相关临床试验
9
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1993
进行中（未招募）
1
11.1%
已完成
5
55.6%
终止
3
33.3%
暂无批准数据
- Rakovina Therapeutics announced up to $1.5 million in new financing through a $1 million convertible debenture and $500,000 private placement to support near-term operations and strategic initiatives. - The company appointed Kim Oishi as Chief Executive Officer and Frank Holler as independent director, strengthening leadership and governance capabilities. - Existing convertible debenture holders consented to extend the maturity date from January 28, 2026 to March 11, 2026, providing additional time for debt restructuring. - The biopharmaceutical company focuses on developing innovative cancer treatments targeting DNA damage response using AI-enabled drug discovery platforms, including the KT-5000 series ATR inhibitors.
- Theratechnologies has launched EGRIFTA WR, an improved weekly formulation of tesamorelin that replaces daily reconstitution with weekly preparation for treating excess abdominal fat in HIV patients with lipodystrophy. - The new formulation offers significant convenience advantages including reduced injection volume by more than half, room temperature storage, and patent protection until 2033 in the U.S. - EGRIFTA WR remains the only FDA-approved medication for reducing excess abdominal fat in HIV patients with lipodystrophy, addressing an underserved market with limited therapeutic alternatives. - Specialty pharmacies are now ordering EGRIFTA WR to fill prescriptions, with a dedicated patient support program facilitating the transition from the previous EGRIFTA SV formulation.
- Theratechnologies Inc. has agreed to be acquired by CB Biotechnology, LLC for $3.01 per share in cash plus contingent value rights worth up to $1.19 per share. - The transaction represents a 126% premium to the closing price on April 10, 2025, with total value reaching $254 million assuming full CVR payout. - Future Pak will fund the acquisition through a combination of debt financing and cash, with a $220 million credit facility commitment from lenders. - Following completion, Theratechnologies will become privately held and delist from both the Toronto Stock Exchange and Nasdaq.
- Peptide drug conjugates represent a novel targeted therapy approach that combines disease-targeting peptides with small molecule drugs to deliver treatments directly to diseased tissues while minimizing systemic toxicity. - The global peptide drug conjugate market has experienced remarkable growth of over 300% absolute growth and 27% CAGR from 2018-2024, with market opportunities exceeding $1.4 billion. - Two peptide drug conjugates have received regulatory approval as of May 2025: Novartis's Lutathera for gastroenteropancreatic neuroendocrine tumors and Oncopeptides' Pepaxti for multiple myeloma. - More than 30 peptide drug conjugate candidates are currently advancing through various stages of clinical trials, primarily focused on oncology applications but expanding into neurodegenerative and inflammatory disorders.
- Theratechnologies has received FDA approval for a Prior Approval Supplement (PAS) for EGRIFTA SV, paving the way for its replacement with the new EGRIFTA WR formulation while ensuring continued distribution of EGRIFTA SV. - Alpha Tau has secured FDA approval to initiate a clinical trial evaluating its Alpha DaRT technology for patients with recurrent glioblastoma, representing a potential new treatment approach for this aggressive brain cancer. - Both regulatory milestones highlight ongoing innovation in specialized therapeutic areas, with Theratechnologies focusing on metabolic conditions and Alpha Tau advancing novel radiation technology for difficult-to-treat cancers.
- Theratechnologies has received FDA approval for EGRIFTA WR™ (tesamorelin F8), a new formulation that requires weekly rather than daily reconstitution for treating excess visceral abdominal fat in adults with HIV and lipodystrophy. - The improved formulation requires less than half the administration volume of the current EGRIFTA SV® version, offering a more convenient patient experience while maintaining bioequivalence to the original tesamorelin formulation. - Recent data presented at CROI 2025 highlights that BMI alone is insufficient for assessing cardiovascular risk in HIV patients, emphasizing the importance of measuring visceral adipose tissue in this population.
• The FDA is set to decide on Bavarian Nordic's CHIKV VLP vaccine for chikungunya, potentially the first VLP-based option in the U.S. • GSK's ABCWY vaccine, targeting multiple strains of Neisseria meningitidis, awaits FDA decision for primary care and pediatric use. • Innoviva Specialty Therapeutics' zoliflodacin, a novel antibiotic for gonorrhea, is under FDA review amid rising antimicrobial resistance. • Merck's clesrovimab, a monoclonal antibody for COVID-19, is being reviewed by the FDA for pediatric patients.
- Theratechnologies' sudocetaxel zendusortide demonstrates favorable tolerability and efficacy signals in heavily pre-treated ovarian cancer patients in a Phase 1b trial. - No dose-limiting toxicities were observed in patients receiving weekly doses of sudocetaxel zendusortide, indicating a manageable safety profile. - Preliminary efficacy data showed significant tumor shrinkage and complete resolution of a liver lesion in some patients at a 2.5-mg/kg/week dose. - The Medical Review Committee recommends further evaluation and exploration of higher doses based on the encouraging tolerability and efficacy data.
- Theratechnologies has submitted a Prior Approval Supplement (PAS) to the FDA for changes in the manufacturing of EGRIFTA SV®. - The FDA's review is expected to take four months, with approval needed before new batches can be distributed, potentially impacting supply. - Current inventory of EGRIFTA SV® is projected to meet patient demand until mid-January 2025, creating a narrow window for approval. - The company is in talks with the FDA to expedite the review process and prevent potential shortages of EGRIFTA SV® in the US.
- Peptide-drug conjugates (PDCs) are emerging as a novel class of cancer therapeutics, offering potential advantages over antibody-drug conjugates (ADCs) due to their smaller size and rapid internalization. - PDCs targeting SORT1, a transmembrane glycoprotein highly expressed in various solid tumors, demonstrate enhanced drug delivery and reduced off-target toxicity in preclinical studies. - Theratechnologies' SORT1+ Technology platform is advancing PDCs, with early clinical data showing durable disease stabilization and a unique mechanism of action in advanced solid tumors. - The versatility of PDCs allows for conjugation with diverse payloads, including radioisotopes, opening new avenues for targeted cancer treatment and potential development partnerships.
