Ankündigung • Jun 03
Cumberland Pharmaceuticals and Vanderbilt Health Announce Positive Results from Phase 2A Clinical Trial of Ifetroban for Metastasis Prevention in High-Risk Solid Tumors Cumberland Pharmaceuticals Inc. and Vanderbilt Health announced data from a Phase 2a clinical trial of ifetroban to prevent metastasis in high-risk solid tumors. The study's primary safety endpoint was achieved, along with favorable trends in decreased metastasis recurrence and metastasis-free survival. The randomized, double-blind, placebo-controlled Phase 2a trial evaluated the safety of ifetroban, an investigational thromboxane A2 receptor antagonist, in patients with solid tumors at high risk of early metastatic recurrence. Cancer types included breast, lung, pancreatic, soft tissue, bladder, and renal cancers. The study met its primary endpoint, demonstrating that ifetroban was safe and well-tolerated in this patient population. Rates for adverse events related to treatment were similar between placebo and ifetroban. No serious adverse events (> grade 3) in either group were identified as being related to study treatment. Treatment discontinuation rates were not statistically different between placebo and ifetroban. Although primarily a safety study and intentionally not powered for efficacy, the study compared the percentage of patients with distant metastatic recurrence 12 months after completion of therapy in both groups (10 placebo-treated and 18 ifetroban-treated participants) as a prespecified secondary endpoint. While 50% of participants experienced distant metastatic recurrence in the placebo arm, only 17% of participants experienced distant metastatic recurrence in the ifetroban arm (p=0.091). Three deaths due to distant metastatic disease occurred in the placebo arm, and none occurred in the ifetroban arm (p=0.037). The premise of this novel therapy is that antagonizing the thromboxane A2 receptor and blocking platelet activation and aggregation lessens tumor cells' ability to migrate, spread, cluster, invade distal organs, and evade immune detection. This was the first trial evaluating the effects of ifetroban in people with solid tumors with high risk for early recurrence, defined as = 50% chance of recurrence within 5 years of diagnosis. The intervention was given after all cancer-related therapies and surgical procedures had been completed; participants received the intervention for 12 months and were then followed for an additional 12 months. Among 29 participants, 10 received placebo and 19 received ifetroban. This clinical trial translated robust in silico and preclinical data to humans, confirming safety of ifetroban in patients with solid tumors and preliminarily suggesting that ifetroban may target biologic mechanisms involved in distant metastatic recurrence. A phenome-wide association study (PheWAS) was conducted by Vanderbilt Health investigators using the BioVU biorepository, which linked a naturally occurring genetic variant in the thromboxane receptor gene (TBXA2R) to an increased risk of metastatic disease across multiple cancer types. Preclinical studies subsequently published in Molecular Cancer Therapeutics demonstrated that ifetroban reduced metastasis in several animal models without affecting tumor growth, and that the drug's effects appeared to involve strengthening of the vascular endothelial barrier and inhibiting the ability of tumor cells to migrate across blood vessel walls. The favorable safety profile of ifetroban in this patient population, combined with the efficacy signals observed in this study, supports continued investigation of ifetroban as a candidate for metastasis prevention. Results of this Phase 2a clinical trial will be used to guide the further clinical development verifying efficacy and further demonstrating safety. Ifetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. It exhibits high affinity for TPr on many cell types including platelets, cardiomyocytes, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. Cumberland is also evaluating ifetroban in Phase 2 clinical programs for patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. Ifetroban has a favorable safety profile as evidenced by multiple completed clinical trials collectively enrolling over 1,400 people. Cumberland's Phase 2 clinical programs are evaluating ifetroban in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis, and Idiopathic Pulmonary Fibrosis, in addition to the oncology program described in this release. Ankündigung • May 28
Cumberland Pharmaceuticals Launches Vibativ Injection in China in Strategic Partnership with SciClone Pharmaceuticals (Holdings) Limited Cumberland Pharmaceuticals Inc. announced the launch of its Vibativ (telavancin) injection in China, following regulatory approval and a strategic partnership with SciClone Pharmaceuticals (Holdings) Limited. The launch follows a previously announced agreement granting SciClone exclusive rights to register, promote and distribute telavancin, injection across China. The product's approval by China's National Medical Products Administration (NMPA) enables SciClone to commercialize the product in one of the world's largest and fastest-growing pharmaceutical markets. Telavancin is a patented, FDA-approved injectable anti-infective that serves as a potentially life-saving treatment for patients with serious bacterial infections, including hospital-acquired and ventilator-associated pneumonia. The therapy is designed to treat infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus (MSSA). Vibativ addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Antimicrobial resistance continues to be a critical global health challenge, reducing the effectiveness of many existing antibiotics and increasing the need for innovative treatments. Telavancin was specifically designed to address resistant pathogens, offering potent activity against difficult-to-treat infections. The successful launch of telavancin for injection in China represents another important milestone for SciClone Pharmaceuticals in the anti-infective field. Currently, MRSA remains a serious challenge and poses a significant clinical threat, particularly in respiratory tract infections, especially those that are hospital-acquired. With its unique dual bactericidal mechanism, broad antibacterial spectrum, and once-daily dosing regimen, telavancin offers an important new anti-infective option for Chinese patients with severe infections, delivering both improved efficacy and clinical convenience. Vibativ (telavancin) injection was discovered in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. It is a once-daily, injectable lipoglycopeptide antibiotic with in vitro potency, bactericidal activity within six hours and penetration into target infection sites. The drug is approved in the U.S. and Saudi Arabia for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. In addition, telavancin is approved in the U.S. and Saudi Arabia for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. The product labeling also describes the use of telavancin in treating patients whose pneumonia or skin infection is complicated by concurrent bacteremia. The product's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with S. aureus infections studied to date. Importantly, these studies demonstrated significantly higher cure rates for telavancin as compared to vancomycin in HABP/VABP due to any single Gram-positive pathogen or S. aureus with vancomycin MIC =1 µg/mL. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Reported Earnings • May 06
First quarter 2026 earnings released: US$0.22 loss per share (vs US$0.084 profit in 1Q 2025) First quarter 2026 results: US$0.22 loss per share (down from US$0.084 profit in 1Q 2025). Revenue: US$9.13m (down 22% from 1Q 2025). Net loss: US$3.29m (down 362% from profit in 1Q 2025). Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has increased by 37% per year, which means it is well ahead of earnings. Ankündigung • Apr 29
Cumberland Pharmaceuticals Inc. to Report Q1, 2026 Results on May 05, 2026 Cumberland Pharmaceuticals Inc. announced that they will report Q1, 2026 results After-Market on May 05, 2026 Ankündigung • Apr 17
Cumberland Pharmaceuticals Inc Announces Expanded Indication for Caldolor Ibuprofen Injection Cumberland Pharmaceuticals Inc. had received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for its Caldolor (ibuprofen) Injection product. The indication now includes the management of postoperative pain, and the approval coincides with the launch of a newly designed website for healthcare professionals highlighting this advancement and the evolving role of non-opioid pain management. With this update, Caldolor is indicated for use in adult and pediatric patients ages 3 months and older for: Management of mild to moderate pain, including postoperative pain; Management of moderate to severe pain, including postoperative pain, as an adjunct to opioid analgesics; Reduction of fever. This expanded labeling reinforces Caldolor's role as a versatile, non-opioid intravenous analgesic option for use in perioperative and acute care settings. The newly launched Caldolor website aligns with this expanded indication, featuring dedicated content on postoperative pain management and the importance of multimodal, opioid-sparing approaches. Postoperative pain remains a significant challenge across surgical setting, with a growing emphasis on reducing opioid exposure while maintaining effective pain control. The updated website provides healthcare professionals with resources that focus on: The role of IV non-opioid options like Caldolor in perioperative care; Strategies to support opioid stewardship amid the ongoing opioid crisis; Clinical data supporting safe and effective pain and fever management with Caldolor. In addition to featuring the new postoperative pain indication, the website offers comprehensive information on safety, dosing, efficacy, and access with J-Code reimbursement support. Ankündigung • Mar 10
Cumberland Pharmaceuticals Inc., Annual General Meeting, Apr 21, 2026 Cumberland Pharmaceuticals Inc., Annual General Meeting, Apr 21, 2026. Location: at 1600 west end avenue, suite 1300, tennessee, nashvile United States New Risk • Mar 09
New major risk - Revenue and earnings growth Earnings have declined by 1.9% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 1.9% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$52.3m market cap). Reported Earnings • Mar 05
Full year 2025 earnings released: US$0.19 loss per share (vs US$0.46 loss in FY 2024) Full year 2025 results: US$0.19 loss per share (improved from US$0.46 loss in FY 2024). Revenue: US$44.5m (up 18% from FY 2024). Net loss: US$2.84m (loss narrowed 56% from FY 2024). Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has increased by 16% per year, which means it is tracking significantly ahead of earnings growth. New Risk • Mar 04
New major risk - Revenue and earnings growth Earnings have declined by 1.9% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 1.9% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$68.5m market cap). Ankündigung • Feb 25
Cumberland Pharmaceuticals Inc. to Report Fiscal Year 2025 Results on Mar 03, 2026 Cumberland Pharmaceuticals Inc. announced that they will report fiscal year 2025 results After-Market on Mar 03, 2026 Ankündigung • Feb 04
Cumberland Pharmaceuticals Inc. Receives FDA Fast Track Designation for Its Ifetroban Duchenne Muscular Dystrophy Program Cumberland Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients. The FDA'sFast Track program facilitates the development and expedites the review of a drug designed to treat a serious or life-threatening condition and unmet medical need. This designation provides an opportunity for more frequent communication with the FDA, enabling Cumberland, as the sponsor, to obtain early feedback and guidance. Under Fast Track, Cumberland can also submit portions of an application for marketing approval on a rolling basis. Cumberland requested Fast Track Designation to streamline the regulatory pathway for ifetroban for DMD heart disease. This Fast Track Designation follows the drug's receipt of both Orphan Drug Designation and Rare Pediatric Disease Designation, confirming both the urgency and the significant impact of the product for this indication. Cumberland previously announced positive results from its Phase 2 FIGHT DMD trial evaluating oral thromboxane receptor antagonist ifetroban in DMD heart disease, demonstrating a 5.4% improvement in left ventricular ejection fraction (LVEF) over 12 months of treatment. New Risk • Dec 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (US$44.4m market cap). Ankündigung • Dec 09
Cumberland Pharmaceuticals Inc. Announces an Important Update Regarding its Caldolor®? (ibuprofen) Injection Cumberland Pharmaceuticals Inc. announced an important update regarding its Caldolor®? (ibuprofen) Injection. The product's permanent J-code, J1741, is now officially associated with a reimbursement price, providing healthcare providers with a CMS- covered, non-opioid option for managing pain and fever. As the nation continues to face an opioid crisis, non-opioid alternatives, like Caldolor, play a critical role in reducing reliance on opioid medications, supporting safer pain management strategies for patients. With the reimbursement price now linked to J1741, providers can access a CMS-covered, non-opioid pain management option and align treatment strategies with opioid-sparing initiatives. Caldolor J-Code Details: Product: Caldolor®? (ib uprofen) Injection; J-Code: J1741 - Injection, ibuprofen, 100 mg; Status: Now associated with reimbursement price. Providers are encouraged to update their internal systems, billing teams, and reimbursement processes to reflect this change. Reported Earnings • Nov 06
Third quarter 2025 earnings released: US$0.13 loss per share (vs US$0.11 loss in 3Q 2024) Third quarter 2025 results: US$0.13 loss per share (further deteriorated from US$0.11 loss in 3Q 2024). Revenue: US$8.29m (down 8.7% from 3Q 2024). Net loss: US$1.94m (loss widened 26% from 3Q 2024). Over the last 3 years on average, earnings per share has increased by 2% per year whereas the company’s share price has fallen by 2% per year. New Risk • Nov 05
New major risk - Revenue and earnings growth Earnings have declined by 1.7% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 1.7% per year over the past 5 years. Minor Risk Market cap is less than US$100m (US$39.8m market cap). Ankündigung • Oct 29
Cumberland Pharmaceuticals Inc. to Report Q3, 2025 Results on Nov 04, 2025 Cumberland Pharmaceuticals Inc. announced that they will report Q3, 2025 results After-Market on Nov 04, 2025 Ankündigung • Oct 13
Cumberland Pharmaceuticals Inc. Adds Their Potent Antibativ®? to National Group Purchasing Agreement with Premier, Inc Cumberland Pharmaceuticals Inc. has added their potent antibiotic, Vibativ®? (telavancin), to a national group purchasing agreement with Premier Inc. Effective October 1, 2025 the product addition allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for Vibativ®? in both the 12-vial carton and the newly introduced 4-vial Starter Pak. With expanded access, Premier member healthcare providers now have greater flexibility in ordering Vibativ, supporting both inpatient and outpatient settings. The 12-vial carton remains the standard packaging for institutions managing higher patient volumes, while the 4-vial Starter Pak provides a cost-effective option designed to help hospitals and clinicians initiate therapy and manage their inventory more effectively. Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,350 U.S. hospitals and 325,000 other providers and organizations to transform healthcare. With integrated data and analytics, collaborations, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost. Vibativ is a once-daily, dual mechanism antibiotic that has proven effective against a broad range of serious Gram-positive bacterial infections. The hydrophilic addition increases Vibativ's penetration into tissue and is able to attack infections that are not reachable by other antibiotics. Studies show that Vibativ is just as potent against difficult-to-treat and multidrug-resistant bacteria as it was when it was introduced over 10 years ago. Vibativ®?®? (telavanc in) injection was discovered in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. Vibativ is an once-daily, injectable lipoglycopeptide antibiotic with in vitro potency, bactericidal activity within six hours and penetration into target infection sites. The drug is approved in the U.S. for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. Ankündigung • Oct 01
Cumberland Pharmaceuticals Announces Product Approval in Mexico Cumberland Pharmaceuticals Inc. announced that its ibuprofen injection product, has received regulatory approval in Mexico. The approval follows Cumberland's partnership with PiSA Farmaceutica, which includes exclusive supply and distribution rights for the ibuprofen product in the Mexican market. PiSA is a well-established Mexican pharmaceutical firm with a leading injectable business in that country. Under the agreement, Cumberland is providing regulatory and manufacturing support, while PiSA led the regulatory process and will now launch the product in Mexico. PiSA plans to introduce the product in 800 mg vials, making it accessible for a variety of clinical uses in Mexican healthcare facilities. With opioid misuse continuing to pose global challenges, the introduction of the injectable ibuprofen product aligns with broader efforts to support multimodal, opioid-sparing pain management strategies. Ankündigung • Sep 30
Tabuk Pharmaceutical Manufacturing Company and Cumberland Pharmaceuticals Inc. Announces the Launch of Cumberland's Vibativ®? (Telavancin) Injection in Saudi Arabia Tabuk Pharmaceutical Manufacturing Company a fully owned subsidiary of Astra Industrial Group and a leading pharmaceutical company in the Middle East and Cumberland Pharmaceuticals Inc. announced the launch of Cumberland's Vibativ®? (telavancin) injection in Saudi Arabia. The announcement follows an agreement between the companies providing Tabuk with the exclusive rights to register and promote the product for patients in Saudi Arabia and other countries in the Middle East. Vibativ is a patented, FDA-approved injectable anti-infective that can serve as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from infections, including the flu and COVID-19. It is intravenously administered with once-daily dosing and does not require therapeutic drug monitoring, decreasing health care professionals' exposure to the patient. It is designed to treat serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including Methicillin-resistant Staphylococcus auresus (MRSA) and Methicillin-sensitive Staphylococcus auredus (MSSA). Vibativ addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. According to a recent report from the World Health Organization, antimicrobial resistance (AMR) is an urgent global health and socioeconomic crisis. Further, the global rise in antibiotic resistance poses a significant threat, diminishing the efficacy of many common antibiotics against widespread bacterial infections. Unlike many recently introduced antibiotics that are quickly losing the battle to fight the bacteria they were designed to kill because those bacteria have become drug-resistant, Vibativ was specifically designed to kill drug-resistant bacteria. Vibativ (telavancin) injections was discovered in a research program dedicated to finding new antibiotics for serious infections due to Staphalococcus aureus (Cumberland Pharmaceuticals) and other Gram- positive bacteria, including MRSA and MSSA. Vibativ is an once-daily, injectable lipoglycopeptide antibiotic with in vitro potency, bactericidal activity within six hours and penetration into target infection sites. The drug is approved in the U.S. and Saudi Arabia for the treatment of adult patients with hospital-acquired & ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. Tabuk Pharmaceuticals reaches patients in 17 countries in the Middle East and Africa, in addition to futuristic plans to expand its presence in the region. Reported Earnings • Aug 06
Second quarter 2025 earnings released Second quarter 2025 results: Net income: (up US$1.09m from 2Q 2024). Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has increased by 11% per year, which means it is well ahead of earnings. New Risk • Aug 06
New major risk - Revenue and earnings growth Earnings have declined by 0.4% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings have declined by 0.4% per year over the past 5 years. Minor Risk Market cap is less than US$100m (US$56.7m market cap). Board Change • Aug 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 4 highly experienced directors. Director Martin Brown was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Ankündigung • Jul 30
Cumberland Pharmaceuticals Inc. to Report Q2, 2025 Results on Aug 05, 2025 Cumberland Pharmaceuticals Inc. announced that they will report Q2, 2025 results After-Market on Aug 05, 2025 New Risk • Jun 30
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (18% average weekly change). Minor Risk Market cap is less than US$100m (US$38.9m market cap). Ankündigung • Jun 24
Cumberland Pharmaceuticals Shares Phase 2 Fight Dmd Trial Results At the Parent Project Muscular Dystrophy Annual Conference Cumberland Pharmaceuticals Inc. shared the latest positive results from its Phase 2 FIGHT DMD trial evaluating ifetroban, a novel oral therapy for Duchenne muscular Dystrophy (DMD) heart disease, at the annual Parent Project Muscular Dystrophy (PPMD) conference in Las Vegas. These new results highlight multiple indicators of cardiac benefit with ifetroban treatment in DMD heart disease, the leading cause of death in DMD, including previously unreported pharmacokinetic findings and cardiac biomarker data that demonstrate the drug's potential to prevent ongoing heart damage. FIGHTDMD helped co-fund the preclinical studies at Vanderbilt's Monroe Carell Jr. Children's Hospital which formed the foundation for the FDA grant funding this trial. The trial was named The FIGHT DMD Trial in honor of their organization's early support. The Marlin family also provided input into the clinical trial design and contributed personal photos for the trial's patient brochure. The 12-month Phase 2 FIGHT DMD trial (NCT03340675) demonstrated that high-dose ifetroban treatment resulted in a significant 5.4% improvement in left ventricular ejection fraction (LVEF) compared to a control group compared of placebo-treated patients combined with propensity score-matched natural history patients. The observed improvement in cardiac function together with the reduction in cardiac damage biomarkers suggest a clinically significant impact for ifetroban in both heart disease and potential to impact overall survival in DMD. Demonstrating confidence in the treatment, all patients who completed the 12-month study opted to continue with the open-label extension. Ifetroban is a once-daily oral medication that works by blocking the thromboxane receptor, which plays a key role in inflammation and fibrosis. The drug has received both Orphan Drug Designation Rare Pediatric Disease Designation, from the FDA for the indication of DMD heart disease. There is currently no approved treatment specifically targeting DMD heart disease, highlighting the critical unmet medical need in this patient population where cardiac complications are universal and represent the leading cause of death. Cumberland has secured a growing portfolio of patents protecting the product for this DMD heart disease indication. Next steps include the analysis of long-term treatment results and discussions with the FDA to determine the regulatory pathway forward based on these encouraging results. DMD is a rare and incurable pediatric disease caused by mutations in the gene encoding dystrophin, a protein critical for muscle function, including the heart. The organization has provided crucial early-stage funding for multiple research projects focused on understanding and treating cardiac complications in DMD patients. Their support has been instrumental in advancing preclinical research that led to FDA grant funding for clinical trials, demonstrating the power of family-driven advocacy in catalyzing medical innovation. Ankündigung • May 28
Cumberland Pharmaceuticals Inc. Announces the Publication of Its Study InvestigatingCaldolor (Intravenous Ibuprofen) in Older Patients Cumberland Pharmaceuticals Inc. announced the publication of its study investigating Caldolor (intravenous ibuprofen) in older patients. The analysis evaluated the safety and efficacy of Caldolor for the management of pain and fever in patients 60 years of age and older. It marks an important advancement in pain management for older individuals, as it's one of the first studies specifically evaluating Caldolor in this vulnerable population. Pain management in older patients presents unique challenges due to their increased sensitivity to opioid analgesics and higher risk of side effects. Nearly one-third of all ambulatory surgeries are performed on older patients, yet this population is often underrepresented in clinical trials, highlighting an important medical need addressed in this study. A post-hoc subgroup analysis was performed using data from four prospective clinical studies in which Caldolor was administered for the treatment of pain and/or fever in hospitalized patients. The efficacy analysis included 591 patients from two placebo-controlled trials, with safety assessed across all 1,041 patients. Today's announcement builds on Cumberland's ongoing commitment to expanding the clinical applications of Caldolor. In June 2023, the company announced the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborn infants, which supported the FDA approval of Caldolor for use in infants 3 to 6 months of age. With these latest findings in older patients, Cumberland continues to demonstrate Caldolor's safety and efficacy across the full age spectrum, from infants to older adults. Caldolor is FDA-approved for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and reduction of fever in adults and pediatric patients three months and older. This new data supports its use specifically in the older patient population. Next steps include further outreach to health care providers treating older patients to share these important findings. Ankündigung • May 14
Cumberland Pharmaceuticals Inc. Partners with Qureight to Advance Innovative Idiopathic Pulmonary Fibrosis Treatment Research Cumberland Pharmaceuticals Inc. announced a partnership with Qureight, a Core Imaging Laboratory developing deep-learning image analytics, to enhance the outcome and output of data from Cumberland's FIGHTING FIBROSIS™? clinical trial. The Phase II study is evaluating Cumberland's ifetroban product candidate in patients with idiopathic pulmonary fibrosis (IPF), the most common form of progressive fibrosing interstitial lung disease. This collaboration aims to address a critical unmet need for the estimated 2 million IPF patients worldwide, who currently have limited treatment options that can effectively halt disease progression. Cumberland's fightING FIBROSIS clinical trial is a multicenter, double-blind, placebo-controlled Phase II study investigating the safety and efficacy of once daily oral ifetroban for 52 weeks in patients with IPF. The study includes both patients on existing antifibrotic therapies and those not currently receiving such treatments, with a primary endpoint focusing on change in forced vital capacity. Both Cumberland and Qureight will be attending the upcoming American Thoracic Society International Conference in San Francisco, where the FIGHTING FIBROS IS™? study will be featured in the Clinical Trial Awareness area. This collaborative presence at one of the world's premier respiratory medicine gatherings underscores the companies' shared commitment to advancing innovative solutions for patients with pulmonary fibrosis. IPF is the most common form of interstitial lung disease and affects up to 2 million individuals globally. While FDA-approved antifibrotic therapies have shown efficacy to slow progression of the disease, there is no approved treatment which effectively halts disease progression and improves patients' symptoms. Therefore, an unmet need exists to identify additional treatments which add benefit and provide alternatives to existing therapies. The FIGHTING FIBROSis™? clinical trial is a double-blind, placebo- controlled Phase II study designed to evaluate 12 months of oral ifetroban and enroll 128 patients in over 20 medical centers of excellence across the U.S. The study is currently actively enrolling at 16 centers. The clinical trial is registered on ClinicalTrials.gov under identifier NCT05571059. For more information about the study, including eligibility criteria and participating sites, visit Ingrid Anderson, PhD at or 615-556-7188. Cumberland is also sponsoring the FIGHT DMD™? trial, a multicenter, randomized, placebo-controlled phase II study evaluating two doses of oral ifetroban for the treatment of the cardiomyopathy associated with Duchenne muscular dystrophy, and has a Phase II clinical program for Systemic Sclerosis. The company develops, acquires, and commercializes products that can effectively halt disease progression, and are available for patients with IPF. Reported Earnings • May 07
First quarter 2025 earnings released: EPS: US$0.084 (vs US$0.14 loss in 1Q 2024) First quarter 2025 results: EPS: US$0.084 (up from US$0.14 loss in 1Q 2024). Revenue: US$11.7m (up 38% from 1Q 2024). Net income: US$1.26m (up US$3.20m from 1Q 2024). Profit margin: 11% (up from net loss in 1Q 2024). Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has increased by 26% per year, which means it is well ahead of earnings. Ankündigung • Apr 30
Cumberland Pharmaceuticals Inc. to Report Q1, 2025 Results on May 06, 2025 Cumberland Pharmaceuticals Inc. announced that they will report Q1, 2025 results After-Market on May 06, 2025 Ankündigung • Mar 11
Cumberland Pharmaceuticals Inc., Annual General Meeting, Apr 22, 2025 Cumberland Pharmaceuticals Inc., Annual General Meeting, Apr 22, 2025. Location: 1600 west endavenue, suite 1300, nashville, tennessee., United States Reported Earnings • Mar 05
Full year 2024 earnings released: US$0.46 loss per share (vs US$0.44 loss in FY 2023) Full year 2024 results: US$0.46 loss per share (further deteriorated from US$0.44 loss in FY 2023). Revenue: US$37.9m (down 4.3% from FY 2023). Net loss: US$6.48m (loss widened 3.2% from FY 2023). Over the last 3 years on average, earnings per share has fallen by 15% per year but the company’s share price has increased by 35% per year, which means it is well ahead of earnings. Ankündigung • Feb 26
Cumberland Pharmaceuticals Inc. to Report Fiscal Year 2024 Results on Mar 04, 2025 Cumberland Pharmaceuticals Inc. announced that they will report fiscal year 2024 results After-Market on Mar 04, 2025 Ankündigung • Feb 18
Cumberland Pharmaceuticals Inc. and SciClone Pharmaceuticals (Holdings) Limited Announce the National Medical Products Administration Approval of Cumberland's Vibativ® (Telavancin) Injection in China Specialty pharmaceutical companies Cumberland Pharmaceuticals Inc. and SciClone Pharmaceuticals (Holdings) Limited announced the NMPA (National Medical Products Administration) approval of Cumberland's Vibativ® (telavancin) injection in China. The announcement follows an agreement between the companies providing SciClone the exclusive rights to register, promote and distribute the product to patients in that country. The NMPA is the Chinese pharmaceutical regulatory authority there, equivalent to the United States' Food and Drug Administration (FDA). Vibativ is a potent, FDA-approved injectable anti-infective that serves as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and are multidrug-resistant. Vibativ is also used for the treatment of complicated skin and skin structure infections, such as MRSA. As a once-daily dosed antibiotic, it does not require therapeutic drug monitoring, decreasing health care professionals' exposure to the patient. SciClone and Cumberland plan to launch Vibativ in China later this year. Ankündigung • Feb 04
Cumberland Pharmaceuticals Announces Breakthrough Results from the Phase 2 Fight DMD Trial in Duchenne Muscular Dystrophy Heart Disease Cumberland Pharmaceuticals Inc. announced positive top-line results from its Phase 2 FIGHT DMD trial. The study evaluated ifetroban, a novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease - the leading cause of death in DMD patients. It marks a breakthrough for these patients, as it's the first successful Phase 2 study specifically targeting the cardiac complications of their condition. Patients with DMD slowly lose muscle function, resulting in the inability to walk, difficulty breathing and heart failure. While current treatments can help manage some DMD symptoms, there are no approved therapies specifically targeting DMD-related heart disease, highlighting a critical unmet medical need. A previous study conducted at Vanderbilt University Medical Center demonstrated that ifetroban is protective against cardiomyopathy in several preclinical models of muscular dystrophy. The results of that study were published in the Journal of the American Heart Association (West 2019). Based on those promising results, Cumberland Pharmaceuticals became the first recipient of an FDA Office of Orphan Products Development clinical trial grant for DMD, funding the development of this Phase 2 clinical trial. Ifetroban is a once-daily oral medication that works by blocking the thromboxane receptor, which plays a key role in inflammation and fibrosis. The drug has received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA, highlighting its potential significance in treating this devastating condition. If approved, ifetroban would be the first therapy specifically indicated for DMD-related heart disease. Cumberland has secured a growing portfolio of patents with claims associated with the product for this DMD indication. Next steps include further data analysis and completion of a full study report in preparation for an end of Phase 2 meeting with the FDA to determine next steps associated with the product's development and commercialization. New Risk • Dec 10
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 28% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (28% average weekly change). Minor Risk Market cap is less than US$100m (US$17.4m market cap). Ankündigung • Dec 10
Cumberland Pharmaceuticals Inc. Announces FDA Approves Supplemental New Drug Application (sNDA) for Its Acetadote (N-Acetylcysteine for Injection) Product Cumberland Pharmaceuticals Inc. announced the FDA has approved a supplemental New Drug Application (sNDA) for its Acetadote® (N-acetylcysteine for injection) product. Acetadote is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen1. Acetaminophen, a common over-the-counter pain reliever and fever reducer, is the leading cause of acute liver failure in the United States. Each year, thousands of individuals experience accidental or intentional acetaminophen poisoning, leading to serious liver damage. The newly approved dosing regimen simplifies the administration of Acetadote by combining the first two bags of the standard regimen into a single, slower infusion. This streamlined approach has been implemented in hospitals across multiple countries and demonstrated to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions (NAARs) without compromising the effectiveness of Acetadote2-6. By simplifying the dosing regimen, health care providers can administer the life-saving treatment more efficiently, potentially improving patient outcomes. Key Highlights: FDA-approved sNDA adds a simplified, IV NAC dosing regimen to the product prescribing information. New IV NAC dosing regimen is both safe and effective. New dosing regimen aims to minimize interruptions in care, medication errors and incidence of dose-related reactions. Reported Earnings • Nov 10
Third quarter 2024 earnings released: US$0.11 loss per share (vs US$0.073 loss in 3Q 2023) Third quarter 2024 results: US$0.11 loss per share (further deteriorated from US$0.073 loss in 3Q 2023). Revenue: US$9.09m (down 9.9% from 3Q 2023). Net loss: US$1.54m (loss widened 47% from 3Q 2023). Over the last 3 years on average, earnings per share has fallen by 23% per year whereas the company’s share price has fallen by 24% per year. Ankündigung • Nov 06
Cumberland Pharmaceuticals Announces New Study Compares Caldolor® (ibuprofen injection) to Ketorolac Cumberland Pharmaceuticals announced the publication of new real-world outcomes research demonstrating the safety and healthcare resource advantages of its Caldolor (ibuprofen) injection over ketorolac in both adult and pediatric populations. The study, published in Frontiers of Pain Research, provides compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions (ADRs) and improved healthcare utilizations when compared to ketorolac. This extensive, retrospective, payer database analysis evaluated the records of over 17 million patients who had received either ketorolac or Caldolor. Ultimately, 31,046 Caldolor and 124,184 ketorolac adult patients were selected and compared for ADRs and subsequent healthcare resource utilization, which includes inpatient, outpatient and emergency department visits as well as all procedures and prescriptions during the follow up time of 29 days. An additional 5,579 pediatric patients were identified in each arm and compared in a separate claims analysis. Key findings reveal that, in adults, Caldolor was associated with a 45% reduction in renal dysfunction (p<0.001) and a 78% decrease in hematuria rates (p<0.001) when compared to ketorolac. Notably, patients also experienced fewer gastrointestinal complications as well as reduced headaches, nausea and abdominal pain. Among pediatric patients, the results showed Caldolor was associated with a 51-65% lower rate of ADRs, including headache and nausea, with 95% confidence intervals supporting clinical significance. Caldolor also demonstrated a positive impact on healthcare resource utilization (HCRU) when compared to ketorolac, with decreased emergency room and outpatient visits, as well as a shortened hospital length of stay for both adults and children. About Caldolor® (ibuprofen) Injection: Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Ankündigung • Nov 01
Cumberland Pharmaceuticals Inc. to Report Q3, 2024 Results on Nov 07, 2024 Cumberland Pharmaceuticals Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024 Reported Earnings • Aug 07
Second quarter 2024 earnings released: US$0.077 loss per share (vs US$0.061 profit in 2Q 2023) Second quarter 2024 results: US$0.077 loss per share (down from US$0.061 profit in 2Q 2023). Revenue: US$9.85m (down 9.6% from 2Q 2023). Net loss: US$1.09m (down 225% from profit in 2Q 2023). Over the last 3 years on average, earnings per share has fallen by 21% per year and the company’s share price has also fallen by 21% per year. Ankündigung • Jul 31
Cumberland Pharmaceuticals Inc. to Report Q2, 2024 Results on Aug 06, 2024 Cumberland Pharmaceuticals Inc. announced that they will report Q2, 2024 results After-Market on Aug 06, 2024 Reported Earnings • May 08
First quarter 2024 earnings released: US$0.14 loss per share (vs US$0.013 profit in 1Q 2023) First quarter 2024 results: US$0.14 loss per share (down from US$0.013 profit in 1Q 2023). Revenue: US$8.50m (down 7.9% from 1Q 2023). Net loss: US$1.95m (down US$2.14m from profit in 1Q 2023). Over the last 3 years on average, earnings per share has fallen by 9% per year whereas the company’s share price has fallen by 14% per year. Ankündigung • May 01
Cumberland Pharmaceuticals Inc. to Report Q1, 2024 Results on May 07, 2024 Cumberland Pharmaceuticals Inc. announced that they will report Q1, 2024 results After-Market on May 07, 2024 Ankündigung • Mar 21
Cumberland Pharmaceuticals Inc. has filed a Follow-on Equity Offering in the amount of $5.8 million. Cumberland Pharmaceuticals Inc. has filed a Follow-on Equity Offering in the amount of $5.8 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Mar 15
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (US$25.5m market cap). Ankündigung • Mar 14
Cumberland Pharmaceuticals Inc., Annual General Meeting, Apr 23, 2024 Cumberland Pharmaceuticals Inc., Annual General Meeting, Apr 23, 2024, at 09:30 Central Standard Time. Location: Cumberland’s Corporate Offices located at 1600 West End Avenue, Suite 1300, Nashsville Tennessee United States Agenda: To consider and act upon a proposal to elect to the Company's Board of Directors, Mr. Martin S. Brown, Jr. and Mr. James R. Jones; to ratify the appointment of Carr, Riggs & Ingram, LLC as company's independent registered public accounting firm for 2024; and to transact such other business as may properly come before company's annual meeting or any postponement or adjournment of the meeting. Reported Earnings • Mar 06
Full year 2023 earnings released: US$0.44 loss per share (vs US$0.38 loss in FY 2022) Full year 2023 results: US$0.44 loss per share (further deteriorated from US$0.38 loss in FY 2022). Revenue: US$39.6m (down 5.9% from FY 2022). Net loss: US$6.28m (loss widened 13% from FY 2022). Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings. Ankündigung • Feb 28
Cumberland Pharmaceuticals Inc. to Report Fiscal Year 2023 Results on Mar 05, 2024 Cumberland Pharmaceuticals Inc. announced that they will report fiscal year 2023 results After-Market on Mar 05, 2024 New Risk • Dec 18
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.0% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (3.0% increase in shares outstanding). Market cap is less than US$100m (US$26.4m market cap). Reported Earnings • Nov 10
Third quarter 2023 earnings released: US$0.073 loss per share (vs US$0.028 loss in 3Q 2022) Third quarter 2023 results: US$0.073 loss per share (further deteriorated from US$0.028 loss in 3Q 2022). Revenue: US$10.1m (down 12% from 3Q 2022). Net loss: US$1.05m (loss widened 157% from 3Q 2022). Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings. Ankündigung • Nov 01
Cumberland Pharmaceuticals Inc. to Report Q3, 2023 Results on Nov 07, 2023 Cumberland Pharmaceuticals Inc. announced that they will report Q3, 2023 results at 4:00 PM, US Eastern Standard Time on Nov 07, 2023 New Risk • Oct 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.2% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (9.2% average weekly change). Market cap is less than US$100m (US$28.5m market cap). Reported Earnings • Aug 09
Second quarter 2023 earnings released: EPS: US$0.061 (vs US$0.091 loss in 2Q 2022) Second quarter 2023 results: EPS: US$0.061 (up from US$0.091 loss in 2Q 2022). Revenue: US$10.9m (up 5.7% from 2Q 2022). Net income: US$872.2k (up US$2.21m from 2Q 2022). Profit margin: 8.0% (up from net loss in 2Q 2022). The move to profitability was primarily driven by lower expenses. Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. Ankündigung • Aug 03
Cumberland Pharmaceuticals Inc. to Report Q2, 2023 Results on Aug 08, 2023 Cumberland Pharmaceuticals Inc. announced that they will report Q2, 2023 results After-Market on Aug 08, 2023 Ankündigung • Jun 27
Cumberland Pharmaceuticals Inc. Announces the Publication of Positive Results from Clinical Study Investigating the Safety and Pharmacokinetics of Caldolor in Newborn Infants, Published in the Journal Pediatric Drugs Cumberland Pharmaceuticals Inc. announced the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborn infants, published in the journal Pediatric Drugs. Caldolor (ibuprofen) injection, is an intravenous non-steroidal anti-inflammatory drug (NSAID) approved by the FDA for the treatment of pain and fever in adults and children. The results of this published study supported the recent FDA approval of Caldolor in infants 3 to 6 months of age. A multicenter, randomized,pen-label, active-comparator trial to determine the eFCacy, safety, and pharmacokinetics of ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb. 1;17(1):42.bout Caldldolor(R) Caldolor is indicated in adults and pediatric patien for the management of mild toto moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as for the reduction of fever. It was the first FDA- approved intravenous therapy for fever. It was the firstF FDA- approved intravenous therapy For fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic-type reactions after taking aspirin or other NSAIDs. Caldolor is contrainDicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during product treatment. Ankündigung • May 24
Cumberland Pharmaceuticals Inc. Announces FDA Clearance of IND for New Treatment of Idiopathic Pulmonary Fibrosis Cumberland Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for a Phase II study in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. As a result, Cumberland will launch its FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S. Idiopathic Pul pulmonary Fibrosis (IPF) is the newest clinical program in the pipeline for Cumberland's first new chemical entity: ifetroban -- a potent and selective thromboxane receptor antagonist. The Company has designed a Phase II clinical trial to study the safety, tolerability, and efficacy of oral ifetroban in patients with IPF. Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models. Cumberland previously received IND clearance from the FDA for several indications including Systemic Sclerosis and Duchenne Muscular Dystrophy. Phase II clinical studies in patients with those conditions are well underway. The FIGHTING FIBROSis clinical trial is a multicenter, double-blind, placebo-controlled Phase II study in patients with IPF. The study will investigate the safety and efficacy of once daily oral ifetroban for 52 weeks. Subjects will be block randomized by background therapy (pirfenidone or nintedanib) and assigned to one of two treatment groups, ifetroban or placebo, at a dose of 250 mg daily. About Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease marked by inflammation and fibrosis of the lungs, resulting in rapidly declining lung function and reduced survival within 5 years of diagnosis. IPF is the most common form of interstitial lung disease and is estimated to affect up to 2 million individuals globally. While FDA-approved antifibrotic therapies have shown efficacy to slow progression of the disease, there is no approved treatment which effectively halts disease progression and improves patients' symptoms. Therefore, an unmet need exists to identify additional treatments which add benefit and provide alternatives to existing therapies. Ankündigung • May 16
U.S. Food and Drug Administration Approves Cumberland Pharmaceuticals Inc.'s Expanded Lab Labulation for Caldolor Cumberland Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor, an intravenously delivered formulation of ibuprofen, to now include use in infants. The non-narcotic agent may now be administered for the treatment of pain and fever in patients three months to six months of age. The newly FDA-approved label includes information regarding the product's indications and usage, appropriate patient populations, clinical study results, potential side effects, patient safety details, and instructions for use in these young children. To support this expanded use of Caldolor, Cumberland sponsored a multi-center study in 21 hospitalized infants. All but one patient was treated with a single dose of the product. Cumberland previously announced FDA approval for use in pre-operative administration. The Non-narcotic pain reliever may be administered just prior to surgery, which enables patients to wake up from their procedures in significantly less pain. Caldolor presents a potentially safer alternative to opioids for controlling pain, as the FDA has recently required new safety warnings on the use of opioids. In addition, the Company recently reported that it expects Caldolor will be eligible for special Medicare reimbursement under the Non-Opioids Prevent Addiction in the Nation Act (the "NOPAIN Act"), which was enacted as part of the Consolidated Appropriations Act of 2023. The NOPAIN Act requires Medicare to provide separate reimbursement for non-opioid products that are used to manage pain during surgeries conducted in outpatient hospital departments or in ambulatory surgical centers. The methodology for reimbursement for non-opioID pain alternatives under the NOPAIN Act will apply to those products that are furnished between January 1, 2025 and January 1, 2028. It is anticipated that in 2024, the Centers for Medicare & Medicaid Services (CMS) will issue regulations implementing the NOPAIN Act and detailing the conditions for, and amount of, the separate reimbursement. Caldolor is now approved by the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients three months and older, for the management of mild to moderate pain as a sole therapy, and for the management of moderate to severe pain as an adjunct to an opioid. A series of published clinical studies have demonstrated that Caldolor significantly reduces patient pain, while also significantly reducing patients' need for opioids. Reported Earnings • May 10
First quarter 2023 earnings released: EPS: US$0.013 (vs US$0.094 loss in 1Q 2022) First quarter 2023 results: EPS: US$0.013 (up from US$0.094 loss in 1Q 2022). Revenue: US$9.22m (down 18% from 1Q 2022). Net income: US$192.2k (up US$1.58m from 1Q 2022). Profit margin: 2.1% (up from net loss in 1Q 2022). The move to profitability was driven by lower expenses. Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings. Reported Earnings • Mar 08
Full year 2022 earnings released: US$0.38 loss per share (vs US$0.37 loss in FY 2021) Full year 2022 results: US$0.38 loss per share (further deteriorated from US$0.37 loss in FY 2021). Revenue: US$42.0m (up 17% from FY 2021). Net loss: US$5.57m (loss widened 1.2% from FY 2021). Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 18% per year, which means it is significantly lagging earnings. Ankündigung • Jan 19
Cumberland Pharmaceuticals Inc. Announces Demise of Joey A. Jacobs, Member of Board of Directors On January 14, 2023, Cumberland Pharmaceuticals Inc. learned that Joey A. Jacobs, a member of Cumberland’s Board of Directors, had passed away. Mr. Jacobs served as a member of the Company’s Board of Directors since 2011. He was the Chairman of company's Governance and Nominating Committee, as well as company's Lead Independent Director. Mr. Jacobs had over 45 years of experience in the healthcare industry. He was the former Chairman and Chief Executive Officer of Acadia Healthcare, a behavioral health company. Mr. Jacobs was also the former Chairman, President and Chief Executive Officer of Psychiatric Solutions Inc. (PSI), which he co-founded in 1997 and grew into a $2 billion behavioral healthcare system before the company’s sale to Universal Health Services in 2010. Prior to founding PSI, Mr. Jacobs spent 21 years at Hospital Corporation of America, or HCA, where he served in various capacities. The Company’s Board of Directors plans to meet and reassign Mr. Jacobs' responsibilities. Ankündigung • Dec 13
Cumberland Pharmaceuticals Inc. Announces Approval of Supplemental New Drug Application from U.S. Food and Drug Administration On December 6, 2022, Cumberland Pharmaceuticals Inc. received notification from Kyowa Kirin Inc. that the U.S. Food and Drug Administration approved a supplemental new drug application associated with a new site at Kindeva Drug Delivery L.P., for the manufacturing and primary packaging of Cumberland’s Sancuso brand. In January 2022, Cumberland acquired the U.S. rights to Sancuso from Kyowa Kirin and assumed full commercial responsibility for the product in the U.S. – including its marketing, promotion, distribution, manufacturing and medical support activities. In March 2019, Kyowa Kirin submitted a Prior Approval sNDA for the new Kindeva manufacturing site. In June 2019, Kyowa Kirin received a complete response letter from the FDA regarding the sNDA submission which included a request for clinical information. On August 12, 2022, Kyowa Kirin submitted an amendment to the sNDA that included the requested information. After the amendment was reviewed by the FDA, approval was granted. Based on the terms of the Sancuso acquisition agreement, Cumberland will provide a $1 million milestone payment to Kyowa Kirin who was responsible for developing the needed clinical and manufacturing data, preparing the submission and securing the FDA approval. Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment. The active drug in Sancuso, granisetron, slowly dissolves in the thin layer of adhesive that sticks to the patient’s skin and is released into their bloodstream over several days, working continuously to prevent chemotherapy-induced nausea and vomiting. Reported Earnings • Nov 19
Third quarter 2022 earnings released: US$0.028 loss per share (vs US$0.10 loss in 3Q 2021) Third quarter 2022 results: US$0.028 loss per share (improved from US$0.10 loss in 3Q 2021). Revenue: US$11.4m (up 41% from 3Q 2021). Net loss: US$408.6k (loss narrowed 74% from 3Q 2021). Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. Reported Earnings • Nov 10
Third quarter 2022 earnings released: US$0.028 loss per share (vs US$0.10 loss in 3Q 2021) Third quarter 2022 results: US$0.028 loss per share (improved from US$0.10 loss in 3Q 2021). Revenue: US$11.4m (up 41% from 3Q 2021). Net loss: US$408.6k (loss narrowed 74% from 3Q 2021). Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has fallen by 23% per year, which means it is significantly lagging earnings. Ankündigung • Nov 02
Cumberland Pharmaceuticals Inc. to Report Q3, 2022 Results on Nov 08, 2022 Cumberland Pharmaceuticals Inc. announced that they will report Q3, 2022 results After-Market on Nov 08, 2022 Reported Earnings • Aug 11
Second quarter 2022 earnings released: US$0.091 loss per share (vs US$0.049 profit in 2Q 2021) Second quarter 2022 results: US$0.091 loss per share (down from US$0.049 profit in 2Q 2021). Revenue: US$10.3m (up 14% from 2Q 2021). Net loss: US$1.34m (down 283% from profit in 2Q 2021). Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings. Ankündigung • Aug 03
Cumberland Pharmaceuticals Inc. to Report Q2, 2022 Results on Aug 09, 2022 Cumberland Pharmaceuticals Inc. announced that they will report Q2, 2022 results After-Market on Aug 09, 2022 Ankündigung • Jul 21
Cumberland Pharmaceuticals Appoints Martin Brown Jr. to Its Board of Directors Cumberland Pharmaceuticals Inc. announced that Martin Brown Jr. has joined the company's Board of Directors. Brown previously served for 10 years on the Board of directors of Brown-Forman Corporation, a large American wine and spirits company listed on the New York Stock Exchange. The brands in Brown-Forman's portfolio include Jack Daniel's and Woodford Reserve whiskeys, Benriach scotch, Herradura tequila and Finlandia vodka. Brown is an attorney at Adams and Reese LLP, a multi-disciplinary law firm with over 270 attorneys and advisors located throughout the United States. He has nearly 30 years of legal experience representing privately held businesses, counseling owners in complex business transactions, intellectual property licensing, international commerce, mergers and acquisitions, and estate planning. He has been listed since 2009 in the corporate law category of in Best Lawyers®. Additionally, he has served since 2018 on the board of directors of the parent company of Aegis Sciences Corporation, a federally certified health care laboratory headquartered in Nashville. Brown has been an active board member for many community organizations, including the Land Trust for Tennessee, Nashville Public Radio, Montgomery Bell Academy, Nashville Public Television, Centerstone Mental Health Center, Cheekwood Estate and Gardens, and Tennessee chapter of the Nature Conservancy. Brown earned his bachelor's degree from Yale University and his juris doctor from Vanderbilt University. Cumberland's Board of Directors also includes Kazimi; Dr. Gordon R. Bernard, executive vice president for research at Vanderbilt University Medical Center; Joey A. Jacobs, former Chairman and CEO of Acadia Healthcare; James R. Jones, former managing partner at KPMG; Caroline R. Young, former CEO of the Nashville Health Care Council and current vice president of partnership development at first Cressey Ventures; Kenneth J. Krogulski, managing partner and chief investment officer at Berkshire Asset Management; and Joseph C. Galante, a music industry executive and former Chairman of Sony Music Nashville and RCA Nashville. Ankündigung • Jun 05
Cumberland Pharmaceuticals Inc. Announces Executive Changes On May 31, 2022, Cumberland Pharmaceuticals Inc. announced the retirement of Leo Pavliv, Cumberland's Executive Vice President, Chief Development & Operations Officer. Mr. Pavliv previously has served as Vice President, Operations and was named Executive Vice President in 2017 and Chief Operations Officer in 2018. In that role, Mr. Pavliv was involved in various regulatory, product development and manufacturing activities for Cumberland. Reported Earnings • May 12
First quarter 2022 earnings: EPS and revenues exceed analyst expectations First quarter 2022 results: US$0.094 loss per share (down from US$0.022 loss in 1Q 2021). Revenue: US$11.2m (up 6.1% from 1Q 2021). Net loss: US$1.39m (loss widened 322% from 1Q 2021). Revenue exceeded analyst estimates by 5.7%. Earnings per share (EPS) also surpassed analyst estimates by 162%. Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has fallen by 28% per year, which means it is significantly lagging earnings. Ankündigung • May 04
Cumberland Pharmaceuticals Inc. to Report Q1, 2022 Results on May 10, 2022 Cumberland Pharmaceuticals Inc. announced that they will report Q1, 2022 results After-Market on May 10, 2022 Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 4 highly experienced directors. Independent Director Joe Galante was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Ankündigung • Apr 01
Tabuk and Cumberland Partner to Bring Innovative Antibiotic with Life-Saving Potential to Middle East Cumberland Pharmaceuticals Inc. and Tabuk Pharmaceutical Manufacturing Company announced the launch of Cumberland's Vibativ® (telavancin) injection in the Middle East. The announcement follows an agreement between the companies providing Tabuk the exclusive rights to register and promote the product for patients in Saudi Arabia, Jordan and potentially other countries in the Middle East. Vibativ serves as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and are multidrug-resistant. As a once-daily dosed antibiotic, Vibativ does not require therapeutic drug monitoring, decreasing health care professionals' exposure to the patient. Reported Earnings • Mar 10
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: US$0.37 loss per share (up from US$0.43 loss in FY 2020). Revenue: US$36.0m (down 3.9% from FY 2020). Net loss: US$5.50m (loss narrowed 16% from FY 2020). Revenue exceeded analyst estimates by 5.7%. Earnings per share (EPS) missed analyst estimates by 162%. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 20% per year, which means it is significantly lagging earnings. Ankündigung • Mar 03
Cumberland Pharmaceuticals Inc. to Report Fiscal Year 2021 Results on Mar 08, 2022 Cumberland Pharmaceuticals Inc. announced that they will report fiscal year 2021 results After-Market on Mar 08, 2022 Buying Opportunity • Jan 14
Now 22% undervalued Over the last 90 days, the stock is up 43%. The fair value is estimated to be US$5.02, however is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has been flat over the last 3 years. Earnings per share has grown by 17% per annum over the last 3 years. Ankündigung • Jan 06
Cumberland Pharmaceuticals Inc. (NasdaqGS:CPIX) acquired SANCUSO from Kyowa Kirin, Inc. for $17 million. Cumberland Pharmaceuticals Inc. (NasdaqGS:CPIX) acquired SANCUSO from Kyowa Kirin, Inc. for $17 million on January 4, 2022. Under the terms of the agreement, Cumberland will acquire U.S. rights to SANCUSO and will assume full commercial responsibility for the product – including its marketing, promotion, distribution, manufacturing and medical support activities. Net sales of the brand in the U.S. were over $14 million in 2020. The financial terms of the acquisition include a $13.5 million payment to Kyowa Kirin upon closing, up to $3.5 million in milestones and tiered royalties of up to 10% on U.S. net product sales. Kyowa Kirin will retain international rights, continuing to deliver the product to address oncology patients' needs throughout the rest of the world.
Cumberland Pharmaceuticals Inc. (NasdaqGS:CPIX) completed the acquisition of SANCUSO from Kyowa Kirin, Inc. on January 4, 2022. Ankündigung • Dec 01
Cumberland Pharmaceuticals Inc. Receives FDA Approval for Expanded Labeling for Caldolor® Cumberland Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has approved expanded labeling for Caldolor®, an intravenously delivered formulation of ibuprofen, to now include use in pre-operative administration. The non-narcotic pain reliever may now be administered just prior to surgery to enable patients to wake up from their procedure in significantly less pain. The newly FDA-approved label includes information regarding the product's indications and usage, appropriate patient populations, clinical study results, potential side effects, patient safety details, and instructions for use in pregnant women, children and other populations. Supporting this expanded use of Caldolor, a study of orthopedic surgical pain confirmed the significant pain reduction when the product was administered every six hours (started pre-operatively) with supplemental morphine available on an as needed basis. A total of 185 patients were randomized and treated with either Caldolor® 800 mg or placebo administered every six hours (started pre-operatively) and morphine provided on an as needed basis. Efficacy was demonstrated as a statistically significant greater reduction in pain intensity over 24 hours post-operatively for patients treated with Caldolor® as compared to those receiving placebo.