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 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])

On December 3, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused clinical-stage biopharmaceutical company, reported a comprehensive update on its therapeutic pipeline. The Company detailed meaningful progress across HT-001, HT-KIT, HT-ALZ, and its newly launched GDNF-based metabolic program, while continuing to strengthen its global intellectual-property portfolio and expand strategic research partnerships.

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Pipeline Highlights

HT-001 (Topical Epidermal Growth Factor Inhibitor) – Phase 2 CLEER-001 Trial Advancing

Hoth continues to advance HT-001 in its Phase 2 CLEER-001 clinical trial targeting EGFR-inhibitor–associated rash, a significant unmet need in oncology supportive care.

Recent progress includes:

Strong safety profile to date with no dose-limiting toxicities observed.
Consistent improvement trends in rash severity and pruritus
Increased clinical-site engagement and favorable investigator feedback.
A further clinical update is anticipated in the coming months as enrollment continues to progress.

HT-KIT (Orphan Drug Designation for Mast Cell Diseases) – IND Preparation Underway

HT-KIT, Hoth’s targeted KIT-inhibitor program for mastocytosis and related mast-cell–driven diseases, continues to progress through IND-enabling activities.

Key accomplishments:

FDA Orphan Drug Designation already granted.
Compelling preclinical efficacy showing potent KIT inhibition and suppressed mast-cell activation.
IND-enabling toxicology studies moving toward completion.
Ongoing manufacturing scale-up and analytical characterization
Hoth expects to finalize its’ IND submission in 2026, followed by first-in-human studies.

HT-ALZ (Therapeutic for Alzheimer’s Disease) – Advancing Through GLP and PK Development.

HT-ALZ continues to deliver supportive data across absorption, distribution, and neuroinflammatory pathways.

Recent highlights:

GLP studies underway with positive PK, biodistribution, and CNS-penetration modeling
Regulatory-facing package expected to mature in 2026.
GDNF-Based Weight-Loss & Metabolic Program (VA Collaboration) – Newly Accelerated Initiative

Hoth’s newest program leverages GDNF (Glial-Derived Neurotrophic Factor) to target obesity, hepatic steatosis, and metabolic dysfunction, representing one of the largest and fastest-growing therapeutic markets globally.

Recent achievements:

Study preparations initiated with the Atlanta VA Medical Center
Mouse procurement completed; high-fat-diet regimen launches per approved VA protocols.
Aim 1 of the research program now underway, with early data expected in 2026.
Program supported by strong academic collaboration and growing IP protection.
Expanding Intellectual Property & Strategic Collaborations

Hoth continues to broaden its IP position through new filings and expanded protection around:

HT-001 dermatology and oncology-supportive-care mechanisms
HT-KIT mast-cell-disease formulations, methods, and manufacturing
HT-ALZ CNS-focused data and delivery systems
GDNF weight-loss and hepatic-function applications
The Company maintains collaborations with leading institutions, including the Atlanta VA Medical Center, academic neuroscience groups, and AI-assisted discovery platforms.

Upcoming Milestones

CLEER-001 Phase 2 HT-001 clinical data update
Completion of toxicology and IND filing for HT-KIT
GLP, BBB, and PK updates for HT-ALZ
VA metabolic program early findings
Management Commentary

Robb Knie, Chief Executive Officer of Hoth Therapeutics, commented:

"Our therapeutic pipeline has never been more focused or better positioned. With HT-001 advancing in the clinic, HT-KIT nearing IND submission, HT-ALZ progressing through GLP development, and our new GDNF program targeting one of the largest markets in medicine."

(Press release, Hoth Therapeutics, DEC 3, 2025, View Source [SID1234661114])

On December 3, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors. CRN09682 is the lead candidate from Crinetics’ proprietary nonpeptide drug conjugate (NDC) platform, which leverages the company’s expertise in GPCR drug discovery and small molecule design to develop a pipeline of modular targeted therapies for endocrine and endocrine-related tumors.

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"We developed CRN09682 to address the need for a more efficacious, safer, and convenient targeted therapy for patients with SST2-expressing tumors," said Stephen Betz, Ph.D., Chief Scientific Officer and Co-Founder of Crinetics. "Dosing the first patient in the Phase 1/2 study marks a major milestone for CRN09682 and our NDC platform as a whole. CRN09682 is the first clinical exploration of this new modality, which we believe has the potential to unlock a new generation of receptor-targeted therapies to treat tumors with precision."

CRN09682 was designed to bind selectively and with high potency to SST2-expressing tumor cells, promoting rapid receptor internalization and linker cleavage to release a potent cytotoxic payload directly within the tumor. This targeted approach is intended to concentrate treatment at the tumor site, by optimizing tumor penetration and limiting systemic exposure and related toxicities. NDCs are manufactured by traditional chemical synthesis methods, eliminating manufacturing constraints and specialized handling required by most antibody drug conjugates and radiopharmaceuticals.

The Phase 1/2 BRAVESST2 trial is a first-in-human, open-label, dose-escalation study with a dose expansion phase designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CRN09682. The Phase 1 portion will enroll patients in escalating dose cohorts to determine the maximum tolerated dose and recommended dose for the expansion phase. Phase 2 will further evaluate and characterize CRN09682 in selected SST2-expressing tumor types. Up to 150 participants are expected to be enrolled across both phases. Eligible patients must have metastatic or locally advanced disease progression following standard therapies and SST2-expressing tumors confirmed by somatostatin receptor imaging.

For more information about the BRAVESST2 trial, visit https://bit.ly/4hMl8qc

ABOUT CRN09682

CRN09682 is an investigational, first-in-class, non-radioactive, nonpeptide drug conjugate (NDC) linking a somatostatin receptor 2 (SST2) agonist with the cytotoxic drug monomethyl auristatin E (MMAE) via a spacer and a cleavable linker for the treatment of neuroendocrine tumors and other solid tumors that express SST2. The ligand on the CRN09682 binds to SST2 on the tumor cell surface and is internalized into the cell whereby enzymes cleave the MMAE and release it within the cell. MMAE is known to cause microtubule disruption leading to cell arrest and death. The NDC approach is intended to enhance tumor penetration and intracellularly release a potent anti-tumor agent, while minimizing systemic exposure and associated toxicities. Additionally, NDCs are manufactured by traditional chemical synthesis methods, avoiding the limitations of fermentation, bioconjugation, and heterogeneous manufacturing methods required by most antibody drug conjugates. NETs are generally incurable when metastatic, regardless of tumor grade. Overall survival rates vary significantly by stage, grade, age at diagnosis, primary site, and time period of diagnosis.

(Press release, Crinetics Pharmaceuticals, DEC 3, 2025, View Source [SID1234661097])

On December 3, 2025 ImpriMed, a precision oncology CRO specializing in ex vivo drug sensitivity testing for hematologic malignancies, reported that it has been selected to present two significant research studies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida, taking place December 6-10.

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"Being featured at ASH (Free ASH Whitepaper) is an important validation of our xCellSense platform for both pharma partners and clinicians," said Sungwon Lim, Chief Executive Officer of ImpriMed. "Our data demonstrates that ex vivo functional testing, combined with genomic profiling, can effectively predict which acute myeloid leukemia (AML) patients will respond to specific therapies. This powerful combination equips drug developers and physicians with the critical evidence needed to select the most effective treatments, design innovative clinical trials, and ultimately improve patient outcomes."

ImpriMed will present data from a prospective study integrating NGS-based genomic profiling with ex vivo drug sensitivity testing across a panel of 21 drugs in AML patients treated with standard-of-care regimens. The data demonstrate that ex vivo drug-sensitivity testing successfully stratified survival risk in AML patients and identified clinically meaningful genotype-drug associations. These results validate the platform’s utility for drug development applications, including lead candidate selection, patient enrichment strategies, and the development of companion diagnostics.

Additionally, the company will share findings on a quantitative ex vivo drug synergy analysis methodology using primary samples from AML patients. This innovative system enables pharmaceutical companies to identify synergistic drug combinations and accurately identify the patient subgroups most likely to benefit from combination therapy.

Oral Presentation Details:

Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology
Date/Time: December 8, 2025, 3:15 PM – 3:30 PM
Publication Number: 939
Title: "Ex vivo drug sensitivity testing in Korean AML patients: Integration of functional and genomic profiles for predicting clinical response and survival"
Poster Presentation Details:

Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology: Poster III
Date/Time: December 8, 2025, 6:00 PM – 8:00 PM
Publication Number: 6137
Title: "Quantitative ex vivo synergy profiling uncovers heterogeneous combination responses in AML primary samples"

(Press release, ImpriMed, DEC 3, 2025, View Source [SID1234661115])