On March 12, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals.

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!

Pierre Fabre Pharmaceuticals, with Atara’s support, will meet with the agency to collaboratively address the points from the CRL and enable a resubmission with the additional efficacy data that has been collected since the original BLA submission.

"We are pleased that the FDA has granted a Type A Meeting to our partner, Pierre Fabre, and hope to gain clarity on a path forward for re-submission of the tab-cel BLA," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We anticipate providing a regulatory update in the second quarter."

(Press release, Atara Biotherapeutics, MAR 12, 2026, View Source [SID1234663486])

On March 12, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter and full year ended December 31, 2025.

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!

"Allogene is approaching a pivotal inflection point, with the first interim data of cema-cel’s ALPHA3 trial just weeks away," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We designed ALPHA3 to answer a bold question: can early, MRD-guided allogeneic CAR T prevent relapse in LBCL? We believe that this trial will answer that question and has the potential to mark one of the most significant advances in the field in decades. Importantly, through ALPHA3 we are working to demonstrate that allogeneic CAR T can move beyond academic settings and be delivered at biologic-like scale. Beyond oncology, ALLO-329 demonstrates how our Dagger technology may redefine the delivery of CAR T in autoimmune disease. Supported by a cash runway into 2028, we are focused on disciplined execution and delivering transformative data across our portfolio."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
Allogene’s lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the pivotal, randomized Phase 2 ALPHA3 trial, the first study designed to test whether early, MRD-guided consolidation with cema-cel can prevent recurrence of large B-cell lymphoma (LBCL).

ALPHA3 seamlessly integrates cema-cel as a "7th cycle" of first-line therapy, without altering existing first-line treatment workflows, enabling early, MRD-guided treatment intervention for patients at high risk of relapse. The trial is enrolling patients across more than 60 activated clinical trial sites, including sites outside the United States, spanning both academic and community cancer centers. This broad site footprint is designed to enhance patient access, particularly as the majority of LBCL patients in the U.S. are treated in community settings.

The interim futility analysis in April 2026 will compare MRD clearance rates between cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation (12 patients in each cohort). The update will also include a summary of safety outcomes and additional information about screening and treatment patterns across the trial site footprint. Clearance of MRD in 25–30% more patients assigned to the cema-cel arm compared to those in the observation arm may indicate a proof of concept that early treatment of MRD+ disease could improve long term outcomes.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease with Built-In Lymphodepletion
ALLO-329 is a next-generation, dual-targeted CD19/CD70 AlloCAR T therapy that incorporates Allogene’s proprietary Dagger technology. Dagger is designed to provide built-in, targeted lymphodepletion by selectively eliminating activated CD70-positive T cells responsible for rejecting AlloCAR T products. This approach is intended to enable robust expansion and persistence of allogeneic CAR T cells, while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion.

The Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, lupus nephritis, scleroderma, and inflammatory myositis. The trial is evaluating up to four dose levels, beginning at 20 million CAR T cells, in two parallel cohorts: one receiving reduced lymphodepletion consisting of cyclophosphamide only and one receiving no lymphodepletion. For context, competitive CAR T programs are evaluating dose levels ranging from approximately 150 million cells (autologous) to nearly 1 billion cells (allogeneic).

Initial data from the patients treated in the first dosing cohort are expected in June 2026. The planned data update is expected to include translational data, including disease-related biomarkers, CAR T expansion, immune reconstitution, and early clinical outcomes.

If successful, ALLO-329 could open one of the largest new markets in cell therapy, where scalable manufacturing, tolerability profile, and accessibility to rheumatologists become critical competitive differentiators.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 remains the only allogeneic CAR T therapy to show clinically significant response rates and meaningful durability of response in a metastatic solid tumor. The TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort and the Company is currently exploring partnering opportunities to advance the asset.

2025 Fourth Quarter and Year End Financial Results

Research and development expenses were $28.6 million for the fourth quarter of 2025, which includes $2.5 million of non-cash stock-based compensation expense. For the full year of 2025, research and development expenses were $150.2 million, which includes $12.9 million of non-cash stock-based compensation expense.
General and administrative expenses were $13.8 million for the fourth quarter of 2025, which includes $5.6 million of non-cash stock-based compensation expense. For the full year of 2025, general and administrative expenses were $56.8 million, which includes $24.7 million of non-cash stock-based compensation expense.
Net loss for the fourth quarter of 2025 was $38.8 million, or $0.17 per share, including non-cash stock-based compensation expense of $8.1 million. For the full year of 2025, net loss was $190.9 million, or $0.87 per share, including non-cash stock-based compensation expense of $37.6 million and non-cash impairment of long-lived asset expense of $2.4 million.
The Company had $258.3 million in cash, cash equivalents, and investments as of December 31, 2025.

Based on its cash, cash equivalents, and investments as of December 31, 2025, the Company has extended its cash runway into the first quarter of 2028. This extension reflects disciplined expense management, focused investment in advancing the ALPHA3 and RESOLUTION programs, the return of $23.7 million in escrow funds in February 2026 related to the favorable outcome in Servier’s arbitration with Cellectis, and the prudent, opportunistic use of the Company’s at-the-market (ATM) facility.

Guidance for operating cash expense in 2026 is expected to be approximately $150 million. GAAP Operating Expenses are expected to be approximately $210 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, MAR 12, 2026, View Source [SID1234663485])

On March 11, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), focused on the development of drugs for pancreatic cancer, reported that CEO and Managing Director Dr. Chris Burns, will present live at the Life Sciences Investor Forum hosted by VirtualInvestorConferences.com on March 12th (US time)/March 13th (AU time), 2026.

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

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

                  Schedule Your 30 min Free Demo!

DATE: March 12th (US)/ March 13th (AU)
TIME: 3:30 – 4:00 pm US EDT; 6:30 – 7:00 am AEDT

REGISTER HERE

Available for 1×1 meetings: March 12-17. Schedule 1×1 Meetings here.

The event will be conducted as a live, interactive online forum, offering investors and industry professionals within the life sciences community the opportunity to submit questions to management in real time. A replay of the webcast will be available following the conclusion of the conference.

It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates.

Learn more about the event at www.virtualinvestorconferences.com.

Recent Company Highlights

Updated ORR of 42% and mPFS of 7.7 mo in ACCENT trial of narmafotinib in metastatic pancreatic cancer
Opening of US sites in second pancreatic cancer trial
Alignment with FDA on structure of planned registrational Phase 2b/3 trial
Compelling preclinical data highlighting clinical potential of narmafotinib combination with kRAS inhibitors in pancreatic and other cancers

(Press release, Amplia Therapeutics, MAR 11, 2026, View Source [SID1234663464])

On March 11, 2026 Curatis Holding AG (SIX: CURN) and Neupharma Co., Ltd. ("Neupharma"), a Japanese pharmaceutical company specializing in oncology, immunology, pulmonology and cardiology disorders, reported an exclusive license and development agreement for corticorelin (C-PTBE-01) in Japan.

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!

Under the terms of the agreement, Neupharma will receive exclusive rights to develop and commercialize corticorelin for the treatment of peritumoral brain edema (PTBE) in Japan. PTBE is a tumor-associated condition for which no approved targeted therapies currently exist. Neupharma will finance and conduct a pivotal clinical trial in Japan to support filing for approval in Japan. Curatis will receive upfront and milestone payments for the achievement of regulatory and commercial targets totaling up to CHF 83.5 million, as well as royalties on future sales in Japan of up to 20%.

The agreement stipulates that corticorelin is planned to be introduced in Japan initially for children and adolescents. A meeting with the Japanese drug regulatory authority PMDA to discuss the registration enabling study is planned for summer 2026, and the clinical study is expected to start in 2027.

At the same time, preparatory work for the pivotal Phase 3 study for approval in the US and Europe as well as global partnering activities are proceeding as planned.

Corticorelin / C-PTBE-01

Curatis’ lead product candidate, C-PTBE-01 (corticorelin), is being developed to treat peritumoral brain edema (PTBE). PTBE occurs in association with many primary and metastatic (secondary) brain tumors, often in connection with metastases caused by lung cancer, breast cancer, melanoma and colorectal cancer. PTBE results in impairment of brain function due to the accumulation of extracellular fluid around the tumor and can cause symptoms such as headaches, vomiting and neurological dysfunction such as paralysis, speech disorders, visual problems and altered mental status. Standard of care treatment for PTBE is the use of corticosteroids which frequently have serious side effects such as severe myopathy, impaired glucose metabolism, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes. Additionally, corticosteroids can also counteract certain cancer therapies such as chemotherapy or emerging immunotherapies that rely on adequate T-cell functionality which is impaired by corticosteroids.

Corticorelin (hCRH), a 41 amino acid endogenous polypeptide, has demonstrated preclinically (in vivo) the ability to positively impact the blood-brain barrier after a disruption due to the underlying malignant tumor. In two clinical studies in patients with PTBE, corticorelin demonstrated the potential to substantially reduce, or in some cases completely replace, steroid use, which may reduce or avoid the severe glucocorticoid-related side effects and subsequently improve quality of life. In the US alone, more than 150,000 patients suffer from PTBE. The estimate for the potential market opportunities for corticorelin is therefore over USD 1 billion per year. Corticorelin is an investigational drug not approved for therapeutic use in the United States or outside the United States.

(Press release, Neupharma, MAR 11, 2026, https://www.businesswire.com/news/home/20260310112972/en/Curatis-and-Neupharma-Announce-Exclusive-Licensing-Agreement-to-Develop-and-Market-Corticorelin-C-PTBE-01-for-the-Treatment-of-Peritumoral-Brain-Edema-in-Japan [SID1234663463])

On March 11, 2026 Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer using its Helicon TM peptide platform to drug historically undruggable targets, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to zolucatetide (previously known as FOG-001), the company’s lead investigational HeliconTM peptide and the first and only direct inhibitor of the elusive β-catenin:TCF interaction, for the treatment of desmoid tumors. Zolucatetide has also received FDA Fast Track Designation in desmoid 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!

"Patients living with desmoid tumors have lacked therapies that directly address the root biological cause of their disease because that biology, the β-catenin:TCF interaction, has long been considered ‘undruggable,’" said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. "With Orphan Drug Designation and Fast Track Designation from the FDA, along with compelling early clinical data showing encouraging evidence of clinical activity, we are building momentum behind zolucatetide as a potential first-in-class therapy that we believe could help redefine the standard of care for patients with desmoid tumors and other tumors driven by the same elusive biology. We are committed to advancing this program with rigor and speed to deliver meaningful impact for patients."

Desmoid tumors are considered a rare condition involving locally invasive soft-tissue tumors that form in the connective tissues. While they do not metastasize, desmoid tumors can be aggressive and recurrent, often causing chronic and significant pain, limited mobility, disfigurement and organ dysfunction, and no existing therapies target the underlying biology of the disease.

Zolucatetide is an investigational first-in-class inhibitor of the Wnt/β-catenin pathway, which is the fundamental driver of desmoid tumor growth. Orphan Drug Designation follows early data, first released at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting, demonstrating that zolucatetide has shown evidence of clinically meaningful antitumor activity in desmoid tumors, including tumor reductions and 100% disease-control rate (DCR) in all 10 patients with at least one post-baseline scan and an 80% objective response rate (ORR) in the five patients with more than one post-baseline scan per RECIST 1.1.

The FDA grants Orphan Drug Designation to drugs and biologics that are intended for safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits towards the cost of clinical trials upon approval and prescription drug user fee waivers. Products with Orphan Drug Designation status are also entitled to a potential seven years of regulatory exclusivity following regulatory approval.

Beyond desmoid tumors, zolucatetide is being evaluated across a broad range of rare and common Wnt/β-catenin-driven tumor types. Clinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC 2025 meeting showed zolucatetide had single-agent activity in five low-complexity tumor types where Wnt/β-catenin mutations are the primary drivers of disease – including desmoid, adamantinomatous craniopharyngioma (ACP), ameloblastoma, salivary gland cancer, and solid pseudopapillary neoplasm (SPN) – with strong scientific rational for combination therapy in more complex cancers such as microsatellite-stable colorectal cancer (MSS CRC). Parabilis also shared early data indicating the potential of zolucatetide in hepatocellular carcinoma (HCC) and familial adenomatous polyposis (FAP) at the JP Morgan Healthcare conference earlier this year.

The company plans to share additional data readouts in 2026 from its ongoing Phase 1/2 trial of zolucatetide, in which more than 150 patients have been dosed to date.

About Zolucatetide (Previously FOG-001)

Zolucatetide is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors and is currently in clinical development. By directly targeting the β-catenin:TCF protein-protein interaction, zolucatetide is intended to block the Wnt signaling pathway irrespective of the various APC and β-catenin mutations that typically drive disease.

Zolucatetide combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: zolucatetide acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and zolucatetide blocks the Wnt pathway at the key downstream node, disrupting the interaction between β-catenin and the TCF transcription factors, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis.

Zolucatetide is currently being evaluated in a Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors. Zolucatetide has received Fast Track Designation and Orphan Drug Designation for the treatment of desmoid tumors from the U.S. Food and Drug Administration (FDA).

About the Phase 1/2 trial of Zolucatetide

Zolucatetide is being evaluated in a Phase 1/2 multicenter, open-label study (NCT05919264) assessing its safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity. The trial includes dose-escalation and dose-expansion phases and is testing zolucatetide both as a monotherapy and in combination with other anticancer agents in patients with advanced or metastatic solid tumors likely or known to harbor a Wnt pathway–activating mutation (WPAM).

(Press release, Parabilis Medicines, MAR 11, 2026, View Source;cateninTCF-Interaction-Receives-FDA-Orphan-Drug-Designation-for-the-Treatment-of-Desmoid-Tumors [SID1234663462])