Caribou Biosciences to Evaluate Strategic Alternatives

On October 6, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported that it is exploring strategic alternatives to maximize stockholder value and plans to discontinue further development activities for its two allogeneic CAR-T cell therapy programs, vispa-cel for the treatment of relapsed or refractory (r/r) B cell non-Hodgkin lymphoma and CB-011 for the treatment of r/r multiple myeloma. In line with this decision, Caribou will implement workforce and cost reductions.

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"This is an extraordinarily difficult decision, particularly because it is in no way a reflection of our belief that vispa-cel and CB-011 have the potential to benefit patients. Vispa-cel is pivotal trial-ready, with FDA alignment already reached on the phase 3 clinical trial design. We believe both programs have demonstrated the potential for allogeneic CAR-T cell therapies to deliver deep and durable responses, while meaningfully expanding access for patients who urgently need treatment options," said Rachel Haurwitz, PhD, president and CEO of Caribou. "Unfortunately, despite the progress we’ve made, the current financing environment for allogeneic CAR-T cell therapies has made it increasingly challenging to secure the capital necessary to responsibly advance these programs. As a result, we’ve made the difficult decision to evaluate strategic alternatives and plan to discontinue further development of our allogeneic CAR-T cell therapy programs. We’re deeply grateful to the patients and families who placed their trust in us, the physicians and site teams who partnered with us, and every member of the Caribou team whose skill and commitment brought these programs this far and advanced the field of cell therapy."

Caribou’s Board of Directors approved initiating a process to evaluate strategic alternatives, including, but not limited to, a merger, acquisition, business combination, or other strategic transactions involving Caribou and/or its assets. Wedbush Securities Inc. has been engaged as the company’s exclusive financial advisor to assist in the strategic evaluation process. Caribou has not set a timeline for the completion of review of strategic alternatives and does not intend to provide further updates unless and until the Board of Directors has approved a course of action, the review process is concluded, or other disclosure is otherwise determined to be appropriate. In conjunction with this announcement, Caribou plans to discontinue further clinical development activities and implement a substantial reduction in workforce, which is expected to be mostly complete in the fourth quarter of 2026.

As of June 30, 2026, Caribou had $113.8 million in cash, cash equivalents, and marketable securities.

About vispacabtagene regedleucel

Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. Vispa-cel is pivotal trial-ready, with FDA alignment already reached on the phase 3 clinical trial design. To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy to demonstrate safety, efficacy, and durability on par with autologous CAR-T cell therapies. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About CB-011

CB-011 is an allogeneic anti-BCMA CAR-T cell therapy evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E-peptide fusion protein to blunt immune-mediated rejection. Clinical data from the CB-011 CaMMouflage phase 1 trial has demonstrated the potential for deep, durable responses in patients with r/r MM. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

(Press release, Caribou Biosciences, OCT 6, 2026, View Source [SID1234673212])

BioOra welcomes commitment to unlock CAR T-cell therapy in New Zealand

On October 6, 2026 New Zealand’s advanced cell therapy company BioOra reported the National Party’s commitment to co‑invest $25 million to expand BioOra’s cell therapy manufacturing, research, and clinical facilities in Christchurch, New Zealand.

The commitment, set out in National’s health policy, "More medicines and earlier care", issued 6th October 2026, would support the production of CAR T-cell therapy here in New Zealand. The policy also proposes a national clinical trials target, a single front door for trials, and simpler approvals.

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"We welcome this commitment. Building CAR T-cell and advanced cellular therapy manufacturing in New Zealand is about sovereign capability, creating skilled jobs, and growing the biotech industry in the South Island. This is about bringing the next generation of cancer treatment closer to home for New Zealanders", said BioOra Chief Executive John Robson.

"We have engaged constructively with a range of political parties across Parliament and have been encouraged by the support we’ve seen. Sovereign biomanufacturing is a long-term national asset, and we look forward to working with government to ensure that novel cell therapies are available to New Zealanders".

Malaghan Institute of Medical Research Chief Executive Professor Kjesten Wiig said the Malaghan welcomed National’s commitment to unlocking CAR T-cell therapy in New Zealand.

"Making CAR T-cell therapy a standard of care in the public health system has been the ultimate goal of our research and development of New Zealand’s first CAR T-cell therapy, one shared with BioOra".

"Investment in the research, development and delivery of advanced therapies in New Zealand is critical for our future health and prosperity as a nation".

BioOra’s VP of Clinical and Medical Affairs, James Oughton, said the proposed clinical trial measures would also be welcomed across the sector.

"Clinical trials are one of the main ways New Zealanders get access to innovative treatments. A clearer, faster, and more consistent approvals process would make New Zealand a more attractive place to run trials, and that benefits patients, clinicians, and researchers alike".

BioOra currently manufactures a CAR T-cell therapy (atla-cel) for ENABLE-2, a Phase II trial sponsored by the Malaghan Institute of Medical Research. Our goal is to make this therapy available to New Zealand patients after the trial, subject to regulatory approval. Any therapy BioOra produces will go through New Zealand’s independent regulatory and funding processes, including Medsafe, Pharmac, and the Health Technology Evaluation Pathway (HTEP). The trial is expected to close in Q2 2027, and BioOra is committed to providing public access pathways for access to their therapy.

(Press release, BioOra, OCT 6, 2026, View Source [SID1234673211])

ArriVent Announces Program Update from the Phase 3 FURVENT Trial of Firmonertinib in First-Line EGFR Exon 20 Insertion Mutant NSCLC

On October 6, 2026 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported that the FURVENT (NCT05607550) Phase 3 trial evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review (BICR). Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed objective response rate by BICR. Although not yet mature, a trend toward an improvement in overall survival was also observed. The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.

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"These disappointing results are not what we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options," said Bing Yao, Ph.D., Chairman, Chief Executive Officer of ArriVent. "While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study. We are deeply grateful to the patients, investigators and clinical teams who made this program possible and are evaluating the full FURVENT dataset as we determine the most appropriate development path for firmonertinib."

Key Results from the Phase 3 FURVENT Trial

The FURVENT key results are summarized below.

Firmonertinib
240mg
Median PFS
(months) Firmonertinib
160mg
Median PFS
(months) Control
Median
PFS
(months) p-value
(240mg vs.
control) HR (95%
CI)
240mg vs
Control HR (95%
CI)
160mg vs
Control Confirmed
ORR
240mg Confirmed
ORR
160mg Confirmed
ORR
control
BICR
11.0

months

8.4

months

9.5 months 0.0654
0.75

(0.55,
1.02)

0.91

(0.67, 1.25)

60% 35% 33%
Investigator’s Assessment
11.1

months

8.3

months

7.1
months
0.61

(0.46,
0.81)

0.86

(0.65,
1.14)

61% 41% 28%

The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified. Treatment-emergent adverse events (TEAE) Grade ≥ 3 were 52% with firmonertinib 240mg, 53% with firmonertinib 160mg, and 55% with the control arm. Treatment-related adverse events (TRAE) Grade ≥ 3 were 26% with firmonertinib 240mg, 22% with firmonertinib 160mg, and 40% with the control arm.

About FURVENT

FURVENT (NCT05607550) is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per RECIST 1.1. Secondary endpoints include overall survival (OS), PFS by investigator’s assessment, confirmed objective response rate by BICR, and in patients with brain metastases at baseline, brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China.

About Firmonertinib

Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. Firmonertinib is approved in China for first-line advanced non-small-cell lung cancer (NSCLC) patients with EGFR exon 19 deletion or L858R mutations, with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, both known as EGFR classical mutations, as well as for with exon 20 insertion mutations who have experienced disease progression during or after platinum-containing chemotherapy, or who are intolerant to platinum-containing chemotherapy.

Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.

Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA; NCT07185997).

About EGFR mutant NSCLC

Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need.

(Press release, ArriVent Biopharma, OCT 6, 2026, View Source [SID1234673210])

Arovella presents at the Cell and Gene Meeting in Phoenix, Arizona

On October 6, 2026 Arovella reported that it will be presenting at the Cell and Gene Meeting on the Mesa in Phoenix, Arizona.

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The Cell and Gene Meeting is organised by the Alliance for Regenerative Medicine. It is the leading annual conference for the cell and gene therapy sector, bringing together senior executives and industry leaders to advance the development of innovative therapies. It is a chance for Arovella to present to an estimated 1500 attendees from regulators, investors and like-minded researchers and companies.

Arovella’s presentation will be delivered as part of the Innovation Spotlight program, which highlights the latest scientific, clinical, manufacturing, regulatory and commercial advancements from organisations across the advanced therapies ecosystem. The presentation will be delivered by Arovella’s Acting Chief Executive Officer, Dr Nicole van der Weerden.

(Press release, Arovella Therapeutics, OCT 6, 2026, View Source [SID1234673209])

Alpha Tau to Participate in October Investor Conferences

On October 5, 2026 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that company management will participate in the following investor conferences in October 2026.

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Event: Fall Focus: Barclays Biotech 1×1 Day
Format: 1×1 Meetings
Date: Tuesday, October 6, 2026
Location: New York, NY

Event: Investment Generation Conference
Format: Presentation
Date: Thursday, October 15, 2026
Time: 12:30 – 1:00 PM
Location: Rishon Letzion, Israel

(Press release, Alpha Tau Medical, OCT 5, 2026, View Source [SID1234673208])