Catalyst Pharmaceuticals (NASDAQ:CPRX), a small-cap rare disease specialist, reported its third-quarter earnings after the bell on Tuesday. 10,793,893, which was granted earlier this month by the U.S. Patent and Trademark Office, covers certain methods for treating disease using amifampridine drug products, including Catalyst’s Firdapse, in patients who are slow metabolizers of amifampridine. Catalyst Pharmaceuticals, Inc. Common Stock (CPRX) Stock Quotes - Nasdaq offers stock quotes & market activity data for US and global markets. [25] A group of UK neurologists and pediatricians petitioned to prime minister David Cameron in an open letter to review the situation. Specifically, Catalyst said patent No. The company is developing therapeutics for rare neurological diseases, including the phosphate salt of amifampridine for the treatment of Lambert–Eaton myasthenic syndrome (LEMS) under the trade name "Firdapse" which was approved by the United States Food and Drug Administration (FDA) for use in Adult LEMS patients on November 28, 2018 and commercially launched in January 2019. ADVERSE REACTIONS The most common adverse reactions are: paresthesia, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms. Catalyst Pharmaceuticals Inc, rebuked by U.S. Stock analysis for Catalyst Pharmaceuticals Inc (CPRX:NASDAQ CM) including stock price, stock chart, company news, key statistics, fundamentals and company profile. Founded in February 1991. Custom Nutraceutical Manufacturing | Catalyst Nutraceuticals Custom manufacturing and formulation of dietary supplements for performance nutrition and wellness brands. [26] The company responded that it submitted the licensing request at the suggestion of the French government, and points out that the increased cost of a licensed drug also means that it is monitored by regulatory authorities (e.g. CATALYST SOFT CHEWS (Ideal for small, medium and large dogs as well as cats) • 540mgs of EPA per chew or per scoop • 360mgs of DHA per chew or per scoop • Vitamin E 55IU INDICATIONS: Fatty acids have been shown to help improve the health of the skin, coat and other body systems. Catalyst Pharmaceuticals is a biopharmaceutical company based in Coral Gables, Florida. Make A World Of Difference. [17], In the 1990s, doctors in the US, on behalf of Muscular Dystrophy Association, approached a small family-owned manufacturer of active pharmaceutical ingredients in New Jersey, Jacobus Pharmaceuticals, about manufacturing amifampridine so they could test it in clinical trials. [44], In February 2019, U.S. WARNINGS AND PRECAUTIONS Jacobus did so, and when the treatment turned out to be effective, Jacobus and the doctors were faced with a choice — invest in clinical trials to get FDA approval or give the drug away for free under a compassionate use program to about 200 patients out of the estimated 1500-3000 LEMS patients in the U.S.. Jacobus elected to give the drug away to this subset of LEMS patients, and did so for about twenty years. Explore our catalyst and intermediaries solutions. Its last market close was $3.72 – a decrease of -INF% over the previous week. Catalyst Pharmaceuticals, Inc is primarely in the business of pharmaceutical preparations. Hypersensitivity: If a hypersensitivity reaction such as anaphylaxis occurs, FIRDAPSE should be discontinued and appropriate therapy initiated. © 2020 Catalyst Pharmaceuticals, Inc. All Rights Reserved. [7] Prior to the price change, patients were able to get the drug for free through a U.S. Food and Drug Administration (FDA) compassionate use program. To report SUSPECTED ADVERSE REACTIONS, contact Catalyst Pharmaceuticals at 1-844-347-3277 (1844-FIRDAPSE) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. At Catalyst Pharmaceuticals, we understand that receiving a rare disease diagnosis can be extremely difficult. FIRDAPSE® is contraindicated in patients with a history of seizures. Invest in Catalyst Pharmaceuticals… Prior to the FDA approval, patients were able to get an experimental version of the drug for free through compassionate use programs in accordance with FDA Rules and Guidelines. Catalyst Pharmaceuticals is committed to improving the lives of people with rare diseases. [5][6][7], Catalyst was founded in 2002, and completed an IPO in 2006. Perhaps the WallStreetBets message board on Reddit will target Catalyst Pharmaceuticals or TherapeuticsMD stock. Often patients feel isolated and hopeless. After the downgrade, the six analysts covering Catalyst Pharmaceuticals are now predicting revenues of US$127m in 2020. Yesterday, the … FREE SHIPPING OVER $19. The drug is used to treat Lambert–Eaton myasthenic syndrome (LEMS), which is a rare neuromuscular disorder. In October 2012, Catalyst announced a strategic collaboration with BioMarin Pharmaceuticals, Inc., which included the in-licensing of the North American rights to amifampridine and responsibility for its clinical development program. [7][49], "Catalyst Pharmaceuticals 2014 Annual Report Form (10-K)", "Breakthrough Drug Approval Process and Postmarketing ADR Reporting", "NDA for Catalyst's LEMS Therapy Firdapse Accepted with Priority Review", "Senator Sanders asks why drug, once free, now costs $375k", "Catalyst Pharmaceuticals Registration Statement Form S-1", "The big gamble: Catalyst Pharmaceuticals of Coral Gables bets on new drug for rare disease", “Synthesis and evaluation of novel heteroaromatic substrates of GABA Aminotransferase”, “Catalyst Pharmaceutical signs licensing deal with Northwestern”, “Catalyst Acquires Late-Stage Orphan Drug from BioMarin, "Catalyst Pharmaceuticals 2018 Annual Report. [21], The licensing of Firdapse in 2010 in Europe led to a sharp increase in price for the drug. [41][14] Catalyst cut 30% of its workforce, mainly from the commercial team it was building to support an approved product, to save money to conduct the trials. [12], In 2018, Catalyst terminated its license for CPP-115 with Northwestern and stopped the development program for that compound. [27] A 2011 Cochrane review compared the cost of the 3,4-DAP and 3,4-DAPP in the UK and found an average price for 3,4-DAP base of £1/tablet and an average price for 3,4-DAP phosphate of £20/tablet; and the authors estimated a yearly cost per person of £730 for the base versus £29,448 for the phosphate formulation. Catalyst Pharmaceuticals Inc () Stock Market info Recommendations: Buy or sell Catalyst Pharmaceuticals stock? Catalyst Pharmaceuticals shares (CPRX.US) are listed on the NASDAQ and all prices are listed in US Dollars. Firdapse is only approved for use in adults. Most recently he has managed Catalyst’s in-licensing of CPP-115 and Catalyst’s newest drug, Firdapse ®, and taken these products through various preclinical and clinical development studies. [4], In October 2014, Catalyst began making available under an expanded access program. 19CRP0211(3) November 2019 |, Hypersensitivity to amifampridine phosphate or another aminopyridine. Catalyst Pharmaceuticals has a 1 year low of $2.55 and a 1 year high of $5.28. [32], In October 2012, while BioMarin had a Phase III trial ongoing in the US, it licensed the US rights to 3,4-DAPP, including the orphan designation and the ongoing trial, to Catalyst Pharmaceuticals. Catalyst Pharmaceuticals, Inc. is regulated by the U.S. Security and Exchange Commission and incorporated in the state of Delaware. The company undertakes research and development activities in the area of developing the molecule vigabatrin, which is used in the treatment for addiction to cocaine, amphetamines and other addictive substances. At Catalyst Pharmaceuticals, we understand that receiving a rare disease diagnosis can be extremely difficult. [39], In December 2015, Catalyst submitted its new drug application to the FDA,[40] and in February 2016 the FDA refused to accept it, on the basis that it wasn't complete and in April 2016 the FDA told Catalyst it would have to gather further data. For patients who wish to have more product on hand, please reach out to YourCatalystPathways.com to make sure that you can remain well supplied through this public health emergency. The company's 50 day simple moving average is $3.49 and its two-hundred day simple moving average is $3.74. That’s why we believe that, when you’re battling a rare disease—it’s all about the company you keep. In October 2012, Catalyst had in-licensed rights to Firdapse from BioMarin Pharmaceutical Inc. for the development and commercialization of the product in the United States. Catalyst Pharmaceuticals, Inc is a biotechnology business based in the US. ... Biopharmaceutical company focusing on the discovery, development, and commercialization of therapeutic products for diseases such as diabetes and pulmonary arterial hypertension. Catalyst Pharmaceuticals' price-to-book ratio is 5.92, while the biotech sector's average P/B is 3.36, which suggests that the company is overvalued compared with the broader biotech market. We've built our peerless industry and product expertise into a supplement superpower. Please follow @CatalystForRare on Facebook and Twitter for updates. [37] In April 2015, Jacobus presented clinical trial results with 3,4-DAP at a scientific meeting. Deals Setback to Catalyst in Race for Drug Approval", "Orphan drugs policies: a suitable case for treatment", "Catalyst Pharmaceuticals And Their Business Plan", "Jacobus and Catalyst Continue to Race for Approval of LEMS Drug", "A family-run drug maker tries to stay afloat in the Shkreli era", "BioMarin licenses North American rights to rare disease drug, invests $5M in Florida company", "Public summary of opinion on orphan designation", "OPi ou comment construire une biopharma en moins de dix ans - Private Equity Magazine", "Huxley Acquisition Lands Biomarin New LEMS Treatment", "Drug firms accused of exploiting loophole for profit", "Open letter to prime minister David Cameron and health secretary Andrew Lansley", "Treatment for Lambert-Eaton myasthenic syndrome", "Evidence Review: Amifampridine phosphate for the treatment of Lambert–Easton Myasthenic Syndrome", "International Nonproprietary Names for Pharmaceutical Substances (INN) Recommended INN: List 58", "Jacobus Begins Invitation-Only Trial of 3,4-DAP in LEMS", "Orphan Drug Designations: amifampridine phosphate for congenital myasthenic syndromes", "Orphan Drug Designations: amifampridine phosphate for myasthenia gravis", "Catalyst Using the Expanded Access Program to Conduct Phase IV Study with LEMS Patients", "Orrphan designation congenital myasthenic syndromes", "A response to a recent editorial by concerned physicians on 3,4-diaminopyridine", "Patients Fear Spike in Price of Old Drugs", "Catalyst Pharmaceuticals hit by FDA extra studies request for Firdapse", "Catalyst to ax 30% of workforce in wake of FDA trial demands", "Catalyst Pharmaceuticals files new drug application with FDA", "Firdapse (amifampridine phosphate) FDA Approval History", "Bernie Sanders asks why drug, once free, now costs $375K", "Family outraged over life-changing treatment going from free to $375,000 a year", "FDA approves first treatment for children with Lambert–Eaton myasthenic syndrome, a rare autoimmune disorder", "FDA undercuts $375,000 drug in surprise move", https://en.wikipedia.org/w/index.php?title=Catalyst_Pharmaceuticals&oldid=1010104311, Biotechnology companies of the United States, Pharmaceutical companies established in 2002, Biotechnology companies established in 2002, Creative Commons Attribution-ShareAlike License, Patrick J. McEnany, co-founder, chairman, president and chief executive officer, Firdapse® (amifampridine) Tablets 10 mg (commercialized 2019), This page was last edited on 3 March 2021, at 20:31. [17] Catalyst went on to obtain a breakthrough therapy designation for 3,4-DAPP in LEMS in 2013,[4] an orphan designation for congenital myasthenic syndromes in 2015[34] and an orphan designation for myasthenia gravis in 2016. Dr. We accept Visa, Mastercard, American Express, and Discover, as well as Paypal Checkout. [18][19][20], Doctors at the Assistance Publique – Hôpitaux de Paris had created a phosphate salt of 3,4-DAP (3,4-DAPP), and obtained an orphan designation for it in Europe in 2002. About Catalyst Pharmaceuticals. See insights on Catalyst Pharmaceuticals including office locations, competitors, revenue, financials, executives, subsidiaries and more at Craft. Senator Bernie Sanders for its high drug prices, on Thursday defended its $375,000 treatment for … As of August 2020 Q2 filing, CPRX (ticker symbol) has had average quarterly revenue of 30M USD, and profits of 9M USD per quarter", "F.D.A. [17][38] Catalyst responded to this editorial with a response in 2016 that explained that Catalyst was conducting a full range of clinical and non-clinical studies necessary to obtain approval in order to specifically address the unmet need among the estimated 1500-3000 LEMs patients since about 200 were receiving the product through compassionate use – and that this is exactly what the Orphan Drug Act was intended to do: deliver approved products to orphan drug populations so that all patients have full access. [13], The development of amifampridine and its phosphate has brought attention to orphan drug policies that grant market exclusivity as an incentive for companies to develop therapies for conditions that affect small numbers of people. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. [23] EUSA, through a vehicle called Huxley Pharmaceuticals, sold the rights to 3,4-DAPP to BioMarin in 2009,[24] the same year that 3,4-DAPP was approved in Europe under the new name Firdapse. The FDA decision dropped the stock of Catalyst Pharmaceuticals. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative … View the latest Catalyst Pharmaceuticals Inc. (CPRX) stock price, news, historical charts, analyst ratings and financial information from WSJ. [9], In 2009, Catalyst in-licensed worldwide rights to a family of GABA inhibitors including CPP-115 from Northwestern University. [28][29], Meanwhile, in Europe, a task force of neurologists had recommended 3,4-DAP as the firstline treatment for LEMS symptoms in 2006, even though there was no approved form for marketing; it was being supplied ad hoc. Any order over $19 … [47] Although Ruzurgi has been approved for pediatric patients, this approval makes it possible for adults with LEMS to get the drug off-label. The ingredients found in our supplements provide the essential nutrition elements to maintain pets’ healthy … FIRDAPSE is contraindicated in patients with a history of seizures. [42] In March 2018 the company re-submitted its NDA. WARNINGS AND PRECAUTIONS Seizures: FIRDAPSE® can cause seizures. [21] The hospital licensed the intellectual property on the phosphate form to the French biopharma company OPI, which was acquired by EUSA Pharma in 2007,[22] and the orphan application was transferred to EUSA in 2008. PAYMENTS ACCEPTED. ADVERSE REACTIONS We assure the LEMS community that we have product available and anticipate no disruptions to our manufacturing facilities as they are all in the US and Canada. The most common adverse reactions are: paresthesia, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms. Buy Catalyst Pharmaceuticals, Inc. stock (CPRX). Catalyst claims Ruzurgi, a treatment for pediatric LEMS patients developed by Jacobus and its partner … For financial reporting, their fiscal year ends on December 31st. Senator Bernie Sanders questioned the high price ($375,000) charged by Catalyst Pharmaceuticals for Firdapse. Catalyst Pharmaceutical Partners is a specialty pharmaceutical company that is focused on the development and commercialization of prescription drugs for the treatment of addiction. Stay up to date with Catalyst Pharmaceuticals, Inc. stock news. BioMarin has been criticized for licensing the drug on the basis of previously conducted research, and yet charging exorbitantly for it. Topic. [21] In 2008 EUSA submitted an application for approval to market the phosphate form to the European Medicines Agency under the brand name Zenas. [48], On February 4, 2019, Bernie Sanders, United States Senator from Vermont, publicly sent a letter to Catalyst asking why they raised the price of their drug Firdapse to an annual cost of $375,000, considering Firdapse was previously free of charge through an FDA compassionate use program . [43] The FDA approved amifampridine for the treatment of adults with Lambert-Eaton myasthenic syndrome on November 29, 2018. $100,000 in the US. Dr. Miller has 25 years of experience in the pharmaceutical and healthcare industries, joining Catalyst in 2007. [10][11] In 2012, it in-licensed patents covering the use of amifampridine phosphate to treat LEMS for the North American market from BioMarin. [23]:5[30] In 2007 the drug's international nonproprietary name was published by the WHO. Catalyst Pharmaceuticals has 76 employees at their 1 location and $500 K in annual revenue in FY 2018. Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment. ... Matthey provides a portfolio of advanced heterogeneous catalysts, homogeneous chemocatalysts and biocatalysts for the pharmaceutical market. Consider discontinuation or dose-reduction of FIRDAPSE® in patients who have a seizure while on treatment. Catalyst Pharmaceuticals, Inc. Pharmaceuticals Coral Gables, Florida 3,246 followers We are focused on developing and commercializing innovative therapies for people with rare neurological diseases. To report SUSPECTED ADVERSE REACTIONS, contact Catalyst Pharmaceuticals at 1-844-347-3277 (1844-FIRDAPSE) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The "next" GameStop is certain to be hit fast and hard. The development of amifampridine and its phosphate has brought attention to orphan drug policies that grant market exclusivity as an incentive for companies to develop therapies for conditions that affect small numbers of people. Jacobus Pharmaceutical had been manufacturing and giving it away for free since the 1990s. In some cases, this has led to hospitals using an unlicensed form rather than the licensed agent, as the price difference proved prohibitive. Catalyst Pharmaceuticals is similar to these companies: MasTec, Amicus Therapeutics, Vertex Pharmaceuticals and more. [45][46], In May 2019, the privately held US company Jacobus Pharmaceutical, Princeton, New Jersey gained approval by the FDA for amifampridine tablets (Ruzurgi) for the treatment of LEMS in patients 6 to less than 17 years of age. Seizures: FIRDAPSE can cause seizures. 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