Clara Dong

Clara Dong asked about the fastest and most realistic path to a pivotal trial and eventual approval for axatilimab in IPF, assuming positive Phase II data, and the criteria for prioritizing future indications.

Answer

Michael Metzger, CEO, and Nick Botwood, Head of R&D and Chief Medical Officer, indicated plans for a single pivotal Phase III trial with a sub-Q regimen, aiming for an expeditious start after positive Phase II results, with a standard 52-week endpoint. They emphasized planning for success and enabling work ahead of time.

Clara Dong asked about the fastest and most realistic path to a pivotal trial and eventual approval for the IPF trial if it reads out positively in Q4, and how Syndax is prioritizing the next indication if the data is positive.

Answer

Michael Metzger, Chief Executive Officer, indicated they would be as expeditious as possible. Nick Botwood, Head of R&D and Chief Medical Officer, added that they are planning for a Phase 3 with a subcutaneous regimen, anticipating only one pivotal Phase 3 trial, and are pre-planning all enabling work for success. He did not elaborate on other indications beyond IPF.

Clara Dong asked about the regulatory dialogue with the FDA regarding the potential pivotal study in pediatric ALL, specifically inquiring about interactions and requirements for the trial to be considered pivotal.

Answer

CEO Dr. Christian Itin confirmed that the phase I data and trial design, developed with the Children's Oncology Group (COG), were reviewed with the FDA. He stated there was agreement on the significant medical need in high-risk patients, the patient population, required data, and study size, and that the decision to move forward was made after gaining clarity on the path.

Clara Dong asked for comments on Legend Biotech's strong international growth, identifying areas of strongest demand/uptake versus higher growth potential after TechLane comes online, and how TechLane capacity will impact EU market share in 2026 and beyond.

Answer

Alan Bash, President of CARVYKTI, highlighted strong international uptake in Germany, Spain, and Belgium, driven by the value of one-time infusion, PFS, and OS benefits. He noted that TechLane, now commercially online, along with Ovalt, will meet growing European demand and support continued launches in 14 markets.

Clara Dong inquired about any anticipated seasonality effects for Brensupri's patient flow in Q4 and beyond, considering weather-related factors or the availability of diagnostic procedures during holiday seasons.

Answer

Martina Flammer, Chief Medical Officer, acknowledged that seasonality can trigger exacerbations but noted no significant limitation on CT scan access. Roger Adsett, Chief Operating Officer, added that while holidays might slow physician visits, the company is more closely monitoring the Medicare deductible reset in 2026 and potential reauthorization criteria changes.

Clara Dong asked if Insmed anticipates any seasonality effects for BRINSUPRI's patient flow in Q4 and beyond, considering weather-related factors or holiday impact on diagnostic procedures.

Answer

Martina Flammer, Chief Medical Officer, noted that seasonality can trigger exacerbations but hasn't seen significant limitations on CT scan access. Roger Adsett, Chief Operating Officer, added that holiday slowdowns and the reset of Medicare co-pays and deductibles in 2026 are factors they are monitoring.

Clara Dong asked if there are plans to stratify or analyze outcomes in the HARMONi-GI3 colorectal phase III study based on the presence of liver versus non-liver metastases. She also inquired about the expected timeline for the next data release from the global phase II FOLFOX combination study and whether U.S. patient data would be included.

Answer

Dave Gancarz, Chief Business and Strategy Officer, confirmed that stratification factors are included in the HARMONi-GI3 trial but declined to make all individual factors public at this early stage. Regarding the global phase II FOLFOX data, he stated that Summit Therapeutics is determining the appropriate time for publishing additional data, including U.S. patient data, prioritizing phase III read-outs.

Asked for details on the Zenerlef 400mg transition's impact on Q2 revenue, its expected normalization timeline, and the role of the new J-code in reimbursement, particularly in conjunction with the NO PAIN Act.

Answer

The company explained that the Zenerlef transition caused a temporary inventory drawdown at wholesalers in Q2 but end-user demand continued to grow. They expect wholesaler ordering to normalize in Q3. The new J-code is viewed as a long-term positive, simplifying reimbursement and improving access, especially as commercial payers begin to follow CMS's lead under the NO PAIN Act, though an immediate impact is not expected.

Clara Dong inquired about the ZINRELEF 400mg transition, its specific revenue impact in Q2, and the timeline for normalization. She also asked about the role the new J-code will play in reimbursement alongside the NO PAIN Act and its potential impact on adoption.

Answer

COO Mark Hensley clarified that the ZINRELEF transition led to a wholesaler inventory drawdown that impacted Q2 net sales by approximately $400,000, but he expects ordering patterns to normalize in Q3. CEO Craig Collard added that while the new J-code is not an immediate catalyst, it is more universally recognized by payers than the previous C-code, which will simplify reimbursement and support broader adoption long-term as commercial payers align with the NO PAIN Act.