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Atossa (Nasdaq: ATOS) highlighted a newly published peer‑reviewed hypothesis article and an invited scientific presentation supporting the investigational therapy (Z)-endoxifen for Duchenne muscular dystrophy (DMD) and symptomatic female carriers (D‑CAPs).
The paper maps multi‑pathway mechanisms — ER modulation, PKC‑β1 inhibition, AKT/mTOR and NF‑κB effects — and notes potential advantages over tamoxifen due to more consistent exposure. Atossa plans preclinical validation and fit‑for‑purpose clinical studies focused on safety, PK/PD, functional and cardiac endpoints; a follow‑up manuscript on utrophin modulation is under review.
Atossa Therapeutics (Nasdaq: ATOS) announced four abstracts featuring (Z)-endoxifen research were accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), Dec 9-12, 2025 in San Antonio, TX. The company will present four posters on Dec 11-12 covering DCIS management, a low-dose I-SPY2 endocrine pilot, ESR1 mutant activity, and a Phase 2 neoadjuvant EVANGELINE trial.
Presentations include scheduled poster sessions on Dec 11 (12:30pm–2:00pm CT) and Dec 12 (7:00am–8:30am CT and 12:30pm–2:00pm CT).
Virax Biolabs (NASDAQ: VRAX) completed full UK recruitment for its multi-centre study of the ViraxImmune™ T cell assay in Post-Acute Infection Syndromes (PAIS), reaching the target of 160 participants in a 3:1 randomised design with 40 symptomatic patients each for Long COVID, PTLD, and ME/CFS. Clinical samples will undergo immunological analysis to evaluate assay performance to support UK regulatory filings with the MHRA and inform potential U.S. submissions.
Virax also received constructive FDA feedback from a Sept 10, 2025 pre-submission meeting and plans a U.S. clinical study with Emory University in 2026. Initial readouts are expected in Q2 2026.
Atossa Therapeutics (Nasdaq: ATOS) highlighted enrollment progress and biomarker strategy for the RECAST™ Phase 2 DCIS platform trial ahead of an Early Detection Research Conference presentation on October 21, 2025.
RECAST is a multi-arm, randomized neoadjuvant trial testing standard endocrine therapy and novel agents—(Z)-Endoxifen, elacestrant, Hav-088—with imaging, biomarker discovery, and quality-of-life endpoints. Enrollment began January 2024 with 50 of 400 patients enrolled across 17 active U.S. sites. The trial aims to identify patients suitable for long-term active surveillance and generate interim imaging and biomarker readouts to de-risk later-stage development.
Atossa Therapeutics (Nasdaq: ATOS) announced that Chairman & CEO Steven Quay, M.D., Ph.D. will present at the Maxim Growth Summit on October 22–23, 2025 at the Hard Rock Hotel, New York City.
The company invited new and existing investors to attend or request one-on-one meetings to discuss Atossa's clinical programs, development plans, and capital-allocation strategy focused on preparing data packages for potential regulatory submissions and commercialization.
Investors are directed to the Atossa investor website for presentations, SEC filings, FAQs, and meeting requests.
Atossa (NASDAQ: ATOS) appointed Mark Daniel, CPA, as Chief Financial Officer effective Oct 14, 2025 to lead finance, systems, and capital strategy as the company prepares for commercial launch of (Z)-endoxifen.
Mr. Daniel brings >25 years of life‑sciences finance experience, including weekly revenue forecasting with commercial teams, management of operating budgets >$200M, implementation and certification of SOX controls, programs delivering >$50M in cost savings, stewardship of a $400M cash and investments portfolio, and participation in nearly $1B of equity, convertible debt, and credit transactions.
Atossa Therapeutics (NASDAQ: ATOS) announced expansion of its global intellectual-property strategy for Z-endoxifen, including issuance of an Israeli patent (No. 304863) granted on July 2, 2025 and a Certificate of Patent Renewal confirming fee payment and active status.
The Israeli claims cover oral delayed-release enteric dosage forms with at least 90% Z-endoxifen, optional impurity limits (<2%), defined gastric/intestinal release characteristics, dose strengths (e.g., 1–4 mg and 8 mg), pharmacokinetic targets, and manufacturing methods that enrich the Z-isomer via crystallization and solvent control.
Stealth BioTherapeutics (NASDAQ) launched the Mito Assist™ Patient Support Program and named AnovoRx as exclusive U.S. specialty pharmacy distributor for FORZINITY™ (elamipretide) injection. FORZINITY received FDA accelerated approval on September 19, 2025 as the first treatment for Barth syndrome to improve muscle strength in patients ≥30 kg. Mito Assist provides co-pay assistance, patient assistance for uninsured or underinsured individuals, at-home subcutaneous injection training, and dedicated case management via AnovoRx. Current Expanded Access Program patients meeting the weight requirement will be contacted for transition. Commercial availability through AnovoRx is anticipated by December 2025, pending distribution readiness and payer coverage activation.
The Joint Corp (NASDAQ: JYNT) was named to the Franchise Times Top 400 for 2025, ranking 139 and moving up 11 spots year-over-year. This marks the company's sixth year inside the top 200 franchised systems by global, systemwide sales. The company highlighted growth across the health and medical and personal services sectors and emphasized its retail clinic model offering no-appointment, no-insurance-hassle, affordable chiropractic care with extended hours. Leadership said the ranking validates the brand and supports continued expansion to increase access to routine chiropractic services nationwide.
Atossa Therapeutics (NASDAQ: ATOS) amended its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal ER+/HER2– early breast cancer to a single-arm, open-label, non-registrational design. The amendment reduces planned enrollment from 214 to 40–65 patients, implements a Cohort A two-stage futility rule using Week-4 Ki-67 ≤10% for earlier go/no-go decisions, and retains unchanged patient-safety data collection and DSMC oversight. Run-in data showed a Week-4 Ki-67 ≤10% rate of 86%. The company says the change aims to cut future study costs, accelerate objective readouts, and prioritize NDA-enabling activities in 2026.
