Core Insights - CRISPR Therapeutics has achieved FDA approval for its gene-editing therapy, Casgevy, making it the only CRISPR company to do so [2] - Despite the approval, CRISPR stock trades significantly below its all-time high, indicating potential undervaluation [2] - The company has a promising pipeline with five therapies in clinical trials, showcasing the potential of CRISPR technology [5] Financial Performance - Casgevy, a one-time gene-editing therapy, had only 64 patients treated in 2025, with 30 in Q4, indicating a slow ramp-up in sales [3] - Sales projections for CRISPR Therapeutics show growth from $37.3 million in 2025 to $134.4 million in 2026 and $374.9 million in 2027 [4] - The company has substantial cash reserves of nearly $2 billion and a manageable long-term debt of $188 million, despite a cash burn of $345.9 million in 2025 [6] Market Position and Challenges - CRISPR Therapeutics earns royalties from Casgevy sales through its collaboration with Vertex Pharmaceuticals, although it captures only a portion of the revenue [4] - The company has increased its share count by 26.9% over the past five years, which may dilute existing investors and limit short-term stock price appreciation [7] - There is uncertainty regarding the success of CRISPR's five experimental therapies, as many therapies fail to gain FDA approval [6]

疫苗生产商Moderna表示，美国食品和药物管理局(FDA)已同意审查其 流感疫苗申请，推翻了早些时候 拒绝该申请的决定。Moderna表示，FDA已经接受了其提出的修订方案，即寻求全面批准50至64岁的成 年人注射该疫苗，并加速批准65岁及以上的成年人注射该疫苗。该公司还补充称，将对老年人进行上市 后研究。 ...

Stock of Spruce Biosciences, Inc. (SPRB) is falling about 5 percent during Wednesday morning trading despite announcement of positive outcomes from two recent Type B meetings with the U.S. FDA regarding its planned biologics license application for tralesinidase alfa enzyme replacement therapy or TA-ERT.The company's stock is currently trading at $54.79, down 5.93 percent or $3.45, over the previous close of $58.24 on the Nasdaq. It has traded between $7.00 and $2,508.75 in the past one year.The company an ...

Summary of Sensei Biotherapeutics and Faeth Therapeutics Acquisition Conference Call Company and Industry Overview - **Company**: Sensei Biotherapeutics (NasdaqGM:SNSE) - **Acquisition Target**: Faeth Therapeutics - **Industry**: Biotechnology, specifically focused on cancer treatment Key Points and Arguments 1. **Acquisition Announcement**: Sensei Biotherapeutics announced the acquisition of Faeth Therapeutics, which includes a concurrent financing and changes to the leadership team and board of directors [2][6] 2. **Strategic Rationale**: The acquisition is seen as a means to maximize shareholder value and is expected to create significant value for stockholders [6] 3. **Faeth's Pipeline**: Faeth is a clinical-stage company developing multi-node therapies aimed at blocking cancer growth signals, with its lead asset, PIKTOR, showing promising safety and efficacy data [6][7] 4. **Financing Details**: Sensei entered into a $200 million private placement with support from leading healthcare investors, which will strengthen its financial position [8] 5. **Cash Runway**: The combined cash from the private placement and existing funds is expected to extend Sensei's cash runway through multiple clinical milestones [8] 6. **Leadership Changes**: Anand Parikh, former CEO and co-founder of Faeth, has joined Sensei as COO and a board member [9] 7. **PIKTOR Overview**: PIKTOR is an investigational oral combination therapy targeting the PI3K/AKT/mTOR pathway, designed to improve tolerability and efficacy compared to traditional treatments [10] 8. **Clinical Trial Results**: In a phase 1b trial, PIKTOR achieved a 47% overall response rate in heavily pre-treated patients with various cancers, including an 80% response rate in endometrial cancer patients [11] 9. **Future Trials**: PIKTOR is currently in phase 2 trials for endometrial cancer, with plans for additional studies in breast cancer and other tumor types [12] 10. **Market Potential**: The focus on cancers with mutations in the PI3K/AKT/mTOR pathway presents a significant market opportunity, particularly as treatment standards evolve towards combination strategies [13] 11. **Preclinical Pipeline**: In addition to PIKTOR, Sensei has a preclinical pipeline that includes therapies for rectal cancer and pediatric rare diseases [13] 12. **Acquisition Structure**: The acquisition was structured as a stock-for-stock merger, with Faeth's equity exchanged for Sensei common stock and newly created Series B non-voting convertible preferred stock [15] 13. **Ownership Post-Acquisition**: Post-acquisition, Faeth's equity holders will own approximately 40.8% of Sensei's common stock, while private placement investors will own about 54.3% [17] 14. **Use of Proceeds**: Proceeds from the private placement will primarily be used to advance PIKTOR for key clinical readouts [17] Additional Important Information - **Forward-Looking Statements**: The call included forward-looking statements regarding the expected effects and opportunities related to the acquisition, which involve risks and uncertainties [3][4] - **Investor Communication**: Investors are encouraged to read the proxy statement and other relevant materials filed with the SEC for important information regarding the transactions [5] - **Future Updates**: Sensei plans to provide updates on the progress of its clinical trials and the integration of Faeth in the coming weeks and months [19]

The U.S. Food and Drug Administration will review the investigational seasonal flu vaccine candidate after rejecting it earlier this month. ...

Initial presentation on January 26, 2026 s howcased Entolimod's potential to mitigate and prevent both gastrointestinal and hematopoietic injury from ionizing radiation exposure. FREMONT, CA / ACCESS Newswire / February 18, 2026 / Tivic (Nasdaq:TIVC), a late-stage immuno-therapeutics company, today announced that a second, follow-up meeting with the Biomedical Advanced Research and Development Authority (BARDA) has been scheduled for March 10, 2026, to continue discussions focused on clinical data and the p ...

Core Insights - NeuroSense Therapeutics announced a statistically significant 65% reduction in the risk of death and a median survival benefit of over 14 months for patients with ALS treated with PrimeC [1] Group 1: Clinical Trial Results - The updated analysis from the PARADIGM Phase 2b clinical trial shows that patients receiving PrimeC had a median survival of 36.3 months compared to 21.4 months for those on placebo, indicating a 70% increase in median survival [1] - The survival benefit was consistent over time, with a log-rank test showing statistical significance (p = 0.0218) [1] - A Cox proportional hazards model indicated that PrimeC treatment was associated with a hazard ratio of 0.35, reflecting a 65% reduction in the risk of death compared to placebo (p = 0.0037) [1] Group 2: Company Overview - NeuroSense is a late-stage clinical biotechnology company focused on developing treatments for neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's [1] - The company aims to address significant unmet medical needs in neurodegenerative diseases, which currently have limited effective therapeutic options [1] - NeuroSense's strategy involves developing combined therapies targeting multiple pathways associated with these diseases [1] Group 3: Product Information - PrimeC is NeuroSense's lead drug candidate, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target mechanisms contributing to neuron degeneration and inflammation [1] - The company continues to engage with regulatory authorities to advance PrimeC into pivotal late-stage development, reinforcing the clinical and regulatory foundation for the drug [1]

Achieved a record $1.4 billion in total revenue for 2025, a 38% increase driven by a 52% surge in royalty revenue from core blockbuster franchises. Transformed the corporate profile from two to four drug delivery technologies through the acquisitions of Elektrofi (Hypercon) and Surf Bio, extending IP protection into the mid-2040s. Performance was anchored by DARZALEX FASPRO, which now holds a 97% share of sales in the U.S., and PHESGO, which surpassed its initial 50% conversion target to reach 54%. ...

Swedish Orphan Biovitrum (OTCPK:SWOB.Y) 2026 Capital Markets Day February 18, 2026 07:00 AM ET Company ParticipantsDuane H. Barnes - Head of North AmericaEvangelos Giamarellos-Bourboulis - Chair of European Sepsis AllianceGerard Tobin - Head of Investor RelationsGuido Oelkers - CEOHenrik Stenqvist - CFOKirsty Ross-Stewart - VP of Pharmaceuticals Equity ResearchKlaus Parhofer - Professor of Metabolism and EndocrinologyLydia Abad-Franch - Head of R&D and Chief Medical OfficerMattias Häggblom - Co-Head of Equi ...

HOUSTON, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that its Chief Executive Officer, Dr. Juan Vera, will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, being held in a virtual format on February 25-26, 2026. Presentation Details: Event:Oppenheime ...