Manufacturing Associate

Catalent, a global contract development and manufacturing organisation, has completed a debt refinancing transaction. The refinancing includes a new $4.1 billion seven-year term loan B facility and a $600 million revolving credit facility, replacing the company's existing term loan B. The transaction is expected to reduce Catalent's annual interest expense by approximately $100 million. Following completion, the company has approximately $1.1 billion of available liquidity, including cash on hand and access to its revolving credit facility. The debt refinancing was led by JP Morgan and Morgan Stanley. Catalent's debt received ratings of B1 from Moody's and B+ from S&P, both with stable outlooks.

Scholar Rock (NASDAQ: SRRK) drops Catalent Indiana as fill-finish site from apitegromab drug application. Scholar Rock (NASDAQ: SRRK) announced Friday that it has removed Catalent Indiana as a fill-finish facility from its Biologics License Application for apitegromab, acting under guidance from the FDA. The decision marks a notable development in the regulatory pathway for apitegromab, Scholar Rock's lead investigational treatment targeting muscle mass and strength in spinal muscular atrophy patients. Fill-finish manufacturing is a critical final stage of biologic drug production, involving the transfer of a drug substance into its final container before it reaches patients. Regulatory agencies frequently scrutinize fill-finish facilities as part of the BLA review process, and any changes to designated sites can carry significant implications for approval timelines. Scholar Rock confirmed the move was made under direct guidance from the FDA, suggesting the agency raised concerns or flagged the Indiana facility as part of its ongoing review. Catalent, a contract development and manufacturing organization, has faced heightened regulatory scrutiny across several of its manufacturing sites in recent periods. Novo Nordisk (NVO) has a financial stake in Catalent, which adds a layer of industry significance to the removal of the Indiana facility from Scholar Rock's application. The timing of the announcement, coming on a Friday morning, prompted a market reaction, with shares of Scholar Rock rising 2.26% while Novo Nordisk gained 1.30% on the session. Investors and analysts will now be watching closely for any updated guidance from Scholar Rock on how this manufacturing change may affect the expected timeline for FDA action on the apitegromab BLA. Scholar Rock has positioned apitegromab as a potentially transformative therapy, and any delays or complications in the regulatory process carry material consequences for the company's commercial outlook and financial position. The company has not yet indicated which alternative fill-finish facility will replace Catalent Indiana in the updated application, a detail that market participants will be eager to see clarified in the near term.

Taysha Gene Therapies and Catalent expand strategic partnership to include future commercial manufacturing support of TSHA-102 gene therapy for Rett Syndrome. 08-03-2026 CAMBRIDGE, Mass. and DALLAS and TAMPA, Fla., Aug. 03, 2026 (GLOBE NEWSWIRE) - Taysha Gene Therapies, Inc., (Nasdaq: TSHA) (Taysha), a clinical-stage biotechnology company focused on developing adeno-associated virus (AAV)-based gene therapies for rare, monogenic diseases of the central nervous system, and Catalent, Inc., (Catalent), the leading global contract development and manufacturing organization (CDMO) dedicated to helping people live better and healthier lives, today announced a commercial supply agreement for TSHA-102, Taysha's investigational gene therapy in pivotal development for Rett syndrome, under which Catalent will serve as Taysha's primary commercial manufacturer following potential U.S. Food and Drug Administration (FDA) approval. Building on a partnership that has supported the development of TSHA-102 since 2020, the agreement secures long-term commercial manufacturing capacity and a scalable supply framework to support a potential commercial launch and future demand. Catalent will provide GMP manufacturing and commercial supply of TSHA-102 at its FDA-licensed commercial gene therapy facility in Harmans, Maryland, leveraging its experience across more than 90 gene therapy programs, including multiple commercial products. "As we continue to advance TSHA-102, establishing long-term commercial manufacturing capacity is a critical component of our launch readiness strategy," said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. "Catalent's deep gene therapy expertise and proven commercial manufacturing capabilities make them an ideal partner as we expand our partnership to further strengthen our commercial infrastructure with a reliable, scalable supply framework. With BLA-enabling Process Performance Qualification activities underway, we believe we have established the manufacturing foundation necessary to support the strong demand we expect following the potential launch and commercialization of TSHA-102." "At Catalent, our priority is to support innovators who are redefining what's possible for patients with rare diseases," said David McErlane, Biologics Group President for Catalent. "Our partnership with Taysha brings together deep AAV expertise and a shared commitment to advancing a potential therapy for Rett syndrome - a condition with significant unmet need. We are proud to help enable the development and future supply of therapies that have the potential to make a meaningful difference for patients and their families." This partnership reflects Catalent's continued commitment to supporting innovators across the cell and gene therapy landscape, providing end-to-end solutions from development through commercialization to help bring transformative therapies to patients. About Rett Syndrome Rett syndrome is a rare neurodevelopmental disorder caused by mutations in the X-linked MECP2 gene encoding methyl CpG-binding protein 2 (MeCP2), which is essential for regulating neuronal and synaptic function in the brain. The disorder is characterized by loss of communication and hand function, slowing and/or regression of development, motor and respiratory impairment, seizures, intellectual disabilities and shortened life expectancy. Rett syndrome progression is divided into four key stages, beginning with early onset stagnation at 6 to 18 months of age followed by rapid regression, plateau and late motor deterioration. Rett syndrome primarily occurs in females and is one of the most common genetic causes of severe intellectual disability. Currently, there are no approved disease-modifying therapies that treat the genetic root cause of the disease. Rett syndrome caused by a pathogenic/likely pathogenic MECP2 mutation is estimated to affect between 15,000 and 20,000 patients in the U.S., EU, and U.K. About Taysha Gene Therapies Taysha Gene Therapies (Nasdaq: TSHA) is a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system. Its lead clinical program TSHA-102 is in development for Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies that address the genetic root cause of the disease. With a singular focus on developing transformative medicines, Taysha aims to address severe unmet medical needs and dramatically improve the lives of patients and their caregivers. The Company's management team has proven experience in gene therapy development and commercialization. Taysha leverages this experience, its manufacturing process and a clinically and commercially proven AAV9 capsid in an effort to rapidly translate treatments from bench to bedside. For more information, please visit www.tayshagtx.com. About Catalent Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers' needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at nearly 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the potential of TSHA-102 and Taysha's other product candidates to positively impact quality of life and alter the course of disease in the patients Taysha seeks to treat, Taysha's research, development and regulatory plans for its product candidates; the potential demand for TSHA-102; and the ability of the agreement between Taysha and Catalent to secure long-term commercial manufacturing capacity and a scalable supply framework for the commercial supply of TSHA-102. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Taysha's business are described in detail in its SEC filings, including in Taysha's Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, which is available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that Taysha makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Taysha disclaims any obligation to update these statements except as may be required by law. Taysha Company Contact: Hayleigh Collins Senior Director, Corporate Communications and Investor Relations Taysha Gene Therapies, Inc. [email protected] Catalent Media Contact: [email protected]