On April 1, 2026 FORE Biotherapeutics, a registration stage company dedicated to developing targeted therapies to treat patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG). Fore Bio believes this is the first BTD granted to a targeted therapy for HGG. Plixorafenib is a novel BRAF inhibitor that is a dimer breaker with high selectivity for BRAF alterations.

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The FDA granted this BTD based on data from approximately 25 patients treated in the completed Phase 1/2a clinical trial and ongoing Phase 2 FORTE basket evaluating plixorafenib in BRAF V600E-mutated central nervous system (CNS) tumors. The CNS tumors treated in FORTE include HGG, low-grade gliomas (LGG), and other primary brain and spinal cord tumors in adults and children. BTD is designed to speed the development and regulatory review of new medicines that are intended to treat a serious or life-threatening condition and that have shown encouraging early results, which demonstrate substantial improvement on one or more clinically significant endpoints (e.g., improved efficacy or improved safety with similar efficacy, etc.), over available therapies.

"High-grade gliomas are aggressive primary brain tumors associated with poor outcomes despite multimodality treatment approaches," said Macarena da la Fuente M.D., Chief, Neuro-Oncology Division, Department of Neurology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine. "In addition to their limited prognosis, patients experience substantial morbidity related to both the disease itself and the toxicities of current therapies. Therefore, there remains a critical need for novel treatments that are not only effective but also better tolerated."

"The granting of Breakthrough Therapy Designation is a significant development milestone for plixorafenib and reinforces our conviction in its unique mechanism of action which, further supported by the tolerability and efficacy profile seen in BRAF-altered tumors, underscores the potential of plixorafenib as a treatment option for patients living with difficult to treat cancers," said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. "BRAF alterations are an important actionable driver in the molecularly integrated clinical decision paradigm for the treatment of high-grade gliomas, and plixorafenib has demonstrated a differentiated profile in patients with primary CNS tumors, including glioblastoma and other high-grade gliomas. The maturation of the data from FORTE may help validate these findings, with BTD status further accelerating the delivery of this promising therapy to patients. We look forward to continued collaboration with the FDA to further advance plixorafenib and to advancing our FORTE basket trial in several types of BRAF altered malignancies."

Data from the Phase 1/2a trial, which were previously presented at ASCO (Free ASCO Whitepaper) 2023 and SNO 2023, show that plixorafenib achieved a 67% overall response rate (ORR) in a pre-specified subgroup of patients with refractory MAPK inhibitor naive BRAF V600-mutated primary CNS tumors with robust anti-tumor activity further supported by duration of response (DOR), and clinical benefit rate (CBR) across BRAF-altered tumor types and CNS histologies. As of the last reporting, the BRAF V600E primary CNS basket of the FORTE study met the pre-specified interim analysis, with the Independent Data Monitoring Committee (IDMC) supporting that the study may continue as planned on the basis of responses assessed by blinded independent central review (BICR), in addition to the IDMC’s ongoing oversight for safety.

BTD provides Fore with more frequent and intensive guidance from and dialogue with the FDA, including the involvement of senior reviewers, as well as eligibility for rolling and priority review of the marketing application. These benefits have the potential to accelerate the development and review of plixorafenib.

Plixorafenib previously received Fast Track Designation for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies and Orphan Drug Designation (ODD) for the treatment of primary brain and CNS malignancies. These, in addition to the BTD, continue to support the development of plixorafenib for the treatment of BRAF-altered primary CNS tumors in adults and children as the broader data set from FORTE continues to mature to provide a sufficient number of patients to support a robust benefit-risk profile across refractory high grade and low grade CNS biomarker-selected histologies.

About the Global Phase 2 FORTE Basket Study
The registration-intended FORTE Master Protocol is a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are recurrent or progressive BRAF V600 primary CNS tumors, solid tumors with BRAF fusions and rare BRAF V600 mutated solid tumors. As part of the Bayesian adaptive design of the trial, interim efficacy analyses are conducted in each basket, for which the company reported a positive outcome from the BRAF V600 CNS basket in the third quarter of 2025.

About BRAF Altered Recurrent Primary CNS Tumors
BRAF altered recurrent primary CNS tumors represent a high unmet medical need and a large market opportunity for plixorafenib. In the advanced treatment setting, patients are offered currently approved therapies, but those therapies have significant limitations in efficacy, tolerability, and safety.

About Plixorafenib
Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. In a previously conducted Phase 1/2 study, in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.

(Press release, Fore Biotherapeutics, APR 1, 2026, View Source [SID1234664123])

On April 1, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported it will attend the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting, taking place April 11–15, 2026, in Toronto, Canada.

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At the event, Delcath’s Hepatic Delivery System for use in percutaneous hepatic perfusion will be featured in three presentations.

On April 13, 2026, at 2:40 PM ET, Dr. Eric Wehrenberg-Klee, an interventional radiologist at Massachusetts General Hospital and Assistant Professor of Radiology at Harvard Medical School, will discuss his HEPZATO user experience at the SIR Innovation Hub;
On April 15, 2026, at 12:18 PM ET, Dr. David Eschelman, Professor of Radiology at Thomas Jefferson University, will present his initial commercial experience with percutaneous hepatic perfusion (PHP) for the treatment of liver metastases from uveal melanoma at Booth 701B; and
On April 15, 2026, at 12:27 PM ET, Dr. Mustafa Ege Seker, Research Fellow in the Department of Radiology, Section of Interventional Radiology from the University of Wisconsin, will present his preliminary clinical experience with percutaneous hepatic perfusion (PHP) for the treatment of liver metastases from uveal melanoma at Booth 701B.
The related abstracts are available at View Source under Scientific Meetings.

(Press release, Delcath Systems, APR 1, 2026, View Source [SID1234664122])

On April 1, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier this year.

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"We are excited to complete our PEAK NDA submission which marks a significant step toward bringing a new therapy to patients with second-line GIST," said Andrew Robbins, President and Chief Executive Officer. "Based on the strength of the PEAK data, we believe the bezuclastinib combination has the potential to meaningfully change the treatment landscape for these patients. We are grateful to the patients, investigators, and study teams who made this possible."

Pivotal data from PEAK, a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with GIST who have received prior treatment with imatinib, were reported in November 2025. As disclosed in the top-line results, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. The bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. Data for overall survival remains immature.

At the time of data cutoff, based on the number of ongoing patients receiving treatment on the bezuclastinib combination arm, the estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months.

Cogent plans to present full results from the PEAK trial at a major medical meeting during the first half of 2026. Additionally, Cogent is on track this quarter to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib. The NDA submission with bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) also remains on track for the first half of 2026.

Bezuclastinib – Expanded Access Program
Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. A growing number of sites now offer access to the bezuclastinib EAPs. For more information please visit: View Source

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on March 30, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of "inducement" equity awards to six new employees under the company’s 2020 Inducement Plan with a grant date of March 30, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 21,100 shares of Cogent common stock and (ii) 15,700 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.

(Press release, Cogent Biosciences, APR 1, 2026, View Source [SID1234664121])

On April 1, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported it will present new data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in San Diego, California from April 17-22, 2026. The Company will demonstrate new data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment (TME).

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 SA, a known T and NK-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.

Data presented at the AACR (Free AACR Whitepaper) meeting will showcase RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits immune cell infiltration and T-cell activity. By remodeling the TME and driving T-cell activation in concert with expression of a T-cell engager, RedTail may overcome these historical limitations.

The Company is developing a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor / on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the TME, limiting the possibility of off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

"We continue to advance the RedTail platform through our lead asset, CLD-401, and now through our work with T-cell engagers," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We believe RedTail represents a major breakthrough in the ability to deliver genetic payloads in a targeted fashion to distal sites of disease through systemic administration."

"The data we will present at AACR (Free AACR Whitepaper) highlight the ability of the RedTail platform to functionally overexpress complex biologics likes cytokines and T-cell engagers and profoundly alter the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "The ability of the RedTail platform to induce high levels of expression of its genetic payloads only at the tumor can potentially overcome many of the limitations currently seen with cytokine and T-cell engager therapies."

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, APR 1, 2026, View Source [SID1234664120])

On April 1, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, reported financial results for the full year 2025 and provided corporate updates.

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"Our clinical data for muzastotug plus pembrolizumab consistently demonstrate potent, dose-dependent efficacy," said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. "The 10 mg/kg data reported at ASCO (Free ASCO Whitepaper) have now matured into the classic long survival tail of CTLA-4 inhibition. By significantly mitigating severe toxicities, patients remain on therapy longer, allowing CTLA-4-mediated intratumoral Treg depletion, alongside PD-1-mediated reinvigoration and CTLA-4-mediated priming of effector T cells, to drive durable disease control. Importantly, these data provide a clear, de-risked read-through to the 20 mg/kg dose, which already shows an encouraging 29% ORR with median duration of response not yet reached.

"Supported by Fast Track Designation and FDA alignment under Project Optimus, we are on track to finalize the optimal combination dose regimen for a potential MSS colorectal cancer registrational trial. The expanded therapeutic window also helps to establish muzastotug as a foundational combination backbone. At AACR (Free AACR Whitepaper), we will showcase this potential with data from triplet regimens—combining with fruquintinib in 3L+ MSS CRC, alongside results from the Morpheus Liver study evaluating a triplet of muzastotug, atezolizumab, and bevacizumab versus atezolizumab and bevacizumab alone in first-line HCC. These readouts underscore our ability to safely unlock deeper responses in hard-to-treat tumors."

2026 OBJECTIVES & CASH RUNWAY INTO EARLY 2028

· Data update from the ongoing Phase 1b/2 study of muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in 3L+ MSS CRC, including 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts

· Complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus, and designed to allow dose regimen selection for Phase 3.

· Provide preliminary clinical data, including pathological responses, to inform future development from investigator-initiated Phase 2 trial for neoadjuvant muzastotug + pembrolizumab in colorectal cancer.

· Provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

· Share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC; liver cancer).

· Establish additional collaboration/licensing agreements.

With cash and cash equivalents of $74.5 million as of December 31, 2025, plus proceeds raised from the ATM Offering in 2026 year-to-date, Company expects a cash runway extending into early 2028.

PIPELINE HIGHLIGHTS

AMERICAN ASSOCIATION FOR CANCER RESEARCH 2026 PRESENTATIONS

The following abstracts have been selected for presentation at AACR (Free AACR Whitepaper) 2026:

1) Title: Ph1b evaluation of ADG126 (muzastotug, an anti-CTLA-4 masking antibody) pembrolizumab (Pembro) IO doublet in combination with fruquintinib (Fruq) in advanced and metastatic microsatellite stable colorectal cancer

This poster will provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

2) Title: Results from the phase 1b/2 Morpheus Liver study in patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC): Muzastotug (ADG126: masked anti-CTLA-4 Ab) combination arm

This poster will share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of liver cancer.

3) Title: Preclinical characterization of XB404, a masked anti-ROR1/2 antibody-drug conjugate

Partner Exelixis will present preclinical data from antibody-drug conjugate, XB404, built with Adagene’s SAFEbody masking technology and designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects.

ONGOING COLLABORATIONS

· Sanofi: Invested up to $25 million to support muzastotug’s randomized Phase 2 study. Separately, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with Sanofi’s SAR445877 (PD-1 x IL-15 fusion protein) in over 100 patients in a Phase 1/2 clinical trial in advanced solid tumors. Sanofi also exercised its option for a third SAFEbody discovery program.

· Third Arc Bio: Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody into next-generation T cell therapies.

· Exelixis: Advanced a third masked ADC against a solid tumor target, building on the 2021 collaboration.

· ConjugateBio: Collaborated on bispecific ADCs using Adagene-derived antibody, further demonstrating scalable platform potential.

· Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC).

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents:

Cash and cash equivalents were US$74.5 million as of December 31, 2025, compared to US$85.2 million as of December 31, 2024. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$6.1 million as of December 31, 2025 from US$ 18.2 million as of December 31, 2024. The associated loan proceeds were primarily used to pay for the company’s R&D activities in China.

Net Revenue:

Net revenue was US$7.7 million for the year ended December 31, 2025, compared to US$0.1 million in 2024. The increase of approximately 7,333% reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology licensing agreements with Sanofi, ConjugateBio and Third Arc Bio, respectively.

Research and Development (R&D) Expenses:

R&D expenses were US$22.0 million for the year ended December 31, 2025, compared to US$28.8 million in 2024. The decrease of approximately 23% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:

Administrative expenses were US$7.1 million for the year ended December 31, 2025, compared to US$7.3 million in 2024. The decrease was mainly a result of cost-control measures.

Net Loss:

Net loss attributable to Adagene Inc.’s shareholders was US$17.6 million for the year ended December 31, 2025, compared to US$33.4 million in 2024.

Ordinary Shares Outstanding:

As of December 31, 2025, there were 59,231,993 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

ADG126- Phase 1b/2 data:

· As presented at ASCO (Free ASCO Whitepaper) 2025, muzastotug showed 29% (6/21) confirmed overall response rate (ORR) in the combined 20 mg/kg dose cohorts.

· Among 41 patients in the combined 10mg/kg dose cohorts, median overall survival (mOS) was 19.4 months with a 17.8-month median follow-up, which compares favorably to 11-12 month mOS from fruquintinib Phase 3 trials in the same population1

· Across 67 patients in all cohorts, a low 4% overall discontinuation rate, no dose limiting toxicities, and no Grade 4 or 5 treatment-related adverse events (TRAEs); Grade 3 TRAEs were 15% in the 10 mg/kg cohorts and 27% in the 20 mg/kg cohorts, which were generally transient and manageable.

· Updated data demonstrate the durability of response and further support the optimized therapeutic index profile of muzastotug, which overcomes well-known dose-limiting toxicities of other CTLA-4 inhibitors at 10-20-fold higher doses2, to provide potentially improved efficacy.

· Randomized Phase 2 trial enrollment ongoing, with results expected in 1H 2027; registration trial expected to begin once optimal dose regimen has been established

(Press release, Adagene, APR 1, 2026, View Source [SID1234664119])