On March 17, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the presentation of new data for zidesamtinib, an investigational ROS1-selective inhibitor, during two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, being held April 17-22 in San Diego. The posters will highlight clinical data from a subset of TKI pre-treated patients with ROS1-positive NSCLC treated in the ARROS-1 Phase 1/2 clinical trial and preclinical data further characterizing zidesamtinib’s brain penetrance and intracranial activity.

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Details of the poster presentations are as follows:

Title: Zidesamtinib in Patients with ROS1+ NSCLC Previously Treated with Repotrectinib or Taletrectinib
Presenting Author: Geoffrey Liu, M.Sc., M.D.1
Abstract Number: CT248
Session Title: Phase II Clinical Trials
Session Date and Time: Tuesday, April 21, 2026, 2:00-5:00 p.m. PT
Location: Poster Section 50
Poster Board Number: 13

Title: Zidesamtinib Has Differentiated Preclinical Brain Penetrance and Intracranial Activity Compared to Other ROS1 Inhibitors
Presenting Author: Anupong Tangpeerachaikul, Ph.D.2
Abstract Number: LB366
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Session Date and Time: Tuesday, April 21, 2026, 2:00-5:00 p.m. PT
Location: Poster Section 53
Poster Board Number: 23

1 Princess Margaret Hospital, Toronto, Ontario, Canada; 2 Nuvalent, Inc., Cambridge, MA, USA

About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.

Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC.

(Press release, Nuvalent, MAR 17, 2026, View Source [SID1234663637])

On March 17, 2026 Pfizer Inc. (NYSE: PFE) reported positive topline results from the randomized Phase 2 FOURLIGHT-1 study evaluating atirmociclib in combination with fulvestrant, versus fulvestrant or everolimus plus exemestane, in people with hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) who had received prior cyclin-dependent kinase (CDK) 4/6 inhibitor-based treatment. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as assessed by the investigator [HR: 0.60 (95% CI: (0.440, 0.825)), p=0.0007].

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The PFS results were consistent across all prespecified subgroups, including performance status, menopausal status, presence of visceral disease, duration of treatment with prior CDK4/6 inhibitor (< or > 12 months), and regardless of prior CDK4/6 inhibitor received. More than 90% of patients initiated treatment with atirmociclib within three months of their last CDK4/6 inhibitor treatment. Overall survival (OS), a secondary endpoint, was not mature at the time of the analysis, with approximately 20% of participants having an event. These are the first randomized Phase 2 data in HR+ MBC for atirmociclib, an investigational, potential first-in-class CDK4 inhibitor.

"These results are especially encouraging given that the FOURLIGHT‑1 study enrolled patients whose disease had progressed soon after prior CDK4/6 inhibitor therapy, a difficult-to-treat population," said Jeff Legos, Chief Oncology Officer, Pfizer. "The strength of these data reinforces our confidence that atirmociclib may meaningfully differentiate from the CDK4/6 inhibitor class, the standard-of-care backbone in HR-positive breast cancer, with the potential for improved efficacy and tolerability. We are continuing to accelerate development of this next-generation cell cycle inhibitor in earlier lines of therapy where it may offer even greater benefit for patients."

In FOURLIGHT-1, atirmociclib demonstrated manageable safety and was well tolerated, with 6.4 percent of patients discontinuing atirmociclib due to treatment-emergent adverse events. Its safety profile was consistent with prior studies, and no new safety signals were identified. Detailed results will be submitted for presentation at a future medical meeting.

These findings support Pfizer’s strategy to advance atirmociclib in first-line and early-stage disease, where durable endocrine-based control has the potential to have the greatest impact. A Phase 3 registrational study for atirmociclib in the first-line metastatic setting is ongoing and results from a Phase 2 neoadjuvant study in early breast cancer will be shared at a future medical meeting.

About the FOURLIGHT-1 Trial

FOURLIGHT-1 (NCT06105632) is an interventional, open-label, randomized, multicenter Phase 2 study evaluating atirmociclib plus fulvestrant compared with fulvestrant or everolimus plus exemestane, in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC). The trial enrolled 264 patients in 14 countries whose disease progressed after cyclin-dependent kinase (CDK) 4/6 inhibitor-based treatment. The primary endpoint was progression-free survival (PFS) as determined by investigator assessment. Secondary endpoints include overall survival, objective response, duration of response and clinical benefit response.

About Atirmociclib

Atirmociclib is an investigational oral inhibitor of cyclin-dependent kinase 4 (CDK4), a key regulator of the cell cycle that triggers cellular progression. It was conceptualized and discovered at Pfizer and is being developed for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

(Press release, Pfizer, MAR 17, 2026, View Source [SID1234663653])

On March 17, 2026 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company focused on the design and development of next-generation medicines for cancer, reported it will introduce its next-generation KRAS pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. These two non-covalent pan-KRAS inhibitors leverage a differentiated chemical scaffold to address limitations of contemporary molecules – achieving sub-nanomolar potency and a prolonged off-rate, combined with oral bioavailability. In addition, the company will present new preclinical data supporting the continued advancement of its clinical programs BH-30643, a first-in-class, mutant-selective, macrocyclic OMNI-EGFRTM inhibitor, and BH-30236, an oral CLK inhibitor for hematologic malignancies. The AACR (Free AACR Whitepaper) Annual Meeting 2026 will be held April 17-22, 2026, in San Diego.

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"We are excited to share new data from across our pipeline at AACR (Free AACR Whitepaper), including new preclinical data supporting the continued advancement of our lead clinical programs BH-30643 and BH-30236, and the introduction of our novel switch II-targeting KRAS programs, one of which will be highlighted during a minisymposium," said Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. "KRAS remains one of the most important and historically difficult targets in oncology. Our next-generation pan-KRAS inhibitors are intentionally designed using a differentiated chemical scaffold to deliver pseudo-irreversible target engagement and improved drug-like properties we believe will translate to clinical impact. We look forward to engaging with the scientific community at the upcoming AACR (Free AACR Whitepaper) meeting."

Details of the presentations are as follows:

Title: Discovery and characterization of BH-501284: A non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors (#6736)
Date & Time: April 21, 2026; 2:30-4:30 p.m. PT
Session Title: Targeted Therapies
Session Type: Minisymposium
Location: San Diego Convention Center
Key Findings: BH-501284 is a potent, selective, orally available non-covalent pan-KRAS inhibitor that demonstrates picomolar binding affinity, broad activity across KRAS mutations, and durable tumor regression in non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC models). By preferentially targeting inactive KRAS and maintaining activity under growth factor-driven resistance conditions, BH-501284 may overcome key limitations of existing KRAS inhibitors.

Title: Design and discovery of BH-501242, a novel pan-KRAS on/off inhibitor targeting KRAS switch II pocket (#5120)
Date & Time: April 21, 2026; 9:00 a.m.-12:00 p.m. PT
Session Title: New Ligands and Inhibitors
Location: San Diego Convention Center, Poster Section 38
Key Findings: Preclinical data demonstrate that BH-501242, a novel pan-KRAS inhibitor targeting the switch II pocket, potently inhibits a broad range of KRAS mutations, including G12D, G12V, and G12C, with sub-nanomolar cellular activity and robust tumor regression in multiple xenograft models. Its ability to bind both active and inactive KRAS and achieve strong oral exposure supports further development as a differentiated, mutation-agnostic KRAS therapy.

Title: CLK inhibitor BH-30236 synergizes with venetoclax in anti-leukemia activity via splicing modulation in preclinical AML and CLL models (#5872)
Date & Time: April 21, 2026; 2:00-5:00 p.m. PT
Session Title: Tyrosine Kinase, Phosphatase, and Other Inhibitors
Location: San Diego Convention Center, Poster Section 18
Key Findings: BH-30236, a novel oral CLK1/2/4 inhibitor, modulates alternative splicing to induce apoptosis and suppress leukemia stem cell–associated pathways, demonstrating robust anti-leukemia activity in acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL) models. In combination with venetoclax, BH-30236 produced synergistic tumor regression, including durable, complete responses in resistant xenograft models.

Title: BH-30643, a novel macrocyclic non-covalent, mutant-selective EGFR inhibitor, addresses the resistance and potency limitations of contemporary EGFR TKIs (#5877)
Date & Time: April 21, 2026; 2:00-5:00 p.m. PT
Session Title: Tyrosine Kinase, Phosphatase, and Other Inhibitors
Location: San Diego Convention Center, Poster Section 18
Key Findings: BH-30643 is a macrocyclic, non-covalent, mutant-selective OMNI-EGFR inhibitor that uniquely overcomes T790M and C797S resistance mutations while maintaining potent activity against classical EGFR drivers and sparing wildtype EGFR. In preclinical studies, BH-30643 demonstrated prolonged suppression of tumor cell proliferation compared to osimertinib, including under growth factor-mediated resistance conditions.

(Press release, BlossomHill Therapeutics, MAR 17, 2026, View Source [SID1234663669])

On March 17, 2026 Gritstone bio reported that after emerging from Chapter 11 bankruptcy, hiring a new management team and a dedicated new team of scientists, Gritstone bio is changing its name to Nexoplex bio. This change is reflective of new energy and focus on the development of our portfolio of bispecific antibodies.

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(Press release, Gritstone Bio, MAR 17, 2026, View Source [SID1234670435])

On March 17, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the full year of 2025 and recent operational progress.

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"2026 is about building a steady cadence of biopsies and treatments," said Vish Seshadri, Chief Executive Officer of Abeona. "We are focused on ensuring every ZEVASKYN patient has a seamless experience throughout their treatment journey. Establishing these commercial foundations will position us to scale-up ZEVASKYN in 2026 and beyond."

ZEVASKYN (prademagene zamikeracel) updates

● First ZEVASKYN commercial patient treatment completed in December; launch momentum building in first quarter 2026: Following the optimization of a release assay in 2025, ZEVASKYN commercial launch activities commenced in the fourth quarter, with the first patient treatment completed in December prior to a mandatory annual manufacturing facility shutdown. Since resuming manufacturing in late January 2026, multiple biopsies have been collected with additional biopsies expected this month. One patient has completed treatment with ZEVASKYN so far in 2026, and other collected biopsies are at various stages in the manufacturing process.
● Growing ZEVASKYN treatment experience expected to catalyze further ZEVASKYN demand: Growing ZEVASKYN treatment experience across the initial Qualified Treatment Center (QTC) network is establishing the institutional workflows and scalable foundation necessary to accelerate patient throughput and streamline the referral-to-treatment timeline. As the RDEB community shares in the positive experiences of the initial ZEVASKYN patients, the Company believes this will continue to catalyze sustained demand for ZEVASKYN.
● Abeona expands patient access to ZEVASKYN across Texas and the Gulf Coast region with activation of its newest QTC: In December, the Company announced activation of The University of Texas Medical Branch (UTMB), in Galveston, Texas, as the fourth QTC for ZEVASKYN. UTMB is a major academic medical center renowned for its expertise in comprehensive complex skin disease and wound care.

Full Year 2025 Financial Results

Abeona reported total revenue of $5.8 million for the year ended December 31, 2025. This was comprised of $3.4 million in license and other revenues and $2.4 million in net product revenue. License and other revenues were driven by a clinical milestone reached under the October 2020 sublicense agreement with Taysha Gene Therapies for its investigational Rett syndrome gene therapy.

Net product revenue reflects the single patient treatment in December. While net product revenue reflects Medicaid coverage for the patient treated in December, the Company expects average net revenues to normalize over time as the payer mix expands to include commercially insured patients. Cash was received from the December treatment in the first quarter 2026.

Cost of sales for 2025 was $1.5 million, primarily driven by the first commercial ZEVASKYN treatment in December and costs from an August production batch that was not released due to technical challenges related to the FDA-mandated rapid sterility lot release assay.

Total research and development (R&D) spending for 2025 decreased $7.6 million to $26.8 million, compared to $34.4 million in 2024. This reduction was primarily driven by the April 2025 FDA approval of ZEVASKYN, which resulted in certain production costs being capitalized into inventory and engineering runs that are no longer classified as R&D expense.

Selling, general and administrative (SG&A) expenses for 2025 were $65.0 million, an increase of $35.1 million over 2024. This increase primarily reflects Abeona’s commercial transition following the April 2025 FDA approval of ZEVASKYN, including $18.6 million in personnel and stock-based compensation and $2.3 million in direct commercialization costs. Additionally, certain engineering and training expenses previously classified as R&D were transitioned to SG&A post-approval.

In May 2025, Abeona sold the Rare Pediatric Disease Priority Review Voucher (PRV) awarded following the FDA’s approval of ZEVASKYN. The Company received $155.0 million in gross proceeds from the sale in June 2025, resulting in a $152.4 million gain net of $2.6 million in transaction costs.

Net income was $71.2 million for the year ended December 31, 2025, or $1.34 per basic and $1.01 per diluted common share. Net loss in 2024 was $(63.7) million, or $(1.55) per basic and diluted common share.

Cash, cash equivalents and short-term investments totaled $191.4 million as of December 31, 2025.

Conference Call Details

The Company will host a conference call and webcast on Tuesday, March 17, 2026 at 8:30 a.m. ET to discuss its 2025 financial results and corporate progress. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 977217 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, MAR 17, 2026, View Source [SID1234663604])