VANCOUVER, BC / ACCESS Newswire / December 16, 2025 / Tactical Resources Corp. (TSXV:RARE)(OTC PINK:USRED) ("Tactical" or the "Company"), a mineral exploration and development company, is pleased to announce that, at the annual general and special meeting (the "Meeting") of holders of common shares ("Shareholders") held today, Shareholders overwhelmingly voted in favour of the special resolution (the "Arrangement Resolution") to approve the previously announced plan of arrangement (the "Arrangement") entere ...

Group 1 - Ultragenyx Pharmaceutical Inc. is recognized as one of the best biotech stocks to buy, with a Consensus Strong Buy rating from 13 Wall Street analysts, including 12 Buys and 1 Hold [1] - The average price target for Ultragenyx is $76.83, indicating a potential upside of 111.65% from the current price of $36.30 [2] - Cantor Fitzgerald reaffirmed its Overweight rating and set a price target of $105 following the company's Q3 2025 results and financial actions [2] Group 2 - Ultragenyx reported Q3 revenue of $160 million, which was below the consensus estimate of $167 million, and an EPS of -1.81 compared to the expected -1.23 [3] - Despite the revenue shortfall, Ultragenyx maintained its full-year revenue guidance of $640 to $670 million [3] - The company sold 25% of its North American Crysvita economics for $400 million upfront, which is expected to strengthen its liquidity [3] Group 3 - Ultragenyx focuses on developing treatments for severe, debilitating, rare, and ultra-rare genetic diseases, utilizing modalities such as biologics, gene therapies, and ASOs [4]

Core Viewpoint - Century Lithium Corp. has announced significant findings regarding the recovery of rare earth elements (REEs) from its Angel Island Lithium Project, indicating the potential for REEs to become a strategically important by-product alongside lithium carbonate production [1][9]. Summary by Sections REE Recovery Process - The company utilized a patent-pending chloride-based process combined with targeted ion-exchange, achieving high recoveries of REEs from a bulk sample of claystone [1][2]. - The claystone sample contained 0.024% total rare earth oxides (TREO) and 1101 ppm lithium, with REE distribution showing approximately 75% light rare earth elements and 25% heavy rare earth elements [2][3]. Testing Results - Chloride leaching yielded solution concentrations of 210 mg/l lithium and 36 mg/l TREO, demonstrating that REEs can be extracted under the same conditions as lithium [3]. - Ion-exchange tests showed high recovery rates for various REEs, with total REO recovery reaching 99.6% [4][5]. Strategic Importance - The Angel Island project is expected to process between 2.75 to 5.5 million tonnes of claystone annually, generating 10 to 20 million tonnes of leach solution per year, which could translate into significant quantities of REEs [8]. - The project is positioned to contribute meaningfully to North America's critical mineral supply chain, enhancing the company's revenue streams [2][9]. Future Development - Century Lithium is currently focused on further reserve definition and metallurgical testing before evaluating the economic contribution of REE recovery [9]. - The company is committed to completing an updated feasibility study and advancing permitting for the Angel Island project, which is crucial for its development [9][12].

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]

Summary of Ultragenyx Pharmaceutical FY Conference Call Company Overview - **Company**: Ultragenyx Pharmaceutical (NasdaqGS:RARE) - **Focus**: Development and commercialization of drugs for patients with rare diseases, particularly Osteogenesis Imperfecta (OI) and Angelman syndrome [2][26] Key Points Product Pipeline and Development - **Current Products**: Success with Crysvita, supported by Mepsevii, Evkeeza, and Dojolvi [2] - **Upcoming Data**: Anticipation for phase three data readouts, particularly for Osteogenesis Imperfecta [2] - **Setrusumab**: Expected to show significant results in both Orbit and Cosmic studies, with a focus on the probability of success [5][6] Financial Strategy - **Royalty Financing**: Initiated due to the delay in potential revenue from the Sanfilippo program, allowing for a stronger balance sheet without diluting stock [3] Clinical Trials - **Orbit and Cosmic Studies**: Both studies are designed to be reported together, with confidence in their success [4] - **Effect Size Expectations**: A treatment effect size of 30% to 40% is considered clinically meaningful, with a powered expectation of at least 50% [6][7] - **Rescue Treatment Protocol**: Ethical considerations in allowing patients to receive rescue treatment if they experience high fracture rates [9][10] Commercial Considerations - **Pricing Strategy**: Pricing for Osteogenesis Imperfecta will be informed by the successful launch of Crysvita [11] - **Duration of Treatment**: Setrusumab is expected to be a lifelong treatment due to its mechanism of action [12] Patient Demographics - **Trial Composition**: Orbit phase three includes approximately 50% type 3 and 4 patients, with a commercial mix of about 60% type 1 and 38% type 3 and 4 patients [14][15] Confidence in Data - **Confidence Level**: High confidence in the upcoming data readout for Setrusumab, supported by consistent results in earlier phases [16] Angelman Syndrome Program - **Phase 1/2 Study**: Enrollment of 74 patients, with ongoing discussions about data release prior to the next phase [17] - **Safety Monitoring**: Close monitoring of lower extremity weakness, with mild cases reported and resolved quickly [18][19] - **Dropout Rates**: Expected to remain low due to the nature of the study and the potential benefits for patients [19] Developmental Outcomes - **Cognitive Improvement**: Unique potential to improve cognition and communication in patients with Angelman syndrome, rather than just preventing deterioration [22] - **Primary Endpoint Focus**: Cognition is the primary endpoint, followed by communication and motor skills [25] Future Outlook - **Gene Therapy Programs**: Continued focus on gene therapy programs, with upcoming PDUFA dates for Sanfilippo and GSD1A expected to lead to successful launches [26]

Core Insights - The session features Ultragenyx with Chief Medical Officer Eric Crombez presenting at the Global Healthcare Conference in Miami, indicating ongoing engagement and interest in the biotech sector [1] Company Overview - Ultragenyx has been under coverage for several years, highlighting its progress and developments in the biotech industry [1]

Core Viewpoint - Volvo Cars, based in Sweden, has reported a significant decline in sales for November, continuing a downward trend observed throughout the year due to trade tariffs and weakened demand in the United States [1] Company Summary - November sales for Volvo Cars have slumped, indicating ongoing challenges faced by the company [1] - The decline in sales is attributed to external pressures such as trade tariffs and a decrease in consumer demand, particularly in the U.S. market [1] Industry Summary - The automotive industry is experiencing pressures from trade tariffs, which are impacting sales figures for companies like Volvo Cars [1] - There is a notable subdued demand in the U.S. market, contributing to the overall decline in sales for the industry [1]

Financial Data and Key Metrics Changes - The company is focused on the upcoming data readout for setrusumab, which is expected by the end of the year or early January, marking a significant near-term value driver [2][34] - The company has achieved a 67% reduction in fracture rates from baseline in the phase 1/2 study with 24 patients, indicating strong efficacy [8][15] Business Line Data and Key Metrics Changes - The company is advancing its program for Osteogenesis Imperfecta (OI), which is seen as a major opportunity, with an estimated 60,000 patients in the covered geographies [3][4] - The ORBIT trial has enrolled an additional 159 patients, maintaining a two-to-one randomization of setrusumab to placebo, with a focus on patients aged 5 to 26 [10][12] Market Data and Key Metrics Changes - The company is preparing to launch setrusumab, which aims to outperform bisphosphonates, currently the only available treatment for OI, which has a treatment effect estimated around 20% [15][16] - The company is also working on gene therapies for Sanfilippo and GSD1A, with expected PDUFA dates comfortably within the PRV window [38][39] Company Strategy and Development Direction - The company aims to leverage lessons learned from the successful launch of Crysvita to enhance the launch of setrusumab [4] - The strategy includes not compromising data quality to meet regulatory deadlines, emphasizing the importance of robust data packages for OI [30][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts and the potential for successful product launches, highlighting the importance of OI and gene therapy programs [2][38] - The company is optimistic about achieving profitability within the timeframe of its monetization deal for Crysvita, which allows for revenue generation without immediate payment obligations [91][92] Other Important Information - The company is exploring the use of AI to analyze data sets and streamline documentation processes for regulatory submissions [32] - The company has received a complete response letter for Sanfilippo but is confident in addressing the FDA's requirements for re-filing [38][39] Q&A Session Summary Question: What is the expectation for the benefit of bisphosphonates compared to setrusumab? - Management estimates the benefit of bisphosphonates to be around 20%, while setrusumab has shown a 67% reduction in fracture rates in early studies [15][16] Question: Do both ORBIT and COSMIC studies need to be successful for regulatory approval? - Management indicated that while both studies are important, a positive outcome from either could still support a successful product launch, although statistical significance in COSMIC would be crucial for claiming superiority [12][13] Question: What is the timeline for filing the BLA for Sanfilippo and GSD1A? - The company plans to refile for Sanfilippo at the beginning of next year and expects to complete the rolling BLA for GSD1A this month, both aiming for PDUFA dates within the PRV window [38][39]

Financial Data and Key Metrics Changes - The company is focused on the upcoming data readout for setrusumab, which is expected by the end of the year or early January, marking a significant near-term value driver [2][34] - The company has achieved a 67% reduction in fracture rates from baseline in the Orbit trial, indicating strong efficacy of setrusumab [8][15] Business Line Data and Key Metrics Changes - The company is advancing its gene therapy programs, particularly for Sanfilippo and GSDIa, with both expected to file for approval within the PRV window by the end of September [38][91] - The company is also conducting a seamless phase I/II/III study for Wilson disease, aiming to demonstrate the efficacy of its gene therapy in reducing the need for chelators [52][54] Market Data and Key Metrics Changes - The potential market for Osteogenesis Imperfecta (OI) is estimated at 60,000 patients in the covered geographies, presenting a unique opportunity for the company [3][4] - For Sanfilippo, the patient population is estimated between 3,000 and 5,000, while GSDIa has around 6,000 patients, indicating significant market potential for these gene therapies [42] Company Strategy and Development Direction - The company aims to leverage lessons learned from the successful launch of Crysvita to enhance the launch of setrusumab for OI [4] - The strategy includes not compromising data quality to meet regulatory deadlines, emphasizing the importance of robust data packages for successful product launches [30][92] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts and the potential for successful regulatory filings, highlighting the importance of these products to the company's future [34][92] - The company is actively exploring the use of AI to streamline data analysis and document preparation, aiming to enhance efficiency in the approval process [32] Other Important Information - The company has successfully monetized a deal with OMERS for Crysvita, which is expected to provide financial flexibility as it approaches profitability [91] - The company is committed to ensuring that all patient populations affected by Angelman syndrome can benefit from its therapies, aiming for a full label upon approval [87] Q&A Session Summary Question: What is the timeline for the data readouts for setrusumab? - The company has defined the end of the year as December or January for the data readouts, indicating a near-term timeline [34] Question: How does the company view the efficacy of bisphosphonates compared to setrusumab? - Management estimates the treatment effect of bisphosphonates to be around 20%, while setrusumab has shown a 67% reduction in fracture rates, indicating a significant improvement [15][16] Question: What is the company's approach to regulatory filings for Sanfilippo and GSDIa? - The company plans to refile for Sanfilippo early next year and is on track to complete the rolling BLA for GSDIa this month, both aiming for PDUFA dates within the PRV window [38][91] Question: How does the company plan to address the potential for opportunistic infections with immunomodulation therapies? - Management indicated that while there are concerns with immunosuppressants like sirolimus, the focus is on optimizing efficacy and safety through careful study design [67]

Financial Data and Key Metrics Changes - The company is focused on the upcoming data readout for setrusumab, which is expected by the end of December or January, marking a significant near-term value driver [2][34] - The company has achieved a 67% reduction in fracture rates from baseline in the phase 1/2 study, indicating strong efficacy [7][15] Business Line Data and Key Metrics Changes - The company is advancing its Osteogenesis Imperfecta (OI) program, which targets a patient population of at least 60,000 in the covered geographies, aiming to replicate the success of Crysvita [3][4] - The ORBIT trial has enrolled an additional 159 patients, maintaining a two-to-one randomization of setrusumab to placebo, with a focus on patients aged 5 to 26 [10][12] Market Data and Key Metrics Changes - The company is preparing for a market launch of setrusumab, which is positioned as a superior treatment compared to bisphosphonates, currently the only available treatment for OI [2][11] - The potential market for Sanfilippo is estimated at 3,000 to 5,000 patients, while GSD1A is slightly larger at 6,000 patients, indicating a strategic focus on rare disease markets [42] Company Strategy and Development Direction - The company is committed to not compromising the quality of data for the OI filing, despite the ambitious timeline for approval by the end of September [30][32] - The strategy includes leveraging AI for data analysis and document preparation to enhance efficiency in the filing process [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the probability of success for the final data readout, maintaining that the interim analyses have not negatively impacted their outlook [20][28] - The company is optimistic about achieving profitability within the timeframe of their recent monetization deal, which allows for revenue generation without immediate repayment obligations [93] Other Important Information - The company is actively working on gene therapy programs, with a focus on Sanfilippo and GSD1A, both of which are expected to have PDUFA dates within the PRV window [38][39] - The company has learned from previous regulatory feedback, applying those lessons to improve the quality of their gene therapy programs [40][42] Q&A Session Summary Question: What is the timeline for the data readout for setrusumab? - The company has defined the end of year as December or January for the data readout [34] Question: How does the company view the efficacy of bisphosphonates compared to setrusumab? - Management estimates the treatment effect of bisphosphonates to be around 20%, while setrusumab has shown a 67% reduction in fracture rates [14][15] Question: What is the company's approach to the upcoming regulatory filings? - The company plans to ensure high-quality data packages for regulatory submissions, emphasizing that they will not rush the process [30][32] Question: How does the company plan to address the market for Sanfilippo and GSD1A? - The company is confident in the clinical data for both programs and is preparing for timely submissions to the FDA [38][39]