The biotechnology sector is entering a period of rapid growth and meaningful innovation. Global biotech revenue is expected to expand at roughly 13 to 14% annually over the next decade, moving from over US$1.5 trillion in 2024 to more than US$5 trillion by 2034. At the same time, the cell and gene therapy market is poised to surge from about US$25 billion in 2025 to over US$115 billion by 2034, growing at nearly 20 percent per year.

These numbers reflect more than market trends. Scientific advances, non-invasive delivery methods, next-generation therapeutics, and supportive regulatory frameworks are all converging. Clinical trials, manufacturing capabilities, and regulatory pathways are finally scaling to meet the rising demand for safer, more precise therapies.

The result is a biotech environment where companies can hit major milestones faster than ever. Some niches are already showing real clinical progress and attracting serious attention. With that in mind, here are a few companies that have been making moves worth watching.

Medicus Pharma Ltd. (NASDAQ: MDCX) is starting to gain attention in biotech circles, and its recent developments suggest the company could be entering a pivotal stretch. On September 8, the company announced that patient recruitment had commenced in the United Arab Emirates for its SKNJCT-004 phase 2 clinical study. This program is designed to evaluate a dissolvable microneedle patch, known as D-MNA, that delivers chemotherapy directly to basal cell carcinoma lesions without the need for invasive surgery. Recruitment began at Cleveland Clinic Abu Dhabi, one of six leading hospitals in the region participating in the trial.

Dr. Raza Bokhari, Executive Chairman and CEO, framed the update as an important milestone. “Commencing patient recruitment in the SKNJCT-004 clinical study at Cleveland Clinic Abu Dhabi is a promising step forward towards our goal to bring to market a first-in-class novel non-invasive alternative to treat BCC,” he said. With basal cell carcinoma being the most common form of skin cancer worldwide, a non-invasive treatment option could address a multibillion-dollar market.

The UAE study follows progress in the company’s other phase 2 program, SKNJCT-003, which is being conducted in the United States and Europe. As of August, more than seventy-five percent of the ninety planned participants had already been randomized, with interim data showing more than sixty percent clinical clearance. That trial alone represents what the company has described as a potential market opportunity of more than two billion dollars.

At the same time, Medicus Pharma Ltd. (NASDAQ: MDCX) has been expanding beyond dermatology. Earlier this month, the company completed its acquisition of Antev Limited, a UK-based late-stage biotech developing Teverelix, a next-generation GnRH antagonist. Teverelix is being advanced as a treatment for high cardiovascular risk prostate cancer patients and for preventing acute urinary retention relapses in men with enlarged prostates. Together, these indications represent a market opportunity of roughly six billion dollars annually. Patrick Mahaffy, the former CEO of Clovis Oncology and Pharmion, joined Medicus’s board of directors following the transaction, bringing significant drug development and commercialization experience.

The strategic rationale is clear. By adding Antev’s clinical programs to its portfolio, MDCX is diversifying its pipeline while also positioning itself in two therapeutic areas with substantial unmet needs. Prostate cancer continues to be one of the most prevalent cancers in men, and options that are safer for patients with cardiovascular risk profiles could be particularly valuable.

Financially, the company has strengthened its balance sheet in recent quarters, ending June with nearly ten million dollars in cash compared to four million three months earlier. That cushion provides more flexibility as the clinical programs advance and as new opportunities, such as a memorandum of understanding with Helix Nanotechnologies to explore mRNA vaccine applications, begin to take shape.

For investors new to the story, the highlights are straightforward. MDCX is advancing a non-invasive microneedle therapy for the most common form of skin cancer and is rapidly progressing through phase 2 recruitment in both the United States and UAE, and has just added a late-stage prostate cancer therapy with billion-dollar potential through acquisition. With clinical data expected ahead and regulatory dialogue underway, Medicus Pharma Ltd. (NASDAQ: MDCX) is positioning itself as a small-cap biotech with meaningful catalysts on the horizon.

Arcutis Biotherapeutics (NASDAQ: ARQT) is gaining momentum in medical dermatology, and its latest regulatory move could unlock an important new market. On September 3, the company submitted a supplemental New Drug Application to the FDA for ZORYVE cream 0.3% in children ages 2 to 5 with plaque psoriasis. If approved, ZORYVE would become the first and only topical PDE4 inhibitor indicated for patients as young as 2, giving families and physicians a much-needed steroid-free option for long-term use in sensitive skin areas.

This potential expansion builds on a strong foundation. ZORYVE has already become the most prescribed branded topical across three inflammatory skin conditions, and quarterly revenue for the franchise climbed to $81.5 million in the second quarter of 2025, up 164 percent from last year. The foam formulation recently secured FDA approval for scalp and body psoriasis in patients as young as 12, while the cream has been steadily gaining traction in both plaque psoriasis and atopic dermatitis. Over one million prescriptions have now been written since launch, underscoring physician confidence in the brand’s safety and efficacy.

Beyond ZORYVE, Arcutis is also progressing ARQ-234, a novel fusion protein for atopic dermatitis, with an IND filed in July. The company holds nearly $200 million in cash and has managed to narrow its net loss as product sales ramp higher, suggesting a path toward greater financial stability.

For investors, the near-term catalyst is the FDA’s October decision on ZORYVE cream 0.05% in children ages 2 to 5 with atopic dermatitis. Combined with the new psoriasis submission, Arcutis is positioning ZORYVE as a foundational treatment across age groups and conditions. Success here could solidify Arcutis as a leader in immunodermatology and drive further revenue growth in the years ahead.

CorMedix Inc. (NASDAQ: CRMD) has quickly become one of the more intriguing names in hospital acute care following a series of headline-making moves. The company is already commercializing DefenCath, its catheter lock solution for hemodialysis patients, which generated $39.7 million in revenue in the second quarter, compared with less than $1 million a year earlier. That growth helped CorMedix swing to net income of $19.8 million for the period, showing how rapidly the product is scaling.

The bigger catalyst, however, arrived on September 2 when CorMedix closed its acquisition of Melinta Therapeutics. The $300 million deal brings seven marketed anti-infective and cardiovascular drugs into the fold, including MINOCIN, REZZAYO, VABOMERE, ORBACTIV, BAXDELA, KIMYRSA, and TOPROL-XL. Management now projects pro forma 2025 revenues in the range of $325 million to $350 million, up from $200 million to $215 million previously expected from DefenCath alone. CEO Joseph Todisco called the transaction “a transformational step in the evolution of CorMedix,” noting that it creates “a formidable and diversified specialty platform with a deep and experienced team in the hospital acute care and infectious disease arena.”

The addition of Melinta’s portfolio does more than broaden revenue. REZZAYO, already approved for candidemia, is in Phase III testing for prophylaxis of invasive fungal infections in transplant patients. If approved, peak annual sales in that setting could top $200 million. The company also sees DefenCath expanding into new patient groups such as those on total parenteral nutrition, which could add another $150 million to $200 million in peak sales.

CorMedix reinforced its business development push with a $5 million strategic investment in Talphera on September 8, gaining rights of first negotiation on Niyad, a late-stage anticoagulant candidate. With accelerating sales, expanded assets, and a stronger pipeline, CorMedix has set the stage for durable growth into 2026 and beyond.

MaxCyte, Inc. (NASDAQ: MXCT) continues to position itself as a key enabler of next-generation cell therapies. The company’s Flow Electroporation and ExPERT platforms are becoming standards in non-viral cell engineering, offering the scalability and precision needed for advanced cell-based treatments. That positioning has recently been reinforced through new strategic platform license agreements with both Anocca AB and Adicet Bio.

In July, MaxCyte signed a deal with Anocca, a clinical-stage T-cell immunotherapy company, which will use MaxCyte’s technology to advance its pipeline of engineered T-cell receptor therapies. The partnership underscores the importance of non-viral editing in building scalable and regulatory-compliant manufacturing systems. A week later, MaxCyte added another SPL with Adicet Bio, which is developing allogeneic gamma delta T-cell therapies for cancer and autoimmune disorders. In both cases, MaxCyte will receive licensing fees and program-related revenue, strengthening its base of recurring cash flow. CEO Maher Masoud noted that these partnerships highlight “the versatility of our platform and its ability to enable the development of next-generation cell therapy candidates with increased efficiency and accessibility.”

Financially, the second quarter showed some mixed signals. Total revenue came in at $8.5 million, down 18 percent from the prior year, largely due to a sharp drop in program-related revenue. Core revenue, however, rose 8 percent to $8.2 million, driven by growth in instrument sales and consumables. The installed base of instruments increased to 814 from 723 a year ago, supporting long-term visibility as customers adopt MaxCyte’s systems. The company posted a net loss of $12.4 million in the quarter but ended June with more than $155 million in cash and investments, providing a strong balance sheet to weather near-term volatility.

With its expanding roster of SPL partners and a proven platform that sits at the center of cell therapy innovation, MaxCyte is carving out a strategic role in one of biotech’s fastest-growing fields.

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