STOUGHTON, Mass. - Collegium Pharmaceutical , Inc. (NASDAQ: NASDAQ:COLL), announced today that the U.S. Food and Drug Administration (FDA) has granted an extension of pediatric exclusivity for its Nucynta and Nucynta ER medications.
This extension adds six months to the exclusivity period of the Nucynta franchise, now set to expire on January 3, 2027, for Nucynta, and December 27, 2025, for Nucynta ER.
The FDA's decision follows the agency's previous grant of New Patient Population exclusivity for pediatric use of Nucynta in 2023. The exclusivity period for Nucynta was initially set to end on June 27, 2025, but with the new pediatric exclusivity grant, the period has been extended.
Nucynta is approved in the United States for managing acute pain severe enough to require opioid analgesic treatment in adults and pediatric patients aged six years and older, weighing at least 40 kg.
Nucynta ER is approved for the management of severe and persistent pain in adults that requires long-term opioid treatment, and for neuropathic pain associated with diabetic peripheral neuropathy when other treatments are inadequate.
Dr. Thomas Smith, Chief Medical Officer at Collegium, expressed satisfaction with the FDA's decision, stating that the pediatric exclusivity grant enhances the value of the Nucynta franchise and supports the company's near-term outlook.
Collegium Pharmaceutical emphasizes its commitment to improving the lives of individuals with serious medical conditions through science-based solutions. The company, headquartered in Stoughton, Massachusetts, continues to focus on providing effective treatments while addressing the risks associated with opioid use.
The announcement includes important safety information about Nucynta and Nucynta ER, outlining the risks of addiction, abuse, misuse, life-threatening respiratory depression, accidental ingestion, and concomitant use with benzodiazepines or other CNS depressants.
This news is based on a press release statement from Collegium Pharmaceutical, Inc. and does not include any independent verification of the claims. The information presented is for educational purposes and should not be considered an endorsement of the products mentioned.
In other recent news, Collegium Pharmaceutical has seen a mix of analyst upgrades and downgrades. Jefferies upgraded Collegium's stock from Hold to Buy, setting a new price target at $44.00, influenced by strong second-quarter trends and an undervalued market position. Contrastingly, Piper Sandler downgraded the stock from Overweight to Neutral based on financial projections and market conditions, maintaining a price target of $39.00.
As part of its financial strategy, Collegium initiated a $35 million accelerated share repurchase, a segment of a larger $150 million share repurchase program. The company's Chief Financial Officer, Colleen Tupper, cited strong cash generation and prescription growth for products Belbuca® and Xtampza® ER as contributing factors.
Collegium posted first-quarter earnings for 2024 at an adjusted diluted EPS of $1.45 on revenue of $144.9 million, slightly missing consensus estimates. However, the company has reaffirmed its financial guidance for 2024 and expects an improved outlook for 2025 and beyond, partly due to the anticipated benefits from the Medicare Part D redesign.
These recent developments also include a leadership transition with Mike Heffernan taking over as Interim President and CEO. Collegium's recent actions and analyst predictions indicate a period of significant activity and potential growth for the company.
InvestingPro Insights
Following the FDA's extension of pediatric exclusivity for Collegium Pharmaceutical's Nucynta products, investors may be interested in how the company's financial metrics reflect its current market position and future prospects. Collegium Pharmaceutical (NASDAQ: COLL) has been recognized for its strong shareholder yield, a metric that combines dividend payments, share repurchases, and debt reduction. An InvestingPro Tip points out that management has been aggressively buying back shares, which can indicate confidence in the company's future and often leads to an increase in earnings per share.
Moreover, analysts are optimistic about Collegium's financial trajectory. Another InvestingPro Tip suggests that net income is expected to grow this year, which could be a result of the extended exclusivity period boosting the company's revenue prospects. This aligns with the company's solid gross profit margin of 86.08% over the last twelve months as of Q1 2024, showcasing its ability to retain a significant portion of its revenue after accounting for the costs of goods sold.
InvestingPro Data further reveals that Collegium Pharmaceutical has a market capitalization of $1040M and a price-to-earnings (P/E) ratio of 10.69, adjusted for the last twelve months as of Q1 2024. This P/E ratio suggests that the stock may be reasonably valued relative to its earnings. Additionally, the company has achieved a revenue growth of 8.0% over the same period, indicating a healthy expansion in its business operations.
Investors seeking to delve deeper into Collegium Pharmaceutical's financial health and investment potential can explore additional InvestingPro Tips at https://www.investing.com/pro/COLL. There are 6 more tips available, offering a comprehensive analysis for those considering an investment in the company. For those ready to access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, enhancing your investment research with valuable data and expert analysis.
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