Biotechnology
Search documents
Tyra Biosciences to Participate in Upcoming Investor Conferences
Prnewswire· 2026-02-19 21:05
Tyra Biosciences to Participate in Upcoming Investor Conferences [Accessibility Statement] Skip NavigationCARLSBAD, Calif., Feb. 19, 2026 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, today announced participation at the following investor conferences:36th Annual Oppenheimer Life Sciences Healthcare ConferenceFormat: Vi ...
Cullinan Therapeutics, Inc. (CGEM) Presents at Citi's 2026 Virtual Oncology Leadership Summit Transcript
Seeking Alpha· 2026-02-19 21:05
Core Viewpoint - The session features Cullinan Therapeutics' leadership, highlighting the company's focus on oncology and its strategic direction in the biotech sector [1] Company Overview - Cullinan Therapeutics is represented by CEO Nadim Ahmed and CMO Jeff Jones during the Citi's Virtual Oncology Leadership Summit [1] Industry Context - The event is part of Citi's initiative to engage with key players in the oncology field, reflecting the growing importance of biotech in addressing cancer treatment [1]
Spyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Globenewswire· 2026-02-19 21:02
On track for 6 proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials Part A readouts from SKYLINE platform trial in ulcerative colitis ("UC") expected to begin in the second quarter, with enrollment continuing ahead of schedule Enrollment on track in Phase 2 SKYWAY basket trial evaluating TL1A inhibition in rheumatoid arthritis ("RA"), psoriatic arthritis ("PsA"), and axial spondyloarthritis ("axSpA"), with fourth quarter readouts expected in each sub-study Strengthened the balance ...
Agenus Presents Biomarker Data Demonstrating Survival Stratification in MSS mCRC and Other Immunologically Cold Tumors Treated with BOT+BAL
Businesswire· 2026-02-19 20:15
and balstilimab (BOT+BAL) program entering 2026. The ses...[Back to Newsroom]## Wish your news had this kind of reach?[Sign Up][Learn About Business Wire] adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit [www.agenusbio.com] or @agenus_bio. Information that may be important to investors will be ...
4 Ways Market Dynamics Are Changing In 2026
Seeking Alpha· 2026-02-19 20:00
Live Chat on The Biotech Forum sees frequent discussion of specific covered call trades. To see what covered call trades I am currently executing along with a model portfolio of attractive biotech stocks, just initiate your free trial into The Biotech Forum by clicking HERE .We are coming up on being two months into 2026. Equities have become significantly more volatile here in February after posting modest gains in January to open the new year. While it is early in 2026, some changesBret Jensen has over 13 ...
RGNX INVESTOR NOTICE: Faruqi & Faruqi, LLP Reminds REGENXBIO (RGNX) Investors of Securities Class Action Deadline on April 14, 2026
Prnewswire· 2026-02-19 19:47
Group 1 - The law firm Faruqi & Faruqi, LLP is investigating potential claims against REGENXBIO Inc. related to a federal securities class action due to alleged violations of federal securities laws [1] - The complaint alleges that REGENXBIO and its executives made false or misleading statements and failed to disclose material adverse facts regarding the efficacy and safety of its RGX-111 trial study [1] - On January 28, 2026, REGENXBIO announced that the FDA placed a clinical hold on its RGX-111 investigational gene therapy for MPS I after a case of neoplasm was reported in a participant [1] - The FDA also placed a clinical hold on RGX-121 for MPS II, citing similarities in products and shared risks between the clinical studies [1] - Following the FDA's announcement, REGENXBIO's stock price fell by $2.40 per share, or 17.9%, closing at $11.01 per share [1] Group 2 - The deadline for investors to seek the role of lead plaintiff in the class action is April 14, 2026 [1] - Any member of the putative class can move the Court to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [1] - Faruqi & Faruqi encourages individuals with information regarding REGENXBIO's conduct to contact the firm, including whistleblowers and former employees [1]
Olema Pharmaceuticals (NasdaqGS:OLMA) 2026 Conference Transcript
2026-02-19 19:02
Summary of Olema Pharmaceuticals Conference Call Company Overview - **Company**: Olema Pharmaceuticals (NasdaqGS:OLMA) - **Focus**: Improving standard of care for patients with ER-positive, HER2-negative breast cancer - **Lead Asset**: Palazestrant, a complete estrogen receptor antagonist, administered as a once-daily oral pill [3][6] Clinical Trials - **OPERA-01**: Phase 3 trial comparing palazestrant monotherapy to fulvestrant or exemestane in second- or third-line settings, results expected in Fall 2026 [3][19] - **OPERA-02**: Phase 3 trial evaluating palazestrant in combination with ribociclib in first-line treatment, results anticipated around 2028-2029 [4][31] - **OP-3136**: An oral KAT6 inhibitor currently in Phase 1, moving to Phase 2, exploring both monotherapy and combination therapy with palazestrant [4][65] Key Differentiators of Palazestrant - **Complete Estrogen Receptor Antagonism**: Unlike other therapies, palazestrant fully inhibits estrogen receptor signaling, which is crucial for treating ER-positive breast cancer [6][7] - **Pharmacokinetics**: Palazestrant has a longer half-life (8 days) and better pharmacokinetic properties compared to other SERDs, allowing for sustained receptor blockade [8][9] - **Combination Therapy**: Palazestrant can be combined with other agents without dose reduction, enhancing its therapeutic potential [9][17] Competitive Landscape - **lidERA Trial**: Roche's trial demonstrated the efficacy of giredestrant, raising questions about the competitive positioning of palazestrant [10][12] - **PersevERA Trial**: Ongoing discussions about the implications of this trial for palazestrant's market positioning, especially if it shows positive results [11][17] Market Potential - **Second-Line Market**: Estimated at $5 billion annually, with a significant unmet need in the ESR1 wild-type population, which is currently unaddressed [19][20] - **Approval Bar**: A 2-month increase in median progression-free survival (PFS) over standard care is required for approval in OPERA-01 [20][26] Future Plans - **Commercial Strategy**: Olema plans to file for approval in the U.S. and EU independently, while seeking a collaborator for global marketing [30][75] - **Pipeline Expansion**: Olema continues to explore additional research programs focused on breast cancer and other indications [71] Considerations for Adjuvant Trials - **Potential for Future Trials**: Discussions on the feasibility of conducting adjuvant studies based on the outcomes of ongoing trials, particularly if positive results are seen in the persevERA trial [72][76] Conclusion - Olema Pharmaceuticals is positioned to make significant advancements in the treatment of ER-positive, HER2-negative breast cancer with its lead asset, palazestrant, and is actively navigating the competitive landscape while preparing for future trials and market entry strategies [3][30][71]
Moonage Media Review: Clearmind's MEAI and GLP-1 - Are These the Next-Generation Treatment for Weight Loss?
Prnewswire· 2026-02-19 18:05
Core Insights - Clearmind Medicine is advancing its proprietary compound MEAI, a non-hallucinogenic neuroplastogen, as a potential next-generation treatment for obesity, targeting the psychological roots of eating behaviors [1] - The obesity treatment market is projected to exceed $100 billion, indicating significant growth potential for innovative therapies like MEAI [1] Company Overview - Clearmind Medicine is a clinical-stage biotech company focused on developing novel therapeutics to address under-treated health issues, particularly obesity [1] - MEAI is designed to disrupt rigid behavioral patterns, promote cognitive flexibility, and enhance neuronal plasticity while providing metabolic benefits [1] Mechanism of Action - Unlike GLP-1-based treatments that primarily target gut hormones, MEAI works directly in the brain by modulating the monoaminergic system, addressing compulsive eating behaviors and food addiction [1] - Pre-clinical studies indicate that MEAI can modulate energy balance, boost fat burning, improve insulin sensitivity, and significantly decrease fat mass while preserving lean muscle mass [1] Comparative Analysis - MEAI shows a potential weight loss profile of approximately 20% reduction in pre-clinical studies, prioritizing fat loss and muscle preservation, compared to GLP-1 drugs which show a 15-22% reduction often accompanied by muscle loss [1] - MEAI has a favorable safety profile with no reported sedation or hyperactivity, contrasting with common gastrointestinal issues associated with GLP-1 drugs [1] Strategic Developments - Clearmind has filed new patent applications targeting obesity and metabolic disorders and is collaborating with Polyrizon to develop an intranasal formulation for enhanced delivery [1] - The company is progressing in its FDA-approved Phase I/IIa trial for alcohol use disorder, with successful cohort completions and upcoming data readouts [1] Future Outlook - Clearmind's leadership emphasizes MEAI's potential as a safer, more effective alternative to current therapies, focusing on behavioral aspects of obesity that hormonal drugs often overlook [1] - The combination of pre-clinical and clinical evidence, intellectual property advancements, and strategic partnerships positions MEAI as a promising solution for sustainable weight management [1]
Rhythm Pharmaceuticals Is Well-Positioned, Analyst Says Could Capture Big Share Of Rare Obesity Market
Benzinga· 2026-02-19 17:42
RBC Capital Markets initiated coverage on Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) , citing it as a commercial-stage biotech pioneering the rare genetic obesity market.Analyst Lisa Walter wrote on Wednesday that Rhythm Pharmaceuticals’ Phase 3 success in hypothalamic obesity (HO) in 2025 led to a stock rally and a ~$3.5 billion market-cap gain.Hypothalamic obesity is a rare type of obesity resulting from damage to the hypothalamus, a brain region that regulates appetite and metabolism.Rare Obesity Opportun ...
Moderna Stock Jumps After FDA Reverses Course on Flu Shot
ZACKS· 2026-02-19 16:30
Core Viewpoint - Moderna's shares increased by 6% following the FDA's decision to review its regulatory filing for the seasonal influenza vaccine, mRNA-1010, with a final decision expected by August 5, 2026 [1][8]. Group 1: Regulatory Developments - The FDA had previously refused to review the mRNA-1010 filing, citing inadequacies in the late-stage study that compared it to a standard-dose influenza vaccine [2]. - Moderna has modified its regulatory filing to seek full approval for adults aged 50-64 and accelerated approval for those aged 65 and above [2][4]. - The filing is supported by data from multiple late-stage studies demonstrating that mRNA-1010 generates immune responses comparable to existing flu vaccines from GSK and Sanofi [4]. Group 2: Market Implications - If approved, Moderna plans to commercially launch mRNA-1010 for the 2026/2027 vaccination season and will conduct additional studies for older adults as part of post-marketing requirements [3]. - The FDA's reversal is seen as a significant step in expanding Moderna's product portfolio beyond its COVID-19 vaccine and RSV vaccine [5]. Group 3: Future Prospects - The recent developments have also raised optimism for mRNA-1083, a combination vaccine for COVID-19 and influenza, which is awaiting further guidance from the FDA [6]. - Year-to-date, Moderna's stock has increased by 58%, significantly outperforming the industry growth of 9% [7].