catalyst pharmaceuticals
catalyst pharmaceuticals inc (cprx) and achillion pharmaceuticals, inc. (achn) among five cheap healthcare stocks to buy now
catalyst pharmaceuticals, inc. common stock (cprx) historical prices & data - urltoken
sources: catalyst pharmaceuticals and filings with the u. s. securities and exchange commission .
catalyst pharmaceuticals announces publication of cpp - 115 clinical efficacy data for infantile spasm - bioflorida, inc .
company contact patrick j. mcenany catalyst pharmaceuticals chief executive officer (305) 420 - 3200 pmcenany @ urltoken
catalyst pharmaceuticals inc’s (nasdaq: cprx): catalyst pharmaceuticals, inc. , a biopharmaceutical company, focuses on the development and commercialization of therapies for people with rare debilitating diseases. with the latest financial year lossread more ...
catalyst pharmaceuticals, inc. (nasdaq: cprx) files sec prospectus - abn newswire (@ abn _ newswire )
catalyst pharmaceuticals stock split history | www. stock split history. com | copyright © 2013 - 2018, all rights reserved
looking at the catalyst pharmaceuticals stock split history from start to finish, an original position size of 1000 shares would have turned into 1000 today. below, we examine the compound annual growth rate — cagr for short — of an investment into catalyst pharmaceuticals shares, starting with a $ 10, 000 purchase of cprx, presented on a split - history - adjusted basis factoring in the complete catalyst pharmaceuticals stock split history .
coral gables - based catalyst pharmaceuticals is betting its future on a drug called firdapse, which is used to treat a rare neurological disease called lems .
she began taking firdapse, a new drug that was then being tested in clinical trials by coral gables - based catalyst pharmaceuticals, and saw dramatic improvement .
coral gables, fla. , june 13, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic ...
catalyst pharmaceuticals reported a net loss for the second quarter of 2015, but also said it expects to submit a new medication for federal drug administration approval in the fourth quarter of this year .
cprx catalyst pharmaceutical partners inc. stock and investing information on stocktwits (cprx )
patrick mcenany is the ceo and co - founder of catalyst pharmaceuticals. the company is betting its future on a drug called firdapse, which is used to treat a rare neurological disease called lems .
coral gables, fla. , june 13, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today
coral gables, fla. , may 31, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today
coral gables, fla. , may 02, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today
coral gables, fla. , may 09, 2018 - - catalyst pharmaceuticals, inc. , a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic ...
historical stock splits for catalyst pharmaceuticals since 2006. prices shown are actual historical values and are not adjusted for either splits or dividends. please see the
historical prices
tab for adjusted price values .
reata enrolls first patient in phase 3 catalyst trial of bardoxolone methyl in ctd - pah patients and reports positive interim data from ctd - pah patients in phase 2 lariat trial | reata pharmaceuticals, inc .
coral gables, fla. , april 24, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today is
catalyst pharmaceuticals, inc. (catalyst) (cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced the appointment of daniel j. brennan as chief commercial officer. mr. brennan will be responsible for leading the company’s marketing, sales and commercial operations as catalyst prepares for a potential launch of firdapse®. “we are pleased to welcome dan to the catalyst team, as he brings extensive experience in leading the commercial efforts at biopharmaceutical companies, particularly those focused on orphan, neurological diseases, ” said patrick j. mcenany, chairman and chief executive officer of catalyst pharmaceuticals .
these analysts, plus piper jaffray, have all assigned “buy” ratings to catalyst stock .
historical daily stock prices for catalyst pharmaceuticals since 2006 adjusted for splits and dividends. open, high, low, close (ohlc) data as well as percentage changes for multiple date ranges. display 20, 50 and 200 day moving averages and export charts as images to use in articles and blogs. the latest closing price for catalyst pharmaceuticals (cprx) as of july 06, 2018 is 3. 29 .
- - pdufa date set for november 28, 2018 coral gables, fla. , may 29, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with ...
teva pharmaceuticals has agreed with procter & gamble to terminate the pgt healthcare partnership that they founded in 2011 to market otc medicines .
catalyst pharmaceuticals, inc. , may also evaluate that drug for the treatment of myasthenia gravis and other rare neuromuscular diseases. no clinical programs for these indications have yet been developed, the company stated in the prospectus .
- - pdufa date set for november 28, 2018 coral gables, fla. , may 29, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular
pivotal study sites in u. s. and italy coral gables, fla. , april 19, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular
or successfully commercialized, and those other factors described in catalyst' s annual report on form 10 - k for the fiscal year 2015 and its other 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 .
at catalyst pharmaceuticals, we understand that receiving a rare disease diagnosis can be extremely difficult. often patients feel isolated and hopeless. that’s why we believe that, when you’re battling a rare disease—it’s all about the company you keep .
investor contact brian korb the trout group llc (646) 378 - 2923 media contact david schull russo partners (212) 845 - 4271 company contact patrick j. mcenany catalyst pharmaceuticals chief executive officer (305) 420 - 3200
derek, i think your picture of catalyst pharmaceuticals is incomplete at best. they have licensed gaba - aminotransferase inhibitors from rick silverman’s lab, and it looks like they are supporting preclinical studies with these compounds for ptsd and other disorders :
coral gables, fla. , may 10, 2017 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, today reported financial results for the first quarter ended march 31, 2017 .
catalyst pharmaceutical partners signed a licensing deal with northwestern university for a potential new treatment for neurological diseases .
since 2011, catalyst has raised about $ 86. 4 million by selling shares to the public .
two months ago the fda slapped a refuse to file letter on catalyst pharmaceuticals’ ($ cprx) rare disease drug firdapse - - and the woe keeps raining down as the u. s. regulator now wants the biotech to undertake more trials .
current and historical pe ratio for catalyst pharmaceuticals (cprx) from 2006 to 2018. the price to earnings or pe ratio is calculated by taking the latest closing price and dividing it by the most recent earnings per share (eps) number. the pe ratio is a simple way to assess whether a stock is over or under valued and is the most widely used valuation measure. the current pe ratio for catalyst pharmaceuticals (cprx) as of march 31, 2018 is 0. 00 .
friday, catalyst stock closed at $ 5. 21 a share, down 1 cent from the previous day. the 52 - week range for catalyst was $ 2. 14 to $ 5. 30 .
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catalyst also hit a bump in the road late last year when a small group of catalyst shareholders sued the company for damages, claiming that catalyst failed to disclose that another company — jacobus — was testing a drug biologically equivalent to firdapse. that omission caused them to lose money on the stock in 2013, they claimed — although catalyst shares in the five years leading up to year - end 2014 have increased significantly .
coral gables, fla. , march 29, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and ...
coral gables, fla. , march 12, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and ...
coral gables, fla. , aug. 09, 2017 (globe newswire) - - catalyst pharmaceuticals, inc. (catalyst) (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, today reported financial results for the second quarter ended june 30, 2017 and provided a corporate update .
coral gables, fla. , feb. 28, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and ...
this prospectus offering is part of the company’s shelf registration statement declared effective by the sec on march 19, 2014. that enabled it to periodically sell its stock shares in the aggregate of $ 33, 842, 512, catalyst pharmaceuticals said in the new prospectus filing .
coral gables, fla. , march 29, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced its
coral gables, fla. , march 12, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that
thanks for posting links. loathsome individuals all. my sentiment is that if readers find the actions and behavior of catalyst pharmaceuticals’ executive management, bos, and sab professionally and ethically objectionable (certainly do), then make their lives as difficult and as uncomfortable as legally permissible .
catalyst pharmaceuticals has announced they are offering an expanded access program (eap) for firdapse™ (amifampridine phosphate tablets equivalent to 10 mg amifampridine). eligible patients will be part of a phase iv open label study the company is conducting as they complete the submission requirements for regulatory approval .
or catalyst could decide that it can’t afford to move ahead, and investors could lose tens of millions of dollars .
investors focus will be on pipeline and regulatory updates during catalyst' s (cprx) fourth - quarter earnings call .
catalyst pharmaceuticals, inc. (catalyst) (cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that the company will be presenting at the jefferies 2018 global healthcare conference, in new york. patrick j. mcenany, catalyst’s chief executive officer and steven miller, ph. d. , chief scientific officer / coo, will provide an overview of the company and its key programs on wednesday, june 6 at 8: 00 am et .
investor contact brian korb the trout group llc (646) 378 - 2923 company contact patrick j. mcenany catalyst pharmaceuticals chief executive officer (305) 420 - 3200 media contacts david schull matt middleman, m. d. russo partners (212) 845 - 4271 (212) 845 - 4272
for many years, mcenany was an executive in the pharmaceuticals industry. he had been chairman and chief executive office of miami - based royce laboratories inc. , and oversaw its merger with watson pharmaceuticals of california. after the merger, he was president of royce, then a wholly owned subsidiary of watson, and vice president for corporate development at watson .
- - company to host quarterly conference call at 8: 30 am et tomorrow coral gables, fla. , may 09, 2018 (globe newswire) - - catalyst pharmaceuticals, inc. (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating ,
catalyst pharmaceuticals, inc. (catalyst) (cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that it will release first quarter 2018 financial results after market close on wednesday, may 9, 2018. further, catalyst management will host an investment - community conference call at 8: 30 a. m. et on thursday, may 10, 2018 to discuss the financial results and to provide a corporate update. a webcast replay will be available on the catalyst website for 30 days following the call by visiting the investor page of the company' s website at www. catalystpharma. com .
catalyzed reactions can be broadly characterized into two categories: heterogeneous and homogeneous. in heterogeneous reactions, the phase of catalyst is different from that of reactants, i. e. solid, liquid or gas. however, it can also mean that the miscibility of the catalyst is different from the reaction mixture too. with homogeneous reactions, the catalyst and other reactants are the same phase and are miscible with one another. the type of reaction will have implications for the recovery of the catalyst post - reaction .
analysts from two other investment advisory firms, suntrust robinson humphrey and mlv & co. , also have assigned “buy” ratings to catalyst. thompson / first call reported this month that four analysts cover catalyst, and all four currently have a “buy” rating on the stock .
not sure i’d get that worked up about this. catalyst is running a phase 3 trial. they are putting money into this .
at june 30, 2017, catalyst had cash and cash equivalents and short - term investments of $ 35. 1 million and no debt. catalyst believes that its existing capital resources will be sufficient to support its planned operations through at least the next 12 months .
at march 31, 2017, catalyst had cash and cash equivalents and short - term investments of $ 36. 5 million and no debt. catalyst believes that its existing capital resources will be sufficient to support its planned operations through at least the next 12 months .
when the drug failed to work on cocaine addicts during clinical trials, catalyst lost millions of dollars and saw its shares plummet in 2012 .
investors apparently agree. in february, catalyst raised about $ 34. 7 million by selling 11. 5 million shares of its stock .
catalyst has said however that, should it gain approval, it will discount the drug heavily if a patient struggles substantially to pay it .
catalyst is a small biopharmaceutical company that finds and develops drugs to treat rare diseases, a business that requires large investments and carries a high level of risk. although it currently does not sell any drugs, the company has invested heavily in developing one new compound — called firdapse — for treating two rare and debilitating neurological diseases. catalyst will soon apply to the u. s. food and drug administration (fda) for approval to sell firdapse in north america. if the fda grants approval, catalyst expects to begin selling this new drug sometime next year. the company is also developing another new drug to treat other rare medical conditions such as infantile spasms and tourette syndrome. the fda defines rare diseases or disorders as those affecting less than 200, 000 people in the united states. the company, originally founded as catalyst pharmaceutical partners inc. , recently changed its name to catalyst pharmaceuticals inc .
catalyst is designed to detect a minimum treatment effect of 12. 5 meters assuming a standard deviation of 50 meters. the observed treatment effect in the lariat ctd - pah subgroup analyses, both with and without the anemic patients included, is larger than the minimally detectable treatment effect in catalyst. further, the pooled standard deviation observed in lariat of 37 meters is lower than the estimated standard deviation of 50 meters in catalyst .
rountree, for example, received firdapse at no charge under catalyst’s phase iii clinical trial and currently obtains it under the company’s expanded access program .
as a development - stage specialty pharmaceutical company, catalyst had no revenues in either the first quarter of 2017 or the first quarter of 2016 .
now catalyst is poised to face the final hurdle in the fda process: applying for new drug approval (nda). to succeed, catalyst must submit data proving conclusively to regulators that firdapse is safe to use on patients. the company expects to do that this summer or early fall .
investment advisory firm suntrust robinson humphrey recently predicted that catalyst will price firdapse at $ 70, 000 to $ 100, 000 per year per patient. another equity research firm, mlv & co. , predicted that catalyst could charge between $ 150, 000 to $ 200, 000 per year .
major pharmaceutical companies like merck, bayer and pfizer spend most of their research money — estimated by the pharmaceuticals industry to have totaled more than $ 51 billion last year — on new drugs targeting large population groups .
huckel, who died in december, also had a long career in the pharmaceutical sector. he earned his medical degree from the university of vienna and worked in the hoechst group for 29 years. he retired in 1993 as chairman of the board of hoechst - roussel pharmaceuticals inc. , and he was a member of the rockefeller university council as well as catalyst’s board .
coral gables - based catalyst pharmaceuticals, which trades on the nasdaq exchange under the symbol cprx, lost $ 15. 5 million last year and nearly $ 12. 2 million in 2013. these losses resulted mostly from large investments in research and development for a drug to treat a rare autoimmune neurological disease called lems (lambert - eaton myasthenic syndrome) and other neurological disorders .
and its development by publicly traded catalyst throws a spotlight on the way orphan drugs are readied for the federal approval they need before they can hit the marketplace .
according to biopharmguy, a national website that provides a data base on pharmaceutical companies in each state, florida has more than 120 biotech, pharmaceutical and life sciences companies. the list includes catalyst, bio - tissue, beckman - coulter, teva and noven pharmaceuticals in the miami area. the fda will not comment on whether any of these companies are seeking approval of a new drug .
coral gables, fla. , feb. 27, 2017 (globe newswire) - - catalyst pharmaceuticals, inc. (nasdaq: cprx), (catalyst) a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that it has joined forces with 30 million americans and health care advocates around the world for rare disease day® on february 28. rare disease day is an annual awareness day dedicated to elevating public understanding of rare diseases and calling attention to the special challenges they present to patients and families .
duncan, and his research analyst associate at piper jaffray, roy buchanan, ph. d. , recommend that investors buy catalyst stock, with an “overweight” rating .
as a development - stage biopharmaceutical company, catalyst had no revenues in either the second quarter of 2017 and 2016 or the first six months of 2017 and 2016 .
coral gables, fla. , september 19, 2016 (globe newswire) - - catalyst pharmaceuticals, inc. (nasdaq: cprx), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that the journal of epilepsy & behavior case reports has accepted for publication a case report on the efficacy of cpp - 115 in a child with refractory infantile spasms .
the corporate chain reaction that eventually led catalyst to obtain the rights to the drug in north america started when eusa pharma first acquired development rights from the french hospital group .
irving, texas, oct. 06, 2016 (globe newswire) - - reata pharmaceuticals, inc. (nasdaq: reta) (
reata
or
the company
) today announced that it has enrolled the first patient into its phase 3 trial (catalyst) to evaluate the efficacy and safety of bardoxolone methyl in patients with connective tissue disease - associated pulmonary arterial hypertension (ctd - pah) .
today, urltoken takes a close look at the following generic drugs stocks: catalent inc. (nyse: ctlt), catalyst pharmaceuticals inc. (nasdaq: cprx), collegium pharmaceutical inc. (nasdaq: coll), and diplomat pharmacy inc. (nyse: dplo). generic pharmaceutical and medicine manufacturers develop prescription and over - the - counter drug products that are used to prevent or treat illnesses in humans or animals .
as required for all prescription drugs seeking approval for commercial use in the united states, firdapse has completed all the necessary steps. biomarin and catalyst carried out four different phase i studies. biomarin started the phase iii clinical trial, which was taken over and completed successfully by catalyst. in this case, the fda did not require a phase ii, but rather one, well - controlled pivotal study (in catalyst’s case, phase iii) and other supportive evidence because of orphan drug designation and the very small number of patients with lems .
patrick j. mcenany has been chief executive officer and a director of catalyst since its formation in january 2002. in 2006 he became chairman, president and chief executive officer. from 1991 to april of 1997, mr. mcenany was chairman and chief executive officer of royce laboratories, inc. from 1997 to 1998, after the merger of royce into watson pharmaceuticals, inc. , mr. mcenany served as president of the wholly - owned royce laboratories subsidiary and vice president of corporate development for watson pharmaceuticals, inc. from 1993 through 1997, he also served as vice chairman and director of the national association of pharmaceutical manufacturers. he currently serves on the board of directors for the jackson memorial hospital foundation .
new york, new york, 08: 30 est feb 22, 2017 (networknewswire) – catalyst pharmaceuticals, inc. (nasdaq: cprx) on january 10, 2017, filed with the sec a prospectus (urltoken) for the sale in the aggregate of $ 33, 842, 512 of its common stock. the use of proceeds will be to fund both clinical and non - clinical studies of its product candidates and for general working capital .
biomarin ($ bmrn) has marketed the drug in europe since 2009, and, in out - licensing firdapse to catalyst in 2012, took a $ 5 million stake in the biotech .
solvent extraction, nanofiltration, chemical precipitation, and adsorption are catalyst recovery techniques typically employed in industrial and pharmaceutical processes. nanofiltration recovery is used only with homogeneous processes and catalysts are immediately re - used in the liquid phase. therefore, nanofiltration is not particularly amenable to incineration and recovery of the catalysts for later use. solvent extraction and chemical precipitation tend to be somewhat non - specific and can lead to yield losses of the api. adsorptive recovery techniques can include materials such as activated carbon and ion exchange resins to recover either homogeneous catalysts, or homogeneous ligand and / or leachate. with a homogeneous catalyst, the carbon or resin will selectively absorb the catalyst. the catalyst is then stripped from the adsorbent for reuse or sent to a recovery specialist for incineration and recovery. for a homogeneous ligand and / or leachate, a fragment of a heterogeneous catalyst is shed and then dissolved in the phase where the chemical transformation is taking place. the catalyst is filtered from the batch and the ligand and and / or leachate that remains in solution is removed via resin or carbon treatment. whichever is the case, the spent heterogeneous catalyst (or carbon used to scrub the batch of catalyst leachates, ligands, and / or impurities) is washed with fresh solvent. these solvents can vary widely from process to process in pharmaceutical production, but typical organic solvents used in synthesis are mtbe, dichloromethane, tetrahydrofuran (thf), 2 - methyl thf, acetonitrile, toluene, acetone, methanol, ethanol, ethyl acetate, or water .
1 statements made in this press release include a non - gaap financial measure. such information is provided as additional information and not as an alternative to catalyst' s financial statements presented in accordance with generally accepted accounting principles (gaap). this non - gaap financial measure is intended to enhance an overall understanding of catalyst' s current financial performance. catalyst believes that the non - gaap financial measure presented in this press release provides investors and prospective investors with an alternative method for assessing catalyst' s operating results in a manner that catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. the non - gaap financial measure in this press release excludes from the calculation of net loss the expense (or the income) associated with the change in fair value of the liability - classified warrants. non - gaap net loss per share is calculated by dividing non - gaap net loss by the weighted average common shares outstanding .
should firdapse not make it through this final step, catalyst might consider taking another gamble, this time on the success of other drugs it has in development, and raise millions in new capital .
catalyst also came under criticism from a writer at thestreet, an online publication that provides financial news and analysis. in its articles, thestreet accused catalyst of “profiteering, ” saying it will charge lems patients $ 60, 000 to $ 80, 000 a year for firdapse if it receives fda approval. it also suggested that jacobus would seek fda approval for its version of the lems drug .
catalyst pharmaceutical partners inc. (nasdaq: cprx) said its oral potassium channel blocker firdapse amifampridine met the co - primary endpoints in a phase iii trial to treat lambert - eaton ...
availability in the united states, both the phosphate and the free base have completed clinical trials to treat lems. both formulations are available to lems patients in the u. s. : the free base is available to patients with lems and congenital myasthenic syndromes under a compassionate distribution program by jacobus pharmaceutical company, and the phosphate salt is available to lems patients under an expanded access program by catalyst pharmaceuticals. patients must be diagnosed with lems or congenital myasthenic syndrome and meet appropriate inclusion criteria .
brian elsbernd joined catalyst in february 2016 as the senior vice president of legal and compliance. prior to joining catalyst, mr. elsbernd was senior director of us healthcare compliance at mallinckrodt pharmaceuticals, a growing us specialty pharmaceutical business. from its inception, he led their healthcare compliance and business ethics program while also managing multiple other legal and business functions. previously, mr. elsbernd was an associate at proskauer rose llp, within its health care practice group, representing healthcare providers nationwide in matters pertaining to regulatory and administrative law, transactional matters, litigation, and reimbursement issues. mr. elsbernd earned his law degree from saint louis university school of law and his undergraduate degree at the university of illinois .
catalyst launched a clinical trial for cpp - 109 – its version of vigabatrin – to treat cocaine addition, but it stopped the study in may when it failed to find any statistical significance in curing patients .
catalyst pharmaceuticals is a development stage biopharmaceutical company which is developing cpp - 115 to treat reduced gabaergic signaling - associated neurological conditions, such as tourette’s and post - traumatic stress disorder. the fda has designated cpp - 115 orphan drug status in the u. s. for the treatment of infantile spasms. in europe, for the treatment of west syndrome, it has been granted e. u. orphan medicinal product designation. in addition, the company is also developing a generic version of sabril® (vigabatrin) .
a graph published in catalyst’s 2014 annual report indicated that $ 100 invested in catalyst shares at the end of december 2009 would have been worth $ 471. 73 at the end of dec. 2014. in comparison, $ 100 invested in the same period in the nasdaq composite index would have been worth $ 223. 74, in the russell microcap $ 211. 34 and in the nasdaq biotechnology index $ 379. 71 .
catalyst is also developing cpp - 115 to treat refractory infantile spasms, and possibly refractory tourette' s disorder. cpp - 115 has been granted u. s. orphan drug designation for the treatment of infantile spasms by the fda and has been granted e. u. orphan medicinal product designation for the treatment of west syndrome by the european commission. in addition, catalyst is developing a generic version of sabril® (vigabatrin) .
currently 16, up from eight last year. catalyst plans to add more professional staff in anticipation of a new drug launch in 2016. the company contracts outside laboratories and institutions to conduct clinical trials and other studies .
his investment firm and others are optimistic that catalyst will obtain fda approval to market firdapse in north america to about 900 neuromuscular specialist and will be able to obtain substantial revenues to cover their past investments and financial losses .
catalyst pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including lambert - eaton myasthenic syndrome (lems), congenital myasthenic syndromes (cms), infantile spasms, and tourette' s disorder. firdapse® has received breakthrough therapy designation from the u. s. food and drug administration (fda) for the treatment of lems and orphan drug designation for lems, cms and myasthenia gravis. firdapse is the first and only approved drug in europe for symptomatic treatment in adults with lems .
catalyst pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including lambert - eaton myasthenic syndrome (lems), congenital myasthenic syndromes (cms), infantile spasms, and tourette' s disorder. firdapse® for the treatment of lems has received breakthrough therapy designation from the u. s. food and drug administration (fda) and orphan drug designation for lems, cms and mysthenia gravis. firdapse is the first and only approved drug in europe for symptomatic treatment in adults with lems .
catalyst has not yet released its projected price for firdapse, which is sold by biomarin in europe for an annual cost of about $ 60, 000 a patient. but like other orphan drugs, it won’t be cheap .
approval this year would come about six years after biomarin acquired the rights to the drug, which it called firdapse, and began clinical trials, and three years after catalyst continued the clinical trials, which concluded last year .
as it moves closer to firdapse’s final review for commercial use, however, catalyst is dealing with some thorny problems. among those is a potential challenge from a family - owned pharmaceutical company based in princeton, n. j .
jacobus pharmaceutical co. inc. produces 3, 4 - dap in a formulation different from catalyst' s firdapse. jacobus has conducted clinical trials and is providing the drug to lems patients as part of an expanded access program .
catalyst has zero revenues because it doesn’t sell anything — as yet. still, the company has raised tens of millions of dollars through public stock offerings in recent years and stock analysts have assigned a “buy” rating to its shares .
behind every discovery, there are people who we must praise. behind every business decision, there are also people. let’s not talk about catalyst pharmaceuticals, but about the fine people who want to transform the treatment of lems and cms. the board of directors: urltoken the c - level management: urltoken the scientific advisory board (academic mds who treat lems, check for any of your colleagues you might want to have a talk with): urltoken let’s see how well mcenany likes being as well - recognized for his contributions to medicine as shkreli .
mcenany and hubert huckel, m. d. , established catalyst in 2002 to develop a drug that held promise for treating cocaine addiction, using their own savings and money from friends and family to fund the then - private company .
firdapse has already been approved for sale in the european union and is being produced and sold there by another u. s. pharmaceutical firm, california - based biomarin, which sold the firdapse north america rights to catalyst in 2012 .
the drug is also being studied in patients with musk - antibody positive myasthenia gravis and this year, catalyst also expects to complete a clinical trial of firdapse for pediatric patients with cms. the fda’s request does not affect these trials .
historically, adsorption techniques for catalyst recovery have involved activated carbon. carbon is well characterized, it is relatively inexpensive and it is relatively effective in removing spent catalysts from process streams. however, carbon suffers from several drawbacks. first, it can be difficult to handle and filter from the process stream. this is usually overcome by operating the removal process with pre - packed carbon cartridges. the second, and more difficult, drawback is the non - specific adsorptive nature of carbon. carbon will remove the catalyst, but it will also bind a percentage of the api. this leads to yield losses and increased production costs. the selective removal of the catalyst would be a more attractive adsorption option .
lexington, mass. - - (business wire) - - may 10, 2017 - - inotek pharmaceuticals corporation (nasdaq: itek), a clinical - stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for ocular diseases, today reported financial results and operational highlights for the quarter ended march 31, 2017 .
some financial analysts who have watched as firdapse has wended its way through the regulatory process are excited by the drug’s possibilities and have given catalyst a “buy” rating because of that. doctors who treat lems patients are also generally positive about it .
it is not clear how far along jacobus may be in seeking fda approval for its lems drug. but in recent reports to investors, two analysts who cover catalyst said they did not view jacobus as a likely threat to firdapse’s approval .
for 78 - year - old tony, 3, 4 dap — which can be obtained at low cost from compounding pharmacies or for free through a compassionate - use program supported by a small privately held company, jacobus pharmaceuticals — is a lifesaver. but for catalyst, the pharmaceutical company that purchased the north american rights to a slightly modified formulation of 3, 4 dap (firdapse) in 2012, the drug represented a market opportunity to the tune of $ 300 million to $ 900 million annually ($ 60, 000 to $ 100, 000 or more per patient) .
catalyst shares surged 53 cents, or 115 percent, to 99 cents in midday trading. the 52 - week high was $ 4. 34 on aug. 29, 2008. the 52 - week low was 39 cents on july 23 .
there are plenty of opportunities to invest in healthcare stocks, as there are thousands of companies, ranging from big and well - established pharmaceuticals that also pay substantial dividends, to small, emerging companies without any products on the market or revenue, but backed by their research into novelty therapies for various illnesses. when looking for healthcare stocks [ … ]
shin j. oh, an alabama neurologist who has been seeing lems patients for more than 30 years, is more enthusiastic: he sees firdapse as an important new drug for treating lems. he became a consultant for catalyst about a month ago .
if firdapse is approved by the fda, catalyst will work with eap physicians to help their patients understand how to transition to the approved drug and make sure all patients who need firdapse have access to the drug, regardless of their ability to pay .
catalyst is also developing cpp - 115 to treat infantile spasms, epilepsy and other neurological conditions associated with reduced gabaergic signaling, like post - traumatic stress disorder and tourette' s disorder. cpp - 115 has been granted u. s. orphan drug designation for the treatment of infantile spasms by the fda and has been granted e. u. orphan medicinal product designation for the treatment of west syndrome by the european commission. in addition, catalyst is developing a generic version of sabril® (vigabatrin) .
the company believes it currently has enough cash to launch firdapse commercially next year, when it expects to receive the fda’s approval: as of march 31, 2015, catalyst reported it had more than $ 41 million on hand in cash and cash equivalents .
a big reason why catalyst found firdapse an attractive investment was that the drug had already been studied and tested. other companies that owned the rights to 3, 4 dap before 2012 also had spent millions assembling 57 pre - clinical studies, in addition to early clinical studies. the fda also was aware that firdapse has been sold in the european union since 2010. these facts enabled catalyst to greatly reduce the amount of time and money a company would typically spend on preliminary research for a drug in development .
and don’t forget catalyst took some risk bringing this in front of the fda. sure there is some data to suggest the srug works, but what if the trial failed? they’re out probably a few millions dollars. you need to reward the risks taken !
other new drugs in catalyst’s pipeline: cpp - 115, which appears to be useful in treating infantile spasms, epilepsy, tourette syndrome and post traumatic stress disorder (ptsd); and cpp - 109, which also may be useful in treating ptsd and tourette’s .
the drug has however proved controversial. as thestreet' s adam feuerstein has previously reported, a family - owned outfit called jacobus pharmaceuticals has been giving away doses of 3, 4 - dap - - a treatment similar to firdapse - - for more than 20 years. that drug has never secured fda approval and thus can' t be sold legally in the u. s .
catalyst ceo patrick mcenany said in a news release that the gaba aminotransferase inhibitors have been 200 times more potent than cpp - 109 in initial lab tests. he said they could lead to a more powerful drug with fewer of vigabatrin’s side effects, such as impaired vision .
“our mission is to develop treatments for rare neurological diseases like lems, and firdapse fit our model, ” patrick mcenany, chairman, ceo and co - founder of catalyst. “to do this, a lot of money has to be invested in r & d. ”
“catalyst is a business, but we got into this business to help people, ” mcenany said. “if small companies like ours don' t take the financial risks to develop drugs for rare diseases, the big pharma companies aren’t going to not fill the gap. ”
catalyst says that firdapse, a tablet, dramatically relieves symptoms, as it did for rountree. it has benign side effects, the company says, and is more stable than another version of 3, 4 - dap made by a different company, which requires refrigeration .
about inotek pharmaceuticals corporation inotek pharmaceuticals is a clinical - stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases. the company’s lead product candidate, trabodenoson, is a first - in - class selective adenosine mimetic currently in phase 3 development. trabodenoson was developed in inotek’s laboratories and is designed to restore the eye’s natural pressure control mechanism. additionally, the company is evaluating the potential for selective adenosine mimetics to address optic neuropathies and other degenerative retinal diseases, including naion, and to improve the patho - physiology associated with dry eye disease. for more information, please visit urltoken. the inclusion of our website address here and elsewhere in this press release does not include or incorporate by reference the information on our website into this press release .
two research analysts at piper jaffray investment research, charles duncan and roy buchanan, also believe that catalyst is on track for firdapse approval; they also believe that the drug has the potential to treat another rare disease, congential myasthenic syndrome (cms), and perhaps other disorders .
reata pharmaceuticals, inc. , is a clinical - stage biopharmaceutical company that develops novel therapeutics for patients with serious or life - threatening diseases by targeting molecular pathways involved in the regulation of cellular energy production and inflammation. our two most advanced clinical candidates (bardoxolone methyl and omaveloxolone) target important transcription factors, called nrf2 and nf - îºb, to restore mitochondrial function, reduce oxidative stress, and resolve inflammation .
catalyst said it expects to win approval for the drug next year, and some financial analysts are excited about its possibilities. doctors have also spoken positively about the drug. but an fda denial could spell big trouble for the publicly traded firm and mean that it spent millions of dollars in vain .
catalyst plans to submit the drug for fda approval in the fourth quarter of 2015. firdapse is designed to treat lambert - eaton myasthenic syndrome, or lems — a rare and sometimes fatal autoimmune neuromuscular disease that affects about 3, 000 people in the u. s. , according to the company .
with the initiation of catalyst, we have brought bardoxolone methyl one step closer to ctd - pah patients who respond poorly to currently available therapies, have a high mortality rate, and are in need of new therapeutic options ,
said warren huff, reata' s chief executive officer and president .
bardoxolone methyl has a novel mechanism of action that has the potential to complement current vasodilator therapy by addressing the bioenergetic impairment and chronic inflammation that are key features of ctd - pah. we are looking forward to working with the trial investigators and coordinators and the pah clinical community as we conduct catalyst .
“we were able to show definite benefits with firdapse among lems patients, ” said oh, who was an independent researcher on the phase iii clinical trials of firdapse conducted for catalyst on lems patients at 13 clinical sites in the u. s. and europe. “this drug will make a difference for patients. ”
i’ve been blaming the fda for providing incentives to do this sort of thing, so this latest news is interesting. the agency has sent catalyst a rare refusal - to - file letter for their drug, saying that the application was incomplete. further details are lacking, but this is potentially an interesting development .
catalyst agreed to a $ 3. 5 million settlement last november to dismiss the class action lawsuit, which was covered by its insurance carrier. at the time, mcenany said the company believed it would have prevailed in court but decided to settle to “avoid potential costs of continued litigation” and disrupting the company and its management .
opiant pharmaceuticals, inc. (
opiant
) (opnt), a specialty pharmaceutical company developing pharmacological treatments for addictions, today announced the appointment of richard j. daly as a non - executive director and a member of the audit committee. mr. daly has supported the successful launch of 10 drugs during a 27 - year career in the biotech and pharmaceutical industry. with his appointment, the opiant board now consists of six members, four of whom are independent .
firdapse is one of a group of specialized “orphan drugs” being developed across the country to treat rare diseases, mostly by small pharmaceutical companies like catalyst. its chemical name is a mouthful: amifampridine phosphate, or 3, 4 - dap. it is an organic compound first synthesized by researchers at a paris hospital center more than three decades ago .
there is no cost to patients who are eligible. catalyst pharmaceutical has stated they will absorb all costs and the drug firdapse will be shipped to the patient’s home on a periodic basis (usually 90 days’ supply). costs for other diagnostic tests or routine medical treatment will need to be covered by the patient’s insurance or at the patient’s expense .
the method of statistical analysis for the catalyst primary endpoint is the placebo - corrected change from baseline in 6mwd to the end - of - treatment at 24 weeks. this method allows for greater separation in 6mwd values between active and placebo groups assuming improved efficacy over time, which was observed in the ctd - pah patients in lariat (figure 1) .
since 2011, catalyst has raised $ 86. 4 million dollars by selling shares to the public. currently the largest shareholders are institutional and mutual fund investors: baker brothers advisors; point72 asset management; consonance capital management; broadfin capital and federated kauffman fund, according to yahoo! finance. fifteen other institutional investors hold stakes, and mcenany is also a large shareholder .
catalyst continues to support patient organizations that provide disease awareness for lambert - eaton myasthenic syndrome (lems) and congenital myasthenic syndromes (cms). these are rare diseases in which patients are often misdiagnosed with other diseases prior to getting a definitive diagnosis, thus educating the patient and physicians at medical congresses is an important outreach to the rare disease community to facilitate proper and prompt diagnoses .
another analyst concurred. “we expect catalyst to file for approval of firdapse by the fourth quarter of this year and receive regulatory approval by mid - 2016, paving the way for a second - half 2016 launch of the drug in the united states, ” said raghuram selvaraju, a researcher at mlv & co. , an investment bank and institutional broker dealer, in a recent report .
catalyst management will host an investment - community conference call and webcast at 8: 30 a. m. edt on thursday, august 10 th, 2017 to discuss the financial results and provide a corporate update. investors who wish to participate in the conference call may do so by dialing (877) 407 - 8912 for domestic and canadian callers or (201) 689 - 8059 for international callers. those interested in listening to the conference call live via the internet may do so by visiting the investors page of the company' s website at urltoken and clicking on the webcast link on the investors home page. a webcast replay will be available on the catalyst website for 30 days following the call by visiting the investor page of the company' s website at urltoken .
catalyst management will host an investment - community conference call and webcast at 8: 30 a. m. edt on thursday, may 11 th, 2017 to discuss the financial results and provide a corporate update. investors who wish to participate in the conference call may do so by dialing (877) 407 - 8912 for domestic and canadian callers or (201) 689 - 8059 for international callers. those interested in listening to the conference call live via the internet may do so by visiting the investors page of the company' s website at urltoken and clicking on the webcast link on the investors home page. a webcast replay will be available on the catalyst website for 30 days following the call by visiting the investor page of the company' s website at urltoken.
catalyst pharmaceuticals is a biopharmaceutical company based in coral gables , florida . the company is developing therapeutics for rare neurological diseases , including firdapse ( 3,4-diaminopyridine phosphate , a potassium channel blocker ) for the treatment of lambert-eaton myasthenic syndrome ( lems ) and cpp-115 ( a gaba transaminase ) for the treatment of infantile spasms . 
catalyst pharmaceuticals is a biopharmaceutical company based in coral gables, florida. the company is developing therapeutics for rare neurological diseases, including firdapse (3,4-diaminopyridine phosphate, a potassium channel blocker) for the treatment of lambert-eaton myasthenic syndrome (lems) and cpp-115 (a gaba transaminase) for the treatment of infantile spasms.
catalyst pharmaceuticals is a biopharmaceutical company based in coral gables, florida. the company is developing therapeutics for rare neurological diseases, including firdapse (3,4-diaminopyridine phosphate, a potassium channel blocker) for the treatment of lambert-eaton myasthenic syndrome (lems) and cpp-115 (a gaba transaminase) for the treatment of infantile spasms.