Adicet Bio shares maintain Neutral rating after FDA IND amendment

On Thursday, H.C. Wainwright maintained its Neutral stance on shares of Adicet Bio Inc. (NASDAQ: ACET), following the company's announcement that the U.S. Food and Drug Administration (FDA) has agreed to an amendment to its Investigational New Drug (IND) application. The amendment will allow Adicet Bio to evaluate its drug candidate ADI-001 for additional autoimmune diseases within its ongoing Phase 1 trial.

ADI-001, Adicet Bio's allogeneic gamma delta T cell product candidate, which includes an anti-CD20 CAR, will now be tested for its potential in treating idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS). These conditions are part of a group of rare autoimmune disorders that lead to chronic muscle inflammation and progressive muscle weakness, affecting primarily the skeletal muscles.

The five main subtypes of IIM, which include dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis, are characterized by a range of symptoms related to muscle inflammation. Similarly, SPS is noted for causing severe muscle stiffness and spasms, predominantly impacting the torso and limbs.

Currently, there is no cure for SPS or the various subtypes of IIM, underscoring the significance of the FDA's agreement to the IND amendment for Adicet Bio's clinical trial. This development could potentially lead to new treatment options for patients suffering from these debilitating autoimmune diseases.

H.C. Wainwright's reiterated Neutral rating comes in the wake of this update, with the firm indicating no change in its stance towards Adicet Bio's stock following the recent advancement in the company's clinical trial program.

In other recent news, Adicet Bio, a biotechnology firm, has been granted approval from the U.S. Food and Drug Administration to expand its Phase 1 trial of ADI-001. The trial now includes two additional autoimmune diseases: idiopathic inflammatory myopathy and stiff person syndrome. This expansion follows the FDA's recent consent to evaluate ADI-001 for three other diseases beyond lupus nephritis, broadening the scope of Adicet Bio's clinical program to six autoimmune indications.

H.C. Wainwright has maintained a neutral rating on Adicet Bio, pending the release of clinical data in autoimmune indications. Adicet Bio has reported positive biomarker data from a Phase 1 GLEAN study, showing that ADI-001 led to the depletion of B cells, a promising development for the treatment of autoimmune diseases.

In response to these developments, Canaccord Genuity and Jones Trading have adjusted their price targets for Adicet Bio. Lastly, Adicet Bio has expanded its board with the appointment of Dr. Lloyd Klickstein, an expert in rheumatology, immunology, and drug development, expected to advance its autoimmune programs. These are the recent developments for Adicet Bio.

InvestingPro Insights

As Adicet Bio (NASDAQ: ACET) advances its clinical trial program for ADI-001, investors may find additional context from InvestingPro's real-time data and tips. The company's market capitalization stands at $122.78 million, reflecting its current position in the biotech sector.

InvestingPro Tips highlight that Adicet Bio holds more cash than debt on its balance sheet, which could be crucial for funding its ongoing clinical trials and potential expansion into new autoimmune disease treatments. This financial stability is particularly important given that the company is not currently profitable, as indicated by its negative P/E ratio of -1.02 over the last twelve months.

Despite the challenging path to profitability common in biotech firms developing novel therapies, ACET has shown a strong return over the last three months, with a price total return of 16.41%. This recent performance may reflect investor optimism about the company's pipeline developments, including the FDA's agreement to expand the ADI-001 trial.

It is worth noting that InvestingPro offers 7 additional tips for ACET, providing a more comprehensive analysis for investors interested in the company's prospects as it pursues treatments for rare autoimmune disorders.

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