On February 26, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported that results from the Phase 1, first-in-human portion of the ongoing Phase 1/2 PYNNACLE study evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation were published in the New England Journal of Medicine (NEJM). The publication provides a summary of the Phase 1 safety and efficacy results across 77 patients.

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 study published in NEJM entitled, "Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors," highlighted the antitumor activity of rezatapopt in heavily pretreated patients across multiple solid tumor-types establishing proof-of-concept for p53 reactivation. All responding patients had a TP53 Y220C mutation and were KRAS wild-type. The manuscript can be accessed here.

In the Phase 1 portion of the PYNNACLE clinical trial, 77 heavily pretreated patients with advanced solid tumors harboring a TP53 Y220C mutation received oral rezatapopt across dose-escalation cohorts to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), characterize safety, pharmacokinetics, and biomarker effects. Rezatapopt was generally well tolerated; dose-limiting toxicities were infrequent, supporting selection of the RP2D. Objective responses were observed across multiple tumor types. Clinical activity and biomarker data were consistent with selective binding to the Y220C pocket and restoration of wild-type p53 tumor suppressor function.

"Publication of the rezatapopt Phase 1 results in the New England Journal of Medicine underscores the emerging clinical impact of reactivating p53 in patients whose cancers are driven by a TP53 Y220C mutation," said Deepika Jalota, Pharm.D., Chief Development Officer of PMV Pharma. "These peer-reviewed findings further validate our scientific approach, support our registrational Phase 2 strategy and our plan to submit a New Drug Application in platinum-resistant/refractory ovarian cancer in the first quarter of 2027. We remain focused on advancing rezatapopt as a potential first-in-class therapy for ovarian cancer patients harboring a TP53 Y220C mutation, an area of high unmet medical need."

In October 2025, the Company presented updated interim clinical results from the Phase 2 pivotal portion of the PYNNACLE study, highlighting confirmed responses in patients whose tumors were TP53 Y220C mutated and KRAS wild-type across eight tumor types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder cancers, and ampullary carcinoma. As of the September 4, 2025 data cutoff date, the overall response rate (ORR) across all cohorts was 34% (35/103 patients), with an ORR of 46% (22/48 patients) in ovarian cancer per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including confirmed and unconfirmed responses. Across all cohorts, the median time to response was 1.3 months, and the median duration of response was 7.6 months. In the ovarian cancer cohort, the median time to response was 1.3 months and the median duration of response was 8.0 months.

About Rezatapopt
Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.

About the PYNNACLE Clinical Trial
The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, FEB 26, 2026, View Source [SID1234663108])

On February 26, 2026 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the fourth quarter and full year ended December 31, 2025 and recent business highlights related to the commercial launch of Vafseo (vadadustat) as well as its robust pipeline.

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!

"Vafseo commercial trends are showing marked improvement in early 2026, built on the solid foundation we created for the brand in its first year of launch," said John P. Butler, Chief Executive Officer of Akebia. "Patient access to Vafseo therapy now stands at 290,000 patients, and early data points to improved patient adherence rates, which we believe are enhanced as a result of dialysis organizations deciding to implement observed dosing protocols. These dynamics, along with the building evidence of clinical differentiation, are expected to drive significant Vafseo revenue growth in 2026 and beyond as we work toward our goal to make Vafseo standard of care for treating anemia due to CKD in patients on dialysis. Separately, we are advancing our pipeline in rare kidney disease and actively enrolling patients into the Phase 2 trial of praliciguat in FSGS. We expect to initiate an open-label rare kidney disease basket study with our tissue-targeted complement inhibitor, AKB-097, in the second half of 2026 with initial data expected in 2027. Through these efforts, we remain steadfast in working to better the lives of people impacted by kidney disease."

Vafseo Q4 2025 Commercial Updates

•Total number of prescribers increased to approximately 800 in Q4, representing an increase of 10% over the number of prescribers in Q3.
•Broadened customer base as approximately 25% of new patients in Q4 originated from dialysis organizations other than U.S. Renal Care (USRC), an increase from less than 10% in Q3.
•Patient demand was approximately $11 million. This approximately $1 million decline in demand versus Q3 was driven by fewer patient starts, which Akebia believes was a result of providers at select dialysis organizations anticipating the initiation of new in-center observed dosing protocols.
•Within centers that adopted an in-center observed dosing protocol in Q4, first refill adherence rates improved to 91% in Q4 from 75% in the first 9 months of 2025 with daily dosing.
2025 Vafseo Post Marketing Clinical Development Achievements

•In November at the American Society of Nephrology Kidney Week 2025, Dr. Glenn M. Chertow presented a post-hoc analysis of data from the INNO2VATE trials comparing dialysis patients taking vadadustat or darbepoetin alfa for CKD-related anemia. The data demonstrated statistically significant favorable outcomes in the hierarchical composite endpoint of all-cause mortality and hospitalization in patients treated with vadadustat compared to patients in the erythropoietin stimulating agent (ESA) control group.
•In July, enrolled the first patient in VOCAL, a Phase IIIb trial evaluating three times weekly (TIW) dosing of Vafseo versus ESAs, which is expected to report topline data in Q4 2026. The VOCAL trial of approximately 350 total patients also contains a sub-study of Vafseo’s impact on red blood cell characteristics.
•In June, USRC completed enrollment in VOICE, a large Phase IV trial of over 2,100 patients evaluating Vafseo TIW against standard-of-care ESAs using a hierarchical composite endpoint of all-cause mortality and all-cause hospitalization. VOICE topline results are expected in early 2027.

Rare Kidney Disease and Early-Stage Pipeline Progress

•Initiated a Phase 2 clinical trial of praliciguat, an oral, once-daily soluble guanylate cyclase (sGC) stimulator being evaluated for the treatment of biopsy-confirmed FSGS, a rare kidney disease, and dosed the first patient in December 2025. Akebia expects to enroll approximately 60 patients in this trial.
•In November 2025, Akebia acquired a humanized anti-C3d monoclonal antibody fusion protein from Q32 Bio Inc. which is designed to act as a complement inhibitor through a tissue-targeted mechanism. A Phase 2 open-label rare kidney disease basket study is expected to start in the second half of 2026 evaluating AKB-097 in IgA nephropathy, lupus nephritis and C3 glomerulopathy. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on disease-relevant biomarkers, including proteinuria and measures of kidney function. Initial data is expected in 2027.

•Akebia plans to initiate a Phase 1 study of AKB-9090 in healthy volunteers. The study is expected to begin in the first half of 2026 with topline data expected by the end of the year. The initial target indication for AKB-9090 is the treatment of acute kidney injury associated with cardiac surgery.

Financial Results

•Revenues: Total revenues were $57.6 million in the fourth quarter of 2025 compared to $46.5 million in the fourth quarter of 2024, and $236.2 million for the full-year 2025 compared to $160.2 million for the full-year 2024. These increases were driven by sales of Vafseo, which was launched in the U.S. in January 2025, and an increase in Auryxia (ferric citrate) sales volumes.
◦Vafseo net product revenues were $6.2 million in the fourth quarter of 2025 and $45.8 million for the full-year 2025.

◦Auryxia net product revenues were $48.1 million in the fourth quarter of 2025 compared to $44.4 million in the fourth quarter of 2024, and $181.5 million for the full-year 2025 compared to $152.2 million for the full-year 2024. We expect generic competition for Auryxia to expand this year beyond the current authorized generic competition and therefore expect Auryxia revenues to decrease in 2026 as compared to 2025 Auryxia revenues.

◦License, collaboration and other revenues were $3.3 million in the fourth quarter of 2025 compared to $2.1 million in the fourth quarter of 2024, and $8.9 million for the full-year 2025 compared to $8.0 million for the full-year 2024.
•COGS: Cost of goods sold was $12.5 million in the fourth quarter of 2025 compared to $20.4 million in the fourth quarter of 2024, and $39.5 million for the full-year 2025 compared to $63.2 million for the full-year 2024. COGS in both periods was driven by higher Auryxia sales volumes in 2025, and was impacted by the elimination in 2025 of a quarterly $9.0 million non-cash intangible amortization charge that Akebia incurred through the fourth quarter of 2024. In addition, COGS for the full-year 2024 included a $12.3 million benefit due to our ability to sell inventory previously written-down as excess inventory. Of note, Vafseo-related COGS in both periods was derived from pre-launch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as research and development expenses in the period incurred prior to Vafseo’s approval in the U.S.

•R&D Expenses: Research and development expenses were $26.6 million in the fourth quarter of 2025 compared to $11.8 million in the fourth quarter of 2024, and $62.4 million for the full-year 2025 compared to $37.7 million for the full-year 2024. The increase in expenses in both periods was driven by increased clinical trial activities related to Vafseo and our other product candidates, higher headcount related costs, as well as by a $12.8 million charge incurred during the fourth quarter of 2025 related to acquired in-process R&D costs associated with the acquisition of AKB-097 from Q32 Bio Inc.
•SG&A Expenses: Selling, general and administrative expenses were $26.1 million in the fourth quarter of 2025 compared to $27.7 million in the fourth quarter of 2024, and $107.5 million for the full-year 2025 compared to $106.5 million for the full-year 2024.
•Net Loss: Net loss was $12.2 million in the fourth quarter of 2025 compared to a net loss of $22.8 million in the fourth quarter of 2024. Net loss was $5.3 million for the full-year 2025 compared to $69.4 million for the full-year 2024. The decrease in net loss in both periods was driven by the increase in net product revenues, which was partially offset by higher expenses.

•Cash Position: Cash and cash equivalents as of December 31, 2025, were approximately $184.8 million compared to $51.9 million as of December 31, 2024. Akebia expects its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years.

Conference Call

Akebia will host a conference call on Thursday, February 26, 2026 at 8:00 a.m. EST to discuss fourth quarter and full year 2025 earnings. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the "Investors" section of Akebia’s website at: View Source/." target="_blank" title="View Source/." rel="nofollow">View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

(Press release, Akebia, FEB 26, 2026, View Source [SID1234663058])

On February 26, 2026 ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported completion of enrollment in its Phase 2 clinical trial evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.

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 QUILT 2.005 trial (NCT02138734), which completed enrollment ahead of schedule, includes 366 patients randomized to receive either BCG alone, the current standard-of-care for NMIBC CIS, or ANKTIVA in combination with BCG. An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated that treatment with ANKTIVA plus BCG resulted in a statistically significant improvement in the duration of complete response compared with BCG alone, with no significant safety concerns reported.

The interim analysis demonstrated that at six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients treated with BCG alone. At nine months, 84% of subjects in the ANKTIVA plus BCG arm maintained a complete response, compared with 52% of patients in the BCG-alone arm. Despite the limited sample size of the interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455).1

"The interim results from this randomized study are encouraging and suggest that ANKTIVA plus BCG may improve the durability of response in patients with BCG-naïve NMIBC," said Dr. Christopher Pieczonka, Corporate Director of Clinical Research at U.S. Urology Partners and Global Principal Investigator of the trial. "Given the historical limitations of BCG alone, continued evaluation of this combination has the potential to inform future treatment strategies and potentially change the current standard-of-care recommendations for NMIBC. Importantly, no new or worsening safety signals have been observed to date, which is encouraging when considered alongside prior studies evaluating BCG in combination with checkpoint inhibitors in this disease setting."

Additional study results are expected to be available in the fourth quarter of 2026. Based on these data, ImmunityBio anticipates submitting a biologics license application (BLA) to the FDA by Q4 2026.

"We are encouraged by these interim results and await the final unblinding of the completed trial," said Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "If approved, ANKTIVA plus BCG could offer a new treatment option earlier in the disease course for patients with NMIBC CIS, building on the therapy’s existing approval in the BCG-unresponsive setting."

In parallel, ImmunityBio continues to address the ongoing shortage of TICE BCG through its Expanded Access Program (EAP) for recombinant BCG (NCT06810141), which is progressing and supporting patient access. The Company has requested consultation with the FDA regarding the potential approval of recombinant BCG as an alternative supply source in anticipation of continued clinical need, including for patients with BCG-naïve disease.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, FEB 26, 2026, View Source [SID1234663077])

On February 26, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported participation at the following investor conferences:

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!

TD Cowen 46th Annual Health Care Conference – Dave Lennon, PhD, President and CEO, will participate in a hybrid presentation and fireside chat on Tuesday, March 3 at 10:30 AM ET

Leerink 2026 Global Healthcare Conference – executives will participate in investor meetings on Monday, March 9

Citizens Life Sciences Conference – Dave Lennon, PhD, President and CEO, will give a corporate presentation on Tuesday, March 10 at 12:30 PM ET
A live webcast of the TD Cowen and Citizens presentations can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, FEB 26, 2026, View Source [SID1234663093])

On February 26, 2026 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery and development of next generation non-cereblon/VHL targeted protein degradation (TPD) medicines, reported new data at the Keystone Symposia on Proximity Based Biology and Therapeutics: Targeted Protein Degradation and Beyond in Banff, AB, Canada, 23-26 February.

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!

In an oral presentation titled "Expanding Targeted Glue Applications for Clinical Use by Recruiting Novel E3 Ligases", Louise Modis, Chief Scientific Officer at Amphista outlined the translation of Amphista’s Targeted Glue technology from discovery to clinical development. It showcased how the Company’s target-first approach and proprietary chemistry is delivering differentiated and advanced molecular glue degraders beyond traditional cereblon/VHL-based approaches.

The presentation built on insights shared at the TPD & Induced Proximity Summit in October 2025, demonstrated how Amphista is leading the rational discovery and development of molecular glue degraders functioning via novel E3 ligases, including DCAF16, FBXO22 and DCAF11 into clinically viable oral therapeutics.

Louise provided new data from Amphista’s Targeted Glue pipeline, which exemplifies the exquisite selectivity, deep and sustained target degradation, and exceptional degradation kinetics that can be achieved in vivo with this innovative approach. Amphista’s progress is underpinned by its proprietary Eclipsys platform technology which combines high-resolution CryoEM of ternary complexes, geometric deep learning, advanced folding algorithms and cheminformatics to rationalize and enhance molecular glue degrader development. The therapeutic potential of Amphista’s chemistry is further expanded by its compatibility with degrader-antibody conjugate (DAC) approaches.

Louise Modis, Chief Scientific Officer of Amphista Therapeutics, said: "We have made significant progress in advancing our Targeted Glue technology toward clinical application. This presentation at Keystone demonstrates how Amphista’s mechanistically differentiated approach of recruiting the most structurally efficient E3 ligase – including DCAF16, FBXO22 and now DCAF11 – translates into exceptional molecular properties, tissue distribution and degradation of the target. We have now demonstrated that we can successfully and reproducibly harness multiple novel E3 ligases beyond cereblon/VHL with advanced drug-like degraders. We’re excited to share data on AMX-883, our first clinical candidate, alongside innovations in degrader-antibody-conjugates and CNS-penetrant degraders that further expands the therapeutic opportunity for our Targeted Glue technology."

Presentation details:

Title: Expanding Targeted Glue Applications for Clinical Use by Recruiting Novel E3 Ligases
Date and Time: Wednesday 25 February 2026, 8:00–11:00 AM MST (UTC-7)
Presenter: Louise Modis, Chief Scientific Officer, Amphista Therapeutics

(Press release, Amphista Therapeutics, FEB 26, 2026, View Source [SID1234663059])