|Bid||3.6000 x 2200|
|Ask||3.6100 x 800|
|Day's Range||3.5000 - 3.7100|
|52 Week Range||1.8500 - 6.1600|
|Beta (3Y Monthly)||2.95|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 7, 2018 - Aug 13, 2018|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||8.50|
Catalyst Pharma (CPRX) files lawsuit against FDA's approval of Jacobus Pharmaceutical Co's drug, Ruzurgi, for the treatment of LEMS in pediatric patients.
Catalyst Pharmaceuticals Inc, which has come under fire for the high price tag on its rare disease drug, on Wednesday sued the U.S. Food and Drug Administration to challenge the recent approval of a lower-cost rival drug. The lawsuit alleges that the approval of Ruzurgi, a rival drug from privately held Jacobus Pharmaceutical Co, in May violated provisions of FDA regulations and Catalyst's rights to exclusivity for its drug, Firdapse. For years, patients were able to access the same drug for free from Jacobus, a small, family-run company in New Jersey, through an FDA program called "compassionate use".
Catalyst (CPRX) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Catalyst Pharmaceuticals, Inc. (Catalyst) (CPRX), today announced it has filed a suit against the U.S. Food and Drug Administration (FDA) and several related parties challenging the recent approval of a new drug application and related drug labeling for Jacobus Pharmaceutical Company’s drug Ruzurgi™ for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in pediatric patients. The complaint was filed today in the United States District Court for the Southern District of Florida.
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 2019 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 Thursday, June 6 at 10:30 am ET.
Traders should look for short-term opportunities in penny stocks as macroeconomic events cast a shadow of uncertainty on the markets.
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 has amended its license agreement for Firdapse® to expand its commercial territory. The original license was for North America, and has been amended to include Japan. Upon the achievement of a certain milestone in Japan, Catalyst will have the option to expand the territory further to include most of Asia and Central and South America. “We are pleased to have expanded the scope of our license to include Japan and possibly other territories, as we believe that Japan represents an attractive strategic opportunity for Catalyst,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals, Inc. “The available treatment options for LEMS patients in Japan are very limited and without an approved evidence-based therapy.
Catalyst Pharmaceuticals has ended a legal fight with Northwestern University, according to a recent filing with the U.S. Securities and Exchange Commission. The settlement resolves a patent dispute in which neither company admitted fault, according to Catalyst. The dispute arose from a Aug. 27, 2009, license agreement in which Catalyst tapped Northwestern to develop CPP-115, a drug intended to treat infantile spasms.
Catalyst Pharma (CPRX) gains on the successful launch of Firdapse. The company is looking to develop drug for additional indications.
Biotechnology stocks can generate strong opportunities, as they are riddled with catalytic events through the development, regulatory and commercial processes. Catalyst Pharmaceuticals CPRX [NSC] – $3.14 has had an incredibly strong start to the year. After receiving FDA approval for Firdapse back in November of 2018 for adults with Lambert-Eaton Myasthenic Syndrome (LEMS), Catalyst has pleased investors with its commercialization efforts and the potential revenue that the treatment would generate.
Investors need to pay close attention to Catalyst Pharmaceuticals (CPRX) stock based on the movements in the options market lately.
Catalyst (CPRX) delivered earnings and revenue surprises of 92.31% and 1045.17%, respectively, for the quarter ended March 2019. Do the numbers hold clues to what lies ahead for the stock?
On a per-share basis, the Coral Gables, Florida-based company said it had a loss of 1 cent. The results topped Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment ...
-Firdapse® Launch Off to Strong Start with First Quarter Net Revenues of $12.4 Million -81 Patients Without Previous Access to any Form of Amifampridine Have Been Prescribed.
Biotech stocks saw a reversal in sentiment as the week saw an earnings deluge from small-, micro- and nano-cap biotechs and some M&A activity . Here are some key catalysts for the unfolding week that should ...
This week turned out to be a nightmare for shareholders of Catalyst Pharmaceuticals (CPRX), as the stock price plummeted over 50%. So what caused investors to hit the exits? The key concern is competition.On Tuesday, privately held and New Jersey-based Jacobus Pharmaceuticals secured FDA approval for its Lambert-Eaton myasthenic syndrome (LEMS) drug, Ruzurgi, for patients between six to 17 years of age. LEMS is a rare and progressive neuromuscular disease caused by problems in neuromuscular transmission. Investors see this approval as a very big problem for Catalyst as its lead drug, Firdapse, also contains the same active ingredient to treat LEMS. However, analysts remain largely positive in the long run."We believe that Jacobus’ approval [...] is largely a symbolic FDA gesture addressing the political pressures surrounding drug pricing. Although the long-time brushfire competition between Catalyst (Firdapse) and Jacobus (Ruzurgi) ended up in both scoring a regulatory nod, we think the race was effectively over when Firdapse passed the finish line first and ended up with the big prize. Ruzurgi’s approval, in our view, has minimal impact on Firdapse for the following reasons: (1) Firdapse and Ruzurgi are approved in non-overlapping adult and pediatric LEMS patient population, respectively; (2) compared to the adult LEMS patient population, pediatric LEMS patient numbers could be insignificant," said H.C. Wainwright's Andrew Fein.Echoing H.C. Wainwright's sentiment, Oppenheimer analyst Leland Gershell says his initial impression is that of an over-reaction to the downside that may be driven more by fear than by fact. Gershell noted, "We expect to hear Firdapse's launch continuing on the strong trajectory described on the company's 4Q18 call held March 19, which will likely include sales as well as other metrics e.g. patient starts."Last but not the least, Cantor's Charles Duncan commented, "We do not see this approval having a large impact in Firdapse’s market potential as we guesstimate that the pediatric population consists of <5% of the prevalent LEMS population. Therefore, we do not believe it is a slippery slope for Catalyst and Firdapse, as the company has already gained traction with a prescriber and patient base, despite only one quarter into its post-approval launch. In our view, the clinical development (two P3 trials), expanded access, and patient assistance program underscores Firdapse leadership in the LEMS community. This creates goodwill that should benefit the brand and the company in its efforts to identify additional LEMS patients, and in its future label expansion efforts (CMS, Musk-MG). Also, we see the two labels as clearly distinguished and therefore, should there be efforts to capture adult market share made for Ruzurgi, then the label would be violated, in our view."These analysts are not the only fans of the biotech company on Wall Street, as TipRanks analytics exhibit CPRX stock as a Strong Buy. Based on 6 analysts polled in the last 3 months, all 6 rate the stock a Buy.Many biotech companies are making their way towards the cannabis medical sector as a source of inspiration to find the benefits of cannabis plant use for patients with various diseases. To read more on the nitty gritty of what’s going on in the rising cannabis industry, click here. More recent articles from Smarter Analyst: * Hexo Has Difficult Days Ahead, Analyst Says * Square (SQ) Growth Slowing, But Evercore Remains Bullish on the Stock * This Analyst Sticks with His Buy Rating on Aphria (APHA) Stock, But Trims Price Target * Cannabis Stock Village Farms (VFF) Has a Lot Going for It