Welcome to our dedicated page for Societal CDMO news (Ticker: SCTL), a resource for investors and traders seeking the latest updates and insights on Societal CDMO stock.
Societal CDMO, Inc. (SCTL) is a prominent player in the pharmaceutical manufacturing industry, specializing in solid dosage form development, clinical and commercial manufacturing, and packaging and logistics services. Under its subsidiary Recro Gainesville, LLC, the company provides expert solutions for extended-release solid dose and DEA-controlled substances. Their state-of-the-art, 97,000-square-foot manufacturing facility is equipped to handle the most complex pharmaceutical development and manufacturing projects.
The company recently announced additional work across its facilities in California and Georgia, which now includes analytical method development and validation, dissolution testing, and manufacturing of prototype, surrogate, and engineering batches. This expansion aims to enhance their service offerings and increase operational efficiency.
In response to macro pharmaceutical market financing challenges, Societal CDMO has initiated a strategic realignment to right-size its organization. This move is designed to boost efficiency in areas of historical strength and ensure long-term sustainability.
The company’s recent acquisition, Benuvia Operations, LLC, specializes in the development and manufacturing of controlled substance APIs and drug products, focusing on cannabinoids and psychedelics. Benuvia owns the FDA-approved cannabinoid drug product SYNDROS, aimed at alleviating chemotherapy-induced nausea and vomiting (CINV) and anorexia in AIDS patients. Operating out of an 83,000-square-foot, FDA-registered manufacturing facility, Benuvia adheres to cGMP standards, offering both APIs and complex finished dosage forms.
With a commitment to innovation, Societal CDMO continues to expand its portfolio of DMFs and is actively pursuing new intellectual property avenues for its drug products. The company's integrated services extend from research and route scouting to the commercialization of high-value, low-volume products, making it a reliable partner for end-to-end pharmaceutical development.
Societal CDMO (NASDAQ: SCTL) has announced work order extensions with multiple existing customers across its various service areas. This strategic growth is a significant aspect of the company’s operations, complementing efforts to acquire new clients. Current projects include the manufacturing of an antibiotic capsule, analytical method validations for ADHD treatments, stability studies for a cancer therapy, and clinical trial services for depression treatments. COO Scott Rizzo expressed satisfaction with these expansions as a validation of their service quality, contributing to revenue growth. The company maintains a strong focus on solving complex formulation and manufacturing challenges in the pharmaceutical industry.
Societal CDMO, Inc. (SCTL), a bi-coastal contract development and manufacturing organization, announced on April 6, 2023, the hiring of new employees across its operations in San Diego and Gainesville. As part of this initiative, the board approved inducement stock option grants for 135,060 shares of common stock, intended to incentivize new hires. These options were granted on March 31, 2023, at the closing price on that date, with a ten-year term and a vesting schedule over four years, contingent on continued employment. Societal CDMO specializes in small molecule therapeutic development, encompassing pre-IND development to commercial manufacturing, supported by two state-of-the-art facilities totaling 145,000 square feet.
Societal CDMO, Inc. (NASDAQ: SCTL) has been selected by Longboard Pharmaceuticals (NASDAQ: LBPH) to provide contract development and manufacturing services for its lead asset, LP352, a potential treatment for refractory seizures. The collaboration includes technology transfer and analytical method validation to support the PACIFIC Study, a Phase 1b/2a trial targeting various developmental and epileptic encephalopathies (DEEs). This partnership underscores Societal CDMO's growing reputation as a preferred CDMO for biopharmaceutical companies.
Societal CDMO has received FDA approval to manufacture its first commercial tablet product, expanding its capabilities beyond capsules. This milestone is set to enhance the company’s position in the pharmaceutical manufacturing sector. Expected to commence production at its Gainesville, Georgia facilities later this year, the approval signifies a critical advancement in Societal CDMO's operational capabilities. With extensive experience in small molecule therapeutics, the company aims to address complex manufacturing challenges in a competitive market. This achievement reflects two years of dedicated efforts in technology transfer and regulatory compliance.
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