We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Catalyst (CPRX) to Gain DMD Drug Licensing Rights From Santhera
Read MoreHide Full Article
Catalyst Pharmaceuticals (CPRX - Free Report) announced entering into a definitive licensing agreement with Santhera Pharmaceuticals Holding, which will grant Catalyst exclusive rights to manufacture and supply Santhera’s vamorolone in North America. Vamorolone is Santhera’s investigational dissociative steroid, which is currently under the FDA review for the treatment of Duchenne Muscular Dystrophy (“DMD”).
The North American region comprises the United States, Canada and Mexico territories. Furthermore, if Santhera chooses not to market vamorolone directly in certain countries, including Europe and Japan, it has granted Catalyst the right of first negotiation in partnering discussions.
The licensing agreement adds a promising drug candidate to Catalysts’ diversifying rare neuroscience product portfolio.
Shares of the company jumped 3.44% on Tuesday, following the encouraging news. Year to date, shares of CPRX have plunged 32.2% compared with the industry’s fall of 0.5%.
Image Source: Zacks Investment Research
Santhera’s new drug application for vamorolone was based on positive results from the company’s pivotal phase IIb VISION-DMD study. The study reportedly met its primary endpoint, demonstrating statistical significance over treatment with placebo. A decision from the FDA is expected on Oct 26, 2023. Subject to approval, Catalyst anticipates the commercial launch of vamorolone in early 2024.
Per the terms of the agreement, CPRX is liable to make an upfront payment of $75 million to Santhera, along with a concurrent strategic equity investment of $15 million into Santhera. Santhera plans to use the equity investment proceeds for phase IV studies in DMD and further development of additional indications. Additionally, Santhera is entitled to receive future payments from Catalyst, upon achieving certain regulatory and sales-based commercial milestones, along with tiered royalty payments.
Moreover, the companies have agreed to jointly oversee the development of vamorolone for additional indications beyond DMD. The transaction is expected to close in the third quarter of 2023, subject to regulatory and shareholders’ approvals.
DMD is a rare congenital disease, predominantly affecting males. Symptoms of DMD include inflammation, which is present at birth or shortly thereafter. Inflammation often leads to fibrosis of muscle, causing progressive muscle degeneration and weakness. The current standard-of-care treatment for DMD is corticosteroids.
The FDA had previously granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations for vamorolone. The drug also enjoys Orphan Drug designation in the EU and similar status in the U.K. However, vamorolone is currently not approved for use in any market.
Catalyst Pharmaceuticals, Inc. Price and Consensus
In the past 90 days, the Zacks Consensus Estimate for Akebia Therapeutics’ 2023 loss per share has narrowed from 45 cents to 28 cents. During the same period, the estimate for Akebia Therapeutics’ 2024 loss per share has narrowed from 25 cents to 16 cents. Year to date, shares of the company have gained by 95.8%.
AKBA beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average earnings surprise of 41.41%.
In the past 90 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 loss per share has narrowed from 80 cents to 54 cents. During the same period, the estimate for ImmunoGen’s 2024 loss per share has narrowed from 53 cents to 27 cents. Year to date, shares of the company have rallied by 284.9%.
IMGN beat estimates in two of the trailing four quarters and missed twice, delivering an average earnings surprise of 7.09%.
In the past 90 days, the Zacks Consensus Estimate for Iterum Therapeutics’ 2023 loss per share has narrowed from $5.91 to $3.31. During the same period, the estimate for Iterum Therapeutics’ 2024 loss per share has narrowed from $4.95 to $3.08. Year to date, shares of the company have risen by 27.2%.
ITRM beat estimates in three of the trailing four quarters and missed the mark once, delivering a negative average earnings surprise of 6.56%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Catalyst (CPRX) to Gain DMD Drug Licensing Rights From Santhera
Catalyst Pharmaceuticals (CPRX - Free Report) announced entering into a definitive licensing agreement with Santhera Pharmaceuticals Holding, which will grant Catalyst exclusive rights to manufacture and supply Santhera’s vamorolone in North America. Vamorolone is Santhera’s investigational dissociative steroid, which is currently under the FDA review for the treatment of Duchenne Muscular Dystrophy (“DMD”).
The North American region comprises the United States, Canada and Mexico territories. Furthermore, if Santhera chooses not to market vamorolone directly in certain countries, including Europe and Japan, it has granted Catalyst the right of first negotiation in partnering discussions.
The licensing agreement adds a promising drug candidate to Catalysts’ diversifying rare neuroscience product portfolio.
Shares of the company jumped 3.44% on Tuesday, following the encouraging news. Year to date, shares of CPRX have plunged 32.2% compared with the industry’s fall of 0.5%.
Image Source: Zacks Investment Research
Santhera’s new drug application for vamorolone was based on positive results from the company’s pivotal phase IIb VISION-DMD study. The study reportedly met its primary endpoint, demonstrating statistical significance over treatment with placebo. A decision from the FDA is expected on Oct 26, 2023. Subject to approval, Catalyst anticipates the commercial launch of vamorolone in early 2024.
Per the terms of the agreement, CPRX is liable to make an upfront payment of $75 million to Santhera, along with a concurrent strategic equity investment of $15 million into Santhera. Santhera plans to use the equity investment proceeds for phase IV studies in DMD and further development of additional indications. Additionally, Santhera is entitled to receive future payments from Catalyst, upon achieving certain regulatory and sales-based commercial milestones, along with tiered royalty payments.
Moreover, the companies have agreed to jointly oversee the development of vamorolone for additional indications beyond DMD. The transaction is expected to close in the third quarter of 2023, subject to regulatory and shareholders’ approvals.
DMD is a rare congenital disease, predominantly affecting males. Symptoms of DMD include inflammation, which is present at birth or shortly thereafter. Inflammation often leads to fibrosis of muscle, causing progressive muscle degeneration and weakness. The current standard-of-care treatment for DMD is corticosteroids.
The FDA had previously granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations for vamorolone. The drug also enjoys Orphan Drug designation in the EU and similar status in the U.K. However, vamorolone is currently not approved for use in any market.
Catalyst Pharmaceuticals, Inc. Price and Consensus
Catalyst Pharmaceuticals, Inc. price-consensus-chart | Catalyst Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Catalyst currently has a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks from the same industry are Akebia Therapeutics (AKBA - Free Report) , Immunogen and Iterum Therapeutics (ITRM - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Akebia Therapeutics’ 2023 loss per share has narrowed from 45 cents to 28 cents. During the same period, the estimate for Akebia Therapeutics’ 2024 loss per share has narrowed from 25 cents to 16 cents. Year to date, shares of the company have gained by 95.8%.
AKBA beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average earnings surprise of 41.41%.
In the past 90 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 loss per share has narrowed from 80 cents to 54 cents. During the same period, the estimate for ImmunoGen’s 2024 loss per share has narrowed from 53 cents to 27 cents. Year to date, shares of the company have rallied by 284.9%.
IMGN beat estimates in two of the trailing four quarters and missed twice, delivering an average earnings surprise of 7.09%.
In the past 90 days, the Zacks Consensus Estimate for Iterum Therapeutics’ 2023 loss per share has narrowed from $5.91 to $3.31. During the same period, the estimate for Iterum Therapeutics’ 2024 loss per share has narrowed from $4.95 to $3.08. Year to date, shares of the company have risen by 27.2%.
ITRM beat estimates in three of the trailing four quarters and missed the mark once, delivering a negative average earnings surprise of 6.56%.