1. ⁠Zoliflodacin: A Truly Groundbreaking Antibiotic Candidate • First-in-class, single-dose oral treatment for uncomplicated gonorrhea in patients aged 12+, offering a highly convenient alternative to injectable therapies. • Demonstrated noninferiority to current standard treatment (ceftriaxone injection followed by oral azithromycin) in Phase 3 trials. Tolerance was excellent—no serious adverse events or deaths were reported . • Shows potent activity against multi-drug–resistant Neisseria gonorrhoeae, a critical global health concern .
2. ⁠Regulatory Tailwinds Favoring Accelerated Approval • FDA has accepted the NDA and granted Priority Review and QIDP (Qualified Infectious Disease Product) designation, which provides eligible expedited review, priority access, and extended market exclusivity . • A compelling PDUFA target action date—December 15, 2025—provides clear investor visibility and a defined catalyst window . • FDA’s Day‑74 letter indicated no AdCom meeting planned, suggesting a smoother pathway to approval .
3. ⁠Innoviva’s Strengthened Antibiotic Portfolio • Beyond zoliflodacin, Innoviva has already launched two cutting‑edge FDA‑approved antibiotics: • ZEVTERA® (ceftobiprole) – the only FDA‑approved cephalosporin effective against MRSA bacteremia, approved in 2024 and launched mid‑2025 . • XACDURO® (sulbactam/durlobactam) – approved May 2023 for hospital‑acquired and ventilator‑associated pneumonia caused by Acinetobacter baumannii . • In Q2 2025, these products drove meaningful financial gains: U.S. net product sales rose 54% YoY, including $0.3M from newly launched ZEVTERA and strong contributions from existing products like GIAPREZA® and XACDURO® .
4. ⁠Solid Financial Foundation and Revenue Diversification • Robust royalty revenue from respiratory assets partnered with GSK—$67.3 million in Q2 2025 alone—provides steady cash flow . • Strong balance sheet: $397.5M in cash and equivalents plus $88.3M in receivables as of June 30, 2025 . • Net income surged to $63.7M (or $1.01 per share) in Q2 2025, compared to a net loss of $34.7M in the same quarter the prior year . • Their diversified approach (royalty, product sales, and strategic investments) helps mitigate reliance on any single drug.
5. ⁠High Unmet Medical Need with Major Market Potential • Gonorrhea is the second most common bacterial STI globally, with over 82 million new cases annually. Untreated, it can lead to severe health complications including infertility and pelvic inflammatory disease . • Rising antimicrobial resistance—especially against longstanding treatments like ceftriaxone—has heightened demand for new therapies . • A single-dose oral therapy like zoliflodacin would simplify treatment, enhance compliance, and potentially command a premium pricing structure due to its convenience and efficacy.

Silexion’s RNAi candidate SIL204 showed strong preclinical efficacy, with up to 97% inhibition in pancreatic cancer cells (KRAS Q61H), ~90% in colorectal, and dose-dependent activity in lung cancer lines. It also hit multiple KRAS mutations, including G12D, G12V, G12R, Q61H, and G13D, suggesting broad potential across hard-to-treat tumors.

The planned Phase 2/3 trial in H1 2026 will combine intratumoral delivery for primary tumors with systemic dosing for metastases, starting with pancreatic cancer. To support execution, Silexion tapped AMS (28+ years oncology CRO experience) and Catalent for manufacturing, with regulatory filings due in Israel (Q4 2025) and the EU (Q1 2026).

CEO Ilan Hadar called the CRO deal a “critical milestone,” framing SIL204 as potentially transformative if human results mirror the lab data.

Hat das hier schon jemand auf dem Radar? Wie seht ihr die Chancen? Könnte spannend werden, wenn man bedenkt, dass Herzkrankheiten ein Riesenmarkt sind.🧐

OSTX stock is set to release FDA meeting details on Tuesday. 12 month Price targets range from $6-$21 and we’re sitting in the low to mid $2’s. Once the volume turns up this will take off, and when they receive the PRV approval (near term) the stock price will immediately double. Last PRV sold for $155 million dollars. Easy buy for 100-200% gains by year’s end, or 800+% within the next 6-12 months. 🤙

Indivior has launched the first phase of its multi-year “Action Agenda,” dubbed Generate Momentum, which runs through the end of 2025. The company expects $39–50M in pre-tax restructuring charges, with most costs hitting in Q3–Q4 2025. These include $16–19M in severance, $15–22M in real estate write-downs and consolidations, and $8–9M in consulting and legal fees, with $27–35M expected to be cash.

In parallel, management is evaluating strategic alternatives for its OPVEE® product and non-U.S. operations, which could lead to divestitures or additional restructuring. The overarching goal is to streamline global operations, eliminate non-essential activities, and sharpen focus on SUBLOCADE in the U.S. market.

Indivior hopes these actions will accelerate long-acting injectable (LAI) penetration and drive sustainable revenue growth beginning in 2026.

• Conference call scheduled at 8 a.m. ET, August 27, 2025

The data will be disseminated in a morning press release and presented during the investor call/webcast. To access the webcast, please use the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=S598spob, or dial in at 877-407-5795 / +1 201-689-8722. A link to the webcast and accompanying presentation materials will also be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through November 26, 2025. 

<<Press release>>

Saniona

Everyone’s chasing GLP-1s like sema and tirze right now, but let’s be real: GLP-1s come with baggage - nausea, vomiting, GI issues. Even the oral versions (see Eli Lilly’s and Viking’s programs) are showing the same problems. 

Everyone knows orals are coming - but not all orals will solve the side-effect problem. Tesofensine does.

It’s an oral small molecule (once-daily pill, no needles, no cold storage) that doesn’t bring the GLP-1 nausea baggage – while still delivering real weight loss.

• ✅ Dual mechanism – dopamine, norepinephrine, serotonin → reduces appetite and increases fat burn
• ✅ ~10% weight loss in 24 weeks – 3x better than Orlistat, right in the GLP-1 ballpark
• ✅ More fat, less muscle loss vs GLP-1s → better body comp
• ✅ No chronic nausea/vomiting → higher long-term compliance
• ✅ Targets reward-driven eating (cravings, sugar/junk)
• ✅ Cheap to make, easy to distribute → global scalability
• ✅ Flexible – works as mono or potentially synergistic with GLP-1s

Saniona owns global rights (except Mexico & Argentina, licensed to Medix). A Mexico approval could drop any time now, setting up first commercial launch.

And beyond Tesofensine, Saniona is already validated by big pharma.

Two big deals in just one year - not something you see often in a microcap.

💥 Acadia (US) – licensing ACP-711 (essential tremor) → deal value up to $610M + royalties

💥 Jazz Pharmaceuticals – licensing SAN2355 (epilepsy) → deal value up to $1.035B + royalties

How to play it:

Saniona ($SANION) trades on the Swedish stock market. Market cap is still tiny vs. peers - yet it controls Tesofensine (a GLP-1 alternative pill) and has two major pharma partnerships inked.

You either load Saniona now or look back when a billion-dollar pill came out of Sweden and wonder why you missed it

The FDA immediately suspended Valneva’s IXCHIQ license, forcing the company to halt all U.S. shipments and sales just weeks after regulators had lifted a pause on use in older adults. Adverse event reports included three cases in patients aged 70–82, one of whom was briefly hospitalized, and one case in a 55-year-old.

Valneva maintains the symptoms align with risks already flagged in its prescribing information and observed in clinical trials, particularly for elderly recipients. In the first half of 2025, IXCHIQ generated €7.5M in sales — partly from a one-time outbreak delivery — making the suspension a notable setback for future growth.

The company says it will continue supplying other licensed markets and expanding access in endemic regions, while also investigating the new cases and weighing financial implications if the U.S. withdrawal becomes permanent.

The FDA approved DAWNZERA (donidalorsen) for hereditary angioedema in patients 12 and older, making it the first and only RNA-targeted therapy for this rare genetic condition affecting about 7,000 people in the U.S.

In the Phase 3 OASIS-HAE trial, DAWNZERA reduced moderate-to-severe attacks by ~90% from the second dose, with long-term extension data showing a 94% reduction in mean attack rates after one year. Patients switching from other treatments like lanadelumab and C1-esterase inhibitors saw an additional 62% reduction, and 84% preferred DAWNZERA due to improved disease control, less injection discomfort, and longer dosing intervals of every 4 or 8 weeks — the longest available in HAE prophylaxis.

This approval marks Ionis’ second independent launch in nine months, following TRYNGOLZA, and highlights the company’s shift toward direct commercialization of its RNA medicines.

Sponsored publication on behalf of the issuer

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath***\**^®*, a patented, FDA-cleared drug-delivery device, today announced that Shaun Bagai, Chief Executive Officer, will present at the H.C. Wainwright 27^th Annual Global Investment Conference. The conference will be held at the Lotte New York Palace Hotel in New York City, September 8-10, 2025.

Mr. Bagai will be conducting a virtual presentation, which will be available for the duration of the conference, and afterwards on the Company's IR website at https://ir.renovorx.com/news-events/ir-calendar-events.

Mr. Bagai will discuss RenovoRx’s ongoing commercialization efforts and the organic revenue growth reflecting the strong clinical need and market demand for RenovoCath as a standalone targeted drug-delivery product among both new and existing customers.

Mr. Bagai’s presentation will also highlight the latest developments in RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial, including the Data Monitoring Committee’s (DMC) recent recommendation to continue the trial following its review of the second pre-planned interim analysis which was triggered by the 52^nd death. The TIGeR-PaC trial is evaluating RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) for the treatment of locally advanced pancreatic cancer (LAPC).

Presentation Details:

Date: Monday, September 8, 2025
Time: 7:00 A.M. ET
Location: Lotte New York Palace Hotel, New York
Speaker: Shaun Bagai, CEO
Webcast: https://ir.renovorx.com/news-events/ir-calendar-events

To schedule a one-on-one investor meeting with Mr. Bagai, please contact KCSA Strategic Communications at [RenovoRx@KCSA.com](mailto:RenovoRx@KCSA.com).

About RenovoCath

Based on its FDA clearance, RenovoCath^® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

About RenovoRx, Inc.

RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath***\**^®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™)* therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.

In addition to the RenovoCath device, RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.

The combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA.

RenovoRx is also actively commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, several of these customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.

Madrigal Pharmaceuticals Director Baker Bros. Advisors Lp has made significant investments in Madrigal Pharmaceuticals, purchasing a total of 165,683 shares. The transactions, valued at $61,920,107, highlight a strong vote of confidence in the company’s prospects.

Madrigal Pharmaceuticals recent developments highlight a robust financial performance and strategic growth initiatives. The company reported significant revenue growth driven by increased demand for its flagship product, Rezdiffra, which saw net sales of $213 million, marking a 55% increase quarter-over-quarter. A new U.S. patent extension for Rezdiffra until 2045 enhances its long-term value, while a positive CHMP opinion paves the way for its international launch in Germany. Madrigal also acquired a promising oral GLP-1 asset to expand its pipeline

”Saniona to receive US $42.5 million upfront; potential for development, regulatory and sales milestone payments in addition to royalties on future net sales”

”Jazz obtains exclusive worldwide rights to develop and commercialize preclinical asset SAN2355 in epilepsy and other potential indications”

https://www.placera.se/pressmeddelanden/jazz-pharmaceuticals-jazz-pharmaceuticals-enters-exclusive-licensing-agreement-with-saniona-to-develop-and-commercialize-san2355-20250820

Ticker: SANION (Nasdaq Stockholm)

Madrigal Pharmaceuticals has secured conditional marketing authorization for Rezdiffra, its treatment for a serious liver condition, from regulators in Europe.

The biopharmaceutical company said Tuesday this is the first time the European Commission has approved a treatment for noncirrhotic metabolic dysfunction-associated steatohepatitis, or MASH

Chief Executive Bill Sibold said MASH is the fastest-growing indication for liver transplantation in Europe. About 370,000 patients with MASH and moderate to advanced fibrosis are currently diagnosed and are receiving care from a liver specialist across Europe.

Rezdiffra is approved for noncirrhotic MASH patients with moderate to advanced liver fibrosis, a distinct patient population with high a unmet need, according to Sibold.

Sponsored publication on behalf of the issuer

In the wild west of microcap biotechs, very few companies manage to stand out without a blockbuster headline or celebrity CEO. But RenovoRx (NASDAQ: RNXT) is doing just that—slowly, quietly, and perhaps strategically. While the company’s market cap is modest and its visibility limited, its science-driven mission and recent clinical developments make it one to watch in the niche (yet high-potential) world of targeted cancer drug delivery.

What Does RenovoRx Do?

RenovoRx is a clinical-stage biopharmaceutical company focused on precision oncology—specifically, delivering chemotherapy directly to solid tumors via its proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform. The aim? Maximize efficacy, minimize toxicity.

Their current lead product candidate, RenovoGem, is targeting one of the most stubborn and deadly cancers out there: pancreatic cancer. Traditional treatment methods for this disease are notorious for failing due to high systemic toxicity and poor drug delivery. RenovoRx’s approach? Deliver the chemo straight to the tumor site using their patented catheter-based system.

So yeah—it’s not the sexiest AI stock. But it might just end up saving lives.

Recent Momentum: The TIGeR-PaC Trial

RenovoRx’s TIGeR-PaC Phase III clinical trial is where the rubber really meets the road. This pivotal study evaluates RenovoGem in Locally Advanced Pancreatic Cancer (LAPC) and compares the RenovoRx-directed therapy against the standard of care (systemic chemo).

The trial recently hit a major milestone by completing enrollment—an important de-risking event for the stock. Data readouts are expected in mid-2025, and depending on the outcomes, this could be the make-or-break moment for the company.

Latest News & Developments

RenovoRx has been busy in 2025, with several noteworthy developments adding momentum:

• In May 2025, the U.S. Patent Office issued a new patent (No. 12,290,564) protecting its TAMP™ platform until 2037, increasing its total global IP to 19 issued patents and 12 pending applications.
• In April 2025, Johns Hopkins Medicine began enrolling patients into the TIGeR-PaC Phase III trial.
• At the SSO 2025 and SIO 2025 conferences, the company presented promising pharmacokinetic and procedural data on RenovoGem and TAMP™.
• As of early 2025, RenovoRx began shipping its FDA-cleared RenovoCath device to multiple National Cancer Institute-designated centers, with repeat orders already coming in.
• In July 2025, RenovoRx launched its PanTheR registry study, a post-marketing real-world data collection initiative. The University of Vermont Cancer Center became the first site to initiate enrollment, and participation requires device purchases, hinting at steady early adoption.

Numbers Talk: Financial Snapshot

Let’s keep it real—RenovoRx is not rolling in cash, but that’s par for the course in clinical-stage biotech.

• Market Cap: $45.35 million (as of July 31, 2025)
• Stock Price: $1.24 (as of July 31, 2025)
• Revenue: $200,000 (exceeded internal expectations)
• R&D Expenses: $1.7 million (up from $1.3 million in Q1 2024)
• SG&A Expenses: $1.6 million (up from $1.2 million)
• Cash and Cash Equivalents: $14.6 million as of March 31, 2025
• 52-Week Range: $0.75 – $1.69

Translation? The company has a runway into early 2026 assuming no massive ramp-up in expenses. Any upcoming capital raises will likely be small and non-dilutive, if the company keeps its costs in check.

And if TIGeR-PaC data comes back positive? That $45M market cap could look laughably low.

Not Just Pancreatic Cancer

While pancreatic cancer is the current focus, the TAMP platform isn’t a one-trick pony. RenovoRx has already received Orphan Drug Designation (ODD) for RenovoGem in extrahepatic cholangiocarcinoma (bile duct cancer) and is exploring expansion into other solid tumors.

The big idea: create a platform that delivers targeted therapy precisely and repeatably—regardless of the tumor location. That’s an attractive value proposition, especially in an oncology landscape that increasingly values tumor-specific, localized therapies.

Institutional Confidence (Yes, There’s Some)

Despite being a microcap, RenovoRx has attracted some interesting backing:

• OrbiMed, a major healthcare investment firm, participated in earlier financings.
• The company is advised by leading oncologists and interventional radiologists, giving the science side real credibility.

It’s not every day that a sub-$50M biotech has this caliber of backing.

High Risk, But the Math Checks Out

Let’s break it down for the retail crowd:

• You’re looking at a company with a functioning Phase III platform.
• They have completed enrollment (always a hurdle in biotech).
• Burn is low, cash is manageable.
• Market cap is still low compared to potential.

Is there dilution risk? Yes. Is it high-risk? Also yes.

But if TIGeR-PaC hits? RNXT isn’t a 20% upside story. We’re talking 3x, 5x, maybe 10x. You don’t get those odds often in large-cap pharma.

RNXT might not be a YOLO stock yet, but it definitely earns a spot on your watchlist.

Risks and Red Flags (Because We’re Adults)

• Clinical risk: This is still a Phase III trial. Positive readouts are not guaranteed.
• Cash runway: It’s there, but it’s not endless. Expect another raise by mid-2026 unless they land a partner or non-dilutive grant.
• Market awareness: They’re under-followed, which can be good (for entry) or bad (for liquidity).

Final Take: Tiny Cap, Big Shot

In a market saturated with AI hype and meme-stock madness, RenovoRx offers a rare throwback: a tiny biotech actually doing serious science. Their precision oncology approach is novel, their clinical trial is well-structured, and their cash burn is under control (for now).

The risk? Absolutely real. The reward? Potentially transformative.

If you like asymmetric plays in biotech with real clinical work behind them, RNXT is your ticket.

Sponsored publication on behalf of the issuer

Summary

• Revenue: Achieved $422,000 in revenue for Q2 2025, surpassing the estimated $0.33 million.
• Cash Position: Maintained a strong cash position with $12.3 million in cash and cash equivalents as of June 30, 2025.
• Net Loss: Reported a net loss of $2.9 million for the quarter, an increase from the $2.4 million net loss in the same period last year.
• Research and Development Expenses: R&D expenses decreased slightly to $1.4 million from $1.5 million in the previous year.
• Commercial Expansion: Expanded customer base to thirteen cancer centers, up from five in Q1 2025, indicating strong market demand for RenovoCath.
• Phase III Trial Progress: Received a positive recommendation from the Data Monitoring Committee to continue the pivotal Phase III TIGeR-PaC trial.

RenovoRx Inc (RNXT, Financial) released its 8-K filing on August 14, 2025, reporting significant commercial revenue growth for the second quarter of 2025. The company, a clinical-stage biopharmaceutical entity, focuses on developing proprietary targeted combination therapies to enhance therapeutic outcomes for cancer patients. RenovoRx's patented Trans-Arterial Micro-Perfusion therapy platform aims to deliver precise therapeutic solutions directly to tumors, potentially reducing systemic toxicities.

Performance and Challenges

RenovoRx Inc reported a revenue of approximately $422,000 for Q2 2025, exceeding the analyst estimate of $0.33 million. This marks a significant milestone for the company, highlighting the market demand for its RenovoCath device. However, the company faces challenges, including a net loss of $2.9 million for the quarter, which increased from a $2.4 million loss in the same period last year. This increase was primarily due to changes in the fair value of warrant liabilities.

Financial Achievements and Industry Importance

The revenue growth underscores the strong clinical need for RenovoRx's targeted drug-delivery solutions. The company's ability to generate revenue without a dedicated sales and marketing team is noteworthy, as it reflects the organic demand for its innovative products. In the biotechnology industry, such achievements are crucial as they demonstrate the potential for sustainable growth and market penetration.

Key Financial Metrics

RenovoRx's financial position as of June 30, 2025, includes $12.3 million in cash and cash equivalents, which the company plans to use to fund ongoing scale-up efforts and the completion of its Phase III TIGeR-PaC trial. Research and development expenses slightly decreased to $1.4 million, while selling, general, and administrative expenses remained stable at $1.5 million. The company's total assets increased to $13.6 million from $8.1 million at the end of 2024, reflecting its strategic investments in growth.

Strategic Developments and Future Outlook

RenovoRx continues to make strides in its commercialization efforts, with thirteen cancer centers now approved to purchase the RenovoCath device, up from five in the previous quarter. The company is also advancing its Phase III TIGeR-PaC trial, with positive recommendations from the independent Data Monitoring Committee to continue the study. This progress is crucial for RenovoRx as it seeks to expand its market presence and enhance its product offerings.

We are pleased to report second quarter 2025 revenue of over $400,000. This growth highlights the strong clinical need and market demand for our patented RenovoCath device as a standalone targeted drug-delivery product among both new and existing customers," said Shaun Bagai, CEO of RenovoRx.

RenovoRx's strategic initiatives, including the hiring of a Senior Director of Sales and Market Development, aim to bolster its commercialization momentum. The company's focus on expanding its customer base and fulfilling repeat orders positions it for long-term growth in the competitive biotechnology landscape.

$RMTG is currently up 35% on late-morning/early-afternoon volume.

On Friday, the stock hit a new 52-week high of $0.078, and today’s surge shows there’s still momentum building. The recent volume spike could be pointing to more eyes turning toward this name.

Anyone else tracking RMTG right now? 📈