Although fully recruited, screened, and ready to start, our SMA trial subjects in Serbia were not yet initiated when the pandemic began, and, due to this recent decision by the Serbian government, they are not permitted to start. Catalyst believes that as COVID-19 vaccines are administered over the next few quarters, Catalyst will see a more robust uptake in new patient starts and revenues. As we reported on our fourth quarter and year end conference call a few weeks ago, we have an adequate supply of Firdapse to address patients’ needs through December and are pleased to report that we have just completed a manufacturing campaign that will provide an additional six months of inventory beyond December. You'll now be able to see real-time price and activity for your symbols on the My Quotes of Nasdaq.com. Shares of Catalyst Pharmaceuticals Inc. CPRX, -1.91% slid 1.91% to $3.60 Friday, on what proved to be an all-around mixed trading session for the stock market, with the … This press release contains forward-looking statements. Firdapse is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis. This press release contains forward-looking statements. Catalyst announced today a corporate partnership with First Responders Children’s Foundation to support the COVID-19 Emergency Response Fund. 19CRP0211(3) November 2019 |. Catalyst is continuing to monitor sites through remote means in accordance with guidance recently provided by the FDA and is working with sites remotely on data entry and data checking, to the extent that sites will allow and study coordinators are able. Corporate Partnership with First Responders Children’s Foundation to Support COVID-19 Emergency Response Fund. When the symbol you want to add appears, add it to My Quotes by selecting it and pressing Enter/Return. Outsmart the market with Smart Portfolio analytical tools powered by TipRanks. 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. Like Catalyst, our U.S. manufacturing partners have implemented contingency plans to remain in operation, and we are confident in their ability to continue to produce domestically our active ingredient and finished Firdapse product. Catalyst believes that as COVID-19 vaccines are administered over the next few quarters, Catalyst will see a more robust uptake in new patient starts and revenues. Catalyst is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases. On our March 16th fourth quarter and year end conference call, we reported full-year 2019 net revenues of $102 million and reiterated our net revenue guidance in the range of $135 to $155 million for full-year 2020. We expect that we will be able to provide more current information on our clinical programs during our first quarter earnings call that is scheduled for next month. Although fully recruited, screened, and ready to start, our SMA trial subjects in Serbia were not yet initiated when the pandemic began, and, due to this recent decision by the Serbian government, they are not permitted to start. ... About Catalyst Pharmaceuticals. Mr. McEnany continued, “Additionally, well before the COVID-19 pandemic, we had worked diligently to establish our supply chain to ensure that LEMS patients would have access to Firdapse® without interruption, no matter the circumstances.”. Our Firdapse supply chain remains robust and ready for any contingencies that arise due to the COVID-19 outbreak, and thus far we have observed no disruptions in the production of Firdapse. Thus far the impact that we have seen has been minimal, but we will continue to evaluate our yearly guidance based on this dynamic environment. On March 16th, Catalyst implemented a number of safety related initiatives among its employees, including a travel ban and a work from home policy for all employees. Corporate Partnership with First Responders Children’s Foundation to Support COVID-19 Emergency Response Fund. 23, 2020 8:51 AM ET Catalyst Pharmaceuticals, Inc. (CPRX) IBB XBI XLV 18 Comments 7 Likes Illumination Capital Catalyst is following the guidance from the U.S. Centers for Disease Control and Prevention (CDC) and will continue to assess when it is appropriate for our team to return to normal work practices. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and other neurological and neuromuscular … Catalyst Pharma is … “We are committed to protecting the safety and well-being of our personnel, the entire LEMS community, healthcare providers, patients in clinical trials, and clinical trial site employees, and this will remain our priority throughout these challenging times,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. Assuming this trial is successful, we hope to submit an sNDA for Firdapse for MuSK-MG by the end of this year. We expect that we will be able to provide more current information on our clinical programs during our first quarter earnings call that is scheduled for next month. Create your Watchlist to save your favorite quotes on Nasdaq.com. Copy and paste multiple symbols separated by commas. We are committed to meeting our patients needs for Firdapse and believe that our supply chain will remain solid and uninterrupted through the current COVID-19 outbreak and beyond. CORAL GABLES, Fla., April 08, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today provided an update on certain impacts of COVID-19 on its business operations. Catalyst Pharmaceuticals: A beaten-down orphan drug play If you're looking for extreme bargains in this market, Catalyst Pharmaceuticals needs to be at the top of your shopping list. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert- Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. "First Responders Children's Foundation would like to thank Catalyst for supporting the Foundation and for the company's contribution to the COVID-19 Emergency Response Fund," said Jillian Crane, President of First Responders Children's Foundation. Catalyst announced today a corporate partnership with First Responders Children’s Foundation to support the COVID-19 Emergency Response Fund. A number of factors, including (i) the impact of the effects of the COVID-19 pandemic on Catalyst's 2020 net product revenues and on the timeline for reporting the top-line results from Catalyst's MuSK-MG trial and SMA Type 3 proof-of-concept study, and (ii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2019 and Catalyst's other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. We are committed to meeting our patients needs for Firdapse and believe that our supply chain will remain solid and uninterrupted through the current COVID-19 outbreak and beyond. Catalyst Pharmaceuticals is committed to improving the lives of people with rare diseases Make A World Of Difference At Catalyst Pharmaceuticals, we understand that receiving a rare disease diagnosis can be extremely difficult. Like Catalyst, our U.S. manufacturing partners have implemented contingency plans to remain in operation, and we are confident in their ability to continue to produce domestically our active ingredient and finished Firdapse product. The Foundation has established this fund to provide emergency grants to first responder families enduring financial hardship due to the COVID-19 pandemic. Thus far the impact that we have seen has been minimal, but we will continue to evaluate our yearly guidance based on this dynamic environment. Catalyst Withdraws Previous 2020 Revenue Guidance Due to COVID-19 Uncertainties. "The support of Catalyst has allowed the Foundation to provide much needed financial assistance to first responders on the front lines during these challenging times.". 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. At this time, we continue to believe that we will report top-line results from our Phase 3 trial for MuSK-MG in the current quarter, but the worldwide travel restrictions and social distancing requirements of the COVID-19 pandemic have put a strain on clinical trial staff and their availability for study close-out activities. Taking a look at our data on the ownership groups (below), it seems that institutional investors have bought into the company. However, many activities at trial sites need to occur before our study can be unblinded. “We are committed to protecting the safety and well-being of our personnel, the entire LEMS community, healthcare providers, patients in clinical trials, and clinical trial site employees, and this will remain our priority throughout these challenging times,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. In light of these regulations, we now know that it will not be possible for us to report top-line results from this trial before the end of this quarter. This included Catalyst’s customer-facing employees, who are working remotely and utilizing telephone and web-based technologies to provide support to patients and their healthcare providers. In light of these regulations, we now know that it will not be possible for us to report top-line results from this trial before the end of this quarter. A number of factors, including (i) the impact of the effects of the COVID-19 pandemic on Catalyst's 2020 net product revenues and on the timeline for reporting the top-line results from Catalyst's MuSK-MG trial and SMA Type 3 proof-of-concept study, and (ii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2019 and Catalyst's other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Prior to its approval, Firdapse for LEMS had received breakthrough therapy designation and orphan drug designation from the FDA. Catalyst is also continuing to market expansion activities in the territory of Japan as was previously reported COVID-19 delayed our meeting with the Japanese pharmaceuticals … We reiterate that we are committed to providing patients with the ability to obtain an uninterrupted supply of Firdapse. We reiterate that we are committed to providing patients with the ability to obtain an uninterrupted supply of Firdapse. Catalyst Pharmaceuticals Stock Gets Unwanted Attention Although Catalyst was enjoying a major clinical victory, getting approval from the FDA is only half the battle. Catalyst is following the guidance from the U.S. Centers for Disease Control and Prevention (CDC) and will continue to assess when it is appropriate for our team to return to normal work practices. About Catalyst Pharmaceuticals Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative … ... Covid … In addition, we had planned to report top-line results from our SMA Type 3 proof-of-concept trial in the current quarter. Catalyst ended 2019 in a strong financial position. Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q3 2020 Earnings Conference Call November 10, 2020 8:30 AM ET Company Participants Alicia Grande - … The tiny biopharmaceutical company has been embroiled with a lawsuit against the U.S. Food and Drug Administration. Catalyst is continuing to monitor sites through remote means in accordance with guidance recently provided by the FDA and is working with sites remotely on data entry and data checking, to the extent that sites will allow and study coordinators are able. We continue to assess the potential impact that COVID-19 could have on our revenue and expect to provide an update during our first quarter 2020 results call next month. These symbols will be available throughout the site during your session. Firdapse is currently being evaluated in clinical trials for the treatment of MuSK-MG and SMA Type 3 and has received Orphan Drug Designation from the FDA for myasthenia gravis. Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) said it is offering shares of its common stock in an underwritten public offering. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. Shares of Catalyst Pharmaceuticals Inc. CPRX, +3.06% dropped 0.57% to $3.51 Tuesday, on what proved to be an all-around favorable trading session for … CORAL GABLES, Fla., April 08, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today provided an update on certain impacts of COVID-19 on its business operations. Assuming this trial is successful, we hope to submit an sNDA for Firdapse for MuSK-MG by the end of this year. 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. 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's new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse is now commercially available in the United States. Catalyst Pharmaceuticals is a smaller company with a market capitalization of US$435m, so it may still be flying under the radar of many institutional investors. However, the Serbian government has recently imposed temporary new regulations for clinical trials requiring all clinical activities not needed for patient safety to be halted. In addition, we had planned to report top-line results from our SMA Type 3 proof-of-concept trial in the current quarter. Catalyst is fortunate that enrollment had been completed, and the trial was nearly finished, before the advent of the COVID-19 health emergency. On March 16th, Catalyst implemented a number of safety related initiatives among its employees, including a travel ban and a work from home policy for all employees. Catalyst Pharmaceuticals Inc ... and assumptions that are difficult to predict and may prove not to be accurate, especially in light of the COVID … However, many activities at trial sites need to occur before our study can be unblinded. All of the shares in the offering are being offered by Catalyst. Prior to its approval, Firdapse for LEMS had received breakthrough therapy designation and orphan drug designation from the FDA. Type a symbol or company name. © 2021, Nasdaq, Inc. All Rights Reserved. Catalyst also estimates that it ended 2020 with approximately $140 million in cash and investments, compared to $94.5 million at the end of 2019, up $46 million , or approximately 48%. Catalyst ended 2019 in a strong financial position. The Foundation has established this fund to provide emergency grants to first responder families enduring financial hardship due to the COVID-19 pandemic. Catalyst's new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in November 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse is now commercially available in the United States. As we reported on our fourth quarter and year end conference call a few weeks ago, we have an adequate supply of Firdapse to address patients’ needs through December and are pleased to report that we have just completed a manufacturing campaign that will provide an additional six months of inventory beyond December. This included Catalyst’s customer-facing employees, who are working remotely and utilizing telephone and web-based technologies to provide support to patients and their healthcare providers. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. Catalyst Pharmaceuticals, Inc. CPRX was a big mover last session, as the company saw its shares rise nearly 6% on the day. For the past 20 years, First Responders Children's Foundation has been providing college scholarships to children of first responders who have lost a parent in the line of duty. Summary Catalyst Pharma is a commercial-stage small biotech with a highly profitable orphan drug Firdapse for adult LEMS patients in the US market. On our March 16th fourth quarter and year end conference call, we reported full-year 2019 net revenues of $102 million and reiterated our net revenue guidance in the range of $135 to $155 million for full-year 2020. U.S. Centers for Disease Control and Prevention, Nasdaq Boardvantage Board Portal Software, Do Not Sell My Personal Information (CA Residents Only). Catalyst Pharmaceuticals, Inc. Has 'Anti-Virus' Protection Mar. Catalyst is fortunate that enrollment had been completed, and the trial was nearly finished, before the advent of the COVID-19 health emergency. CORAL GABLES, Fla., April 08, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical … The Company reported that it had $94.5 million of cash and investments as of December 31, 2019 and that it had increased its cash and investments by approximately $36 million during full year 2019. The move came on … The COVID-19 pandemic has affected nearly every aspect of society, including the way scientists conduct the testing of medicines. Also, as of today, Catalyst continues to have no funded debt. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. Our Firdapse supply chain remains robust and ready for any contingencies that arise due to the COVID-19 outbreak, and thus far we have observed no disruptions in the production of Firdapse. Shares of Catalyst Pharmaceuticals Inc. CPRX, +5.69% rose 5.69% to $3.53 Monday, on what proved to be an all-around dismal trading session for … Catalyst Pharmaceuticals Provides Update on Impact of COVID-19 Pandemic on its Business Activities, © 2020 Catalyst Pharmaceuticals, Inc. All Rights Reserved. First on the list is Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX). In late 2018, Catalyst Pharmaceuticals was ... Catalyst stock has been bouncing up and down, but some Wall Street analysts are giving the company the benefit of the doubt. At this time, we continue to believe that we will report top-line results from our Phase 3 trial for MuSK-MG in the current quarter, but the worldwide travel restrictions and social distancing requirements of the COVID-19 pandemic have put a strain on clinical trial staff and their availability for study close-out activities. Also, as of today, Catalyst continues to have no funded debt. Shares of Catalyst Pharmaceuticals Inc. CPRX, +2.09% rallied 2.58% to $3.58 Tuesday, on what proved to be an all-around positive trading session … For the past 20 years, First Responders Children's Foundation has been providing college scholarships to children of first responders who have lost a parent in the line of duty. However, the Serbian government has recently imposed temporary new regulations for clinical trials requiring all clinical activities not needed for patient safety to be halted. Mr. McEnany continued, “Additionally, well before the COVID-19 pandemic, we had worked diligently to establish our supply chain to ensure that LEMS patients would have access to Firdapse® without interruption, no matter the circumstances.”. The Company reported that it had $94.5 million of cash and investments as of December 31, 2019 and that it had increased its cash and investments by approximately $36 million during full year 2019. "First Responders Children's Foundation would like to thank Catalyst for supporting the Foundation and for the company's contribution to the COVID-19 Emergency Response Fund," said Jillian Crane, President of First Responders Children's Foundation. CORAL GABLES, Fla., April 08, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today provided an update on certain impacts of COVID-19 on its business … 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. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. We continue to assess the potential impact that COVID-19 could have on our revenue and expect to provide an update during our first quarter 2020 results call next month. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert- Eaton myasthenic syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA) Type 3. "The support of Catalyst has allowed the Foundation to provide much needed financial assistance to first responders on the front lines during these challenging times.".