Pharmaceuticals & Biopharmaceuticals

Athens – October 27, 2026 -- Month 6 interim data comparing single-dose Cecolin 9 with Gardasil 9 were presented at the 38th Annual Conference of the International Papillomavirus Society (IPVS 2026), while final results from the Phase III SHINE I study are not expected until 2028.

Navrongo researcher presents Month 6 analysis of PATH's SHINE I study

Dr. Nana A. Ansah of Ghana's Navrongo Health Research Centre presented the interim analysis of PATH's Single-dose HPV Immunobridging Study with New Vaccines (SHINE I; CVIA 104). The Phase III, double-blind, randomized, multinational study runs in Ghana and the Philippines. It compares the immunogenicity and safety of single-dose Cecolin 9, developed by Xiamen Innovax Biotech Co., Ltd. (IX), with Gardasil 9.

Participants include girls aged 9–14 and young women aged 15–20.

TAMPA – October 27, 2026 -- Akari Therapeutics (Nasdaq: AKTX) is planning preclinical studies that pair its PH1 spliceosome-modulating payload with Whitehawk Therapeutics' topoisomerase I inhibitor (TOP1i) ADC platform, CEO Abizer Gaslightwala said in a Virtual Investor "What This Means" interview.

Whitehawk studies target dual-payload synergy

The preclinical work is designed to assess synergy between the two payload classes and to generate data that could support future development of next-generation ADCs. The announcement does not disclose financial terms for the collaboration.

Gaslightwala said recent strategic transactions show the market placing growing value on novel payload innovation. Akari argues PH1 extends beyond conventional payload approaches, and management believes the Whitehawk tie-up supports the platform's broad applicability across future oncology programs.

TAMPA, FL – October 27, 2026 -- Akari Therapeutics (Nasdaq: AKTX) is pairing its proprietary PH1 spliceosome-modulating payload with WhiteHawk Therapeutics' TOP1 inhibitor antibody drug conjugate (ADC) platform to test a dual-payload approach in oncology. President and CEO Abizer Gaslightwala laid out the rationale in a new CEO Corner segment released today. The release does not disclose financial terms.

Akari combines two payload mechanisms in one research program

The strategic research collaboration joins PH1, which targets RNA splicing, with WhiteHawk's TOP1 inhibitor technology. Gaslightwala said the ADC field is moving beyond single-payload development toward combinations of complementary mechanisms. Akari expects the pairing to broaden therapeutic activity and to demonstrate the applicability of PH1 across multiple uses.

Tampa – October 27, 2026 -- Akari Therapeutics (Nasdaq: AKTX) reported a second-quarter 2026 net loss of $4.8 million, up from $1.9 million a year earlier, as research and development spending tripled to $2.1 million ahead of a planned Phase 1 start for its lead antibody drug conjugate (ADC), AKTX-101, in mid-2027.

Akari raised $8.6 million gross in the quarter, lifting cash to $7.7 million

The company closed a private placement with $5.5 million in gross proceeds and booked $3.1 million in gross proceeds from warrant exercises. Total gross financing was approximately $8.6 million, with approximately $8.0 million in net proceeds. Cash stood at $7.7 million on June 30, 2026, up from $5.2 million at December 31, 2025. Akari said long-term strategic investors led the financing.

TAMPA – – October 27, 2026 -- Akari Therapeutics (Nasdaq: AKTX) reported that its TROP2-targeted ADC AKTX-101 slowed tumor growth in urothelial cancer models with limited response to Padcev or acquired resistance to Trodelvy. The company is targeting a Phase 1 start in mid-2027.

AKTX-101 inhibits tumor growth where Padcev shows limited response

In the UM-UC-14 advanced urothelial carcinoma model, which represents metastatic urothelial cancer, AKTX-101 achieved statistically significant tumor growth inhibition versus vehicle. Padcev (enfortumab vedotin), approved as first-line therapy in this setting, had limited responsiveness on the tumor in the same model, according to Akari.

Trodelvy-resistant tumors slow again after switch to PH1 payload

Tumors first treated with Trodelvy (sacituzumab govitecan) developed resistance and resumed growth. When they were switched to AKTX-101, growth slowed again.

TAMPA – October 27, 2026 -- Akari Therapeutics (Nasdaq: AKTX) plans to begin Phase 1 clinical development of its lead antibody drug conjugate, AKTX-101, in mid-2027, with the compound now moving through IND-enabling toxicology and safety studies and large-scale GMP manufacturing.

CEO Abizer Gaslightwala laid out the strategy in a new CEO Corner segment. He argues that payload differentiation will matter more as ADCs move into front-line therapy and patients develop resistance to current payload classes, leaving few follow-on options.

PONTE VEDRA – – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) has agreed to raise $3 million in gross proceeds from a single healthcare-focused institutional investor. Warrants could bring in about $5.8 million more if exercised in full for cash.

Cadrenal prices 960,000 shares at $3.125 with two warrant series attached

The private placement covers 960,000 common shares, or pre-funded warrants in lieu, at a combined price of $3.125 per share with accompanying warrants. The deal is priced at-the-market under Nasdaq rules. Each unit carries series C-1 and series C-2 warrants, each series covering up to 960,000 shares at a $3.00 exercise price. H.C. Wainwright & Co. is exclusive placement agent. Closing is expected on or about July 1, 2026, subject to customary conditions.

PARIS – – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) reported that its 12-lipoxygenase inhibitor CAD-1005 reduced new or worsening thrombotic events by more than 25 percentage points versus placebo in a Phase 2 trial in heparin-induced thrombocytopenia (HIT), with 50% of treated patients affected versus more than 75% on placebo. The data were presented as one of three late-breaking abstracts at the ISTH 2026 Congress in Paris.

Trial is first randomized, blinded, placebo-controlled study in HIT

Principal Investigator Dr. Steven E. McKenzie delivered the oral presentation, which Cadrenal describes as the first randomized, blinded, placebo-controlled trial in HIT patients. CAD-1005 was formerly known as VLX-1005. The study was not sufficiently powered for statistical significance.

Ponte Vedra, Fla. – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) has launched a structured process to secure out-licensing, portfolio monetization or co-development partners for its late-stage cardiovascular assets, after grouping them into a Cardiac Acute Critical Care Franchise.

The company is exploring development, licensing and commercialization deals for CAD-1005, frunexian and tecarfarin. It describes the approach as capital-efficient and says it is shifting to a partnership-driven business model.

PONTE VEDRA, Fla. – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) reached agreement with the FDA on the primary endpoint and placebo-controlled design of its Phase 3 registration study of CAD-1005, a first-in-class 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT). The agreement came at a Type D meeting held July 28, 2026.

FDA accepts thrombus-extension definition of worsening HIT

The agency agreed to define worsening HIT as progression of thrombotic events through Day 14 of treatment or hospital discharge. Worsening will also include extension of an existing thrombus into a new vascular segment or bed. Cadrenal said this avoids site-to-site variability from manual size measurements.

The composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.