On March 10, 2026 Piston Bio LLC, a clinical-stage biotechnology company developing therapeutics targeting neuroimmune mechanisms in cancer, reported the completion of a Type B Pre-IND meeting with the Division of Psychiatry and the Division of Oncology of the U.S. Food and Drug Administration (FDA) to discuss the clinical development program for PST-101 in the treatment of cancer-related apathy, a potential first-in-class therapy for this emerging indication.

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At the meeting, Piston Bio aligned with the FDA on key elements of the proposed Phase 2 study design, including endpoints, patient population, treatment duration, and dose selection. The agreed Phase 2 outcome measures include the Apathy Evaluation Scale – Clinician Version, clinician and patient global ratings of disease severity and improvement, and the EORTC QLQ-C30 Role Functioning subscale.

Cancer-related apathy is an underrecognized neuropsychiatric syndrome in patients with cancer characterized by diminished motivation, reduced goal-directed behavior, and impaired engagement in daily activities. Reduced motivation among patients with advanced cancer has been associated with poorer survival. Emerging evidence suggests inflammatory signaling may disrupt dopaminergic motivation circuits in the brain, contributing to apathy. No therapies are approved for cancer-related apathy, representing a significant unmet medical need in oncology.

PST-101 is an adenosine A2A receptor antagonist that modulates dopaminergic signaling in the central nervous system and may restore motivational function in patients with cancer-related apathy.

"We are encouraged by the open and constructive tone of our meeting with FDA," said Walter Hong, MD, Founder and Chief Executive Officer of Piston Bio. "This clarity from FDA de-risks our development strategy, confirms alignment with regulatory expectations, and strengthens our position as we advance PST-101 toward IND submission."

Based on FDA feedback from the meeting, Piston Bio plans to submit an IND for PST-101 in 2026.

(Press release, Piston Bio, MAR 10, 2026, View Source [SID1234663431])

On March 10, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the exercise of its option to expand the existing license agreement with Joyo Pharmatech Co., Ltd. (Joyo) to include China, Hong Kong, and Macau, which will provide Erasca with worldwide rights to its potential best-in-class pan-RAS molecular glue ERAS-0015.

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Under the terms of the ERAS-0015 license agreement, Erasca exercised its option to convert its territory to worldwide and is obligated to make a one-time payment to Joyo based on the stage of Joyo’s development program. Securing rights in China, Hong Kong, and Macau will provide Erasca with exclusive global rights for ERAS-0015, enabling the company to pursue a unified worldwide development and commercialization strategy.

"We are encouraged by the early clinical activity observed for ERAS-0015 across multiple tumor types and RAS mutations at a fraction of the dose seen for RMC-6236. We believe that the clinical data generated to date, including what we have observed from a substantial number of patients treated in China, underscore the potential differentiation and benefit of ERAS-0015 for patients with RAS-mutant cancers globally," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Exercising this option to expand our license agreement and secure worldwide rights reflects our strong conviction in ERAS-0015’s potential, and we look forward to collaborating with the Chinese investigators to continue developing ERAS-0015 for patients in China and globally."

Erasca is advancing ERAS-0015 in the ongoing AURORAS-1 Phase 1 dose escalation trial in patients with RAS-mutant solid tumors with initial Phase 1 monotherapy data expected in the first half of 2026.

About ERAS-0015
ERAS-0015 is an oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability, well-behaved, linear PK, and confirmed and unconfirmed responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed and unconfirmed partial responses at doses as low as 8 mg once daily (QD). In preclinical studies versus RMC-6236, ERAS-0015 demonstrated approximately 8-21 times higher binding affinity to cyclophilin A (CypA), approximately 5 times greater potency in RAS inhibition, and greater in vivo antitumor activity evidenced by achieving comparable or greater tumor growth inhibition or regression at doses that are as low as approximately one-tenth to one-fifth of the dose of RMC-6236. ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species.

(Press release, Erasca, MAR 10, 2026, View Source [SID1234663430])

On March 10, 2026 BioXcel Therapeutics, Inc. (the "Company") (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence to develop transformative medicines in neuroscience, reported that it has entered into a securities purchase agreement with an institutional investor for the purchase and sale in a registered direct offering of 4,500,785 shares (the "Shares") of common stock, par value $0.001 per share ("Common Stock") (or common stock equivalents in lieu thereof), and accompanying warrants (the "Accompanying Warrants") to purchase up to 4,500,785 shares of Common Stock at a combined offering price of $1.739 per Share (or per common stock equivalent in lieu thereof) and Accompanying Warrant. The Accompanying Warrants will have an exercise price of $1.614 per share of Common Stock, will be exercisable at any time after the date of issuance, subject to certain ownership limitations, and will expire five years from the date of issuance.

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The Company has also agreed to reduce the exercise price of warrants to purchase up to an aggregate of 1,385,083 shares of Common Stock previously issued to and currently held by the investor to $1.614 per share and will extend those warrant expiration dates to the five year anniversary of the closing of the offering, effective upon the closing of the offering. The investor will pay approximately $173,000 in exchange for the reduction in exercise price of these warrants.

The transaction will result in aggregate gross proceeds to the Company of approximately $8.0 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company (excluding the proceeds, if any, from the exercise of the Accompanying Warrants).

The closing of the offering is expected to occur on or about March 11, 2026, subject to the satisfaction of customary closing conditions.

Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering.

The securities described above are being offered pursuant to a shelf registration statement on Form S‑3 (File No. 333‑275261) that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on November 13, 2023. The offering of such securities is being made only by means of a prospectus supplement that forms a part of such effective registration statement. A prospectus supplement, which contains additional information relating to the offering, and the accompanying base prospectus will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540‑4414, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

(Press release, BioXcel Therapeutics, MAR 10, 2026, View Source [SID1234663429])

On March 10, 2026 Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers, reported financial results for the full year ended December 31, 2025, and highlighted recent progress.

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"2025 was a year of strong execution as we advanced our AlloNK program, successfully enrolling patients in community settings across autoimmune indications and prioritizing refractory RA as our lead indication," said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. "AlloNK has the potential to redefine the treatment paradigm for refractory RA by combining the durable efficacy of deep B-cell depletion with an outpatient-ready profile suitable for community rheumatology practices."

Dr. Aslan continued, "In 2026, our focus is to advance AlloNK from an early clinical program in the deep B-cell depletion space to what could become the first therapy in this class to initiate a registrational trial in RA, the autoimmune disease with the largest refractory population. We look forward to sharing initial clinical response data and engaging with the FDA on a potential pivotal trial design in refractory RA in the first half of 2026."

Recent Business Highlights

Prioritized refractory RA as lead indication: Received FDA Fast Track designation for AlloNK in refractory RA and prioritized RA as the program’s lead autoimmune indication.
Despite multiple approved biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), there are more than 150,000 RA patients in the U.S. who have failed at least two prior therapies. Real-world data suggest ACR50 response rates at six months are typically in the 10 – 20% range, underscoring the significant unmet need and opportunity for AlloNK plus rituximab to drive deeper and more durable responses with a single treatment cycle.
Artiva has successfully enrolled refractory RA patients across dose levels and will provide initial clinical response data from at least 15 patients, most of whom are expected to have six or more months of follow-up, in the first half of 2026.
Demonstrated deep and consistent B-cell depletion supporting intended mechanism of action: Across patients analyzed, AlloNK plus rituximab resulted in non-quantifiable peripheral CD19+ B-cell levels by Day 13. These findings were confirmed using a high-sensitivity assay with 10- to 50-fold greater sensitivity than standard assays. Early reconstitution data demonstrated predominantly naïve and transitional B cells, consistent with immune reconstitution patterns observed with CD19-directed autologous CAR-T therapies.
Established favorable safety and outpatient feasibility profile in autoimmune disease, leading to strong enrollment: As of the Oct. 1, 2025 data cutoff, 32 patients were treated with AlloNK plus rituximab across refractory RA, Sjögren’s disease, systemic lupus erythematosus (SLE), lupus nephritis and systemic sclerosis, entirely in the outpatient setting, with the majority treated in community rheumatology clinics. The regimen was well tolerated, with no reported cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease or hypogammaglobulinemia.
Reported continued durability in Phase 1/2 oncology trial: Presented longer-term data from the completed Phase 1/2 trial of AlloNK plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma demonstrating a 64% complete response rate and a median duration of response not yet reached, exceeding 19.4 months at data cutoff, in line with commercially approved auto-CAR-T results in a comparable patient population.
Enhanced executive leadership to support late-stage development and capital strategy: Appointed Subhashis Banerjee, M.D. as chief medical officer and Thad Huston as chief financial officer, adding deep rheumatology development expertise, regulatory experience and global financial leadership as AlloNK advances toward potential registrational development.
Strengthened board leadership with deep immunology and commercial expertise: Appointed Dan Baker, M.D. and Elaine Sorg to the board of directors, adding extensive experience in autoimmune drug development, regulatory strategy and large-scale immunology commercialization, including leadership roles supporting major therapies for rheumatoid arthritis and other immune-mediated diseases in multibillion dollar franchises.

Upcoming Milestones

Initial clinical response data in refractory RA expected in the first half of 2026: Artiva expects to report initial clinical response data in at least 15 patients, most of whom are expected to have six or more months of follow-up.
Planned FDA interaction in the first half of 2026 to discuss potential pivotal trial design in refractory RA: Subject to feedback and alignment with the FDA, AlloNK has the potential to become the first deep B-cell depleting therapy to initiate a pivotal trial in patients with refractory RA.

Full Year 2025 Financial Results

Cash, Cash Equivalents and Investments. As of December 31, 2025, Artiva had cash, cash equivalents, and investments of $108.0 million, which is expected to fund operations into Q2 2027.
License and Development Support Revenue. License and development support revenue was zero for the year ended December 31, 2025, compared to $0.3 million for the year ended December 31, 2024.
Research and Development Expenses. Research and development expenses were $69.5 million for the year ended December 31, 2025, compared to $50.3 million for the year ended December 31, 2024.
General and Administrative Expenses. General and administrative expenses were $20.3 million for the year ended December 31, 2025, compared to $17.2 million for the year ended December 31, 2024.
Other Income, net. Other income, net, was $5.9 million for the year ended December 31, 2025, compared to other income, net, of $1.9 million for the year ended December 31, 2024.
Net Loss. Net loss totaled $83.9 million for the year ended December 31, 2025, as compared to net loss of $65.4 million for the year ended December 31, 2024, with non-cash stock-based compensation expense of $6.8 million and $7.0 million for the years ended December 31, 2025 and 2024, respectively.

(Press release, Artiva Biotherapeutics, MAR 10, 2026, View Source [SID1234663428])

On March 10, 2026 C-Further, an international consortium committed to creating new therapeutics for childhood cancers, reported the first early-stage therapeutic programmes for its pipeline, dedicated to paediatric oncology indications. Through its collaborative model, C-Further has partnered with investigators at UVA Comprehensive Cancer Center, Dana-Farber Cancer Institute and Mass General Brigham to advance CF-012 for the potential treatment of Ewing sarcoma. In parallel, the consortium has partnered with investigators at MiNK Therapeutics (Nasdaq: INKT) to advance CF-033, leveraging MiNK’s proprietary platform with translational support by investigators at the University of Southampton, for the potential treatment of multiple children’s cancers, including bone sarcoma, medulloblastoma and acute myeloid leukaemia.

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Enabled by C-Further’s core partners, Cancer Research Horizons, LifeArc and Great Ormond Street Hospital Charity (GOSH Charity), the consortium will support the progression of CF-012 and CF-033 up to preclinical candidate nomination, subject to completion of scientific milestones. Together, these projects form the foundation of C-Further’s expanding pipeline which is supported by an initial $40m (£30m) budget.

Lone Friis, PhD, C-Further Programme Co-lead said: "By combining the pioneering approaches of our scientific collaborators with industry-standard drug discovery capabilities, expertise of our core partners and reach into critical paediatric-focused networks, C-Further is advancing a pipeline of potential first-in-class therapies for childhood cancers. Guided by an indication-agnostic but child-first approach, we believe the initial CF-012 and CF-033 programmes have the potential to address a profound unmet need across multiple children’s cancers."

The selected research partners represent top academic and industry investigators from across the globe, underscoring the international reach and ambition of C-Further.

CF-012 targets ETV6, a newly identified and critical transcriptional dependency that is essential for tumour growth and metastasis. The aim is to develop a potential first-in-class inhibitor with a precise mechanism to disrupt tumour growth and metastasis in young patients.

John Bushweller, PhD, Professor at the University of Virginia School of Medicine and a member of UVA Comprehensive Cancer Center, investigator for CF-012, said: "We’re excited to partner with C-Further to progress CF-012. Children and young people have historically lacked effective, targeted cancer treatments and CF-012 has the potential to address an urgent unmet need in relapsed and metastatic Ewing sarcoma – a rare, aggressive bone tumour that most commonly occurs in young people. With C-Further’s collaborative, child-first drug discovery model, we believe we have the power to bring these medicines to market."

Other key investigators for the CF-012 therapeutic programme include Kimberly Stegmaier, MD, Chair of the Department of Pediatric Oncology at Dana-Farber Cancer Institute, and Miguel Rivera, MD, Assistant Molecular Pathologist at Massachusetts General Hospital.
CF-033 is a potential first-in-class allogeneic iNKT cell therapy engineered with a specific T-cell receptor targeting PRAME, which bridges innate and adaptive immunity and is designed to enable both direct tumour cell killing and broader immune activation within the tumour microenvironment. As an allogeneic, off-the-shelf approach without the need for toxic lymphodepletion, CF-033 has the potential to support more timely treatment delivery and improved tolerability, which are important considerations in paediatric oncology, where new therapeutic approaches are urgently needed.

Marco Purbhoo, PhD, Head of Translational Medicine at MiNK Therapeutics, investigator for CF-033, said: "CF-033 is a PRAME-targeted invariant NKT (iNKT) cell therapy developed to address the urgent needs of children with high-risk cancers, which are often marked by treatment resistance and a weakened immune response that cannot sustain tumour control. Unlike conventional CAR-T or TCR-T therapies, CF-033 harnesses the unique biology of iNKT cells — immune cells that can both directly kill cancer and help coordinate a broader, longer-lasting anti-tumour response. Importantly, this approach is designed to be delivered without the need for HLA matching or toxic lymphodepletion, which is particularly meaningful for this vulnerable paediatric population."

Ali Roghanian, PhD, Associate Professor at the University of Southampton, is the other key investigator leading the CF-033 therapeutic programme.
C‑Further welcomes expressions of interest from researchers, innovators and partners who share its mission to accelerate new tailored and well-tolerated treatments for children and young people with cancer. The deadline to be considered for the next round of submissions is 13 March 2026.

C-Further has also commenced preliminary research on a third, undisclosed project. Additional programmes are expected to be announced in 2026.

(Press release, C-Further, MAR 10, 2026, View Source [SID1234663427])