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Creative Medical (CELZ) Up on Orphan Drug Tag for CELZ-101
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Creative Medical Technology Holdings, Inc. (CELZ - Free Report) announced that the FDA has granted an Orphan Drug designation to its cell-based immunotherapy, CELZ-101, also known as ImmCelz.
CELZ-101 is being developed for the prevention of allograft rejection in patients undergoing pancreatic islet cell transplantation for the treatment of type 1 diabetes.
Type 1 diabetes is marked by extreme fluctuations in blood glucose levels.
The perquisites that come from Orphan Drug designation include assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and some years of post-approval marketing exclusivity.
Shares of the company were up 17% on Mar 6 following the announcement of the news. However, the stock has plunged 20.3% in the past year compared with the industry’s decline of 3.7%.
Image Source: Zacks Investment Research
Per the company, CELZ-101 is an innovative therapy that works by using the patient's own regulatory T cells (Tregs) to combat autoimmune and alloimmune responses, which can kill insulin-producing cells.
The main objective of creating such cell-based immunotherapy is to leverage the human body's natural regenerative capabilities to create lasting health solutions.
Creative Medical Technology uses stem cell treatments for multiple indications in immunotherapy, endocrinology, urology, gynecology and orthopedics.
The company remains focused on advancing CELZ-101 for all necessary regulatory pathways with the aim of treating patients in need of islet transplantation.
Zacks Rank & Stocks to Consider
Creative Medical Technology currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 18 cents to 30 cents. In the past year, shares of ADMA have risen 79.5%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once. ADMA delivered an average earnings surprise of 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. In the past year, shares of VNDA have plunged 36.9%.
Vanda Pharmaceuticals’ earnings beat estimates in each of the trailing three quarters. VNDA delivered an average earnings surprise of 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.22. In the past year, shares of ANIP have increased 52.6%.
Earnings of ANI Pharmaceuticals beat estimates in each of the trailing four quarters. ANIP delivered a four-quarter average earnings surprise of 109.60%.
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Creative Medical (CELZ) Up on Orphan Drug Tag for CELZ-101
Creative Medical Technology Holdings, Inc. (CELZ - Free Report) announced that the FDA has granted an Orphan Drug designation to its cell-based immunotherapy, CELZ-101, also known as ImmCelz.
CELZ-101 is being developed for the prevention of allograft rejection in patients undergoing pancreatic islet cell transplantation for the treatment of type 1 diabetes.
Type 1 diabetes is marked by extreme fluctuations in blood glucose levels.
The perquisites that come from Orphan Drug designation include assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and some years of post-approval marketing exclusivity.
Shares of the company were up 17% on Mar 6 following the announcement of the news. However, the stock has plunged 20.3% in the past year compared with the industry’s decline of 3.7%.
Image Source: Zacks Investment Research
Per the company, CELZ-101 is an innovative therapy that works by using the patient's own regulatory T cells (Tregs) to combat autoimmune and alloimmune responses, which can kill insulin-producing cells.
The main objective of creating such cell-based immunotherapy is to leverage the human body's natural regenerative capabilities to create lasting health solutions.
Creative Medical Technology uses stem cell treatments for multiple indications in immunotherapy, endocrinology, urology, gynecology and orthopedics.
The company remains focused on advancing CELZ-101 for all necessary regulatory pathways with the aim of treating patients in need of islet transplantation.
Zacks Rank & Stocks to Consider
Creative Medical Technology currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Vanda Pharmaceuticals Inc. (VNDA - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 18 cents to 30 cents. In the past year, shares of ADMA have risen 79.5%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once. ADMA delivered an average earnings surprise of 85.00%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. In the past year, shares of VNDA have plunged 36.9%.
Vanda Pharmaceuticals’ earnings beat estimates in each of the trailing three quarters. VNDA delivered an average earnings surprise of 92.88%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.22. In the past year, shares of ANIP have increased 52.6%.
Earnings of ANI Pharmaceuticals beat estimates in each of the trailing four quarters. ANIP delivered a four-quarter average earnings surprise of 109.60%.