Latest news with #Catalent
Associated Press
08-07-2025
- Business
- Associated Press
GenSight Biologics Reports Cash Position as of June 30, 2025
PARIS--(BUSINESS WIRE)--Jul 8, 2025-- Regulatory News: GenSight Biologics (" GenSight Biologics " or the " Company ") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of June 30, 2025. 'The second quarter of 2025 marked a period of significant operational progress for GenSight Biologics. We successfully completed the technology transfer of LUMEVOQ's upstream manufacturing process to our new partner Catalent, secured the ANSM's agreement to consider opening the AAC program in France, and closed our private placement financing in July, ' commented Jan Eryk Umiastowski, CFO of GenSight Biologics. ' We continue to actively pursue non-dilutive financing options to support our critical value-driving activities. With the AAC program launch planned for Q4 2025, we have established a clear financial pathway through H2 2026, when we expect to initiate our Phase III RECOVER trial and submit our marketing application to the MHRA of the UK.' Cash position as of June 30, 2025 GenSight Biologics' cash and cash equivalents totaled €0.3 million as of June 30, 2025, compared to €0.9 million as of March 31, 2025. With the equity-with-warrants-attached and pre-funded warrants financing announced on July 1, 2025 (approximately €3.9 million) and the anticipated collection of approximately additional €0.2 million in Research Tax Credit (CIR) in September, and based on current operations, plans, and assumptions, this balance should fund operations until early October 2025. EUR 0.7 million of the proceeds from the financing has been used for the repayment in principal on the convertible bonds held by Heights Capital through offset against their subscription. The funds are insufficient to cover operational requirements for the next 12 months. However, the anticipated opening of the AAC program in France in Q4 2025 (targeted for October) will establish a clear cash pathway until H2 2026, when the company expects to initiate the RECOVER Phase III clinical trial and to submit the UK MHRA marketing application for LUMEVOQ ®. The company is pursuing strategic options that could generate funds for the Phase III trial and UK regulatory submission. These include: In the first quarter of 2026, the company will have a precise view of residual financing needs and will make a strategic decision on additional financing modalities. If necessary, GenSight Biologics may access financial markets. Options in the medium term include partnering or M&A arrangements. Recapitulation of Recent Milestones Number of outstanding shares As of July 8, 2025, GenSight Biologics' number of outstanding shares was 152,717,762 ordinary shares. Financial Agenda The Company will report its interim H1 financial results by the end of September 2025. About GenSight Biologics S.A. GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the completion expected proceeds and anticipated use of proceeds of the Private Placement; the anticipated cash runway of the Company; and future expectations, plans, and prospects of the Company. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' and 'future' or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed Private Placement and the terms thereof are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the filings the Company makes with the AMF from time to time. The Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. View source version on CONTACT: GenSight Biologics Chief Financial Officer Jan Eryk Umiastowski [email protected] KEYWORD: FRANCE EUROPE INDUSTRY KEYWORD: HEALTH NEUROLOGY GENETICS CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: GenSight Biologics Copyright Business Wire 2025. PUB: 07/08/2025 02:11 PM/DISC: 07/08/2025 02:11 PM
Reuters
07-07-2025
- Business
- Reuters
Italy set to speed through $2.3 billion Novo Nordisk investment
ROME, July 7 (Reuters) - Italian authorities on Monday appointed a special commissioner to help Danish drugmaker Novo Nordisk ( opens new tab speedily deliver its promised 2 billion-euro ($2.34 billion) investment in a factory south of Rome. As part of Novo Holdings' takeover of pharmaceutical company Catalent ( opens new tab last year, Novo Nordisk acquired a site in Italy along with two others, one in Belgium and one in the United States. Francesco Rocca, president of the Lazio region that includes Rome and is where the Anagni factory is based, was made special commissioner for the site, a role giving him powers to speed up projects related to the facility, including upgrades. The factory will produce weight loss and anti-diabetes drugs, the region said in a statement, adding that Rocca's appointment "aims to ensure administrative speed and institutional coordination, essential elements for a project of this magnitude". Italy's government approved Novo's plans to upgrade capacity at the Anagni site in March, saying the company had pledged to invest more than 2 billion euros in 2025-2029 and hire around 800 people, boosting the total workforce to 1,500. The government declared the plans to be of "pre-eminent strategic interest", a status granted to large foreign investment projects that allows the fast-tracking of approval procedures. ($1 = 0.8530 euros)
Zawya
07-07-2025
- Business
- Zawya
Italy set to speed through $2.3bln Novo Nordisk investment
Italian authorities on Monday appointed a special commissioner to help Danish drugmaker Novo Nordisk speedily deliver its promised 2 billion-euro ($2.34 billion) investment in a factory south of Rome. As part of Novo Holdings' takeover of pharmaceutical company Catalent last year, Novo Nordisk acquired a site in Italy along with two others, one in Belgium and one in the United States. Francesco Rocca, president of the Lazio region that includes Rome and is where the Anagni factory is based, was made special commissioner for the site, a role giving him powers to speed up projects related to the facility, including upgrades. The factory will produce weight loss and anti-diabetes drugs, the region said in a statement, adding that Rocca's appointment "aims to ensure administrative speed and institutional coordination, essential elements for a project of this magnitude". Italy's government approved Novo's plans to upgrade capacity at the Anagni site in March, saying the company had pledged to invest more than 2 billion euros in 2025-2029 and hire around 800 people, boosting the total workforce to 1,500. The government declared the plans to be of "pre-eminent strategic interest", a status granted to large foreign investment projects that allows the fast-tracking of approval procedures. ($1 = 0.8530 euros)
Business Wire
26-06-2025
- Business
- Business Wire
GenSight Biologics Announces Significant Milestone in New Manufacturing Partnership with Catalent
PARIS--(BUSINESS WIRE)--Regulatory News: " ... a significant milestone in GenSight's strategy for securing the supply of LUMEVOQ for clinical use and for supporting the planned regulatory submissions ..." Share GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced the successful transfer of the upstream phase of the manufacturing process for LUMEVOQ ®, the Company's gene therapy candidate product for the rare mitochondrial disease Leber Hereditary Optic Neuropathy (LHON), to its new manufacturing partner, Catalent, Inc. ' This outstanding result is a significant milestone in GenSight's strategy for securing the supply of LUMEVOQ for clinical use and for supporting the planned regulatory submissions,' commented Scott Jeffers, Chief Technical Officer of GenSight Biologics. ' Our new partnership is proving to be highly effective, not just in completing the tech transfer process successfully, but also in improving the yield and upgrading the analytical methods used to reinforce control over the safety and quality of each batch. The level of collaboration and coordination between our teams has been truly impressive. ' Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. It is the only CDMO with a successfully commercialized gene therapy produced in their facility. Catalent offers gene therapy companies both production and in-house testing capabilities, and the GMP capacity at the facility used for LUMEVOQ ® will provide GenSight Biologics greater flexibility in the manufacture of the gene therapy. Catalent successfully manufactured the drug product batch that was released as safe for human use in November 2024 and which will be the source of product supply for the named patient early access program (AAC) and dose-ranging study in France. After the tech transfer is completed, Catalent will also manufacture the drug for the planned global Phase III trial RECOVER and the regulatory submissions. The Partnership as a Critical Element of GenSight Biologics' Strategy Following agreement with the French agency ANSM to consider opening the AAC program expeditiously after approval of a dose-ranging study, the Company is currently implementing a financing strategy, as it continues to advance its global marketing authorization strategy: Preparation for regulatory consultations in the US and EU Planning for the global Phase III trial scheduled to begin in 2026, designed to meet FDA and EMA requirements Completing the transition to a new manufacturing partner (Catalent) to secure reliable clinical and commercial supply Advancing preparations for MHRA submission in the United Kingdom ' Our partnership with a manufacturing powerhouse like Catalent is a critical enabler of our global strategy,' explained Laurence Rodriguez, CEO of GenSight Biologics. ' The outputs from their work with our team will allow us to reassure regulators that we have surmounted the challenges we faced in the past and, ultimately, to fulfill our mission to provide LHON patients a safe and effective treatment for their urgent unmet need.' About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. About Leber Hereditary Optic Neuropathy (LHON) Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1 st eye, with the 2 nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of subjects have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. About LUMEVOQ ® (GS010; lenadogene nolparvovec) LUMEVOQ ® (GS010; lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. 'LUMEVOQ' was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018. LUMEVOQ ® (GS010; lenadogene nolparvovec) has not been registered in any country at this stage.
Yahoo
26-06-2025
- Business
- Yahoo
GenSight Biologics Announces Significant Milestone in New Manufacturing Partnership with Catalent
Upstream phase of LUMEVOQ® manufacturing process successfully transferred Milestone follows successful manufacture of drug product batch to be used for named early access program (AAC) and dose-ranging study in France Partnership expected to improve yield and upgrade analytical methods ahead of clinical use and regulatory submissions PARIS, June 26, 2025--(BUSINESS WIRE)--Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced the successful transfer of the upstream phase of the manufacturing process for LUMEVOQ®, the Company's gene therapy candidate product for the rare mitochondrial disease Leber Hereditary Optic Neuropathy (LHON), to its new manufacturing partner, Catalent, Inc. "This outstanding result is a significant milestone in GenSight's strategy for securing the supply of LUMEVOQ for clinical use and for supporting the planned regulatory submissions," commented Scott Jeffers, Chief Technical Officer of GenSight Biologics. "Our new partnership is proving to be highly effective, not just in completing the tech transfer process successfully, but also in improving the yield and upgrading the analytical methods used to reinforce control over the safety and quality of each batch. The level of collaboration and coordination between our teams has been truly impressive." Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. It is the only CDMO with a successfully commercialized gene therapy produced in their facility. Catalent offers gene therapy companies both production and in-house testing capabilities, and the GMP capacity at the facility used for LUMEVOQ® will provide GenSight Biologics greater flexibility in the manufacture of the gene therapy. Catalent successfully manufactured the drug product batch that was released as safe for human use in November 2024 and which will be the source of product supply for the named patient early access program (AAC) and dose-ranging study in France. After the tech transfer is completed, Catalent will also manufacture the drug for the planned global Phase III trial RECOVER and the regulatory submissions. The Partnership as a Critical Element of GenSight Biologics' Strategy Following agreement with the French agency ANSM to consider opening the AAC program expeditiously after approval of a dose-ranging study, the Company is currently implementing a financing strategy, as it continues to advance its global marketing authorization strategy: Preparation for regulatory consultations in the US and EU Planning for the global Phase III trial scheduled to begin in 2026, designed to meet FDA and EMA requirements Completing the transition to a new manufacturing partner (Catalent) to secure reliable clinical and commercial supply Advancing preparations for MHRA submission in the United Kingdom "Our partnership with a manufacturing powerhouse like Catalent is a critical enabler of our global strategy," explained Laurence Rodriguez, CEO of GenSight Biologics. "The outputs from their work with our team will allow us to reassure regulators that we have surmounted the challenges we faced in the past and, ultimately, to fulfill our mission to provide LHON patients a safe and effective treatment for their urgent unmet need." About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. About Leber Hereditary Optic Neuropathy (LHON) Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1st eye, with the 2nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of subjects have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. About LUMEVOQ® (GS010; lenadogene nolparvovec) LUMEVOQ® (GS010; lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. "LUMEVOQ" was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018. LUMEVOQ® (GS010; lenadogene nolparvovec) has not been registered in any country at this stage. View source version on Contacts GenSight Biologics Chief Financial OfficerJan Eryk Umiastowskijeumiastowski@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
