- Presented positive updated data in Phase 1/2 TakeAim Leukemia study of CA-4948 Monotherapy in Targeted Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
- Presented initial clinical data from Phase 1 study of CI-8993 in Patients with Relapsed or Refractory Solid Tumors
- Adopted "emavusertib" as the generic name for CA-4948 and introduced "TakeAim" as brand name for related clinical trials
- Strong balance sheet with $139.8 million in cash, cash equivalents and investments at December 31, 2021; expected to maintain planned operations into 2024
?Today, Curis announced that it will be implementing the new name "emavusertib" for all future references of CA-4948, including in scientific publications and corporate materials. The Company also announced new branding of its existing clinical trials of emavusertib as TakeAim Leukemia and TakeAim Lymphoma to highlight the targeting mechanisms.
Upcoming 2022 Planned Milestones ? In the first half of 2022, discuss potential for rapid registrational path for emavusertib with FDA ? In the first half of 2022, report initial data for emavusertib in combination with ibrutinib in NHL ? In 2022, report updated data for emavusertib in AML/MDS monotherapy ? In the second half of 2022, report initial efficacy data for CI-8993 (VISTA) ? In the second half of 2022, report initial data for emavusertib in combination with azacitadine or venetoclax in AML/MDS
?As of December 31, 2021, Curis's cash, cash equivalents and investments totaled $139.8 million, and there were approximately 91.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.
In a report released today, Justin Walsh from B.Riley Financial reiterated a Buy rating on Curis (CRIS ? Research Report), with a price target of $22.00. The company?s shares closed last Friday at $3.20, close to its 52-week low of $2.78.
According to TipRanks.com, Walsh is currently ranked with 0 stars on a 0-5 stars ranking scale, with an average return of -38.0% and a 14.3% success rate. Walsh covers the Healthcare sector, focusing on stocks such as Checkpoint Therapeutics, Compass Therapeutics, and Vor Biopharma.
Curis has an analyst consensus of Strong Buy, with a price target consensus of $21.00, which is a 558.3% upside from current levels. In a report issued on February 25, H.C. Wainwright also reiterated a Buy rating on the stock with a $20.00 price target.
Curis Announces FDA Partial Clinical Hold for TakeAim Leukemia Study of Emavusertib (CA-4948)
...While the partial hold is in place, no new patients will be enrolled in the study, and current study participants benefitting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower.
With the partial hold, the FDA is requesting additional data from the study, including data related to the death of a R/R AML patient who experienced, among several conditions, rhabdomyolysis, which has previously been identified as a dose-limiting toxicity of emavusertib. Additionally, the FDA is requesting safety, efficacy, and other data, including data related to rhabdomyolysis and the Company's determination of the Recommended Phase 2 Dose for emavusertib in this study.
"We are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients' lives," said James Dentzer, Chief Executive Officer of Curis. "Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with AML or MDS."
Curis expects to provide updated guidance on the timing of discussing the potential for a rapid registrational path for emavusertib with the FDA after the partial clinical hold is resolved and the related impact on the trial can be determined.
While this partial hold does not affect the TakeAim Lymphoma study (NCT03328078), a Phase 1/2 open-label dose escalating clinical trial investigating emavusertib in patients with B-cell malignancies, the Company has decided to pause enrollment of new patients in that study as well, pending resolution of the partial clinical hold in the TakeAim Leukemia study.
Seit langer Zeit habe ich CRIS im Blick. Der teilweise klinische Stopp für CA-4948 den die FDA heute verhangen hat bringt den Kurs auf ein interessantes Niveau zurück, bei dem ich beginne über ein Investment nachzudenken.
die FDA fordert zusätzliche Daten aus der Studie an, einschließlich Daten im Zusammenhang mit dem Tod eines R/R-AML-Patienten, bei dem neben mehreren Erkrankungen auch Rhabdomyolyse auftrat, die zuvor als dosisbegrenzende Toxizität von Emavusertib identifiziert wurde
Curis hängt derzeit etwas in der Luft, solange die bestehenden Fragen nicht geklärt sind. Wenn man wüsste, dass der partielle Stop wieder aufgehoben wird, dann wären das aktuell m.M.n. Einstiegskurse, andererseits, wenn es sich länger hinzieht oder das Ergebnis der Überprüfung negativ für CRIS ausfällt könnte es nochmal einen Rutsch geben.
Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced the presentation of encouraging clinical data from both the TakeAim Lymphoma and TakeAim Leukemia studies at the 2022 American Society of Clinical Onc ...