Allarity Therapeutics Hit By SEC Notice Related Disclosures Of Once Lead Cancer Program
Allarity Therapeutics Hit By SEC Notice Related Disclosures Of Once Lead Cancer Program
Allarity Therapeutics Inc (NASDAQ:ALLR) revealed on Monday it received a "Wells Notice" from the U.S. Securities and Exchange Commission (SEC).
Allarity Therapeutics Inc（纳斯达克股票代码：ALLR）周一透露，它收到了美国证券交易委员会（SEC）的 “富国银行通知”。
This notice pertains to the company's disclosures about meetings with the Federal Drug Administration (FDA) regarding their New Drug Application (NDA) for Dovitinib or Dovitinib-DRP, submitted in 2021.
本通知涉及该公司就其于2021年提交的多维替尼或多维替尼-DRP的新药申请（NDA）与联邦药品监督管理局（FDA）会晤的披露。
In December 2021, Allarity Therapeutics submitted a marketing application to the FDA seeking approval for dovitinib for the third-line treatment of renal cell carcinoma (RCC) patients.
2021年12月，Allarity Therapeutics向美国食品药品管理局提交了上市申请，寻求批准多维替尼用于肾细胞癌（RCC）患者的三线治疗。
The company's NDA filing was supported by its prior pre-market approval (PMA) submission with the FDA for using Dovitinib-DRP, its companion diagnostic for the drug, to select and treat RCC patients most likely to respond to dovitinib.
该公司的保密协议申请得到了其先前向美国食品药品管理局提交的上市前批准（PMA）申请的支持，该申请涉及使用该药物的伴随诊断药物多维替尼-DRP来选择和治疗最有可能对多维替尼产生反应的RCC患者。
Additionally, three former officers of Allarity have received similar notices from the SEC related to this issue.
此外，Allarity的三名前官员已收到美国证券交易委员会与此问题有关的类似通知。
A Wells Notice indicates the SEC staff made a preliminary determination to recommend enforcement action, alleging violations of federal securities laws.
富国银行的一份通知显示，美国证券交易委员会的工作人员已初步决定建议采取执法行动，指控其违反了联邦证券法。
It is not a formal charge but suggests potential legal action.
这不是一项正式指控，但暗示了潜在的法律行动。
Allarity disclosed that all conduct related to the SEC's notice occurred during or before the fiscal year 2022.
Allarity透露，与美国证券交易委员会的通知有关的所有行为都发生在2022财年或之前。
The company remains cooperative with the SEC and plans to submit a formal response, asserting its actions were appropriate.
该公司继续与美国证券交易委员会合作，并计划提交正式答复，声称其行动是适当的。
Allarity's board of directors has proposed a reverse stock split to shareholders to regain and sustain compliance with NASDAQ's listing requirements.
Allarity董事会已向股东提议反向股票拆分，以恢复和维持对纳斯达克上市要求的遵守。
The company said it will focus on advancing stenoparib, a novel dual PARP and Tankyrase inhibitor.
该公司表示，将专注于开发stenoparib，这是一种新型的双重PARP和Tankyrase抑制剂。
Recently, Allarity Therapeutics announced the early discontinuation of its Phase 2 clinical trial of stenoparib for advanced recurrent ovarian cancer.
最近，Allarity Therapeutics宣布提前停止其治疗晚期复发性卵巢癌的Stenoparib的2期临床试验。
The trial, evaluating stenoparib given twice daily, showed clear clinical benefits, including tumor shrinkage and long-term disease stability, in heavily pretreated ovarian cancer patients.
该试验评估了每天给药两次的stenoparib，显示出明显的临床益处，包括肿瘤缩小和长期疾病稳定性，适用于经过大量预处理的卵巢癌患者。
Allarity Therapeutics announced the company has a financial runway extending into 2026 at its current burn rate with a cash balance of $20 million.
Allarity Therapeutics宣布，按目前的消耗率计算，该公司的财务状况将持续到2026年，现金余额为2000万美元。
The company also plans to pause its ATM offering program for the foreseeable future.
该公司还计划在可预见的将来暂停其自动柜员机发行计划。
ALLR Price Action: Allarity stock is down 8.33% at 15 cents at last check Monday.
ALLR价格走势：周一最后一次查看时，Allarity股价下跌8.33％，至15美分。
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