TORONTO, Nov. 21, 2025 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures, announced today an update on its ongoing research study evaluating Bucillamine as a potential treatment for nerve agent exposure. The study is being conducted in collaboration with Defence R&D Canada – Suffield Research Centre (“ ...

Key Takeaways JAZZ shares surged after positive late-stage HERIZON-GEA-01 results in first-line HER2 GEA.The study showed significant PFS gains and strong OS outcomes for Ziihera-based regimens.JAZZ plans to seek Ziihera label expansion in 2026 following these first late-stage results.Shares of Jazz Pharmaceuticals (JAZZ) rose nearly 21% on Monday after it announced positive top-line results from the late-stage HERIZON-GEA-01 study. This study evaluated different combination regimens involving Ziihera (zani ...

BridgeBio Pharma (NasdaqGS:BBIO) 2025 Conference November 18, 2025 11:00 AM ET Company ParticipantsMatt Outten - Chief Commercial OfficerThomas Trimarchi - CFOConference Call ParticipantsAndrew Tsai - Senior Biotech AnalystAndrew TsaiWelcome to Day Two of our London Healthcare Conference. I'm Andrew Tsai, Senior Biotech Analyst at Jefferies, and it's my pleasure to have the BridgeBio team with me. To my direct right, Thomas Trimarchi, CFO, and to his right, Matt Outten, Chief Operating Officer.Matt OuttenCo ...

Glen Rock, N.J., Nov. 18, 2025 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. (“RespireRx”, “RSPI”, “Respondent” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, announces the receipt of an Order Making Findings and Revoking Registration of Securities Pursuant to Section 12(j) of the Securities Exchange Act of 1934. The Order On November 13, 2025, effective November 14, 2025 the Securiti ...

Company Performance - Sagimet Biosciences Inc. reported a GAAP EPS loss of -$0.40 for Q3 2025, missing analyst expectations by $0.01 [1] - The company recorded a net loss of $12.91 million for the quarter [1] Market Reaction - The market reaction to the earnings report was negative, indicating a lack of forgiveness from investors [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis [1] - The focus is on identifying promising biotechnology companies with innovative approaches, including novel mechanisms of action and first-in-class therapies [1] - The analyst emphasizes the importance of evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while balancing financial fundamentals [1]

Core Insights - Serina Therapeutics is advancing its lead investigational drug SER-252 for advanced Parkinson's disease, with a key milestone achieved in FDA alignment for a 505(b)(2) NDA pathway [2][6] - The company reported a net loss of $4.6 million for Q3 2025, compared to a net income of $1.4 million in Q3 2024, indicating a significant shift in financial performance [8][22] - Serina has secured up to $20 million in funding through a convertible note and warrant financing agreement, with the first tranche of $5 million already drawn [6] Financial Performance - Operating expenses for Q3 2025 were $6.4 million, up from $5.3 million in Q3 2024 [3] - Research and Development (R&D) expenses increased to $3.6 million in Q3 2025 from $2.4 million in Q3 2024, driven by higher outsourced research services and clinical activities [4] - General and Administrative expenses decreased slightly to $2.7 million in Q3 2025 from $2.9 million in Q3 2024, attributed to reduced compensation costs [5] - Other income for Q3 2025 was $1.8 million, a decrease from $6.7 million in Q3 2024, primarily due to changes in fair value of liability classified warrants [7] Liquidity and Capital Structure - As of September 30, 2025, cash and cash equivalents totaled $8.6 million, a significant increase from $3.7 million at the end of 2024 [9][20] - The company has entered into an At-the-Market (ATM) equity program allowing it to sell up to $13.3 million of common stock, with $2.8 million net proceeds from shares issued as of November 7, 2025 [6] Regulatory and Development Updates - The FDA has placed the IND for SER-252 on clinical hold pending additional information, but this does not relate to the active drug substance [6] - Serina is advancing SER-270 for tardive dyskinesia, with plans to complete formulation optimization and pre-IND activities in 2026 [6] - The SER-252 registrational study is designed to evaluate safety, tolerability, and pharmacokinetics, with a focus on motor fluctuations in Parkinson's disease [14]

Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio - **Industry**: Biotechnology Key Points and Arguments 1. Business Split Announcement - AnaptysBio plans to split into two entities: a royalty-focused company and a biopharma company, aimed at enhancing shareholder value and focusing on distinct investor interests [6][9][10] 2. Rosnilimab Development - Rosnilimab, a selective T cell depleter, completed a phase 2b trial in arthritis with 424 patients, showing significant efficacy and safety, with statistically significant results at week 12 [2][3] - The drug demonstrated low disease activity and remission rates that improved over six months and persisted for nine months post-treatment [2][3][18] 3. ANB033 Development - ANB033, a CD122 receptor antagonist, is currently in a phase 1b trial for celiac disease, with plans to announce a second indication in 2026 [4][30] - The trial design includes two cohorts: one undergoing a gluten challenge and another with significant mucosal damage not receiving gluten [28][29] 4. Jemperli Royalty Stream - AnaptysBio has a significant royalty stream from Jemperli, projected to reach a $1.5 billion run rate by year-end, with potential royalties of $390 million when GSK achieves peak sales of over $2.7 billion [4][5][11] - Jemperli is positioned as a market leader in frontline endometrial cancer, with expectations for substantial growth [7][12] 5. Market Expectations and Consensus - There is a notable discrepancy between GSK's sales guidance for Jemperli and Wall Street consensus, with GSK projecting far greater sales than the consensus estimate of $1.9 billion [10][11] - AnaptysBio believes the royalty from Jemperli alone is worth significantly more than its current market cap [12] 6. Future Plans and Funding - AnaptysBio plans to meet with the FDA to discuss the phase 3 program for Rosnilimab and explore various funding options for the RA program [19][20] - The company is considering strategic collaborations to support the development of its pipeline [20] 7. Safety and Efficacy in Trials - The safety profile of Rosnilimab is favorable, with less than 2% of patients discontinuing due to adverse events [18][23] - The company remains confident in the RA program despite a recent setback in ulcerative colitis trials, citing strong translational data supporting the drug's mechanism of action [21][22][24] 8. Market Opportunity in Arthritis - There is a significant market opportunity in the arthritis space, with over 500,000 patients in the U.S. on biologics and many progressing beyond TNFs [15][16] - Rosnilimab is expected to perform well in patients who have previously undergone multiple therapies [16][17] 9. Upcoming Data and Milestones - Data from the ANB033 trial is expected next year, which will provide insights into its efficacy and potential for future development [30] Additional Important Information - The company is well-capitalized, anticipating over $300 million in cash by year-end, including milestone payments from GSK [5]

Key Takeaways IRWD's Q3 earnings of $0.24 per share topped estimates and rose from $0.02 in the prior-year quarter.Revenues rose 33% year over year to $122.1M, driven by Linzess sales growth and profit share from ABBV.Ironwood lifted 2025 revenue guidance to $290-$310M and EBITDA forecast to above $135M.Ironwood Pharmaceuticals (IRWD) reported adjusted earnings of 24 cents per share for the third quarter of 2025, which comprehensively beat the Zacks Consensus Estimate of 9 cents. The company had reported ea ...

Core Insights - Biohaven Ltd. reported its financial results for Q3 2025, highlighting its focus on innovative therapies for various diseases and its strategic cost optimization efforts [1][3][4]. Financial Performance - The company reported a net loss of $173.4 million, or $1.64 per share, for Q3 2025, compared to a net loss of $160.3 million, or $1.70 per share, for the same period in 2024 [13][20]. - Research and Development (R&D) expenses decreased to $141.2 million in Q3 2025 from $157.6 million in Q3 2024, primarily due to reduced direct program spending [8][10]. - General and Administrative (G&A) expenses increased to $28.2 million in Q3 2025 from $20.6 million in Q3 2024, attributed to higher non-cash share-based compensation and legal costs [9][10]. Pipeline and Development - Biohaven's pipeline includes several key programs targeting unmet medical needs, such as epilepsy, autoimmune diseases, obesity, depression, and cancer [2][4]. - The company is advancing its Kv7 ion channel activator, opakalim, and plans to initiate a Phase 2 clinical trial for taldefgrobep alfa in obesity in Q4 2025 [5][10]. - Biohaven aims to continue patient enrollment in expanded Phase 1b studies for IgA nephropathy (IgAN) and Graves' disease, progressing to pivotal studies [4][10]. Strategic Initiatives - The company has initiated strategic cost optimization efforts, targeting a 60% reduction in annual direct R&D spending, focusing resources on late-stage clinical programs [10][12]. - Biohaven's management emphasized a "right-sizing" approach to innovation, aiming to balance growth and resource allocation effectively [2][10]. Capital Position - As of September 30, 2025, Biohaven's cash, cash equivalents, marketable securities, and restricted cash totaled approximately $263.8 million [7][18].

Core Insights - Pasithea Therapeutics Corp. has activated a new clinical trial site at the University of Alabama at Birmingham (UAB) for its Phase 1/1b study of PAS-004 in adult patients with neurofibromatosis type 1 (NF1) [1][2] - The company is also serving as a Platinum Sponsor for the 2025 NF Caregivers Symposium, emphasizing its commitment to the NF1 community [3] Clinical Trial Details - The Phase 1/1b study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult NF1 patients with symptomatic and inoperable plexiform neurofibromas [2][4] - The trial will be conducted in two parts: Part A will involve dose escalation with up to 24 participants receiving one of four planned dose levels (4mg, 8mg, 12mg, 18mg) [5] - Part B will enroll approximately 24 participants to receive doses at the recommended phase 2 dose (RP2D) for up to six continuous 28-day treatment cycles [5][6] Objectives of the Study - Primary objectives include evaluating the safety and tolerability of PAS-004, identifying the recommended Part B dose, and assessing preliminary efficacy on target neurofibromas and quality of life [4][5] - Secondary objectives focus on the impact of PAS-004 on cutaneous neurofibromas and associated symptoms, as well as pain and function related to plexiform neurofibromas [4][5] Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing PAS-004, a next-generation macrocyclic MEK inhibitor for treating RASopathies and MAPK pathway-driven tumors [7] - The company is currently conducting multiple clinical trials, including a Phase 1 trial in advanced cancer patients [7]