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Thursday, May 19, 2022

Curis, Inc. (CRIS) Stock Nosedived Premarket Following Partial Clinical Hold on CA-4948 by FDA.

Curis, Inc. (CRIS) is a leading biotherapeutics firm engaged in the production of novel therapeutics for treating cancer. The company is developing a diverse pipeline of products including CA-170, CA-327, and CA-4948 via its collaboration with Aurigene.


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CRIS stock price during the regular trading session of April 1, 2022, was $2.43 with a gain of 2.10%. Its price sand as of the writing in the premarket session of April 4, 2022, by 34.5%.

CRIS: Recent Activity

On April 4, CRIS announced the placement of clinical hold by the FDA on its TakeAim Leukemia Phase 1/2 trials of emavusertib or CA-4948. FDA had requested additional data in this regard. It is a pipeline product of the company used to treat patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndrome. CA-4948 had already received the orphan drug designation from FDA. No new patient enrollment will take place while the partial hold is in place.

CRIS: Events and Happenings

On March 7, CRIS updated on the publication of a manuscript in the peer-reviewed journal Gastroenterology, determining the role of IRAK4 in pancreatic ductal adenocarcinoma and the preclinical efficacy of CA-4948 along with checkpoint immunotherapy.

On January 20, CRIS reported the participation of its Executive management at the following conferences.

  • Virtual B. Riley Oncology Conference held on January 27, and
  • SVB Leerink 11th Annual Global Healthcare Conference held February 18, 2022. at 11:20 a.m. ET

CRIS: Financials

CRIS released its unaudited fourth quarter 2021 financials on February 24, 2022, for the three months ended December 31, 2021.

  • The company’s revenue of $3.1 million during the fourth quarter of 2021 in comparison to $3.0 million in the comparable quarter in 2020 and its revenue grew by $0.1 million YoY.
  • Per-share basic and diluted net loss in the fourth quarter of 2021 was $13.6 million or $0.15 versus $7.5 million, or $0.11 during the comparable period of 2020, and deceleration was observed in its EPS YoY.

Conclusion

CRIS shares dipped by 69% in the last half-year as the Omicron variant of the COVID-19 emerged. The current stock position of the company is not good as it nosedived in Monday’s premarket owing to the placement of clinical hold by the FDA and request of supplementary information for the company’s lead candidate CA-4948.

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