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Chemomab (CMMB) Up on Fast Track Designation to CM-101 for PSC
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Shares of Chemomab Therapeutics Ltd. (CMMB - Free Report) were up 33.9% on Wednesday after the company announced that the FDA has granted Fast Track designation to its pipeline candidate, CM-101, for the treatment of primary sclerosing cholangitis (PSC) in adults.
PSC is a rare type of fibrotic liver disease that can cause cancer and, eventually early death. Currently, there is no FDA-approved treatment for the given indication.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
The Fast Track designation allows therapeutic candidates for priority review and accelerated approval if supported by clinical data.
CM-101 is a monoclonal antibody designed to bind and block CCL24 activity.
Shares of Chemomab have plunged 74.5% so far this year compared with the industry’s decline of 22.5%.
Image Source: Zacks Investment Research
Chemomab is conducting the placebo-controlled phase II SPRING study, which is evaluating the safety and tolerability of CM-101 in PSC patients. The study is currently enrolling patients with top-line data from the same expected in the second half of 2024.
CM-101 is also being developed for several other indications.
Chemomab has announced promising data from several studies on CM-101, including a phase Ib study in nonalcoholic fatty liver disease patients, a phase IIa fibrosis study in non-alcoholic steatohepatitis patients, as well as an investigator-initiated study in patients with severe lung injury.
Also, CM-101 is currently phase II-ready for the treatment of patients with systemic sclerosis.
We note that Chemomab currently does not have any approved product in its portfolio. Therefore, in the absence of a marketed product, the successful development of CM-101 holds the key for the company.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 27.2%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 293.21%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 15.5%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have decreased 10.2%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Chemomab (CMMB) Up on Fast Track Designation to CM-101 for PSC
Shares of Chemomab Therapeutics Ltd. (CMMB - Free Report) were up 33.9% on Wednesday after the company announced that the FDA has granted Fast Track designation to its pipeline candidate, CM-101, for the treatment of primary sclerosing cholangitis (PSC) in adults.
PSC is a rare type of fibrotic liver disease that can cause cancer and, eventually early death. Currently, there is no FDA-approved treatment for the given indication.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
The Fast Track designation allows therapeutic candidates for priority review and accelerated approval if supported by clinical data.
CM-101 is a monoclonal antibody designed to bind and block CCL24 activity.
Shares of Chemomab have plunged 74.5% so far this year compared with the industry’s decline of 22.5%.
Chemomab is conducting the placebo-controlled phase II SPRING study, which is evaluating the safety and tolerability of CM-101 in PSC patients. The study is currently enrolling patients with top-line data from the same expected in the second half of 2024.
CM-101 is also being developed for several other indications.
Chemomab has announced promising data from several studies on CM-101, including a phase Ib study in nonalcoholic fatty liver disease patients, a phase IIa fibrosis study in non-alcoholic steatohepatitis patients, as well as an investigator-initiated study in patients with severe lung injury.
Also, CM-101 is currently phase II-ready for the treatment of patients with systemic sclerosis.
We note that Chemomab currently does not have any approved product in its portfolio. Therefore, in the absence of a marketed product, the successful development of CM-101 holds the key for the company.
Zacks Rank & Other Stocks to Consider
Chemomab currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector are Dynavax Technologies Corporation (DVAX - Free Report) , Ligand Pharmaceuticals Incorporated and Puma Biotechnology, Inc. (PBYI - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 27.2%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 293.21%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 15.5%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have decreased 10.2%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.