On December 3, 2025 TransThera Sciences Nanjing, Inc. (the "TransThera") reported that Tinengotinib tablets have been included in the List of Products for Priority Review by the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA") of the PRC, with the proposed indication for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib has been granted Breakthrough Therapy Designation by the NMPA for the treatment of CCA.

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Disclaimer: This article serves as a press release by TransThera to disclose the company’s latest developments. It is not intended as a product promotion advertisement and does not constitute the company’s investment advice.

About Tinengotinib

Tinengotinib is an internally discovered, registrational clinical stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs/VEGFRs, Aurora kinases and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by the NMPA in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the EMA.

(Press release, TransThera Biosciences, DEC 3, 2025, View Source [SID1234661112])

On December 3, 2025 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, reported that the previously disclosed 6-month follow-up data from the ongoing Phase 2 study of NDV-01, a sustained release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for non-muscle invasive bladder cancer (NMIBC) will be presented in a poster at the Society of Urologic Oncology 26th Annual Meeting (SUO 2025). The poster (#143) will be presented by Yair Lotan, MD, Chairman of Relmada’s Clinical Advisory Board, on Thursday, December 4th at 2:30 PM MT in Phoenix, AZ.

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Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics, noted, "We believe NDV-01 has the opportunity to transform the treatment of NMIBC by providing patients and physicians with a potential bladder-sparing, in-office, ready-to-use, safe, effective and durable, best-in-class therapy. We are on track to initiate the Phase 3 program in H1 2026, building on the encouraging, recently announced 9-month data, showing a 92% complete response (CR) rate at any time point, and encouraging recent FDA discussions, which provide us with a well-defined registrational strategy in two distinct indications in NMIBC with limited treatment options."

The Society of Urologic Oncology 26th Annual Meeting Information:

Title: Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained-Release Gemcitabine Docetaxel combination (NDV-01) in High-Risk NMIBC: Update with 6-month Complete Response Data
Poster Number: #143
Date and Time: Thursday, December 4th at 2:30 PM MT

A copy of the poster will be available on the Events section of the Relmada website after the session. To review the an overview of the 9-month data and FDA discussions, click here.

About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is a ready to use, convenient to administer in-office in less than 10 minutes, and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About the Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, follow by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50–80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

(Press release, Relmada Therapeutics, DEC 3, 2025, View Source [SID1234661917])

On December 3, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") reported that 184,071,410 shares of CureVac N.V. (Nasdaq: CVAC, "CureVac"), representing approximately 81.74% of CureVac’s issued and outstanding shares, were validly tendered and not properly withdrawn prior to the expiration of the initial offering period at 9:00 a.m. Eastern Time on December 3, 2025. As a result, the minimum condition for the exchange offer (the "Offer") has been satisfied, and all validly tendered shares have been accepted. All closing conditions related to the completion of the post-offer reorganization have now been satisfied. BioNTech will now proceed to deliver BioNTech American Depositary Shares ("ADSs") (and/or cash in lieu of fractional BioNTech ADSs) to the holders of CureVac shares who have tendered their shares, to close the transaction, as set out in more detail in the offer documents (as referred to below).

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BioNTech also announced that the subsequent offering period has commenced. CureVac shareholders who have not yet tendered their shares may still tender during the subsequent offering period, which will expire at 12:01 a.m. Eastern Time on Thursday, December 18, 2025. No guaranteed delivery procedures apply.

The parties will initiate the post-offer reorganization as promptly as practicable following the expiration of the subsequent offering period. The post-offer reorganization will result in non-tendering holders of CureVac shares receiving BioNTech ADSs (and/or cash in lieu of fractional BioNTech ADSs) pursuant to the post-offer reorganization (rather than the Offer). Non-tendering holders of CureVac shares who receive BioNTech ADSs (and/or cash in lieu of fractional BioNTech ADSs) pursuant to the post-offer reorganization generally will be subject to a 15% Dutch dividend withholding tax.

Promptly after the completion of the post-offer reorganization, shares held by non-tendering CureVac shareholders will cease to be tradable on any national stock exchange and may be subject to additional transfer restrictions.

Please refer to the Exchange Offer Prospectus, the EU Prospectus, or the UK exemption document (each as referred below) for more information and a full description of the summaries above.

(Press release, BioNTech, DEC 3, 2025, View Source [SID1234661095])

On December 3, 2025 ImmVira Group ("ImmVira" or the "Company") reported a poster presentation at the 26th Annual Meeting of the Society of Urologic Oncology (SUO 2025). The presentation featured the latest interim clinical data (as of September 19, 2025) for its lead HSV-1 oncolytic virus product. MVR-T3011, in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients.

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The patients were enrolled and treated with intravesical MVR-T3011 at two dose levels: 2×109 PFU and 1×1010 PFU in this study. There were a total of 26 patients with papillary (16 patients at the dosage level of 2×109 PFU, 10 patients at the dosage level of 1×1010 PFU), and a total of 12 patients with carcinoma in situ (CIS) (7 patients at the dosage level of 2×109 PFU, 5 patients at the dosage level of 1×1010 PFU) enrolled in this trial. Data from the patients demonstrated a promising efficacy profile:

Among 16 evaluable patients with BCG-unresponsive papillary who received MVR-T3011 at a dose of 2×109 PFU, the 3-month, 6-month, 9-month and 12-month recurrence-free survival (RFS) rates were 87.1%, 80.4%, 80.4% and 71.4%, respectively. Among 6 evaluable patients who received MVR-T3011 at a dose of 1×1010 PFU, 100% of patients remained recurrence free at Month 3 and Month 6.
As of the same date, among 7 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 2×109 PFU, the CR at any time, 3-month and 6-month CRR was 71.4%, and among 5 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 1×1010 PFU, the CR at any time, 3-month and 6-month CRR was 100%.
Consistent with previous clinical findings, MVR-T3011 continued to demonstrate a favorable safety and tolerability profile in the latest study. Most treatment-emergent adverse events (TEAEs) were at Grades 1 or 2. Only five Grade 3 TEAEs were reported, two of which were treatment-related adverse events (TRAEs) and were consistent with reactions commonly associated with catheterization procedures. No Grade 3 or above TEAEs and no dose-limiting toxicities (DLT) occurred.

According to Frost & Sullivan, bladder cancer is one of the top 10 most common solid tumors globally by incidence and often requires prolonged treatment and surveillance spanning 5-10 years. NMIBC is a main type of bladder cancer, representing approximately 75% of all newly diagnosed bladder cancer cases. The current standard of care for high-risk NMIBC is Bacillus Calmette-Guerin (BCG). However, the availability of BCG is significantly limited by global supply shortages. In the U.S., BCG supply meets less than 30% of the total demand. These significant unmet medical needs highlight a clear opportunity for novel immunotherapies such as oncolytic viruses, which hold considerable potential as a new mechanism of action in this underserved market.

"We are highly encouraged by the interim efficacy data from the study, especially the high CR and RFS rate for both BCG-unresponsive CIS and papillary patients at 1×1010 PFU," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "We have initiated a phase II trial for BCG-unresponsive high-risk NMIBC in the U.S. in June 2025 and are progressing a global multi-regional clinical trial (MRCT) inclusive of China. We believe MVR-T3011 could emerge as the new generation of therapy for patients with high-risk, BCG-unresponsive NMIBC."

About MVR-T3011

MVR-T3011, represents a breakthrough in HSV-1-based oncolytic immunotherapy. Its proprietary "3-in-1" design unites a replication-competent, tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibody and IL-12, enabling it simultaneously to lyse tumor cells and stimulate innate and adaptive immunity. MVR-T3011 has demonstrated its adaptability and feasibility across multiple routes of administration including intratumoral, intracavitary and intravenous administrations. MVR-T3011 is the world’s first HSV-1-based oncolytic immunotherapy that has completed a phase I trial via systemic intravenous dosing under the FDA regulatory regime.

(Press release, Immvira, DEC 3, 2025, View Source [SID1234661113])

On December 3, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported topline data from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor receptor (EGFR) mutations (NCMs) and outlined plans for a randomized Phase 2 trial of silevertinib in patients with newly diagnosed glioblastoma (ND GBM).

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"We are pleased to share these initial data in frontline NSCLC patients showing silevertinib’s activity against a broad spectrum of 35 distinct non-classical EGFR mutations," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are particularly encouraged by the CNS activity of silevertinib in treating NSCLC patients with brain metastases, as published data clearly demonstrate that CNS metastases are a key factor in early disease progression for NCM NSCLC patients treated with second- and third-generation EGFR-TKIs. We also believe that silevertinib is uniquely positioned as a potential treatment for patients with newly diagnosed EGFR-altered GBM, and plan to initiate a randomized Phase 2 trial in the first half of 2026, while PFS data matures in our Phase 2 NSCLC study and we continue our partnering discussions."

Silevertinib Phase 2 1L NSCLC Initial Clinical Results and Program Update

43 frontline NSCLC patients harboring a broad spectrum of 35 distinct non-classical EGFR mutations were enrolled, including 16 patients with brain metastases (7 of whom had measurable CNS target lesions). All patients were enrolled at a 200mg oral daily dose of silevertinib. Efficacy and safety were assessed with a November 3, 2025 data cutoff; median follow-up time as of this date was 7.2 months and the study remains ongoing.

Key data highlights include:

For the 43 patients enrolled, preliminary efficacy data is as follows:

25 confirmed partial responses, 1 confirmed complete response
60% Objective Response Rate (ORR by RECIST 1.1)
86% CNS ORR (by RANO-BM)
91% disease control rate (DCR)

Initial duration of treatment data:

29 patients remain on therapy (5/29 after progression), longest ongoing for >19 months

Summary of safety data:

No new safety signals observed
Adverse events (AEs) experienced by a majority of patients include rash, stomatitis, diarrhea and paronychia
AEs were managed with standard supportive care and dose interruptions/reductions without compromising response depth or durability to date

The Company expects to present updated results from the Phase 2 NSCLC trial, including Duration of Response (DOR) and Progression-free Survival (PFS) data in both the recurrent (83 patients) and frontline (43 patients) settings, at a medical meeting in the second quarter of 2026. Black Diamond continues to explore potential partnerships to advance silevertinib into pivotal development.

"These highly encouraging data speak to the potential of silevertinib to be the treatment of choice for frontline NSCLC patients with the full spectrum of non-classical EGFR mutations" said Sergey Yurasov, M.D., Ph.D., Black Diamond’s Chief Medical Officer. "We are struck by the compelling CNS response rate, which may translate to prolonged durability of response for patients with CNS metastases. Based on these data, and promising Phase 0/1 and Phase 1 GBM results, we are preparing to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients, one of the highest unmet needs in oncology."

GBM Program Update and Phase 2 Plans
Approximately 50% of patients with glioblastoma (GBM) present with an oncogenic EGFR alteration that can be targeted by silevertinib; each year approximately 7,000 patients in the U.S. are diagnosed with GBM harboring these EGFR alterations.

"Prior attempts to treat EGFR-altered GBM patients have been limited by poor brain penetrance of targeted therapies and/or lack of potency of these therapies on the full spectrum of EGFR alterations" said Elizabeth Buck, Ph.D., Chief Scientific Officer of Black Diamond. "Based on encouraging CNS activity demonstrated by silevertinib across multiple trials, and its preclinical potency on all EGFR alterations found in GBM, we believe that silevertinib has the potential to be the first targeted therapy for these patients."

Black Diamond plans to initiate a randomized Phase 2 trial in newly diagnosed GBM patients in the first half of 2026, with preliminary data expected in 2028.

Key trial highlights include:

Expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ (control arm) or silevertinib + TMZ (experimental arm)
Initial focus will be on EGFRvIII-positive patients (approximately 30% of GBM) who are MGMT-negative (unmethylated)
Randomization and treatment will begin after patients have had their surgical resection and radiation
Primary endpoint is PFS (RANO by Blinded Independent Committee Review), with an interim analysis; secondary endpoint is overall survival (OS)
Trial will be governed by an Independent Data Monitoring Committee (IDMC)

Updated Financial Guidance

Black Diamond previously reported cash, cash equivalents and investments of approximately $135.5 million as of September 30, 2025, which the Company now believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.
Financial guidance assumes Black Diamond funds the Phase 2 trial of silevertinib in ND GBM and a potential partner funds pivotal development in NSCLC. Financial guidance does not assume receipt of potential development milestones from the Company’s partnership with Servier Pharmaceuticals LLC for BDTX-4933 (now S241656).

Conference Call Information

Black Diamond will host a conference call and webcast on Wednesday, December 3, 2025, at 8:00 AM ET to discuss the preliminary Phase 2 data for silevertinib in 1L NSCLC and plans for a Phase 2 trial of silevertinib in GBM. The webcast may be accessed online here or by visiting the Events page in the Investors section of the Company’s website at www.blackdiamondtherapeutics.com.

A replay of the webcast will be available for 30 days on the Investors section of Black Diamond’s website.

(Press release, Black Diamond Therapeutics, DEC 3, 2025, View Source [SID1234661096])