Atossa Therapeutics Receives FDA "Study May Proceed" Letter for (Z)-Endoxifen Investigational New Drug Application for Metastatic Breast Cancer

On January 6, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines for unmet medical needs, reported that the U.S. Food and Drug Administration ("FDA") issued a "Study May Proceed" letter for the Company’s study in metastatic breast cancer which was the subject of a recent investigational new drug application for (Z)-endoxifen.

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"This letter marks an important regulatory milestone for Atossa and to potentially expand the use of (Z)-endoxifen for metastatic ER+/HER2- Breast Cancer. We believe its activity, even in tumors that have developed resistance to other endocrine therapies and in the oncogenic signaling pathway, protein kinase C beta 1 (PKCβ1), may offer a new tool in treating this disease.," said Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer. "We appreciate the FDA’s review and look forward to advancing this clinical investigation."

About (Z)-Endoxifen

(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company’s proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa’s (Z)-Endoxifen is not approved for any indication.

Atossa’s (Z)-Endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.

(Press release, Atossa Therapeutics, JAN 6, 2026, View Source [SID1234661773])

OPKO Health to Participate in the 44th Annual J.P. Morgan Healthcare Conference

On January 6, 2026 OPKO Health, Inc. (Nasdaq: OPK) reported that management will be participating in the 44th Annual J.P. Morgan Healthcare Conference, being held January 12-15, 2026, at the Westin St. Francis Hotel in San Francisco. Management will be hosting one-on-one meetings with investors and will be participating in a fireside chat on Wednesday, January 14th at 1:30 p.m. Pacific time.

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The fireside chat will be webcast live and available for replay in the Investors section of OPKO Health’s website.

(Press release, Opko Health, JAN 6, 2026, View Source [SID1234661758])

AbelZeta to Attend 44th Annual J.P. Morgan Healthcare Conference and Join Panel Discussion

On January 6, 2026 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, reported it will attend the 44th Annual J.P. Morgan Healthcare Conference on January 12-15, 2026 in San Francisco, CA, and host meetings showcasing the Company’s recent accomplishments and sharing strategic plans moving forward. The Company’s Chairman and CEO, Tony (Bizuo) Liu, has also been invited as a panel speaker at the Conference.

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Session:

Emerging Biotechs from China

Time & Date:

January 14, 2026, 16:30 – 17:15 PST

Location:

Pacific Hall, Convene, 40 O’Farrell St, San Francisco

Description:

China is emerging as a hub of global biotech innovation. Leveraging on strong capability in early discovery
and clinical resources, China’s biotech companies are joining the global innovation in the next wave of oncology and
autoimmune assets. In this panel, J.P. Morgan invited CEOs with lead assets in cell therapy and other modalities and will
discuss differentiation of their assets and strategy for business developments

(Press release, AbelZeta, JAN 6, 2026, View Source [SID1234661774])

Iksuda to Present Preliminary Analysis of Oesophageal Cancer Data From Phase 1 study of IKS014 at ASCO Gastrointestinal Cancer Symposium

On January 6, 2026 Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), reported the presentation of early analyses of activity in patients with oesophageal cancer during its Phase 1 study of IKS014, a human epidermal growth factor receptor 2 (HER2)-directed ADC, in patients with advanced HER2+ solid tumours, at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in San Francisco, US (8-10 January).

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The Phase 1 study (NCT05872295) is a non-randomised, open-label, multicentre trial evaluating IKS014 in patients with locally advanced or metastatic solid tumours that express HER2. Data was presented from an unplanned sub-population of patients with oesophageal cancers from the dose escalation portion of the trial conducted in Australia, which was designed to establish the maximum-tolerated dose and/or recommended phase 2 dose for IKS014 as monotherapy and to provide initial safety, tolerability, efficacy, PK, PD, and immunogenicity data.

As of July 2025, 62 patients have been treated with IKS014 across five dose levels (40, 60, 90, 120 and 105 mg/m2), including 10 patients with HER2+ oesophageal cancers. Encouraging anti-tumour activity was seen across all dose levels in patients with a variety of tumour indications such as breast, ovarian, gallbladder, lung and oesophageal cancers, and in patients with HER2+ and HER2 low tumours.

Of the sub-set of 10 patients with HER2+ oesophageal cancer, who had received prior therapy (median 3, range 1-6), five achieved a response, including a complete response in one patient with non-measurable disease, whilst three other patients demonstrated stable disease for more than six months, resulting in a clinical benefit rate for IKS014 of 80%. These positive results warrant further exploration, and the dose expansion part of this Phase 1 study will now include an additional expansion cohort specifically for patients with HER2-expressing oesophageal adenocarcinoma who have previously received at least one prior line of standard treatment that may have included a HER2-directed therapy.

Dr. Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, commented: "The early signs of activity and clinical benefit rate in patients with pretreated advanced oesophageal cancer is extremely encouraging. This is a notoriously difficult cancer to treat, with relatively poor survival rates and high treatment toxicity. We look forward to continuing to explore the potential of IKS014 to improve clinical outcomes in this hard-to-treat cancer, as well as across several other HER2-expressing cancers."

Poster Presentation details:

Abstract Title:

Early analysis of activity in esophageal cancer during phase 1 dose escalation of IKS014, a HER2-targeting antibody drug conjugate (ADC), in participants with advanced HER2+ and HER2 low solid tumors

Session Title:

Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers

Date/Time:

8 January 2026, 11:30-13:30 PST

Location:

Level 1, West Hall

Abstract Number:

355

About IKS014

IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with a favourable Therapeutic Index compared with other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences (View Source).

(Press release, Iksuda Therapeutics, JAN 6, 2026, View Source [SID1234661790])

ORIC® Pharmaceuticals to Present at the 44th Annual J.P. Morgan Healthcare Conference

On January 6, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that Jacob M. Chacko, M.D., chief executive officer, will present a company overview at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 9:45 a.m. PT.

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A live webcast of the company presentation will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

(Press release, ORIC Pharmaceuticals, JAN 6, 2026, View Source [SID1234661759])