Prescient Therapeutics ramps up Phase 2 trial as research reiterates valuation upside

On March 17, 2026 Prescient Therapeutics Ltd (ASX:PTX) is advancing enrolment in its Phase 2 clinical trial for lead asset PTX-100, with new research highlighting steady progress across trial execution, regulatory milestones and funding — while pointing to valuation upside from current levels.

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A new report from Pitt Street Research outlines growing momentum behind PTX-100, a first-in-class oncology drug targeting relapsed or refractory cutaneous T-cell lymphoma (CTCL), a rare and difficult-to-treat cancer where treatment options remain limited.

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The therapy works by inhibiting GGTase-1, a pathway involved in cancer cell signalling and survival, offering a differentiated approach compared with existing treatment classes.

Phase 2 footprint expands
The Pitt Street report noted that Prescient’s Phase 2 trial continues to scale, with eight of a planned 16 global sites now established and enrolling patients.

The study is structured in two stages, beginning with dose optimisation before expanding into a broader efficacy and safety phase. Key endpoints include objective response rate, along with progression-free survival and duration of response.

Clinical sites across the US and Australia are already active, with European expansion underway — a key step expected to support recruitment in a relatively small and specialised patient population.

The report highlights European site activation as a critical near-term driver, particularly as new investigators come on board to help lift enrolment rates and accelerate data flow through 2026.

Early data supports differentiated approach
While Phase 2 remains in its early stages, the investment case continues to be anchored by encouraging Phase 1 results.

PTX-100 delivered a 43% overall response rate and a 100% clinical benefit rate in earlier studies, alongside a favourable safety profile with no serious adverse events attributed to the drug.

That combination is particularly relevant in CTCL, where existing therapies often struggle to deliver durable responses without significant side effects.

The research note argues the drug’s unique mechanism and early data position it as a potentially differentiated option in this setting, while also opening the door to broader applications across other cancers.

"PTX-100’s status as the only GGTase-1 inhibitor in clinical development anywhere in the world, and one with far more promising results than any TCL drugs on the market, gives it a uniqueness that is attractive to potential pharmaceutical partners."

Regulatory progress and funding support
Recent regulatory milestones are also strengthening the commercial outlook.

PTX-100 has secured orphan drug designation in both the US and Europe for CTCL, providing incentives such as market exclusivity, regulatory support and reduced fees — factors that can help streamline development and improve long-term economics.

Prescient has also reinforced its balance sheet, raising $9.8 million in capital and receiving a $4.3 million R&D tax incentive refund, extending its cash runway into 2027.

This funding position supports continued clinical progress while allowing the company to explore potential partnering opportunities.

Partnerships and broader pipeline optionality
Beyond PTX-100, the report points to additional upside from Prescient’s pipeline, including its OmniCAR and CellPryme platforms.

These technologies are designed to enhance cell therapy approaches such as CAR-T, addressing limitations around durability, efficacy and control. The company is currently seeking collaborations to advance these programmes, creating additional pathways for value creation.

However, the most significant near-term catalyst remains PTX-100, particularly as Phase 2 data begins to build.

"A pharma partnership — whether in the form of a co-development agreement, regional licensing deal, or broader collaboration — would be a transformative catalyst for Prescient’s valuation and share price."

The report notes that meaningful Phase 2 data will likely be required before major deals are struck, although early engagement with potential partners is already under way.

Valuation highlights upside, with risks in focus
Pitt Street Research has reiterated its valuation range of $0.11 to $0.16 per share, based on a risk-adjusted net present value model incorporating PTX-100, CellPryme and the company’s cash position.

PTX-100 accounts for the majority of that valuation, reflecting its position as the company’s lead and most advanced asset.

At current levels around $0.06 per share, the report implies material upside, contingent on continued clinical progress and successful execution of the Phase 2 programme.

As with all clinical-stage biotech companies, risks remain. Pitt Street notes that for Prescient, these include potential delays in patient enrolment, regulatory uncertainty and the possibility of future capital requirements, alongside the inherent variability of clinical outcomes as trials expand.

According to the researchers, with Prescient’s differentiated mechanism, supportive early data and expanding trial infrastructure, the company is entering a critical period where execution — particularly around enrolment and data delivery — will be key to unlocking that potential.

Alloy Therapeutics Enters Into Agreement to Advance Novel Antibody Discovery Platform

On March 17, 2026 Alloy Therapeutics, Inc. ("Alloy"), a biotechnology ecosystem company dedicated to democratizing access to cutting-edge drug discovery technologies, reported an agreement with AbbVie to develop a new antibody platform to discover potent, specific, and effective antibodies against targets that are difficult to address with current technologies. As part of the multi-year agreement, Alloy will receive an upfront payment, as well as an additional payment in connection with the delivery of the platform to AbbVie.

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The collaboration provides AbbVie with access to the antibody discovery platform as part of its broader research efforts. For Alloy, the collaboration reflects its continued focus on enabling partners through platform-based discovery technologies and reinforces its commitment to advancing antibody therapeutics.

Alloy’s ATX-Gx platform has rapidly become the industry standard for fully humanized transgenic mice, and is now used by over 200 partners to enable many therapeutic discovery programs. Alloy is dedicated to reinvesting its revenue into innovation and has continuously expanded its platform offerings, developing new strains and tools to meet the evolving needs of antibody discovery. This commitment ensures Alloy remains at the forefront of enabling partners to access advanced technologies that accelerate drug development.

"We believe the best technologies are built in close collaboration with partners who share our commitment to innovation and real-world impact," said Davide Schiavone, Senior Director and Head of Genetically Engineered Organisms at Alloy Therapeutics. "This agreement with AbbVie allows us to design a platform that reflects what scientists truly need with practical, modular tools that streamline therapeutic discovery and expand what’s possible in antibody engineering."

(Press release, Alloy Therapeutics, MAR 17, 2026, View Source [SID1234663579])

Soley Therapeutics to Unveil a First-in-Class Small Molecule CKAP2 Modulator with Selective Anti-Tumor Activity at AACR 2026

On March 17, 2026 Soley Therapeutics, a biotechnology company advancing novel therapeutics informed by integrated cell stress biology, reported STX-6398, a first-in-class drug candidate with selective anti-tumor activity through modulation of cytoskeleton-associated protein 2 (CKAP2), a previously undruggable protein central to malignant cancer progression. Preclinical data for STX-6398 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego.

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The AACR (Free AACR Whitepaper) presentation will describe the discovery and preclinical characterization of STX-6398, an oral small molecule that modulates CKAP2 and its downstream signaling pathways. Studies demonstrate selective anti-tumor activity in vitro and in vivo, with efficacy observed across preclinical models following oral administration. These data support advancing STX-6398 as a new therapeutic opportunity for CKAP2-expressing cancers.

"CKAP2 sits at the intersection of microtubule dynamics and malignant progression, shaping proliferation, migration, and angiogenesis," said Yerem Yeghiazarians, M.D., Co-Founder and Chief Executive Officer of Soley Therapeutics. "The data to be presented at AACR (Free AACR Whitepaper) demonstrate that it is possible to pharmacologically modulate CKAP2 with an oral small molecule and achieve meaningful anti-tumor activity across multiple preclinical models. STX-6398 is one of many first-in-class candidates from Soley’s integrated cell stress platform and validates that our approach can enable drugging targets long considered inaccessible."

Soley’s AACR (Free AACR Whitepaper) 2026 Presentation Details

Title: CKAP2 Modulation with a Novel Small Molecule Results in Excellent In-Vitro and In-Vivo Anti-Tumor Activity
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Targets and Pathways
Day and Time: April 20, 2:00 PM to 5:00 PM PDT
Location: Poster Section 15
Poster Number: 3043

(Press release, Soley Therapeutics, MAR 17, 2026, View Source [SID1234663575])

Assertio Reports Fourth Quarter and Full Year 2025 Financial Results

On March 16, 2026 Assertio Holdings reported reported financial results for the fourth quarter and full year ended December 31, 2025.

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Mark Reisenauer, Chief Executive Officer, stated: "Our core asset, Rolvedon, continues to represent a meaningful revenue opportunity, as reflected in both our 2025 results and 2026 outlook, and our strong commercial infrastructure and market access capabilities provide a platform to expand and build an oncology portfolio in a disciplined way.

Since taking over as CEO, I’ve taken a close look at our business to understand where we have a real advantage and where we need to stay disciplined. That has reinforced our focus on finding products that leverage our existing capabilities rather than pursuing on-market specialty product acquisitions, which we do not view as a sustainable path for long-term growth. Our priorities are clear: leverage our core strengths, allocate capital thoughtfully, and build a differentiated oncology franchise that drives durable shareholder value."

Fourth Quarter 2025 Financial Highlights

Rolvedon net product sales were $0.4 million for the fourth quarter of 2025, down from $15.4 million in the prior-year quarter. The expected decline in sales was driven by the sell-in, executed in the third quarter of 2025, which covered the next two quarters of demand to ensure uninterrupted patient supply of Rolvedon as product was transitioned to a new distribution partner and operations were consolidated under a single commercial entity. Rolvedon continues to be a leader in market share in the Medicare Part B clinic space and sales under the new label are expected to begin in the second quarter of 2026.
Sympazan net product sales grew to $3.1 million for the fourth quarter of 2025 from $2.5 million in the prior-year quarter, driven by higher volume and favorable payor mix.
Indocin net product sales were $5.5 million for both the fourth quarter of 2025 and the prior-year quarter, with volume decline from generic competition offset by higher net pricing.
Gross margin1 was 75%, up from 61% in the prior-year quarter, primarily due to the impact of sales product mix as well as inventory write-downs taken in the prior-year quarter.
SG&A expenses were $13.1 million, down from $21.4 million in the prior-year quarter, reflecting lower legal expenses following completion of litigation-related initiatives and lower personnel expenses as a result of restructuring activities in the fourth quarter.
Adjusted EBITDA2 was a loss of $4.1 million for the fourth quarter of 2025, compared with earnings of $3.4 million in the prior-year quarter, driven primarily by the impact of lower Rolvedon net product sales.
Cash, cash equivalents, and short-term investments totaled $63.4 million as of December 31, 2025, compared to $93.4 million as of September 30, 2025 primarily reflecting impacts from the Rolvedon third quarter sell-in. Cash and cash equivalents will be impacted by working capital variability from the Rolvedon sell-in through the first quarter of 2026.
Full-Year 2025 Financial Highlights

Rolvedon net product sales were $68.2 million for full-year 2025, up from $60.1 million in the prior year. The increase was primarily driven by higher volume, including the third quarter sell-in activity, and a $5.4 million favorable adjustment to prior period returns reserve established in connection with the Spectrum acquisition, partially offset by lower net pricing.
Sympazan net product sales grew to $11.3 million for full-year 2025 from $10.5 million in the prior year, driven by higher volume, partially offset by unfavorable payor mix.
Indocin net product sales were $18.9 million for full-year 2025, down from $26.8 million in the prior year, reflecting expected volume and pricing impacts from previously announced generic competition.
Gross margin was 70% in 2025, up from 68% in the prior year, primarily due to a year-over-year decrease in inventory write-downs, and prior year inventory step-up amortization not repeating.
SG&A expenses were $69.0 million for full-year 2025, down from $75.1 million in the prior year, driven by lower legal costs following completion of litigation-related initiatives, a one-time benefit from employee retention tax credits, and lower personnel-related expenses, partially offset by non-recurring Otrexup decommercialization costs.
Adjusted EBITDA3 for full-year 2025 was $22.7 million, up from $18.3 million in the prior year, driven primarily by the impacts of lower SG&A expenses and favorable gross margin.
Cash, cash equivalents, and short-term investments totaled $63.4 million as of December 31, 2025, compared to $100.1 million as of December 31, 2024, primarily reflecting working capital impacts from the Rolvedon third quarter sell-in and cash transferred with the divestment of Assertio Therapeutics.

(Press release, Assertio Holdings, MAR 16, 2026, View Source [SID1234669252])

Half Yearly Report – 31 December 2025

On March 16, 2026 Kazia Therapeutics reported Half Yearly Report.

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(Filing, 3 mnth, DEC 31, Kazia Therapeutics, 2026, MAR 16, 2026, View Source [SID1234669188])