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Kadmon Holdings (KDMN) announced that its drug REZUROCK is now commercially available, achieving $12.2 million in net sales for Q3 2021, a substantial increase from $0.3 million in Q3 2020.
The company is set for a merger with Sanofi, expected to close by November 9, 2021, with shareholders receiving $9.50 per share. Operating expenses rose due to launch activities, but cash resources increased to $251.6 million as of September 30, 2021, providing a solid financial outlook.
Kadmon Holdings (NASDAQ:KDMN) announced the presentation of data from its ongoing Phase 1 clinical trial of KD033, an anti-PD-L1/IL-15 fusion protein, for metastatic or locally advanced solid tumors at the Society for Immunotherapy of Cancer's 36th Annual Meeting, November 10-14, 2021. Key poster presentations include the trial's dose escalation and its impact on anti-tumor immunity. The KD033-101 study aims to establish safety, efficacy, and the maximum tolerated dose. KD033 represents Kadmon's most advanced candidate from its IL-15 fusion platform.
Sanofi has announced a definitive merger agreement to acquire Kadmon Holdings (NASDAQ:KDMN) for $9.50 per share in cash, totaling around $1.9 billion. This acquisition includes Rezurock (belumosudil), an FDA-approved treatment for chronic graft-versus-host disease (cGVHD), enhancing Sanofi's transplant portfolio. The deal is unanimously approved by both companies’ boards and is expected to be completed in Q4 2021, pending shareholder and regulatory approvals. The acquisition is projected to be modestly dilutive to Sanofi's earnings per share in 2022.
Kadmon Holdings (NASDAQ: KDMN) announced the commercial availability of REZUROCK (belumosudil) 200 mg for patients in the U.S. on August 19, 2021. Approved by the FDA on July 16, 2021, REZUROCK treats chronic graft-versus-host disease (cGVHD) in patients 12 and older who have failed at least two systemic therapies. The drug is accessible through authorized specialty pharmacies, with commercial outreach efforts underway to ensure patient access. Approximately 14,000 patients in the U.S. are affected by cGVHD, highlighting the urgency for effective treatment options.
Kadmon Holdings, Inc. (NASDAQ:KDMN) reported a significant milestone with the FDA approval of REZUROCK (belumosudil) for chronic graft-versus-host disease (cGVHD). The product is expected to be available by late August 2021. Kadmon is advancing its clinical trials, with Phase 2 results for systemic sclerosis anticipated by year-end. Financially, the company reported a loss from operations of $32 million for Q2 2021, an increase from $26.9 million in Q2 2020. Despite rising expenses, Kadmon's liquidity has improved, with cash reserves of $270.5 million as of June 30, 2021.
Kadmon Holdings announced that its drug REZUROCK (belumosudil) has been added to the NCCN Guidelines for Graft-Versus-Host Disease (GVHD) management with a Category 2A designation. This follows FDA approval on July 16, 2021, for chronic GVHD treatment in patients aged 12 and older after failure of two prior therapies. The drug's inclusion in NCCN signals its potential clinical impact as a commendable therapy for steroid-refractory chronic GVHD, enhancing awareness among healthcare providers and patients.
Kadmon Holdings announced FDA approval for REZUROCK (belumosudil) to treat chronic graft-versus-host disease (cGVHD) in patients aged 12 and older who have failed at least two prior therapies, as of July 16, 2021. This approval is based on the ROCKstar clinical trial, reaching a 74% overall response rate with durable results. The drug allows significant reductions in corticosteroid use and aims to improve quality of life. The company is focused on making REZUROCK available soon and is also developing belumosudil for systemic sclerosis.
Kadmon Holdings announced the FDA's approval of REZUROCK (belumosudil) for treating chronic graft-versus-host disease (cGVHD) in patients aged 12 and older after failure of at least two systemic therapies. The approval came six weeks ahead of the PDUFA date, bolstered by data showing a 75% overall response rate in clinical trials. REZUROCK is the first small molecule inhibitor targeting ROCK2. The drug is expected to be available in late August 2021, with Kadmon aiding patient access through the Kadmon ASSIST program.
Kadmon Holdings (Nasdaq:KDMN) has announced that its CEO, Harlan W. Waksal, M.D., will present at two upcoming virtual investor conferences. The Jefferies Virtual Healthcare Conference will take place on June 1, 2021, at 9:30 a.m. ET, while the Raymond James Human Health Innovation Conference is scheduled for June 21, 2021, at 12:00 p.m. ET. Live webcasts will be available on the Kadmon website, with replays accessible for 90 days. Kadmon specializes in transformative therapies for unmet medical needs, focusing on immune and fibrotic diseases and immuno-oncology.
Kadmon Holdings announced initial safety data from its Phase 1 clinical trial for KD033, an anti-PD-L1/IL-15 fusion protein targeting metastatic or locally advanced solid tumors. The results indicate that KD033 was well tolerated in all lower-dose cohorts, allowing for dose escalation. No dose-limiting toxicities were reported among nine patients treated with doses up to 50 µg/kg. Additional data from the trial will be presented at the 2021 ASCO Annual Meeting on June 4, with more results expected in Q4 2021.
