This section highlights FDA-related milestones and regulatory updates for drugs developed by Allarity Therapeutics (ALLR).
Over the past two years, Allarity Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Dovitinib and Stenoparib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Dovitinib - FDA Regulatory Timeline and Events
Dovitinib is a drug developed by Allarity Therapeutics for the following indication: Third-Line Treatment of Renal Cell Carcinoma (RCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Dovitinib
- Announced Date:
- March 13, 2025
- Indication:
- Third-Line Treatment of Renal Cell Carcinoma (RCC)
Announcement
Allarity Therapeutics, Inc announced that it has reached a final settlement with the U.S. Securities and Exchange Commission (SEC) relating to the previously disclosed investigation regarding the Company's past disclosures concerning its interactions with the U.S. Food and Drug Administration (FDA) regarding its New Drug Application ("NDA") for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.
AI Summary
Allarity Therapeutics, Inc. announced that it has reached a final settlement with the U.S. Securities and Exchange Commission (SEC) over its past disclosures regarding its interactions with the FDA concerning its New Drug Application for Dovitinib (Dovitinib-DRP), which was submitted in 2021. Under the settlement, Allarity agreed to an administrative cease-and-desist order without admitting or denying the SEC’s findings. This final agreement resolves the SEC’s investigation into whether the company violated certain provisions of the Securities Act of 1933 and the Securities Exchange Act of 1934. The settlement also includes a one-time civil penalty payment of $2.5 million, and Allarity has committed to cooperate with the SEC in any related matters.
With this resolution, the company has closed this regulatory chapter, allowing it to fully focus on advancing its clinical programs and core mission in cancer treatment.
Read Announcement- Drug:
- Dovitinib
- Announced Date:
- July 18, 2024
- Indication:
- Third-Line Treatment of Renal Cell Carcinoma (RCC)
Announcement
Allarity received a "Wells Notice" from the Staff of the Securities and Exchange Commission (the "SEC"), relating to the previously disclosed SEC investigation. The Wells Notice relates to the Company's disclosures regarding meetings with the United States Food and Drug Administration (the "FDA") regarding our NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.
AI Summary
Allarity Therapeutics recently received a "Wells Notice" from the SEC Staff regarding disclosures about its meetings with the FDA. These meetings concerned the company’s New Drug Application (NDA) for Dovitinib, also known as Dovitinib-DRP, which was submitted to the FDA in 2021. The Wells Notice is a preliminary communication that signals the SEC’s intent to potentially recommend enforcement action, though it is not a formal charge or a final determination of wrongdoing.
Allarity explained that the SEC’s concerns relate solely to statements about its meetings with the FDA. The company has stated that all related conduct occurred during or before fiscal year 2022 and is fully cooperating with the investigation. Allarity maintains that its actions were appropriate and is preparing a formal response as the Wells Notice process moves forward.
Read Announcement
Stenoparib - FDA Regulatory Timeline and Events
Stenoparib is a drug developed by Allarity Therapeutics for the following indication: For ovarian cancer (AOC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Stenoparib
- Announced Date:
- June 27, 2025
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc announced that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer.
AI Summary
Allarity Therapeutics, Inc. announced that the second patient has been dosed in its new Phase 2 clinical trial evaluating stenoparib. This trial is focused on patients with advanced, recurrent ovarian cancer who are either resistant to platinum-based treatments or are not eligible for them. The company is exploring stenoparib’s potential as a targeted therapy with a better tolerance profile compared to current chemotherapy options. According to CEO Thomas Jensen, the rapid pace of patient enrollment reflects strong engagement from investigators and a promising interest in finding new treatment options for patients with limited alternatives.
The trial builds on earlier research showing durable clinical benefits and favorable tolerability of stenoparib in a twice-daily dosing schedule. This study will also help further evaluate the unique dual mechanism of action of stenoparib, which targets both PARP and the WNT pathway, potentially offering a new hope for challenging ovarian cancer cases.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- June 2, 2025
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc announced that the first patient has been enrolled in its new Phase 2 clinical trial protocol of stenoparib for the treatment of advanced, platinum-resistant or platinum-ineligible ovarian cancer.
AI Summary
Allarity Therapeutics, Inc. announced that the first patient has been enrolled in a new Phase 2 clinical trial of stenoparib for advanced ovarian cancer patients who are either platinum-resistant or platinum-ineligible. This trial focuses on patients with limited treatment options and aims to assess the safety and overall effectiveness of the drug. The study builds on earlier results showing that twice-daily dosing of stenoparib provided durable clinical benefits and was well tolerated, with some patients experiencing positive outcomes for over 20 months.
The new trial protocol also evaluates the accompanying Drug Response Predictor (DRP®), a companion diagnostic that helps identify patients most likely to benefit from stenoparib. By improving patient selection and exploring an additional dosing level, the study seeks to optimize treatment and potentially offer a safer alternative to conventional chemotherapy.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- April 25, 2025
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc. announced the presentation of a poster containing data on a new DRP for the monoclonal antibody drug daratumumab.
AI Summary
Allarity Therapeutics recently announced that it will present a poster featuring data on a new Drug Response Predictor (DRP) for the monoclonal antibody daratumumab at the AACR 2025 Annual Meeting. The new DRP is designed to help identify multiple myeloma patients who are most likely to benefit from daratumumab treatment. Researchers developed the DRP by analyzing gene expression patterns related to daratumumab-induced antibody-dependent cellular cytotoxicity (ADCC). They pinpointed a set of 53 genes associated with sensitivity and resistance to the drug. Early results from studies using single-cell RNA sequencing and clinical trial data have shown promise in predicting treatment outcomes and patient survival. This advancement demonstrates the versatility of Allarity’s DRP technology, which is now being expanded beyond small-molecule drugs to include antibody therapies.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- March 17, 2025
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc. announced the presentation of new clinical data from its ongoing Phase 2 trial with stenoparib monotherapy in advanced Ovarian Cancer at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer, held March 14-17 in Seattle, Washington.
AI Summary
Allarity Therapeutics, Inc. presented new clinical data at the SGO 2025 Annual Meeting on Women’s Cancer, held from March 14-17 in Seattle, Washington. The data come from an ongoing Phase 2 trial that tests stenoparib monotherapy in patients with advanced ovarian cancer who have received multiple prior treatments. The study focused on patients with platinum-resistant and platinum-refractory disease, showing that stenoparib may provide durable clinical benefit even in difficult-to-treat cases.
During the meeting, Dr. Fernanda B. Musa presented a poster titled “A Phase II Trial of Stenoparib (2X-121): A Novel Dual Tankyrase and PARP Inhibitor in Advanced, Recurrent Ovarian Cancer.” The findings suggest that stenoparib, which targets both PARP and the Wnt pathway, could be a well-tolerated option offering new hope for ovarian cancer patients with limited treatment alternatives.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- March 6, 2025
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc announced plans for a Phase 2 trial evaluating the combination of stenoparib with temozolomide, a DNA-alkylating chemotherapy agent, for the treatment of recurrent Small Cell Lung Cancer (SCLC).
AI Summary
Allarity Therapeutics, Inc. has announced a Phase 2 clinical trial to study a new treatment for recurrent small cell lung cancer (SCLC). The trial will evaluate the combination of stenoparib, a dual PARP and tankyrase inhibitor, with temozolomide, a DNA-alkylating chemotherapy agent. Funded fully by the U.S. Veterans Administration, the study will be conducted at VA medical centers in Indianapolis and Pittsburgh, targeting patients who did not respond to frontline treatment.
The approach is based on promising evidence that PARP inhibitors, when paired with temozolomide, can achieve significant response rates. However, earlier studies noted dose-limiting blood toxicities with other PARP inhibitors. Stenoparib may offer a safer profile while enhancing the effectiveness of temozolomide. Its ability to cross the blood-brain barrier also holds potential for addressing brain metastases in SCLC patients.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- February 6, 2025
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc announced plans for the next step in advancing the clinical development of stenoparib toward FDA approval in advanced ovarian cancer.
AI Summary
Allarity Therapeutics, Inc. announced plans to take the next step in developing stenoparib toward FDA approval for advanced ovarian cancer. The company is moving ahead with a new Phase 2 clinical trial designed to optimize the dosing of stenoparib and refine its proprietary Drug Response Predictor (DRP®) for better patient selection. The trial will focus on patients with advanced, recurrent, platinum-resistant ovarian cancer, a group that has already shown significant benefit from the drug. By enhancing the clinical data set and deepening the understanding of stenoparib’s dual-action mechanism—targeting both PARP and the Wnt pathway—Allarity hopes to speed up regulatory approval. Patient enrollment is planned to begin in early 2025 in the United States, with the potential for expansion to trial sites in the United Kingdom, pending final regulatory reviews.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- February 6, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc announced that Patient enrollment is expected to begin in the first half of 2025
AI Summary
Allarity Therapeutics, Inc. has announced a new Phase 2 clinical trial protocol aimed at advancing the development of stenoparib for treating advanced ovarian cancer. The trial will refine the Drug Response Predictor (DRP®) system to better select patients who are most likely to benefit from stenoparib. This study specifically targets patients with advanced, recurrent, platinum-resistant ovarian cancer who need more treatment options beyond standard chemotherapy. Patient enrollment is expected to begin in the first half of 2025, pending final protocol review by regulatory authorities. Enrollment will start at leading U.S. trial sites, with the possibility of adding sites in the U.K. The company believes that this enrollment phase will help gather crucial data to further understand stenoparib’s unique method of targeting both PARP and the Wnt pathway, ultimately supporting its regulatory approval process.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- November 18, 2024
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc today provided a corporate update highlighting three significant developments: extended treatment duration for patients in its ongoing Phase 2 stenoparib trial, a strengthened cash position supporting initiation of a follow-up FDA registrational trial, and new revenue-generating activities from Allarity's laboratory services.
AI Summary
Allarity Therapeutics, Inc. has announced several important updates in its corporate strategy. In its ongoing Phase 2 trial for advanced ovarian cancer, two patients have experienced a treatment duration of over 14 months. This extended benefit in heavily pretreated patients highlights the potential of stenoparib as an effective treatment option.
The company now holds a cash balance of $18.5 million, which strengthens its financial foundation to begin a follow-up FDA registrational trial. This milestone is critical for advancing stenoparib’s path toward FDA approval. Additionally, Allarity’s Medical Laboratory has expanded its services to generate revenue by offering advanced gene expression and diagnostic testing to external biotech clients. This new business model not only supports the company’s overall mission in oncology but also helps reduce laboratory costs and further promotes its proprietary DRP® platform.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- September 16, 2024
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc announced that two patients enrolled in its Phase 2 clinical trial of stenoparib for advanced, recurrent ovarian cancer have now exceeded one year on therapy.
AI Summary
Allarity Therapeutics announced encouraging news from its Phase 2 clinical trial for advanced, recurrent ovarian cancer. Two heavily pre-treated patients have now exceeded one year on therapy with stenoparib, a novel dual PARP/Tankyrase inhibitor. These patients were selected using Allarity’s Drug Response Predictor (DRP®) companion diagnostic, which identified them as likely to benefit from the treatment. This extended duration of treatment highlights stenoparib’s potential to offer a durable clinical benefit, especially for patients with few remaining treatment options. The sustained response in these patients reinforces the company’s belief in personalized medicine and the value of using specific biomarkers to match patients with promising therapies. Allarity continues to evaluate the safety and efficacy of stenoparib while planning further development as it moves toward regulatory approval.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- June 25, 2024
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc. announced that multiple patients in its Phase 2 clinical trial of stenoparib for advanced recurrent ovarian cancer have been on treatment for more than 30 weeks.
AI Summary
Allarity Therapeutics announced promising news from its Phase 2 clinical trial in advanced recurrent ovarian cancer. Multiple patients treated with stenoparib have now been on therapy for over 30 weeks, demonstrating impressive durability in clinical benefit. This extended treatment period supports earlier findings that showed meaningful tumor shrinkage and long-term disease stability in patients who had already undergone several treatments and had few options remaining.
These results indicate that stenoparib could offer a next-generation alternative with a more favorable safety profile compared to traditional chemotherapies and first-generation PARP inhibitors. The company is now focusing its resources on designing a follow-on trial aimed at advancing stenoparib toward regulatory approval, and it continues refining trial design in collaboration with top experts to further evaluate this promising treatment option.
Read Announcement- Drug:
- Stenoparib
- Announced Date:
- May 2, 2024
- Indication:
- For ovarian cancer (AOC)
Announcement
Allarity Therapeutics, Inc announced the early discontinuation of its Phase 2 clinical trial of stenoparib, a novel PARP inhibitor, for the treatment of advanced recurrent ovarian cancer.
AI Summary
Allarity Therapeutics, Inc. announced the early discontinuation of its Phase 2 clinical trial for stenoparib, a novel PARP inhibitor, aimed at treating advanced recurrent ovarian cancer. The decision comes after the trial showed clear clinical benefits, such as tumor shrinkage and longer-term disease stability, in heavily pre-treated patients who typically have few treatment options. Patients in the study were selected using Allarity’s DRP® companion diagnostic, which identifies those most likely to benefit from the therapy. With these promising early results confirming the proof of concept for stenoparib as a monotherapy, the company has chosen to stop further enrollment in the current trial. This strategic move will allow Allarity to reallocate resources toward designing a follow-on trial with a faster route to FDA regulatory submission, while ongoing patient treatments remain unaffected.
Read Announcement
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