Azitra Receives Study May Proceed letter from the FDA for IND to Treat Skin Rash from EGFR Inhibitors
Azitra Inc (AZTR)
Company Research
Source: Business Wire
New investigational new drug (IND) application cleared to proceed by the US FDA for a Phase 1/2 clinical study of ATR-04 for moderate to severe EGFR inhibitor (“EGFRi”) associated dermal toxicity.There are an estimated 150,000 patients with EGFRi-associated skin rash in the US, representing a $1 billion global market size.Preclinical data show ATR-04 reduces IL-36? and Staphylococcus aureus, key drivers of EGFRi-associated skin rash. BRANFORD, Conn.--(BUSINESS WIRE)--Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the clearance of an investigational new drug (IND) application to U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for moderate to severe EGFRi associated dermal toxicity.Francisco Salva, Azitra’s CEO, stated, "We are delighted to announce a new IND clearance in an indication with high unmet need. Many cancer p
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News
- Azitra, Inc. Announces Q3 2024 Financial Results and Provides Business Updates [Yahoo! Finance]Yahoo! Finance
- Azitra, Inc. Announces Q3 2024 Financial Results and Provides Business UpdatesPR Newswire
- Azitra to Present at BIO-Europe 2024Business Wire
- Azitra to Participate in the 2024 Maxim Healthcare Virtual SummitBusiness Wire
- Azitra, Inc. Announces Late-Breaking Presentation at the European Academy of Dermatology and Venereology CongressBusiness Wire
AZTR
Sec Filings
- 11/13/24 - Form 8-K
- 11/12/24 - Form 10-Q
- 11/6/24 - Form SC
- AZTR's page on the SEC website