Latest news with #LEMS
Yahoo
6 days ago
- Business
- Yahoo
Catalyst Pharmaceuticals Q2 Earnings Beat, Firdapse Revenues Rise Y/Y
Catalyst Pharmaceuticals CPRX reported adjusted earnings of 68 cents per share for the second quarter of 2025, beating the Zacks Consensus Estimate of 58 cents. The company had recorded adjusted earnings of 56 cents in the year-ago quarter. Total revenues, the majority of which comprised product revenues, amounted to $146.6 million in the reported quarter, representing growth of 19% year over year. The recorded figure also surpassed the Zacks Consensus Estimate of $139 million. Catalyst Pharmaceuticals' top line primarily comprised revenues from the sale of Firdapse, the first approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), and the epilepsy drug Fycompa (perampanel) CIII. Revenues generated from the sale of the newly launched muscle disease drug, Agamree (vamorolone), also contributed to the top line. CPRX's Q1 Results in Detail Firdapse generated sales worth $84.8 million in the reported quarter, up 10% year over year, driven by organic sales growth. The reported figure, however, missed the Zacks Consensus Estimate of $88 million as well as our estimate of $87 million. The drug has been witnessing strong demand, increasing prescription rates from LEMS patients and continued diagnosis of new LEMS patients. In 2023, Catalyst Pharmaceuticals acquired the U.S. rights for Fycompa (perampanel) CIII from Eisai Co., Ltd. This acquisition diversified the company's portfolio by adding a commercial-stage epilepsy asset. Catalyst Pharmaceuticals started recording sales of Fycompa in 2023. Fycompa generated net product revenues of $34.3 million, down 6% year over year, as tablet generics began hitting the market in late May following the expiry of the expiration of one of its patents. Oral suspension remains exclusive until mid-December 2025, but revenues are expected to decline with growing generic competition. The reported figure, however, surpassed the Zacks Consensus Estimate of $25.9 million as well as our model estimate of $26.7 million. Year to date, shares of CPRX have gained 4.4% compared with the industry's 5.9% growth. Image Source: Zacks Investment Research In 2023, Catalyst Pharmaceuticals acquired exclusive rights to manufacture and supply Agamree from Santhera Pharmaceuticals through a licensing agreement. In late 2023, the FDA approved Agamree for treating Duchenne Muscular Dystrophy (DMD) in patients aged two years and older, which gave the company a third approved product. The drug was commercially launched in the United States in the middle of March 2024. In the reported quarter, Agamree generated revenues worth $27.4 million, up significantly year over year. The reported figure beat the Zacks Consensus Estimate of $25.1 million and our estimate of $25.2 million. Research and development (R&D) expenses were $4.4 million in the reported quarter, up 46% year over year. Selling, general and administrative (SG&A) expenses totaled $45.9 million, up 13% year over year. As of June 30, 2025, Catalyst Pharmaceuticals had cash, cash equivalents and investments worth $652.8 million compared with $580.7 million as of March 31, 2025. CPRX Reaffirms 2025 Financial Guidance In 2025, Catalyst Pharmaceuticals continues to expect total revenues between $545 million and $565 million, reflecting continued growth in product revenues from Firdapse and Agamree. Firdapse revenues are expected between $355 million and $360 million. Agamree revenues are anticipated to be between $100 million and $110 million in the current year. Fycompa revenues are projected between $90 million and $95 million, which reflects the anticipated impact of the loss of market exclusivity of the drug in 2025. Catalyst Pharmaceuticals expects its R&D expenses to be between $15 million and $20 million in 2025 due to investments in the SUMMIT study evaluating the long-term efficacy and safety of Agamree over other DMD treatments. SG&A expenses are expected to rise steadily in 2025. Catalyst Pharmaceuticals, Inc. Price, Consensus and EPS Surprise Catalyst Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Catalyst Pharmaceuticals, Inc. Quote CPRX's Zacks Rank & Other Stocks to Consider Catalyst Pharmaceuticals currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Arvinas ARVN, CorMedix CRMD and Immunocore IMCR. While CRMD and IMCR sport a Zacks Rank #1 (Strong Buy) each at present, ARVN currently carries a Zacks Rank #2. You can see the complete list of today's Zacks #1 Rank stocks here. In the past 60 days, estimates for CorMedix's earnings per share have increased from 93 cents to 97 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $1.65. Year to date, shares of CRMD have rallied 47.5%. CorMedix's earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 25.82%. In the past 60 days, estimates for Immunocore's 2025 loss per share have narrowed from 86 cents to 68 cents. Loss per share estimates for 2026 have narrowed from $1.34 to $1.10 during the same period. IMCR stock has increased 8.8% year to date. Immunocore's earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 76.18%. In the past 60 days, estimates for Arvinas' 2025 loss per share have narrowed from $1.51 to $1.50. Loss per share estimates for 2026 have narrowed from $3.08 to $2.98 during the same period. ARVN stock has plunged 66.5% year to date. Arvinas' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Catalyst Pharmaceuticals, Inc. (CPRX) : Free Stock Analysis Report CorMedix Inc (CRMD) : Free Stock Analysis Report Arvinas, Inc. (ARVN) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
6 days ago
- Health
- Yahoo
Lambert Eaton Myasthenic Syndrome (LEMS) Antibody Testing and Treatment Recommendations Added to NCCN Clinical Practice Guidelines for Small Cell Lung Cancer (SCLC)
VGCC antibody testing in conjunction with neurologic consultation can diagnose LEMS Amifampridine may be considered as a supportive care treatment Guideline inclusion may raise clinical awareness of cancer-associated LEMS to support broader VGCC diagnostic testing and treatment adoption CORAL GABLES, Fla., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Cell Lung Cancer (SCLC) now include new additions involving Lambert Eaton myasthenic syndrome (LEMS), amifampridine (FIRDAPSE®), and the tests for PQ- and N-type voltage-gated calcium channel (VGCC) antibodies. The updated NCCN Clinical Practice Guidelines in Oncology for SCLC relating to LEMS now include symptom specificity—characterized by proximal muscle weakness and autonomic dysfunction. Under 'Signs and Symptoms of Small Cell Lung Cancer' (SCL-A 2 of 2), the guidelines recommend diagnosis through a neurological evaluation, ideally in consultation with a neurologist, which may include testing for PQ- and N-type VGCC antibodies. Additionally, under 'Principles of Supportive Care' (SCL-D), the guidelines recommend that amifampridine should be considered as a treatment in consultation with neurology.1 Approximately 50 percent of LEMS cases are associated with an underlying malignancy, most commonly SCLC. Literature suggests that LEMS is observed in 3 percent of SCLC patients. Based on an internal healthcare database analysis of SCLC claims, potentially 90 percent of LEMS patients with SCLC went undiagnosed. These undiagnosed LEMS patients may suffer from LEMS symptoms while undergoing treatment for SCLC. 'Early diagnosis of LEMS in SCLC is critical, as it may enable patients to have better outcomes if their LEMS symptoms are effectively treated while fighting SCLC. Accurate identification through VGCC antibody testing and comprehensive neurological evaluation is essential,' said William Andrews, MD, FACP, Chief Medical Officer, Catalyst. 'The NCCN Guidelines are a trusted standard for guiding treatment decisions, and we believe this update will drive greater awareness. Ultimately, it will help patients, caregivers, and healthcare providers make more informed choices when addressing this serious unmet need.' 1NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. To learn more about NCCN go to About Catalyst PharmaceuticalsCatalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies. For more information, please visit Catalyst's website at Forward-Looking StatementsThis press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2024 and its subsequent filings with the U.S. Securities and Exchange Commission ('SEC'), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. Source: Catalyst Pharmaceuticals, Inc. CONTACT: Investor Contact Mary Coleman, Catalyst Pharmaceuticals, Inc. (305) 420-3200 ir@ Media Contact David Schull, Russo Partners (858) 717-2310 in to access your portfolio
Cision Canada
18-06-2025
- Business
- Cision Canada
Kye Pharmaceuticals Receives Health Canada Approval for New Dosing Guidance for FIRDAPSE ® and an additional Pediatric Indication Français
MISSISSAUGA, ON, June 18, 2025 /CNW/ - Kye Pharmaceuticals, Inc. ("Kye") today announced that Health Canada has approved its SNDS (Supplemental New Drug Submission) regarding the recommended dosage of FIRDAPSE® (amifampridine) for adults to include that some patients may benefit from a total daily dose of 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). The direction that some patients may benefit from an increased maximum daily dose of up to 100 mg offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS. The expanded indication includes pediatric dosing guidance for patients 6 years of age and older and offers pediatric neurologists a proven treatment option for children diagnosed with LEMS. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. FIRDAPSE is a potassium channel blocker indicated for the treatment of LEMS in adults and pediatric patients and works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, which helps improve muscle function in people with LEMS. This approval expands the approved dosing options for prescribers treating LEMS as well as broadening the indication to include pediatric patients. "We are pleased to receive the approval for both the additional guidance that some patients may benefit from an increased maximum daily dose of FIRDAPSE as well as the pediatric indication starting at age six," said John McKendry, President and CEO of Kye Pharmaceuticals. "This expanded label highlights our continued commitment to the LEMS community in Canada. We believe that this label update will have meaningful impact on the lives of LEMS patients across Canada and will help to improve patient outcomes." About Kye Pharmaceuticals Kye Pharmaceuticals is a growth-stage Canadian specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that may not otherwise be available to patients across Canada. With a growing pipeline of novel medicines, Kye's portfolio spans a range of therapeutic areas, including cardiology, psychiatry, pediatrics, rare diseases, hematology, and neurology. Kye Pharmaceuticals is a private company headquartered in Toronto focused on bringing medications to the Canadian market which fulfill clinically significant unmet needs. Kye is committed to licensing and launching medicines that matter by delivering better outcomes to our partners, Canadian healthcare professionals, and, most importantly, patients across Canada.
