We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
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.
SELLAS (SLS) Rises on FDA Fast Track Tag to Leukemia Candidate
Read MoreHide Full Article
SELLAS Life Sciences Group, Inc. (SLS - Free Report) announced that the FDA has granted a Fast Track designation to its novel and highly selective CDK9 inhibitor, SLS009, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). Shares rose 4.1% on Jan 9 following the announcement.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of candidates that are being developed to treat serious conditions and have the potential to address unmet medical needs.
The Fast Track tag is likely to expedite the development path for SLS009 and help in a faster regulatory filing for the candidate in r/r AML in the United States.
The FDA has already granted an Orphan Drug designation to SLS009 for r/r AML.
Shares of SELLAS have plunged 79.2% in the past year compared with the industry’s decline of 11.4%.
Image Source: Zacks Investment Research
Concurrently, the company announced initial positive top-line data from the 45 mg (safety) dose cohort of a phase IIa study on SLS009. A total of nine patients were enrolled in the 45 mg cohort.
The phase IIa study is evaluating the safety, tolerability and efficacy of two dose levels of SLS009 — 45 mg and 60 mg — in combination with AbbVie’s Venclexta (venetoclax) and azacytidine (aza/ven) for treating r/r AML.
In the study, treatment with the 45mg dose of SLS009 in combination with aza/ven demonstrated anti-leukemic effects with a favorable safety profile in AML patients who are resistant to venetoclax combination therapies.
Out of the nine patients, one patient died due to sepsis. A significant anti-leukemic effect was observed in 87.5% of the evaluable patients.
The first patient enrolled in the study achieved a complete response (CR) with full peripheral blood recovery. The median overall survival has not been reached yet.
SELLAS also enrolled several patients who are in the ongoing 60 mg cohort of the above study.
Additional data from the fully enrolled 45 mg cohort and initial data from the 60 mg cohort are expected to be reported later in the first quarter of 2024.
SLS009 is also being evaluated in a phase Ib/II study for the treatment of relapsed/refractory peripheral t-cell lymphomas (PTCL). The FDA granted a Fast Track Designation to SLS009 in relapsed/refractory PTCL.
We note that SELLAS currently does not have any approved product in its portfolio. Therefore, in the absence of a marketed product, the successful development of SLS009, along with other candidates, holds the key for the company.
In the past 60 days, estimates for Sarepta’s 2024 earnings per share have improved from 46 cents to $1.72. In the past year, shares of SRPT have lost 0.3%.
Sarepta beat estimates in each of the last four quarters. SRPT delivered a four-quarter earnings surprise of 48.67%, on average.
In the past 60 days, estimates for Freeline Therapeutics’ 2024 loss per share have narrowed from 35 cents to 15 cents. In the past year, shares of FRLN have declined 11.8%.
Earnings of Freeline Therapeutics beat estimates in each of the last three quarters. FRLN delivered a four-quarter average earnings surprise of 67.17%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 2.8%.
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%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
SELLAS (SLS) Rises on FDA Fast Track Tag to Leukemia Candidate
SELLAS Life Sciences Group, Inc. (SLS - Free Report) announced that the FDA has granted a Fast Track designation to its novel and highly selective CDK9 inhibitor, SLS009, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). Shares rose 4.1% on Jan 9 following the announcement.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of candidates that are being developed to treat serious conditions and have the potential to address unmet medical needs.
The Fast Track tag is likely to expedite the development path for SLS009 and help in a faster regulatory filing for the candidate in r/r AML in the United States.
The FDA has already granted an Orphan Drug designation to SLS009 for r/r AML.
Shares of SELLAS have plunged 79.2% in the past year compared with the industry’s decline of 11.4%.
Concurrently, the company announced initial positive top-line data from the 45 mg (safety) dose cohort of a phase IIa study on SLS009. A total of nine patients were enrolled in the 45 mg cohort.
The phase IIa study is evaluating the safety, tolerability and efficacy of two dose levels of SLS009 — 45 mg and 60 mg — in combination with AbbVie’s Venclexta (venetoclax) and azacytidine (aza/ven) for treating r/r AML.
In the study, treatment with the 45mg dose of SLS009 in combination with aza/ven demonstrated anti-leukemic effects with a favorable safety profile in AML patients who are resistant to venetoclax combination therapies.
Out of the nine patients, one patient died due to sepsis. A significant anti-leukemic effect was observed in 87.5% of the evaluable patients.
The first patient enrolled in the study achieved a complete response (CR) with full peripheral blood recovery. The median overall survival has not been reached yet.
SELLAS also enrolled several patients who are in the ongoing 60 mg cohort of the above study.
Additional data from the fully enrolled 45 mg cohort and initial data from the 60 mg cohort are expected to be reported later in the first quarter of 2024.
SLS009 is also being evaluated in a phase Ib/II study for the treatment of relapsed/refractory peripheral t-cell lymphomas (PTCL). The FDA granted a Fast Track Designation to SLS009 in relapsed/refractory PTCL.
We note that SELLAS currently does not have any approved product in its portfolio. Therefore, in the absence of a marketed product, the successful development of SLS009, along with other candidates, holds the key for the company.
Zacks Rank & Stocks to Consider
SELLAS currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Sarepta Therapeutics, Inc. (SRPT - Free Report) Freeline Therapeutics Holdings plc and Puma Biotechnology, Inc. (PBYI - 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 Sarepta’s 2024 earnings per share have improved from 46 cents to $1.72. In the past year, shares of SRPT have lost 0.3%.
Sarepta beat estimates in each of the last four quarters. SRPT delivered a four-quarter earnings surprise of 48.67%, on average.
In the past 60 days, estimates for Freeline Therapeutics’ 2024 loss per share have narrowed from 35 cents to 15 cents. In the past year, shares of FRLN have declined 11.8%.
Earnings of Freeline Therapeutics beat estimates in each of the last three quarters. FRLN delivered a four-quarter average earnings surprise of 67.17%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 2.8%.
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%.