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EnteroBiotix Announces Completion of Enrolment in Phase 2a Trial Evaluating EBX-102-02 Prior to Allogeneic Stem Cell Transplantation

On March 10, 2026 EnteroBiotix, a clinical-stage biopharmaceutical company developing best-in-class microbiome therapies, reported that the investigator-initiated Phase 2a MAST trial (Intestinal Microbiota Transplant prior to Allogeneic Stem Cell Transplantation) has completed its enrolment of 50 adult patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) for defined haematological malignancies. Participants receive EBX-102-02 or matched placebo prior to conditioning chemotherapy and are followed for 12 months post-transplant.

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The study is sponsored by Imperial College London and funded by the Medical Research Council (MRC). It is led by Co-Chief Investigators Professor Julian Marchesi and Dr Jiri Pavlu, together with haematologists across leading UK transplant centres. EnteroBiotix is supplying EBX-102-02 for use in the trial.

Profound disruption of the gut microbiome is common during allo-HSCT, and loss of microbial diversity has been associated with increased risk of infection, graft-versus-host disease (GVHD) and reduced overall survival. The MAST trial will assess whether a single dose of pre-emptive orally administered EBX-102-02 can enhance and preserve microbial diversity during the transplantation period. Exploratory outcomes evaluate clinical transplant outcomes. Topline data are expected in H1 2027.

MAST builds on EnteroBiotix’s broader clinical programme, following previously announced positive Phase 2a data in irritable bowel syndrome (IBS) and Phase 1b data in liver cirrhosis, and supports the Company’s strategy to develop full-spectrum microbiome therapeutics across major disease areas supported by a strong biological rationale.

Professor Julian Marchesi said:

"Profound disruption of the intestinal microbiome is common during allogeneic stem cell transplantation and has been strongly associated with adverse outcomes. MAST builds on prior promising work from the Imperial team utilising traditional FMT approaches and has been designed to assess whether pre-emptive microbiota restoration using EBX-102-02 can preserve microbiome diversity during the transplant period and potentially improve post-transplant outcomes. We are pleased to have completed enrolment and thank the patients and clinical teams involved."

Dr James McIlroy, Chief Executive Officer of EnteroBiotix, said:

"Completion of enrolment in MAST builds on our recent progress in IBS and cirrhosis and marks another step in evaluating the potential of EBX-102-02 across multiple indications with high unmet medical need. We are excited about the potential of our platform and technology for supporting the treatment of oncology patients. We thank the Imperial investigators for their collaboration and look forward to topline data in H1 2027."

Trial Design

MAST (NCT06355583) is a multicentre, randomised (1:1), double-blind, placebo-controlled Phase 2a trial enrolling approximately 50 adult patients undergoing allo-HSCT for certain haematological malignancies. Participants receive EBX-102-02 or matched placebo prior to initiation of conditioning chemotherapy and are followed longitudinally for 12 months after allo-HSCT.

The primary endpoint evaluates change in gut microbiota alpha diversity from baseline to post-transplant timepoints. Secondary and exploratory endpoints include safety, tolerability, clinical transplant outcomes, and translational microbiome and immune analyses.

About EBX-102-02

EBX-102-02 is EnteroBiotix’s next-generation full-spectrum investigational microbiome therapeutic, manufactured using proprietary processing technologies designed to enable safe, stable and orally delivered microbial ecosystem restoration. The product is formulated to deliver consistently high microbial diversity with a robust stability profile.

(Press release, EnteroBiotix, MAR 10, 2026, View Source [SID1234663433])

TECVAYLI® (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy

On March 10, 2026 Johnson & Johnson reported the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI▼(teclistamab) as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.

Bringing new hope to a high unmet need population
Despite major advances in frontline multiple myeloma treatment, including anti-CD38-based quadruplet regimens, most patients will ultimately relapse.2 Outcomes are particularly poor once patients become refractory to key backbone therapies such as anti‑CD38 monoclonal antibodies and lenalidomide.2,3 This patient population has historically faced limited choices and challenging second-line treatment pathways, reinforcing the need for additional effective immunotherapy options that can be given across practice settings.3

"A significant number of patients with multiple myeloma continue to relapse and become refractory to currently available therapies, representing one of the largest and most challenging unmet needs in the disease," said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "Making teclistamab monotherapy available to patients as early as second line, where it has the potential to meaningfully improve long-term outcomes and change the course of the disease, could bring new hope to patients and their families."

MajesTEC-9 study results
The submission is supported by data from the Phase 3 MajesTEC-9 trial evaluating the efficacy and safety of teclistamab versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in 614 patients with RRMM.1 Results show teclistamab delivers superior progression-free survival (PFS) and overall survival (OS) versus standard of care as early as second line, including a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83) in a patient population that was predominantly refractory to anti-CD38 monoclonal antibodies and lenalidomide.2

The safety profile of teclistamab monotherapy was clinically manageable and consistent with its known profile, with no new safety signals identified.2 Infections can be managed with robust infection management protocols, which include patient monitoring, immunoglobulin therapy and antimicrobial prophylaxis.4

The Independent Data Monitoring Committee recommended unblinding the study based on the strength of the data in the first pre-specified interim analysis.2 This submission represents the first of several planned global regulatory filings, with full results to be presented at a future major medical meeting.

"At Johnson & Johnson, we are driven by a clear purpose to deliver innovations that redefine expectations of what a multiple myeloma diagnosis means to patients, at every stage of the disease," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson. "With today’s regulatory milestone for teclistamab, we are advancing a widely available immunotherapy approach with the potential to support deep and sustained responses over time."

About the MajesTEC-9 study
MajesTEC-9 (NCT05572515) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide.1 The majority of patients enrolled were refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%) and more than 90% were refractory to their last line of therapy.2 The primary endpoints are progression-free survival (PFS) and the number of participants reporting cytokine release syndrome (CRS) cases by severity.1 Secondary endpoints include complete response or better (≥CR); duration of response (DOR); time to next treatment (TTNT); progression-free survival on next-line therapy (PFS2); overall survival (OS); number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity; change from baseline in symptoms, functioning and overall health-related quality of life (HRQoL) as assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30); and time to worsening in symptoms, functioning and overall HRQoL.1 The MajesTEC-9 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.1

About Teclistamab
Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.5 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.6

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.4,7 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. Teclistamab is currently being evaluated in several combination studies.4,8,9,10,11

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: View Source

In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.

About Multiple Myeloma
Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.12,13 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.12,13 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.14 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.15,16,17 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.

(Press release, Johnson & Johnson, MAR 10, 2026, View Source [SID1234663432])

Piston Bio Announces FDA Alignment on PST-101 Development Program for Cancer-Related Apathy

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.

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])

Erasca Exercises Option to Secure Worldwide Rights for ERAS-0015 Pan-RAS Molecular Glue to Include China, Hong Kong, and Macau

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.

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])

BioXcel Therapeutics Announces Approximately $8.0 Million Registered Direct Offering

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.

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])