PARIS, France, November 20 at 8:30 am (CET) – Pharnext SCA (FR001400JXB0 – ALPHA)
(the “Company”), an advanced clinical stage biopharmaceutical company developing novel therapies for neurodegenerative diseases without satisfactory therapeutic solutions, announces that it has successfully completed the production of three registration batches of PXT3003 as an oral solution in single-dose sachets in the United States, using cutting-edge innovative technology”
form-fill-seal liquid sachets
(packaging process that integrates thermoforming-filling-sealing) at Unither’s U.S. facility in Rochester, New York, and initiates the regulatory stability study required for the regulatory filing. New Drug Application (NDA).
This step is important in preparation for submitting the NDA application (“
New drug application
“) with the US FDA (”
Food and Drug Administration
“) in 2024, followed by the potential commercialization of PXT3003 in patients with Charcot-Marie-Tooth disease type 1A (CMT1A) in the United States, if the pivotal Phase III clinical trial of PXT3003 (the PREMIER trial) is positive is (basic data to be announced in December 2023).
Subject to FDA approval, this product will be marketed in the form of 5 ml single-use sachets.
As a reminder, the transfer of the production process and the increase in production capacity of PXT3003 took place in January 2023 in the United States.
Raj Thota, director of production and CMC, said
It is a great pleasure to announce the achievement of important milestones such as the completion of production of registration batches of PXT3003 and the initiation of stability for product registration. These milestones bring us closer to our goal of filing the NDA dossier in 2024 and a possible commercial launch, if the dossier is approved in 2025.
Hugo Brugière, management representative, concluded
We have taken another major step toward commercializing the PXT3003. We now eagerly await preliminary data from our pivotal Phase III clinical trial, now expected before mid-December. We will clarify the schedule in the coming days
The company Pharnext has set up a financing in the form of OCEANE-BSA with the company Global Tech Opportunities 13, which, after receiving the shares resulting from the conversion or exercise of these instruments, does not intend to remain a shareholder of the company .
The shares resulting from the conversion or exercise of the above securities will generally be sold very quickly on the market, which may cause strong downward pressure on the share price.
Shareholders may suffer a loss of their invested capital due to a significant decline in the value of the company’s shares, as well as significant dilution due to the large number of securities issued to the Global Tech Opportunities Company.
Investors are advised to be very vigilant before deciding to invest in the securities of any admitted company that engages in such dilutive financing transactions, especially when executed consecutively. The company recalls that this dilutive financing operation is not the first it has carried out.
Investors are particularly requested to note the risks associated with these operations as stated in the press release below.
Pharnext is a late-stage clinical biopharmaceutical company developing novel therapies for neurodegenerative diseases for which no satisfactory therapeutic solutions currently exist. Pharnext has a novel drug candidate, PXT3003, in development for Charcot-Marie-Tooth disease type 1A (CMT1A), a rare and debilitating hereditary peripheral neuropathy. PXT3003 benefits from orphan drug status in Europe and the United States. In 2018, PXT3003 completed a Phase III clinical trial, the PLEO-CMT trial, with encouraging preliminary results. This study was followed by an open-label extension study, the PLEO-CMT-FU study, in which 120 patients continued treatment with PXT3003. The long-term results indicate that the benefit is maintained in terms of tolerability and effectiveness, after a total clinical trial duration of 6 years. A pivotal international phase III clinical trial, the PREMIER trial, which enrolled 387 patients with CMT1A, was completed in August 2023. First results from the PREMIER study are expected in the fourth quarter of 2023. PXT3003 was discovered using the Pleotherapy™ R&D approach. Pharnext draws investors’ attention to the risk factors, especially financial ones, described in its financial reports. More information at www.pharnext.com.
Pharnext is listed on the Euronext Growth market in Paris (ISIN code: FR001400JXB0).
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Pharnext Announces the Successful Transfer of Production and Expansion of PXT3003 Manufacturing Capacity in the United States
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