Written feedback from FDA pre-NDA meeting includes a recommendation to conduct a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for the treatment of schizophrenia Current data package highlights long-term safety profile, broad-spectrum clinical activity, and favorable adherence observed to date for once daily brilaroxazine over up to one year Initiation of RECOVER-2 registrational trial planned in H1 2026, subject to sufficient financing CUPERTI ...

Core Insights - ABIVAX (ABVX) has been recognized as the best performing biotech stock in 2025, achieving a remarkable 1,470% increase year to date [1] Company Overview - The company focuses on innovative biotechnology solutions, emphasizing unique mechanisms of action and first-in-class therapies [1] - ABIVAX is positioned within a sector where breakthrough science can lead to significant financial returns, highlighting the importance of thorough analysis [1] Analyst's Perspective - The analysis combines scientific expertise with financial and market evaluation to provide insights into the biotech sector [1] - The approach includes assessing the science behind drug candidates, the competitive landscape, clinical trial design, and market opportunities while considering financial fundamentals [1]

Core Insights - Intuitive Machines, Inc. (LUNR) experienced a significant stock price increase of 34% over a five-day period, rising from the $10 range to a higher valuation [1] Company Overview - The company is involved in the biotechnology sector, focusing on innovative drug development and therapeutic research [1] - It aims to identify and invest in biotechnology companies that are pioneering unique mechanisms of action and first-in-class therapies [1] Investment Strategy - The investment approach combines scientific expertise with financial and market analysis to evaluate drug candidates, competitive landscapes, clinical trial designs, and market opportunities [1] - The goal is to provide research that is both technically sound and investment-driven, helping investors understand the potential opportunities and risks in the biotech sector [1]

Kalaris Therapeutics, Inc. ( KLRS ) is set to raise $50 million in a private placement by selling about 4.2 million shares at $10 each. Now, these sales also come with pre-funded warrants for 800,000 shares. The proceedsI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave me an appreciation ...

Nektar Therapeutics (NASDAQ: NKTR) is a biopharmaceutical company focusing on autoimmune diseases, oncology, and pain management.H.C. Wainwright set a price target of $135 for NKTR, indicating a potential price increase of approximately 164%.Recent Phase 2b REZOLVE-AA trial results for rezpegaldesleukin showed significant potential in treating severe-to-very-severe alopecia areata.Nektar Therapeutics (NASDAQ: NKTR) is a biopharmaceutical company focused on developing innovative medicines in areas of high un ...

Core Insights - Can-Fite BioPharma Ltd. is advancing its clinical development activities and financial status, focusing on proprietary small-molecule drugs for oncological and inflammatory diseases [1] Clinical Development - Can-Fite is enrolling patients in a pivotal Phase III clinical study for Namodenoson, targeting advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function, addressing a significant unmet medical need [2] - An interim analysis for the Phase III study of Namodenoson is expected in Q4 2026, with potential eligibility for conditional regulatory approval from the FDA and EMA based on positive results [2] - A Phase IIb clinical study of Namodenoson for metabolic dysfunction-associated steatohepatitis (MASH) is ongoing, following positive Phase IIa trial results [3] - Namodenoson is also being evaluated in a Phase IIa study for pancreatic cancer, with data expected in Q2 2026 [4] - Can-Fite is conducting a pivotal Phase III clinical study for Piclidenoson in psoriasis, with interim analysis data anticipated in Q2 2026 [5] - The company has developed a Phase II study protocol for Lowe Syndrome, planning to submit it to regulatory authorities in Italy and EMA in Q1 2026 [5] Financial Status - As of June 30, 2025, Can-Fite had cash and cash equivalents of $6.45 million, and raised $5 million from a public offering in July 2025, followed by an additional $2.2 million through an ATM facility in November 2025 [6] Company Strategy - The company aims to address significant unmet medical needs with orally administered drug candidates, with ongoing pivotal studies in liver cancer and psoriasis, alongside mid-stage programs in MASH and pancreatic cancer [7] - Can-Fite's lead drug candidate, Piclidenoson, is positioned in multi-billion-dollar markets for cancer, liver, and inflammatory diseases, with a strong safety profile demonstrated in over 1,600 patients [8]

Core Insights - Sanofi's tolebrutinib did not meet its primary endpoint in the PERSEUS phase 3 study for primary progressive multiple sclerosis (PPMS), leading the company to decide against pursuing regulatory registration for this indication [1][8][10] Company Updates - Sanofi expressed disappointment over the study results but emphasized the importance of these findings in enhancing the understanding of multiple sclerosis biology [2] - The safety profile of tolebrutinib was consistent with previous studies, with drug-induced liver injury (DILI) identified as a risk, necessitating strict liver monitoring [2][4] - Tolebrutinib was provisionally approved in the UAE for non-relapsing secondary progressive multiple sclerosis and is under regulatory review in the EU and other regions [3] Financial Considerations - Sanofi will conduct an impairment test on the intangible asset value of tolebrutinib, with results expected in January 2026, but this will not impact the business net income or financial guidance for 2025 [4] Industry Context - Multiple sclerosis (MS) is characterized by progressive disability, with PPMS representing about 10% of the overall MS patient population [1][5] - There is a significant unmet need in addressing disability accumulation in MS, particularly for secondary progressive multiple sclerosis [6]

Group 1 - Major Wall Street strategists forecast that the S&P 500 will finish 2026 significantly above current levels, with targets ranging from 7,400 to 8,100 [1] Group 2 - The focus is on identifying promising biotechnology companies that are innovating through novel mechanisms of action, first-in-class therapies, or platform technologies [1] - The analysis emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities while balancing financial fundamentals and valuation [1]

Registration No. 333-291598 As filed with the U.S. Securities and Exchange Commission on December 11, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) England and Wales 2834 Not Applicable (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (IRS Em ...

As filed with the U.S. Securities and Exchange Commission on December 11, 2025. Registration No. 333-291598 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) England and Wales 2834 Not Applicable (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (IRS Em ...