Adherex Technologies’ PEDMARK Push Targets Larger AYA Market After Record Quarter

Key Points

• Fennec Pharmaceuticals said PEDMARK is seeing stronger commercial traction, with first-quarter 2026 revenue reaching a record $15.1 million as the company expands its sales force and targets more than 5,400 U.S. treatment sites.
• The company is focusing on the adolescent and young adult (AYA) market, which management says is about 10 times larger than the pediatric market, and is also promoting home administration through its Fennec HEARS program.
• Fennec highlighted international expansion and patent protection, including a European partnership with Norgine, plans for a Japan deal, and a U.S. settlement that keeps a generic challenger off the market until 2033.

Fennec Pharmaceuticals NASDAQ: FENC executives outlined the company’s commercial strategy for PEDMARK, its sodium thiosulfate product used to prevent cisplatin-related hearing loss, during a fireside chat at the H.C. Wainwright 4th Annual BioConnect Investor Conference.

Ram Selvaraju, managing director and senior healthcare equity research analyst at H.C. Wainwright, introduced the company and said H.C. Wainwright covers Fennec with a buy rating and a 12-month price target of $13 per share. Fennec Chief Executive Officer Jeff Hackman and Chief Financial Officer Robert Andrade discussed PEDMARK’s market opportunity, recent revenue performance, international plans and patent position.

PEDMARK Positioned as Supportive Care Product for Cisplatin Patients

Andrade described PEDMARK as “the first and only approved agent for the prevention of hearing loss” associated with cisplatin, a chemotherapy widely used in solid tumors across pediatric, adolescent, young adult and adult patients. He said cisplatin can be highly effective, with overall effectiveness rates of up to 90% depending on tumor type, but may be associated with hearing loss in up to 75% of patients.

Andrade said PEDMARK has been studied for more than 30 years and was evaluated in two Phase 3 trials, including one published in the New England Journal of Medicine. He said the trials statistically showed that hearing loss was reduced, or at least cut in half, in the overall patient population.

Hackman said a key commercial task is increasing awareness among oncologists that cisplatin-related hearing loss can be prevented. “The awareness levels of PEDMARK are low,” he said, adding that the company views that as an opportunity because patients continue to be at risk of losing hearing from cisplatin therapy.

Commercial Expansion Focuses on AYA Market and Home Administration

Hackman said PEDMARK was initially approved in the pediatric setting, supported by trials conducted with the Children’s Oncology Group at major U.S. centers. He said Fennec’s opportunity expanded after the National Comprehensive Cancer Network issued a Category 2A recommendation for use in adolescents and young adults, or AYA patients, ages 15 to 39.

Hackman said the AYA market is “10x larger than the pediatric market” and is accessed differently because many patients are treated outside academic centers, including in oncology offices and infusion suites. To support broader use, he said Fennec expanded from 10 to 24 sales territories and now targets more than 5,400 sites across the United States.

The company has also built Fennec HEARS, a home administration program. Hackman said PEDMARK must be administered six hours after cisplatin, which can make in-home dosing useful after patients receive cisplatin in an infusion setting.

Andrade said Fennec nearly doubled quarterly revenue since Hackman joined the company, moving from roughly $7 million in quarterly revenue to $15.1 million in the first quarter of 2026, which executives described as a record quarter. Hackman also said April was a record month, though he noted the newly expanded sales territories had only been active for about a month.

Andrade said the $15.1 million quarterly revenue run rate translates to roughly 300 to 400 patients annually, including about 100 AYA patients. He contrasted that with a total AYA market opportunity of more than 20,000 patients and said PEDMARK currently has no competition as the first and only approved product for preventing cisplatin-related hearing loss.

Investigator-Sponsored Trials Aim to Support Broader Use

Fennec executives said the company is working to build additional real-world evidence through investigator-sponsored trials, or ISTs, that could help support future updates to NCCN recommendations. Andrade said the current NCCN Category 2A recommendation provides enough evidence to get oncologists’ attention, while Category 1 would represent the highest level of support.

The company currently has three ISTs enrolling at City of Hope, Tampa General and the University of Arizona. Andrade said these studies are intended to address questions oncologists may have about use in adults, metastatic disease and other real-world settings. Hackman said additional partnerships are expected.

Hackman said the company expects interim looks at data rather than waiting for the completion of longer trials. He said Fennec plans to present some data from one of the ISTs in January of next year, assuming patient enrollment and data generation continue as expected.

International Strategy Relies on Partnerships

Andrade said Fennec sees a global opportunity for PEDMARK, known in Europe as PEDMARQSI, but intends to pursue international markets through partnerships rather than building its own infrastructure outside the United States.

In Europe, Fennec has partnered with Norgine. Andrade said the agreement includes the potential for $200 million in milestones tied to sales or regulatory achievements, along with royalties beginning in the mid-teens percentage range on sales by Norgine. He said the European opportunity is roughly similar to the U.S. opportunity based on population and cisplatin use.

Executives also discussed Japan, where Hackman said a 10-site trial showed results similar to the two prior trials conducted elsewhere. Hackman said Fennec believes the study is sufficient to support filing in Japan and said the company is in discussions with potential partners. Andrade said Fennec expects to announce a Japan partnership “in the near future.”

Patent Settlement Extends U.S. Runway

Andrade said Fennec recently settled ANDA litigation with generic drugmaker Cipla. Under the settlement, he said Cipla will not enter the market until the end of 2033, giving Fennec a “nice runway” for PEDMARK in the United States.

He added that Fennec has 10 years of market exclusivity in Europe through a pediatric-use marketing authorization and global patents extending to 2039, including in Japan.

Looking ahead, Hackman said Fennec is evaluating ways to expand its product offerings by adding complementary products that fit with PEDMARK and the company’s existing customer base. He cited Fennec’s reimbursement, home health, supportive care and medical expertise as capabilities that could be applied to additional products as the company grows.

About Adherex Technologies NASDAQ: FENC

Fennec Pharmaceuticals Inc, a biopharmaceutical company, develops product candidates for use in the treatment of cancer in the United States. Its lead product candidate is the Sodium Thiosulfate, which has completed the Phase III clinical trial for the prevention of cisplatin induced hearing loss or ototoxicity in children. The company was formerly known as Adherex Technologies Inc and changed its name to Fennec Pharmaceuticals Inc in September 2014. Fennec Pharmaceuticals Inc was founded in 1996 and is based in Research Triangle Park, North Carolina.

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