ONCOPEPTIDES AB AK - ONPPF STOCK NEWS

Oncopeptides AB announces a public advisory meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC) on September 22, 2022, to evaluate the benefit/risk profile of Pepaxto (melphalan flufenamide). This follows the company's decision to rescind a prior withdrawal request for the drug's New Drug Application, spurred by a positive review of survival data from the phase 3 OCEAN study. The meeting's goal is to discuss Pepaxto's market status, differing from an earlier ODAC discussion in 2021. The drug has received positive recommendations from the EMA for EU approval.

Oncopeptides AB announces the rescinding of its voluntary withdrawal request for Pepaxto (melflufen) from the US FDA, originally submitted on October 22, 2021. Following further analysis of data from the phase 3 OCEAN study, the company has decided to engage in dialogue with the FDA regarding the new findings. However, Oncopeptides has discontinued marketing Pepaxto in the US and does not plan to reintroduce it at this time. A conference call to discuss this development is scheduled for January 24, 2022.

Oncopeptides AB presented data from the phase 3 OCEAN study at the 18th International Myeloma Workshop, examining melflufen plus dexamethasone against pomalidomide plus dexamethasone in relapsed refractory multiple myeloma patients. Melflufen achieved a superior median Progression Free Survival (PFS) of 6.8 months compared to 4.9 months for pomalidomide (HR: 0.79, p=0.03). However, overall survival favored pomalidomide in patients with prior stem cell transplants. The FDA will discuss safety findings in an upcoming meeting, raising regulatory concerns.

The Annual General Meeting (AGM) for Oncopeptides AB (publ) took place on May 26, 2021. Key resolutions included the adoption of the annual report for 2020, discharging the Board and CEO from liability, and approval of remuneration for the Board and auditor. The AGM re-elected board members and introduced a long-term performance-based incentive program for employees and Board members, comprising a total of 1,391,131 share awards. The Board was also authorized to issue new shares and warrants, potentially diluting shareholder equity by up to 20% to enhance financial flexibility.

Oncopeptides AB announced the completion of patient enrollment in the phase 2 PORT study, assessing the safety and efficacy of melflufen combined with dexamethasone for treating relapsed refractory multiple myeloma. The study employs a randomized, open-label, cross-over design to compare peripheral versus central intravenous administration. Topline data is expected in Q3 2021, potentially paving the way for FDA collaboration to expand the administration modes for PEPAXTO®. The company is further developing therapies for challenging hematological diseases.

Oncopeptides AB published its 2020 Annual Report, highlighting significant advancements in R&D, organizational capabilities, and sustainability despite pandemic challenges. Key achievements include the FDA granting priority review for melflufen in treating triple-class refractory multiple myeloma, leading to the drug's accelerated approval and launch in the U.S. in early 2021. The report underscores the company's growth trajectory and commitment to developing targeted therapies for hematological diseases, utilizing its proprietary peptide-drug conjugate platform.

Oncopeptides AB has submitted an application to the European Medicines Agency (EMA) for conditional marketing authorization of its drug melflufen (melphalan flufenamide) for relapsed refractory multiple myeloma. This application is based on the pivotal phase 2 HORIZON study. CEO Marty J Duvall emphasized the company's commitment to addressing medical needs in Europe. The conditional approval process requires a favorable benefit-risk assessment and is aimed at tackling seriously debilitating diseases. Melflufen is already approved in the U.S. and part of an Early Access Program for European patients.

Oncopeptides AB announced a change in outstanding shares and votes following the exercise of warrants from its incentive program. The number of shares increased by 145,140, bringing the total to 68,084,855. Correspondingly, the share capital increased by approximately SEK 16,127, from SEK 7,548,857 to SEK 7,564,984. This adjustment underscores the company’s ongoing commitment to incentivizing its workforce while continuing to develop targeted therapies for hematological diseases, including the recently FDA-approved PEPAXTO for multiple myeloma.

Oncopeptides AB announced that PEPAXTO^® (melphalan flufenamide) is now commercially available in the United States, with the first patients being treated. This drug, approved by the FDA on February 26, 2021, is intended for adults with relapsed or refractory multiple myeloma who have undergone at least four prior therapies. PEPAXTO, in combination with dexamethasone, provides an innovative treatment option leveraging the company's peptide-drug conjugate technology.