematologists at launch, as most trial data was generated outside the US [9][10] Strategic Initiatives - The company is focusing on increasing awareness and education among physicians about Rytelo's efficacy and appropriate patient management [12][13] - Efforts are being made to shift Rytelo's utilization from later lines of treatment to earlier lines, as indicated by clinical guidelines [12][21] Patient Population and Treatment Dynamics - The real-world patient population primarily consists of third-line and fourth-line patients, which affects treatment duration and outcomes [17][18] - The NCCN guidelines have recently been updated to position Rytelo favorably in treatment protocols, moving it ahead of other therapies like HMAs [18][19][21] Competitive Landscape - Luspatercept's approval as a front-line therapy for RS-positive patients may impact patient flow into later lines of treatment, creating opportunities for Rytelo as a second-line option [30][31] - Physicians' treatment decisions are influenced by baseline transfusion burden, with Rytelo being the only effective option for heavily transfused patients [37][38] Future Outlook - Geron anticipates growth in 2026, supported by a robust cash balance and strategic initiatives aimed at enhancing market presence [11][40][41] - The company has submitted five abstracts for the upcoming ASH conference, including data on cytopenia correlating with response and long-term survival benefits [41][42] International Expansion - Geron is exploring commercialization plans in Europe, including launching under named patient programs and engaging in HTA conversations [50][51] Additional Insights - The company is committed to educating the market about Rytelo's unique mechanism of action and the importance of managing cytopenias effectively [40][41] - There is a focus on building partnerships with both community and academic medical centers to enhance Rytelo's adoption [27][28]

Financial Data and Key Metrics Changes - For Q3 2025, total net revenue was $47 million, an increase from $28 million in Q3 2024 [23] - Cash and marketable securities as of September 30, 2025, were approximately $420 million, down from $503 million as of December 31, 2024 [23] - Research and development expenses for Q3 2025 were $21 million, compared to $20 million for the same period in 2024 [24] - Selling, general and administrative expenses for Q3 2025 were $39 million, up from $36 million in Q3 2024 [24] - The company expects total operating expenses for fiscal year 2025 to be between $250 million and $260 million, below previous guidance of $270 million to $285 million [24] Business Line Data and Key Metrics Changes - Net product revenue for Rytelo was $47.2 million for Q3 2025, with a 3% decrease in demand compared to the previous quarter [5][6] - New patient starts in first and second lines increased to 36% from 30% in Q2 2025, but did not offset discontinuations in later lines [6] - Prescribing accounts increased by 15% in Q3, adding approximately 150 new ordering accounts, bringing the total to 1,150 [6] Market Data and Key Metrics Changes - The company completed its first shipment of Rytelo to Germany under a named patient early access program, preparing for commercialization in select EU markets in 2026 [7] - The company is focusing on increasing awareness of Rytelo among US healthcare providers (HCPs) and expanding its presence in hematology forums [9][10] Company Strategy and Development Direction - The company aims to maximize the impact of Rytelo for patients while advancing its first-in-class telomerase inhibitor to benefit more patients in the future [12] - Key strategic initiatives include increasing awareness among US HCPs, expanding relationships with key opinion leaders (KOLs), and enhancing community site penetration [16][18] - The company is also focusing on investigator-sponsored trials to broaden the clinical evidence base for imetelstat [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, emphasizing the need for improved execution and alignment to drive Rytelo's growth [12][26] - The company acknowledges that building brand awareness and shifting physician behavior takes time, with a focus on 2026 as a growth story [64][65] - Management is confident in the potential of Rytelo to address unmet needs in lower-risk MDS patients [28][62] Other Important Information - The company has identified four initial actions to enhance execution and support future revenue growth, including increasing awareness and education for HCPs [9] - The company plans to engage with patient advocacy organizations and professional societies to raise awareness about lower-risk MDS and Rytelo [15] Q&A Session Summary Question: Insights on current gross-to-net and demand decrease - Management confirmed that the mid-to-high teens range for gross-to-net remains applicable and discussed factors affecting demand, including discontinuations in later lines [32][35] Question: Growth in ordering accounts and prescribing depth - Management reported a 15% sequential increase in ordering accounts, with 80% of accounts having reordered in the last quarter, emphasizing the need for depth in prescribing [41][43] Question: Revised operating expense guidance - Management highlighted savings from CMC investments and slowed infrastructure investments, confirming a revised operating expense guidance of $250 million to $260 million for 2025 [49][50] Question: Sales force effectiveness and EU partner search - Management confirmed the sales force is fully hired and focused on effectiveness, while ongoing discussions for EU partnerships are taking place [53][56] Question: Confidence in awareness as a growth lever - Management expressed high confidence in identifying issues and emphasized that increasing brand awareness is crucial for growth, with 2026 seen as a pivotal year [61][64]

Core Viewpoint - Geron Corporation is facing a class action lawsuit due to alleged misleading statements regarding its revenue outlook and the market potential of its drug Rytelo, leading to significant stock price decline after disappointing financial results were announced [3][4]. Group 1: Class Action Details - The class action lawsuit represents investors who purchased Geron securities between February 28, 2024, and February 25, 2025 [1]. - Investors are encouraged to contact the Portnoy Law Firm for a complimentary case evaluation and to discuss their legal rights [2]. Group 2: Allegations Against Geron - The lawsuit claims that Geron misrepresented its revenue projections and growth potential, downplaying risks related to seasonality and macroeconomic conditions [3]. - It is alleged that Geron's optimistic portrayal of Rytelo's launch was overstated, with actual market conditions affecting patient uptake more than indicated [3]. - The company failed to achieve significant market penetration for Rytelo, particularly among first-line patients, due to limited awareness and competitive pressures [3]. Group 3: Financial Impact - On February 26, 2025, Geron reported stagnant growth for Rytelo, attributing this to seasonality, competition, and monitoring burdens, which led to a stock price drop of over 32% [4].

Group 1 - The article highlights the expertise of an analyst with a background in nursing and business, focusing on healthcare and tech stocks through a combination of clinical insight and valuation methods [1] - The analyst employs scenario-based DCF modeling, sensitivity analysis, and Monte Carlo simulations to identify asymmetric risk-reward opportunities [1] - The emphasis is on translating complex scientific and market dynamics into actionable investment theses, influenced by concepts from "Superforecasting" and "Fooled by Randomness" [1] Group 2 - The article does not provide specific stock recommendations or personalized investment advice, indicating a probabilistic approach to analysis [3] - It emphasizes the importance of independent verification of information and conducting thorough research before making investment decisions [3]

Core Viewpoint - Geron Corporation is facing a class action lawsuit for alleged violations of the Securities Exchange Act of 1934, with claims that the company and its executives misled investors regarding the performance and market potential of its primary product, Rytelo [1][3]. Company Overview - Geron Corporation is a commercial-stage biopharmaceutical company focused on developing therapeutic products for oncology, with its main product being a telomerase inhibitor called imetelstat, marketed as Rytelo [2]. Allegations of the Lawsuit - The lawsuit alleges that Geron and its executives made false or misleading statements about the company's revenue outlook and growth potential, downplaying risks associated with seasonality and macroeconomic factors [3]. - It is claimed that Geron's reports on Rytelo's launch success were overly optimistic, failing to account for significant market challenges such as competition and the need for ongoing monitoring of treatment [3]. - The lawsuit also states that Rytelo lacked sufficient market awareness, hindering Geron's ability to meet the unmet medical needs, particularly among first-line patients [3]. Financial Impact - Following the announcement of its fourth-quarter financial results for fiscal year 2024 on February 26, 2025, which revealed stagnant growth for Rytelo, Geron's stock price dropped by over 32% [4].

Core Viewpoint - Geron Corporation is facing a class action lawsuit for alleged violations of the Securities Exchange Act of 1934, with claims that the company and its executives misled investors regarding the performance and market potential of its primary product, Rytelo [1][3]. Company Overview - Geron Corporation is a commercial-stage biopharmaceutical company focused on developing therapeutic products for oncology, with its main product being a telomerase inhibitor called imetelstat, marketed as Rytelo [2]. Allegations of the Lawsuit - The lawsuit alleges that Geron and its executives made false or misleading statements about the company's revenue outlook and growth potential, downplaying risks associated with seasonality and macroeconomic factors [3]. - It is claimed that the optimistic reports regarding Rytelo's launch success did not reflect the reality of market conditions, including competition and the need for ongoing monitoring of the treatment [3]. - The lawsuit further asserts that Rytelo lacked sufficient market awareness, hindering Geron's ability to meet the significant unmet need for the drug, particularly among first-line patients [3]. Financial Impact - Following the announcement of Geron's fourth-quarter financial results for fiscal year 2024 on February 26, 2025, which indicated a flattening growth for Rytelo, the company's stock price dropped by over 32% [4].

Core Viewpoint - Geron Corporation is facing a class action lawsuit due to alleged misleading statements regarding its revenue outlook and the market potential of its drug Rytelo, leading to significant stock price decline [3][4]. Group 1: Class Action Details - The class action lawsuit represents investors who purchased Geron securities between February 28, 2024, and February 25, 2025 [1]. - Investors are encouraged to contact the Portnoy Law Firm for a complimentary case evaluation and to discuss their legal rights [2]. Group 2: Allegations Against Geron - The lawsuit claims that Geron made false statements about its revenue outlook and growth potential, while downplaying risks related to seasonality and macroeconomic conditions [3]. - It is alleged that Geron's optimistic portrayal of Rytelo's launch was overstated, with significant impacts from seasonality, competition, and monitoring requirements [3]. - The lawsuit also states that Rytelo lacked sufficient market awareness to achieve meaningful penetration, particularly among first-line patients [3]. Group 3: Financial Impact - On February 26, 2025, Geron announced its fourth-quarter financial results for fiscal year 2024, revealing stagnation in Rytelo's growth attributed to seasonality, competitive pressures, and limited awareness [4]. - Following this announcement, Geron's stock price fell by more than 32% [4].

Core Viewpoint - Geron Corporation is facing a federal securities class action due to alleged failure to disclose material information regarding the launch and growth potential of its lead product candidate, Rytelo, during the specified Class Period [4]. Financial Performance - On February 26, 2025, Geron announced its fourth-quarter financial results for fiscal 2024, revealing that the growth of Rytelo had flattened in recent months. The company attributed this stagnation to seasonality, competition, lack of awareness, and monitoring requirements for the drug treatment [3]. - Following the announcement, Geron's share price dropped by $0.76, from $2.37 on February 25, 2025, to $1.61 on February 26, 2025 [3]. Legal Proceedings - A class action has been filed on behalf of investors who acquired Geron securities between February 28, 2024, and February 25, 2025, with a deadline of May 12, 2025, to seek the role of lead plaintiff [1]. - The complaint alleges that the defendants failed to disclose critical information regarding the expectations for Rytelo's launch and growth potential throughout the Class Period [4].