Catalyst Pharmaceuticals

Catalyst Pharmaceuticals and SERB S.A. settled patent litigation with Teva, preventing Teva from marketing a generic version of FIRDAPSE® before February 25, 2035, unless specific conditions occur. Litigation continues against Hetero and Lupin. The agreement will be reviewed by U.S. regulatory bodies.

Catalyst Pharmaceuticals and SERB S.A. settled patent litigation with Teva, preventing Teva from marketing a generic version of FIRDAPSE® before February 25, 2035, unless specific conditions occur. Ongoing litigation against Hetero and Lupin continues. The agreement will be reviewed by U.S. regulatory bodies.

Hoth Therapeutics confirms no plans for offerings, highlighting strong finances and progress in HT-001 trials. Everest Group appoints Jim Williamson as Acting CEO. Boeing to release Q4 2024 results on January 28. Algonquin Power completes sale of renewable energy business to LS Power. ScanTech AI Systems announces growth strategy post-merger, focusing on security solutions. Catalyst Pharmaceuticals settles patent litigation with Teva over FIRDAPSE. Siyata Mobile postpones press conference, secures major transit authority order. Jefferies Financial Group reports strong Q4 2024 results. Quantum clarifies shareholder transactions were warrant exercises, not share dispositions.

China’s NMPA approves Santhera’s Agamree for DMD in patients aged four and above, highlighting its safety benefits over standard corticosteroids. Agamree is already approved in the US, EU, and UK. Sperogenix Therapeutics will commercialize it in China under a $124m licence agreement, paying Santhera royalties and milestone payments.

Agamree (vamorolone) recommended by NICE for NHS use in treating Duchenne muscular dystrophy (DMD) in patients 4 and older. Expected to take effect within 90 days, Agamree aims to preserve muscle function and reduce side effects compared to traditional corticosteroids. Approved in the U.S., EU, U.K., and China, it offers an alternative treatment for DMD.

NICE recommends AGAMREE® (vamorolone) for treating Duchenne muscular dystrophy (DMD) in patients 4 years and older in England, Wales, and Northern Ireland. Santhera works with NHS to ensure rapid patient access and pursues reimbursement in Scotland. AGAMREE is the first DMD treatment approved in the EU, US, and UK, offering an alternative to corticosteroids with reduced side effects.

Trump's reelection may boost biotech innovation and M&A activity, potentially repealing the Inflation Reduction Act. Key roles in federal health agencies will influence drug pricing reforms. The Zacks Medical-Drugs industry, despite headwinds, shows promising trends with innovation in diabetes/obesity, inflammation, and neuroscience. Small drugmakers rely on collaboration partners and R&D funding, with notable stocks including Corcept Therapeutics, Madrigal Pharmaceuticals, Catalyst Pharmaceuticals, Theravance Biopharma, and Larimar Therapeutics.

First Trust NYSE Arca Biotechnology ETF (FBT) is a passively managed ETF launched in 2006, targeting the Healthcare - Biotech sector. With $1.19 billion in assets, FBT tracks the NYSE Arca Biotechnology Index, focusing on biotech companies. The ETF has a 0.56% annual expense ratio, 100% Healthcare sector allocation, and top holdings include Beigene, Exact Sciences, and Catalyst Pharmaceuticals. FBT's performance is up 18.99% in the past year, with a beta of 0.67 and standard deviation of 21.70%. Alternatives include SPDR S&P Biotech ETF (XBI) and iShares Biotechnology ETF (IBB).

Santhera Pharmaceuticals announces Swissmedic's acceptance of the marketing authorization application for AGAMREE® (vamorolone) in Duchenne muscular dystrophy, leveraging existing EU approvals to potentially expedite the Swiss approval process.

DelveInsight's 'Spinal Muscular Atrophy Pipeline Insight, 2024' report details 18+ companies developing 20+ therapies, including key players like Scholar Rock, Biogen, and Roche. The report covers clinical trials, MOA, ROA, recent developments, and emerging therapies like ACTX-401, Apitegromab, and GYM329, expected to impact the SMA market.