On September 24, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, reported that NXP200 (HSK42360), an oral, brain-penetrant, paradox-breaker BRAF inhibitor, has been granted Breakthrough Therapy Designation (BTD) for the treatment of patients with BRAF V600-mutant, recurrent or progressive high-grade glioma by China’s Center for Drug Evaluation (CDE).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

NXP200 is a paradox-breaking BRAF inhibitor designed to block the BRAF pathway without triggering paradoxical activation that is seen with first-generation BRAF inhibitors. To date, NXP200 has demonstrated single-agent clinical activity, including in heavily pre-treated patients as well as in patients previously treated with BRAF inhibitors, against primary central nervous system (CNS) tumors and other tumor types including non-small cell lung, colorectal and papillary thyroid cancers.

In June 2026, Nuvectis in-licensed exclusive worldwide, ex-Greater China rights to NXP200 from Haisco Pharmaceutical Group.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "We congratulate our partner Haisco for achieving this significant regulatory milestone, which is further testament to its tremendous strategic and operational capabilities. The CDE’s granting of Breakthrough Therapy Designation underscores the compelling clinical activity observed to date with NXP200 in patients with recurrent or progressive BRAF V600-mutant high-grade glioma. In parallel, we continue to advance NXP200 toward a U.S. IND submission in the fourth quarter of 2026."

(Press release, Nuvectis Pharma, SEP 24, 2026, View Source [SID1234671069])

On September 24, 2026 Persevere Therapeutics, Inc., a clinical-stage oncology company developing misetionamide — a first-in-class inhibitor of MYC, historically viewed as undruggable and coined ‘the grand orchestrator of cancer growth’ — reported that the first patient has been enrolled and treated in MIROC-1, the company’s Phase 2a clinical trial evaluating misetionamide as monotherapy in patients with platinum-resistant ovarian cancer (PROC). The first patient was treated at the Abramson Cancer Center of the University of Pennsylvania, one of four leading cancer centers participating in the trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MIROC-1 (Misetionamide in Platinum-Resistant Ovarian Cancer) is an open-label, single-arm Phase 2a trial designed to evaluate the safety and efficacy of misetionamide as monotherapy in patients with platinum-resistant ovarian cancer. The trial will enroll 18 patients across four leading U.S. academic cancer centers. Participating sites include: University of Pennsylvania (Philadelphia, PA) — first patient treated; Rush University Medical Center / MD Anderson Cancer Center (Chicago, IL) — currently screening; Beth Israel Deaconess Medical Center / Harvard Medical School (Boston, MA) and University of Kansas Cancer Center (Kansas City, KS) — both expected to begin screening within the month.

"Treating the first patient in MIROC-1 is a defining moment for Persevere Therapeutics and, more importantly, for the women living with platinum-resistant ovarian cancer who urgently need new treatment options," said Seymour Fein, MD, Chief Medical Officer of Persevere Therapeutics. "Misetionamide’s unique ability to target MYC — a driver of tumor growth and proliferation that has proven impervious to prior therapeutic approaches — gives us genuine hope that we can meaningfully change outcomes for these patients. We are deeply grateful to our clinical partners, and above all, to the patients and families who are placing their trust in this program."

Platinum-resistant ovarian cancer represents one of the most challenging malignancies in oncology. According to the American Cancer Society approximately 21,000 women are diagnosed with ovarian cancer in the United States each year, and the majority will eventually develop platinum-resistance, at which point treatment options are limited and median survival is measured in months. 12,400 women die each year of ovarian cancer.

(Press release, Persevere Therapeutics, SEP 24, 2026, View Source [SID1234671068])

On September 24, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an update on operational progress and announced financial results for the first six months of 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our progress in the first half of 2026 continues to support our belief that a physics-based approach to the design and development of nanotherapeutics has the potential to revolutionize treatment possibilities for millions of patients around the world," said Laurent Levy, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. "The JNJ-1900 (NBTXR3) clinical development program continued to produce encouraging data across multiple indications, and adjustments to the Phase 3 NANORAY-312 protocol streamlined the study toward the final analysis. Longstanding shareholders and new investors alike expressed confidence in our vision through our recent capital raise. We enter the second half strategically, operationally, and financially equipped to continue supporting Nanoradioenhancer JNJ-1900 (NBTXR3) and advancing next wave nanotherapeutic platforms such as Nanoprimer."

Operational Highlights

New data from Phase 1 NSCLC study sponsored by The University of Texas MD Anderson Cancer Center ("UT MD Anderson") presented at 2026 WCLC Meeting:
At a median follow-up of 12 months, the one-year locoregional control rate was 79%. One-year local progression-free survival ("LPFS") was 61%, and one-year overall survival ("OS") was 70% in evaluable patients.
Investigators concluded that JNJ-1900 (NBTXR3) may permit clinically meaningful local control using a substantially lower re-irradiation dose.
All 24 patients completed treatment with JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities
No Grade 3 or higher adverse events related to JNJ-1900 (NBTXR3) or to the injection procedure were reported
The recommended Phase 2 dose was established at 33% of gross tumor volume
Included in the Euronext Tech Leaders segment and Euronext Tech Leaders Index, a Euronext flagship initiative dedicated to increasing the visibility and attractiveness of Europe’s leading and high-growth technology companies among international investors.
Closed a global follow-on offering with underwriters’ over-allotment option fully exercised, bringing total gross proceeds to approximately €86 million that will support continued develop of Nanobiotix’s broader therapeutic platforms
Part 1 data from Johnson & Johnson ("J&J")-led Phase 2 JNJ-1900 (NBTXR3) Study in Unresectable Stage 3 NSCLC (CONVERGE) presented at ELCC 2026 and updated at ESTRO 2026
Initial investigator-reported efficacy responses observed in 7 patients following the full treatment regimen of JNJ-1900 (NBTXR3) given prior to concurrent chemoradiotherapy, and consolidation with durvalumab) showed:
Overall response rate ("ORR") = 85.7% (6/7 patients) reported at ESTRO 2026
In the same cohort of 7 patients, ORR observed at earlier time point and reported at ELCC 2026 was 71.4% (5/7 patients)
Complete response rate ("CRR") = 57.1% (4/7 patients) reported at ESTRO 2026
With the current standard of care, concurrent chemoradiation therapy (cCRT) + durvalumab, depth of response remains limited in Stage 3 unresectable NSCLC with very low rates of complete response (~15%)1
Deepening response over time suggests potential for long-term durability
The procedure demonstrated an acceptable safety profile without serious treatment-emergent adverse events (TEAEs)
Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC
Protocol amendment to J&J-led global Phase 3 JNJ-1900 (NBTXR3) study in Cisplatin-ineligible Head and Neck Cancer (NANORAY-312)
Eliminated previously planned interim analysis eliminated and modified the final analysis to include fewer events than originally planned to be conducted sooner
New preclinical data presented at 2026 AACR (Free AACR Whitepaper) Meeting
Pre-treatment with Nanoprimer followed by administration of LNP-delivered recombinant DNA ("LNP-DNA") designed for anti-tumor immunotherapy showed increased systemic bioavailability, reduced hepatic toxicity, and reduced cGAS-STING related inflammation compared to LNP-DNA administered without the Nanoprimer
Half Year 2026 Financial Results

Revenue and Other Income: Revenue and other income amounted to €5.6 million for the six months ended June 30, 2026, as compared to €26.6 million for the same period in 2025. This variance is mainly due to a significant one-off non-cash revenue positive impact amounting to €21.2 million recorded over the first half of 2025 in accordance with IFRS15 revenue recognition accounting principles, further to the transfer of NANORAY-312 study sponsorship to Johnson & Johnson. In addition, Revenue and Other Income for the six months ended June 30, 2026 also included €3.1 million of clinical product supply sales to Johnson & Johnson (as compared to €3.4 million for the same period in 2025) and research tax credit income amounting to €1.9 million (as compared to €1.6 million for the same period in 2025).

Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses including employee-related payroll costs and shared-based payment charges related to the development of JNJ-1900 (NBTXR3) and of new platforms. These R&D expenses for the six months ending June 30 2026, were €12.7 million as compared to €14.5 million for the same period in 2025. The €1.8 million favorable variance was primarily driven by lower clinical development and JNJ-1900 (NBTXR3) production activities in NANORAY-312 study further to the transfer of sponsorship to Johnson & Johnson, and by less patient recruitment on the studies Study 1100 and lower UT MD Anderson studies expense during first half of 2026 as compared to the same period in 2025.

Selling, General and Administrative ("SG&A") Expenses: SG&A expenses consist primarily of administrative employee-related payroll costs, share-based payment charges, insurance, IP, legal, audit and other professional fees. Total SG&A expenses for the six months ending June 30, 2026, were €10.8 million, as compared to €11.3 million for the same period in 2025. The €0.5 million favorable variance is mainly due to the impact of social charges related to stock-option plan and severance expenses occurred over the first half of 2025.

Net loss: Net loss attributable to common shareholders for the six months ending June 30, 2026, was €34.3 million, or a €0.70 basic loss per share. This compares to a net loss attributable to common shareholders of €5.4 million, or €0.11 basic loss per share, for the same period in 2025.

Cash and Cash Equivalents: Cash and Cash Equivalents as of June 30, 2026 were €110.9 million, compared to €52.8 million as of December 31, 2025.

Financial Guidance: Based on the current operating plan and financial projections, the Company anticipates that the cash and cash equivalents of €110.9 million as of June 30, 2026 will fund its operations into 2029.

Availability of the Half Year 2026 Financial Reports

The 2026 half-year financial report has been filed with the French financial market authority (Autorité des marchés financiers) and with the U.S. Securities and Exchange Commission on September 24, 2026. It is available to the public on the Company’s website, www.nanobiotix.com.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when in the presence of radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma study sponsored by Nanobiotix in 2018.

JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations.

In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies being led by Johnson & Johnson include NANORAY-312 (NCT04892173), a global, randomized Phase 3 study in platinum-based chemotherapy-ineligible, locally advanced head and neck squamous cell cancers; LUMIRAY (NCT07219212), a global, phase 1b, open-label study in locally advanced head and neck squamous cell cancers; and CONVERGE (NCT06667908), a phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III non-small cell lung cancer (NSCLC).

(Press release, Nanobiotix, SEP 24, 2026, View Source [SID1234671067])

On September 24, 2026 ADARx Pharmaceuticals, Inc. (ADARx), a late-stage clinical biotechnology company developing next-generation siRNA therapeutics, reported the pricing of its upsized initial public offering of 26,250,000 shares of common stock at a price to the public of $17.00 per share. All of the shares of common stock are being offered by ADARx. The gross proceeds to ADARx from the offering, before deducting underwriting discounts and commissions and offering expenses payable by ADARx, are expected to be approximately $446.3 million. In addition, the underwriters have a 30-day option to purchase up to an additional 3,937,500 shares of common stock at the public offering price, less underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The shares are expected to begin trading on The Nasdaq Global Select Market on September 25, 2026, under the ticker symbol "ADRX." The offering is expected to close on September 28, 2026, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Morgan Stanley, TD Cowen and UBS Investment Bank are acting as lead book-running managers for the offering. LifeSci Capital is acting as a book-running manager for the offering.

Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on September 24, 2026. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a prospectus forming part of the registration statements relating to these securities. When available, copies of the final prospectus relating to the initial public offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected] and [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at 1-866-718-1649, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or UBS Securities LLC, Attention: Equity Syndicate, 11 Madison Avenue, New York, NY 10010 or by email at [email protected].

In addition, AbbVie has agreed to purchase, in a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the Securities Act), a number of shares of ADARx’s common stock that would result in AbbVie owning approximately 4.9% of ADARx’s outstanding shares of common stock following the closing of the initial public offering and the concurrent private placement, at a price of $17.00 per share; provided, however, that in no event would AbbVie purchase more than $100.0 million in shares of common stock. The aggregate gross proceeds to ADARx from the initial public offering and the concurrent private placement, before deducting underwriting discounts and commissions, placement agent fees and other offering and private placement expenses payable by ADARx, are expected to be approximately $535.2 million, excluding any exercise of the underwriters’ option to purchase additional shares of common stock. The concurrent private placement is also scheduled to close on September 28, 2026, subject to the satisfaction of customary closing conditions. The closing of the concurrent private placement is contingent and conditioned upon consummation of the initial public offering. However, the closing of the initial public offering is not contingent on the consummation of the concurrent private placement.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act.

(Press release, ADARx Pharmaceuticals, SEP 24, 2026, View Source [SID1234671066])

On September 24, 2026 Kovina Therapeutics Inc., a biotechnology company developing first-in-class small molecule therapeutics targeting the Human Papillomavirus (HPV) E6 oncoprotein, reported a $2.3 million Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI). The two-year award will support IND-enabling development of Kovina’s lead oral small molecule program for HPV-driven cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The award follows Kovina’s recent publication in the Proceedings of the National Academy of Sciences (PNAS) validating direct pharmacologic targeting of HPV E6. The research demonstrated restoration of p53 tumor suppressor activity, selective killing of HPV-positive cancer cells and tumor growth inhibition in HPV-positive preclinical models.

"This award comes at an important point for Kovina as we move from compelling preclinical science into formal development," said Kristin Sherman, Chief Executive Officer of Kovina Therapeutics. "Together with our recent PNAS publication, the NCI support gives us significant momentum as we advance our lead program through IND-enabling development and toward the clinic."

HPV E6 is a viral oncoprotein that degrades the tumor suppressor p53 and is required for the survival of HPV-positive cancer cells. Kovina’s small molecules are designed to inhibit E6 and restore p53 function, offering a targeted approach to the underlying mechanism of these cancers.

The NCI award will support key development activities, including CMC, IND-enabling pharmacology and toxicology, and other studies required to support an Investigational New Drug application.

"HPV E6 has long been recognized as a compelling cancer target but directly inhibiting it with a small molecule has been challenging," said Elliot Androphy, M.D., Founder and Chief Scientific Officer of Kovina Therapeutics. "Our work demonstrates that E6 can be specifically targeted, restoring p53 and selectively killing HPV-positive cancer cells. This gives us a strong foundation for translating the biology into a new therapeutic approach."

Despite preventive vaccines, HPV causes an estimated 39,300 cancers each year in the United States, according to the Centers for Disease Control and Prevention, including cervical and head and neck cancers. By directly targeting HPV E6, Kovina’s approach has the potential to treat a spectrum of HPV-associated disease, from premalignant disease to invasive cancers.

(Press release, Kovina Therapeutics, SEP 24, 2026, View Source [SID1234671063])