On June 27, 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 a strategic portfolio expansion via a license agreement for exclusive ex-China rights with Haisco Pharmaceutical Group ("Haisco") to two potentially best in-class clinical-stage compounds. Nuvectis will hold a conference call today at 8:30 AM ET to introduce its newly in-licensed products.

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Haisco (SHE ticker code: 002653) is a leading fully-integrated pharmaceutical company with approximately 50 marketed products and 70 research programs, most recently recognized for successfully executing licensing deals with Eli Lilly and AbbVie (both in 2Q2026), and the phase 3 success of envudeucitinib in plaque psoriasis (1Q2026), a compound which Haisco discovered and advanced through development until it was licensed to Alumis, Inc.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "The in-licensing of the two clinical stage drug candidates with best-in-class potential represents an expansion of Nuvectis’ pipeline and strategy." Mr. Bentsur continued, "NXP100 is a late-stage Factor B inhibitor with the potential to become an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as a once-daily oral treatment option for these diseases requiring life-long treatment. With regards to NXP200, the paradox-breaker BRAF inhibitor, the ability to overcome the limitations of older generation BRAF inhibitors, a validated pharmaceutical class, is an area of great interest and we are very pleased to add NXP200 to our oncology pipeline, in which NXP900, our incumbent drug candidate, is progressing toward important clinical inflection points from the ongoing Phase 1b starting in this summer." Mr. Bentsur concluded, "With tremendous in-house drug development capabilities and two recently completed licensing deals with Eli Lilly and AbbVie, Haisco is recognized as a premier drug development company with global reach. We are thankful for this opportunity and are privileged to partner with Haisco as we look forward to our collaboration and advancing these development programs."

Dr. Pangke Yan, Chief Executive Officer of Haisco, commented, "This licensing deal, in addition to our recently completed deals, further strengthens Haisco’s global research and development presence and we are excited to collaborate with Nuvectis on these two projects. We believe that Nuvectis has the relevant experience and capabilities required to advance these projects and that together we can accelerate and offer high-quality treatment options to patients worldwide."

Clinical / Regulatory Status in China and Key Data Summaries for NXP100 and NXP200

NXP100 (HSK39297)

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Two MAAs for NXP100 have been submitted to the Chinese National Medical Products Administration (NMPA) and are currently under review:

The first MAA is based on positive data from a completed randomized, open-label, active comparator-controlled, Phase 3 study (clinicaltrials.gov NCT06799546). In this study, 73 adult Chinese treatment naïve PNH patients were randomized 1:1 to receive either NXP100 or Soliris (eculizumab), a Complement C5 inhibitor, for a 24-week treatment period. The primary efficacy endpoint was to evaluate the proportion of patients achieving hemoglobin (Hgb) levels ≥ 12 g/dL on at least three out of four measurements between Week 18 and Week 24 in the absence of red blood cell (RBC) transfusions. Treatment with NXP100 was superior to treatment with eculizumab in the primary and all key secondary endpoints (overall increase in Hgb levels, reducing the requirement for RBC transfusions, and avoiding extravascular hemolysis).

Parameter NXP100
(n=37) Eculizumab
(N=36)
Primary Endpoint
Proportion of participants achieving Hgb levels ≥12 g/dL without RBC transfusion
% (95% CI) 59.5 (43.2, 75.7) 8.3 (2.8, 19.4)
p-Value < 0.001
The second MAA is based on positive data from a completed single-arm, Phase 3 study (clinicaltrials.gov NCT07052838). In this study, 36 adult Chinese patients with PNH and persistent anemia who failed treatment with C5 inhibitors were treated with NXP100 for a 24-week treatment period. The primary efficacy endpoint was to evaluate the proportion of patients achieving Hgb levels ≥ 12 g/dL on at least three out of four measurements between Week 18 and Week 24 in the absence of RBC transfusions from Week 2, with efficacy prospectively defined as having the lower bound of the 95% CI for the response rate exceeding 20%. The study met the primary and all key secondary endpoints (overall increase in Hgb levels, reducing the requirement for RBC transfusions, and avoiding extravascular hemolysis).

Parameter NXP100
(n=36)
Primary Endpoint
Proportion of participants achieving Hgb levels ≥12 g/dL without RBC transfusion % (95% CI) 52.8 (35.5, 69.6)
Immunoglobulin A Nephropathy (IgAN)

In China, a Phase 3 clinical trial (NCT07390123) is ongoing in IgAN following positive data from a randomized, placebo-controlled Phase 2 (NCT06670352). In the Phase 2 study, the efficacy of treatment with NXP100 was investigated in a 24-week treatment period versus placebo with efficacy defined as reduction in the ratio of 24-hour urine protein to creatinine (24h-UPCR) compared to baseline after 12 weeks of treatment. Treatment with NXP100 resulted in clinically meaningful reduction in 24h-UPCR after 4 weeks, and the magnitude of the treatment effect increased over time. NXP100 also demonstrated excellent estimated Glomerular Filtration Rate (eGFR) control (a secondary endpoint) vs placebo in the study.

Parameter Week 4 Week 12
(Primary Endpoint) Week 24
Reduction in 24h-UPCR relative to baseline vs. placebo

NXP100 N=24
Placebo N=21 -33% -45.3% -57.7%
In addition, a Phase 2 of NXP100 for the treatment of LN is also ongoing in China.

NXP100 Competitive Landscape and Market Analysis

The PNH market size is expected to be >$5.0BN in 2026 with the injectable C5 inhibitor drugs Soliris and Ultomiris, marketed by Alexion/AstraZeneca Rare Disease, projected to be approximately $4.5BN of the total market. The PNH market is expected to more than double to >$10BN within 8 years. Soliris and Ultomiris were the centerpiece of Astra Zeneca’s acquisition of Alexion in 2021 for $39BN.
Fabhalta (iptacopan, launched in 2024), marketed by Novartis, is the only FDA approved Complement Factor B inhibitor with approvals in PNH, IgAN and C3G.
Fabhaltais administered orally, twice per day, vs NXP100 which is administered once a day.
Fabhalta is currently also being investigated in several clinical trials, including LN, Myasthenia Gravis (MG) and dry Age-related Macular Degeneration (dAMD).
Fabhalta peak annual revenue in the currently approved indications is projected by analysts to reach $5B to $10B. The PNH and IgAN markets are estimated to reach >$20BN combined within the next 10 years.
In randomized Phase 3 clinical trials in patients with PNH, treatment with either NXP100 or Fabhalta was superior to treatment with C5 inhibitors, with comparable treatment effect for NXP100 and Fabhalta across studies, positioning CFBis to potentially dominate the PNH market over time.
In IgAN, the Phase 2 data suggests that NXP100 has the potential to be comparable to the best injectable APRIL/BAFF inhibitors on the key renal function endpoints, including 24-hour UPCR and eGFR control.
In cross study comparisons, the observed safety profile of NXP100 appears to be similar to that of Fabhalta.
NXP200 (HSK42360)

Overview, Competitive Landscape and Market Analysis

BRAF is a validated therapeutic target in oncology with first generation drugs such as Tafinlar (dabrafenib, marketed by Novartis) and Braftovi (encorafenib, marketed by Pfizer) approved in multiple indications. These first-generation BRAF inhibitors effectively inhibit the V600-mutated BRAF, which results in initial antitumor activity, but also leads to paradoxical activation through stimulation of the MAPK signaling pathway, causing treatment resistance and development of secondary malignancies, primarily skin squamous cancer and other skin-related side effects. The current solution to the paradoxical activation problem is concomitant administration of MEK inhibitors, but while the skin side effects are reduced, they are not eliminated and acquired resistance still emerges. In addition, Class II and III BRAF mutations are not inhibited by first generation BRAF inhibitors. Designed to overcome this paradoxical activation, paradox-breaking BRAF inhibitors represent the next generation approach to targeting BRAF. There are currently several paradox breakers BRAF inhibitors in clinical development, none are FDA approved.

Available data to date suggests that NXP200 is the only paradox-breaker BRAF inhibitor that has consistently demonstrated single agent activity in CNS tumors but, importantly, also in additional solid tumor types that harbor BRAF mutations. In a completed dose escalation study of NXP200 as monotherapy in heavily pre-treated patients with BRAF V600-mutated solid tumors, including ones previously treated with BRAF/MEK inhibitors, NXP200 demonstrated an acceptable safety profile and single-agent durable clinical activity in various tumor types, including a >40% response rate in low- and high-grade adult glioma, including one Complete Response. Durable responses were also demonstrated in non-small cell lung cancer (NSCLC), colorectal and papillary thyroid cancers.

In this dose escalation program, treatment with a first-generation, free base form of NXP200 was used. A second-generation salt form of NXP200 was recently developed to enhance the pharmacokinetic (PK) profile of NXP200, and early data indeed demonstrate a marked improved PK and greater single agent clinical activity. Thus, with favorable pharmacology, promising early clinical data and possible applicability across V600, Class I and Class II-altered solid tumors, NXP200 could emerge as a best-in-class next-generation BRAF inhibitor. NXP200 is currently in a Phase 1b study in China.

The combined annual revenue for the first-generation BRAF inhibitors, typically administered in combination with a MEK inhibitor to overcome paradoxical activation, is estimated at approximately $4BN.

Of note, in April 2026, Servier acquired Day One Biopharmaceuticals for $2.5BN with its only FDA approved drug, Ojemda (tovorafenib), a first generation BRAF inhibitor which is indicated for the treatment of relapsed or refractory pediatric in BRAF-altered low-grade glioma. With projected 2026 sales of $225-250M, sales of Ojemda represent only 6% of the current BRAF market.

Intellectual Property

Both compounds have strong intellectual property protection including composition of matter patents for NXP100 and NXP200 which expire in 2043 and 2042, respectively.

Transaction Terms

Nuvectis in-licensed exclusive worldwide Ex-China rights for two drug candidates from Haisco. Haisco also retains rights for NXP100 in India and certain Southeast Asia territories. Haisco will receive upfront and near-term payments totaling up to USD $40 million and is eligible to receive up to USD $1.421BN in additional development, regulatory, and commercial milestone payments, as well as tiered royalties on future net sales. The agreement is subject to certain financing conditions which Nuvectis is required to meet to ensure sufficient capital for the development of the licensed products.

Conference Call and Webcast Information

Date: Monday, June 22, 2026, at 8:30 AM ET
Participant Dial-in (U.S.): 1-877-407-0752
Participant Dial-in (International): 1-201-389-0912
Webcast Access: Click Here
A replay of the webcast will be available on the Investors section of the Nuvectis website at: View Source

Third-party products mentioned herein are the trademarks of their respective owners.

(Press release, Nuvectis Pharma, JUN 22, 2026, View Source [SID1234668902])

On June 22, 2026 Hexagon Bio, a biopharmaceutical company pioneering the discovery of novel small molecule payloads for antibody-drug conjugates (ADCs), reported the formation of a clinical advisory board (CAB) consisting of leading experts in the treatment and investigation of new therapies for breast cancer.

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CAB Members:

Hope Rugo, M.D., Division Chief of Breast Medical Oncology and a Professor of Medical Oncology and Therapeutics Research at City of Hope, Los Angeles, California, USA
Erika Hamilton, M.D., Chief Development Officer, Late Phase and Director of Breast Cancer Research at Sarah Cannon Research Institute, Nashville, Tennessee, USA
Javier Cortes, M.D., Ph.D., Co-founder and Scientific Director of IOB Institute of Oncology, Madrid, Spain

Hexagon Bio’s CAB members will provide strategic guidance as the company advances its lead development candidate, HEX-360, toward first-in-human study. HEX-360 is a HER2-targeting ADC that features a novel translation inhibitor payload discovered by Hexagon Bio.

Current ADCs primarily deliver chemotherapeutic payloads for cancer cell killing, which often are associated with poor tolerability and patients’ development of resistance mechanisms. Conversely, HEX-360’s payload is designed to suppress oncogenic protein production, offering the potential for enhanced tolerability and the ability to overcome resistance mechanisms. In preclinical studies, HEX-360 has demonstrated a differentiated profile compared to topoisomerase inhibitor- and tubulin inhibitor-based ADCs.

"We are excited to welcome our distinguished Clinical Advisory Board members, and look forward to their expert input and guidance as we rapidly advance HEX-360 toward planned clinic entry next year," said Maureen Hillenmeyer, Ph.D., Chief Executive Officer at Hexagon Bio. "By targeting translation, a key vulnerability in oncogene-driven tumors, HEX-360 has a mechanistically distinct ADC payload and the potential to be a much-needed therapeutic option for patients who have progressed on or cannot tolerate current treatments for HER2-positive cancers."

"ADCs represent a significant advance in cancer care. But, unfortunately, most patients with advanced breast cancer treated with today’s approved ADCs will eventually relapse primarily due to the development of payload resistance. The development of novel payload mechanisms to overcome these resistance mechanisms is critical to improving patient outcomes," said Hope Rugo, M.D., Chief of Breast Medical Oncology at City of Hope. "I look forward to working with the Hexagon Bio team and my fellow Clinical Advisory Board members as HEX-360 transitions to a clinical-stage candidate for the treatment of breast cancer."

HEX-360 is currently in IND-enabling studies with anticipated initiation of clinical investigation in 1H of 2027.

HEX-360 Preclinical Data Presented at AACR (Free AACR Whitepaper) Annual Meeting 2026

Hexagon Bio recently reported preclinical efficacy and safety data for HEX-360 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, highlighting the potential of its novel payload to address critical gaps in the current ADC landscape.

Transition inhibitor payload results:

Demonstrates potency at low (≤ 10 nM) concentrations in the majority (>90%) of nearly 200 cell lines tested, including cell lines resistant to topoisomerase and tubulin inhibitors
Has low vulnerability to key mechanisms of payload resistance (e.g., drug efflux)
Has good properties (e.g., permeability, lipophilicity), enabling bystander tumor-cell killing similar to topoisomerase inhibitors

HEX-360 results:

Shows equivalent or superior efficacy to a comparator analogous to ENHERTU administered at matched payload exposure in cell line- and patient-derived xenograft models
Achieves deep and durable response in models resistant to topoisomerase inhibitors
Has favorable PK properties in preclinical species, supporting Q3W dosing in humans
Demonstrates good tolerability in both rat and non-human primates, without the hallmark toxicities observed with topoisomerase inhibitor-based ADCs

(Press release, Hexagon Bio, JUN 22, 2026, View Source [SID1234668901])

On June 22, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the first patients were dosed in its global Phase 2 study of lirafugratinib in non-cholangiocarcinoma (CCA) solid tumors with FGFR2 fusion or rearrangement.

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"Elevar believes lirafugratinib has much potential as a strong anti-tumor therapy across a wider range of FGFR2 fusion or rearrangement driven tumors. We are committed to do our best to obtain meaningful study results to present to the FDA," said Dong-Gun Kim, chief executive officer of Elevar. "We are pleased that the first patients have been dosed and we look forward to completing enrollment."

The trial, known as ReFocus202 (Protocol ID ELE-4008-202; NCT07359820), is an open-label, single-arm study evaluating the efficacy and safety among a broad scope of tumors containing an FGFR2 fusion or rearrangement. The primary endpoint is objective response rate.

The first patient was dosed at Samsung Medical Center in Seoul, South Korea, and a second patient at Moffitt Cancer Center in Tampa, Florida. The multi-site study is set to take place in the U.S., Korea, the UK, Spain, and France.

"Patients with advanced solid tumors harboring FGFR2 fusions or rearrangements often have limited treatment options, particularly beyond cholangiocarcinoma," said Dr. Richard Kim, ReFocus202 principal investigator and service chief of medical gastrointestinal oncology at Moffitt Cancer Center. "This study gives us an important opportunity to better understand whether selective FGFR2 inhibition with lirafugratinib can benefit a broader group of patients whose tumors are driven by FGFR2 alterations. I am pleased that our team was able to enroll the first patient in the U.S. and contribute to this important effort."

Lirafugratinib received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for CCA. Priority review of its new drug application for the treatment of patients with CCA with FGFR2 fusion/rearrangement who have received prior therapy is ongoing by the FDA, which set a Prescription Drug User Fee Act date of Sep 27, 2026.

ReFocus202 aims to confirm the tumor-agnostic potential of lirafugratinib in patients with FGFR2 fusion/rearrangement.

In the Phase 1/2 ReFocus study, data from 42 non-CCA solid tumor patients with FGFR2 fusion/rearrangement (13 tumor types) showed meaningful antitumor activity of lirafugratinib. Elevar plans to leverage that dataset, along with data generated under ReFocus202, to conduct an interim analysis across at least seven tumor types with at least five patients per tumor type.

For more information about lirafugratinib, visit ElevarTX.com.

About Lirafugratinib

Lirafugratinib (RLY-4008) is a potent, selective, and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors.

(Press release, Elevar Therapeutics, JUN 22, 2026, View Source [SID1234668900])

On June 22, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics and targeted therapeutics, reported it will present preclinical findings for a novel therapeutic approach that uses small interfering RNAs (siRNAs) that kill squamous and basal skin cancer cells in vitro while leaving non-cancerous skin cells unharmed.

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The newly released findings support the Company’s efforts to develop topical treatments for squamous cell and basal cell carcinoma, two of the most common forms of skin cancer. An estimated 5.4 million cases of these skin cancers are diagnosed every year in the U.S., according to the American Cancer Society. Although surgery is the standard treatment, many patients require additional intervention because of incomplete resection, in which all of the cancerous tissue is not removed, or the risk of recurrence. To date, there is no commercial topical siRNA therapy specifically indicated for basal cell or squamous cell carcinoma.

David J. Elzi, PhD, bioAffinity Technologies Vice President of Product Development, will present the Company’s research at the 2026 RNA Therapeutics (RNATx) Symposium. RNATx brings together researchers, biotech/pharma, clinicians and industry focused on RNA therapeutics, oligonucleotides, mRNA, siRNA, gene editing and translational medicine.

"Basal cell and cutaneous squamous cell carcinomas are among the most common cancers we treat," said surgical oncologist Rosa Cuenca, MD, who is not affiliated with bioAffinity Technologies. "Unfortunately, surgical removal is not always the end of the story. A topical therapeutic that selectively targets malignant cells while preserving healthy skin could potentially expand our treatment options, particularly for patients with recurrent lesions or cosmetically sensitive tumors."

The research builds on earlier findings showing that siRNA silencing of two specific cell surface receptors, CD320 and LRP2, impaired cell viability across multiple cancer cell lines in vitro – including lung, breast, prostate, brain, and skin cancer – while sparing healthy primary cells. That discovery is the subject of U.S. Patent No. 12,305,171, "Compositions and Methods for Treating Cancer," issued in 2025.

"Our in vitro findings indicate that silencing specific cell surface receptors was selectively cytotoxic to or impaired the proliferation of squamous skin cancer cells while leaving normal skin cells unaffected," Dr. Elzi said. "The selectivity observed in these preclinical studies suggests the potential for further development of noninvasive, targeted topical approaches for common cutaneous cancers, subject to further research and regulatory review."

"Our preclinical results represent an encouraging step toward developing less-invasive treatments for some of the most common cancers affecting patients today," said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. "This research reinforces our innovative approach to cancer treatments and expands our mission to improve cancer outcomes by developing technologies designed to detect and treat cancer earlier and more precisely."

In the in vitro study, researchers synthesized siRNAs targeting specific cell receptors and transfected them into squamous and basal skin cancer cell lines and non-cancerous skin cells. Non-cancerous skin cells were unaffected by silencing the receptors, while squamous and basal skin cancer cell proliferation was significantly impaired. Microscopic analysis corroborated these findings, demonstrating cancer cell cytotoxicity following treatment without observable harm to healthy cells. These results were obtained in controlled laboratory conditions and may not be predictive of results in human clinical trials. The Company’s preclinical findings have not been tested in humans, and no Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (FDA).

About the Research

The poster, "siRNAs targeting CD320 and LRP2 are selectively cytotoxic to squamous skin cancer cells while leaving normal skin cells unharmed," will be presented at RNATx 2026 June 24-26 hosted by the RNA Therapeutics Institute at UMass Chan Medical School in Worcester, MA.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, JUN 22, 2026, View Source [SID1234668899])

On June 22, 2026 One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, reported financial support via a Paris-Saclay Cancer Cluster (PSCC) BOOST grant to develop the first single-cell assay for antibody-drug conjugates (ADC) therapies in oncology.

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The rapid growth of ADCs is driving demand for more sophisticated biomarker strategies. By capturing tumor complexity at cellular resolution, single-cell profiling has the potential to enhance patient selection and support the development of next-generation ADCs. Ultimately, it will help match the right patients to the right therapies, maximizing therapeutic benefit.

The PSCC BOOST-funded project seeks to bring a new level of precision to ADC development. It will be conducted in collaboration with Adcytherix, a clinical-stage biotech company developing differentiated ADCs for cancers with high unmet medical need.

The collaboration will combine Adcytherix’s expertise in ADC development with One Biosciences’ AI-powered single-cell profiling technology to analyze tumor samples and explore cellular and molecular signatures associated with treatment response. The long-term objective is to support more precise patient selection and lay the foundation for future companion diagnostic development.

"This grant is an important milestone for One Biosciences and for the broader adoption of single-cell technologies in oncology drug development," said Hedi Ben Brahim, CEO of One Biosciences. "This project enables us to deploy our single-cell platform in the context of an innovative ADC development program with the aim of better understanding treatment response and thereby supporting the development of more precise therapeutic strategies."

Supported by a PSCC BOOST grant, this project aims to position France at the forefront of precision oncology innovation while accelerating the emergence of clinical-grade single-cell companion diagnostics for cancer drug development.

One Biosciences is already accelerated by PSCC and works with many partners within the cluster. This project will further reinforce the company’s ties with the oncology community.

(Press release, One Biosciences, JUN 22, 2026, View Source [SID1234668898])