~ Designation based on 24-month interim Phase I/II clinical data for AMT-130 announced in December 2023 ~
~ AMT-130 is the first therapeutic candidate to receive RMAT Designation for Huntington’s disease ~
~ Receiving RMAT designation enables increased collaboration with the FDA on regulatory approval planning, in addition to the opportunity for expedited product development ~
The METIS trial demonstrated 21.9 months median time to intracranial progression for patients treated with TTFields therapy and supportive care compared to 11.3 months for patients treated with supportive care alone
Patients treated with TTFields therapy experienced prolonged quality of life deterioration-free survival and TTFields therapy was well-tolerated
Data from the METIS trial to be presented today during the 2024 ASCO Annual Meeting
– Phase 1/2 pivotal study met the primary safety and efficacy endpoints –
– 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; complete responses have been durable beyond 12 months with median duration of follow up of 20 months as of data cutoff –
– 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 pre-treatment to 0 post-treatment –
– PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 –
– PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders –
– PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders –
– RRP is a rare, devastating HPV-mediated chronic disease characterized by growth of benign tumors for which the current standard-of-care is repeated surgeries; if approved, PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of RRP –
– Clinical data associated with favorable safety, strong efficacy, ease of administration, and immunological responses, position PRGN-2012 to potentially be the preferred treatment-of-choice for RRP –
– PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024 –
– Precigen to host webcast event today at 6:00 PM CT / 7:00 PM ET –
The Company will host a webcast event today at 6:00 PM CT / 7:00 PM ET to detail the results presented at ASCO.
On May 31, Judge Andrews denied United Therapeutics’ motion for a preliminary injunction to block the launch of YUTREPIA in the PH-ILD indication
Ruling reinforces the clear path for FDA to issue final decision on amended NDA for YUTREPIA to treat both PAH and PH-ILD
Advisers to the U.S. Food and Drug Administration will vote whether to recommend that COVID-19 vaccines for 2024-25 should target the JN.1 variant, the most dominant this year, documents filed on Monday showed.
Shares of Novavax soared 11% in morning trade, after the documents were released. The company had said last month it would only be able to offer a COVID vaccine in the United States this autumn if regulators accept the shot it started manufacturing to target the JN.1 variant.
The FDA's staff in separate documents said vaccine makers developing the new booster shots may need to consider targeting one of the JN.1 subvariants such as KP.2, as further evolution of the virus could take it away from the older strain.
The documents were posted ahead of the advisers' meeting on Wednesday. The meeting was postponed from May 16 as the FDA sought more time to "obtain surveillance data and other information" on the circulating virus.
The FDA staff's review for updating viral strains for vaccines in the U.S. differs from that of the World Health Organization's advisers, who in April recommended targeting only the JN.1 strain.
Since then, the subvariant KP.2 has become the dominant strain in the U.S., estimated to account for about 28.5% of cases over a two-week period ended May 25, according to data from the U.S. Centers for Disease Control and Prevention.
"This change in epidemiology warrants consideration," the reviewers said.
A variation in vaccine strain from the global norm could also pose a challenge for COVID vaccine makers, especially Novavax as it makes a more traditional protein-based shot that takes longer to manufacture.
Vaccines based on messenger RNA (mRNA), like those from Moderna, or Pfizer and its partner BioNTech, can be developed more quickly. In the past, Pfizer had said it could make the shots in 100 days.
Pedro Pizarro, CEO of Edison International, explains that unlike Vistra, Edison has been affected by the forest fires in California. Despite this, Edison continues to target EPS growth of 5-7% through to 2028.
Edison is actively investing in improving and securing its power grid to withstand climatic impacts, including wildfires, and to support increased electrical load due to electrification and AI.
Pizarro also mentions the importance of collaboration with chip manufacturers and data centre providers to meet growing electricity needs.
Members of the EEI (the Edison Environment Institute), of which Edison is a member, have invested a trillion dollars over the last decade in the electricity grid, with $168 billion last year alone. These investments are essential to support decarbonisation, particularly in California, where investments of $370 billion are planned between now and 2045 in order to achieve carbon neutrality.
Pizarro points out that these investments will improve air quality and should reduce energy bills by 40% by 2045. He also highlights the need to adopt a variety of renewable energy sources and new technologies to meet the expected increase in demand.
