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FDA grants orphan drug status to Cardiff Oncology's onvansertib for CMML

Wed, 21 Oct 2026 16:11:10 -0400

Cardiff Oncology, Inc. (NASDAQ: CRDF) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to onvansertib for the treatment of chronic myelomonocytic leukemia (CMML), a rare hematologic malignancy.

The FDA grants Orphan Drug Designation to therapies intended to treat rare diseases affecting fewer than 200,000 people in the United States. The designation may provide benefits including tax credits for qualified clinical trials, exemption from certain FDA user fees, and up to seven years of market exclusivity upon regulatory approval. The designation does not alter standard regulatory requirements or the approval process.

Onvansertib is currently being evaluated in a

Cardiff Oncology Receives FDA Orphan Drug Designation for Onvansertib in Chronic Myelomonocytic Leukemia

Wed, 21 Oct 2026 16:05:00 -0400

SAN DIEGO, Oct. 21, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to onvansertib for the treatment of patients with chronic myelomonocytic leukemia (CMML).

“CMML remains a difficult-to-treat hematologic malignancy with limited treatment options for patients, and 40-50% of myeloproliferative CMML1 patients harbor RAS-pathway mutations, which are associated with more aggressive disease,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “Receiving Orphan Drug Designation for

Cardiff Oncology Receives FDA Orphan Drug Designation for Onvansertib in Chronic Myelomonocytic Leukemia

Wed, 21 Oct 2026 16:05:00 -0400

H.C. Wainwright Upgrades Cardiff Oncology (CRDF) to Buy

Tue, 15 Sep 2026 06:04:32 -0400

H.C. Wainwright analyst Raghuram Selvaraju upgraded Cardiff Oncology (NASDAQ: CRDF) from Neutral to Buy with a price target of $9.00.

For an analyst ratings summary and ratings history on Cardiff Oncology click here. For more ratings news on Cardiff Oncology click here.

Shares of Cardiff Oncology closed at $1.31 yesterday.

Form 8-K Cardiff Oncology, Inc. For: Sep 14

Mon, 14 Sep 2026 09:28:00 -0400

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Cardiff Oncology and Nerviano settle dispute over onvansertib rights

Mon, 14 Sep 2026 08:31:14 -0400

Cardiff Oncology, Inc. (NASDAQ: CRDF) and Nerviano Medical Sciences S.r.l. (NMS) announced a settlement and amendment to their 2017 Exclusive License Agreement, resolving all outstanding disputes related to global rights for onvansertib, a PLK1 inhibitor drug candidate.

The two companies agreed to a full and mutual release of all claims in litigation pending in the U.S. District Court for the Southern District of California, and plan to jointly request dismissal of all claims with prejudice.

The amended agreement clarifies and expands the royalty structure of the original license and includes development objectives tied to Cardiff's planned Phase 3 program. Under the terms,

Cardiff Oncology and Nerviano Medical Sciences Amend their 2017 Exclusive License Agreement

Mon, 14 Sep 2026 08:30:00 -0400

SAN DIEGO and NERVIANO, Italy, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (NASDAQ: CRDF) ("Cardiff") and Nerviano Medical Sciences S.r.l. ("NMS") today announced that they have reached a settlement and amended their 2017 Exclusive License Agreement, resolving all outstanding disputes between the two companies related to the global rights for onvansertib, Cardiff's lead PLK1 inhibitor drug candidate, and establishing an expanded collaborative framework to support onvansertib's continued clinical development.

Cardiff and NMS have agreed to a full and mutual release of all claims asserted in the litigation pending in the U.S. District Court for the

Cardiff Oncology and Nerviano Medical Sciences Amend their 2017 Exclusive License Agreement

Mon, 14 Sep 2026 08:30:00 -0400

Cardiff and NMS have agreed to a full and mutual release of all claims asserted in the litigation pending in the U.S. District Court for the

Form DEFA14A Cardiff Oncology, Inc.

Wed, 26 Aug 2026 16:05:00 -0400

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Form DEFA14A Cardiff Oncology, Inc.

Wed, 26 Aug 2026 16:05:00 -0400

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Form DEF 14A Cardiff Oncology, Inc. For: Aug 26

Wed, 26 Aug 2026 16:01:00 -0400

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Form DEF 14A Cardiff Oncology, Inc. For: Aug 26

Wed, 26 Aug 2026 16:01:00 -0400

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Form PRE 14A Cardiff Oncology, Inc. For: Aug 14

Fri, 14 Aug 2026 16:03:00 -0400

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Form PRE 14A Cardiff Oncology, Inc. For: Aug 14

Fri, 14 Aug 2026 16:03:00 -0400

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William Blair Downgrades Cardiff Oncology (CRDF) to Market Perform

Wed, 12 Aug 2026 02:28:39 -0400

William Blair analyst Andy T. Hsieh downgraded Cardiff Oncology (NASDAQ: CRDF) from Outperform to Market Perform.

The analyst comments: “After markets closed on Tuesday, August 11, Cardiff reported second-quarter financial results and provided an update on recent progress.

We are downgrading Cardiff shares to Market Perform as company fundamentals have deteriorated materially. Specifically, we believe the uncertainty associated with onvansertib rights, coupled with the need to raise additional capital prior to initiating the Phase III study, creates an adverse risk/reward profile. As such, we are downgrading Cardiff to Market Perform.”

For an analyst ratings summary and ratings history on Cardiff Oncology click

William Blair Downgrades Cardiff Oncology (CRDF) to Market Perform

Wed, 12 Aug 2026 02:28:39 -0400

William Blair analyst Andy T. Hsieh downgraded Cardiff Oncology (NASDAQ: CRDF) from Outperform to Market Perform.

The analyst comments: “After markets closed on Tuesday, August 11, Cardiff reported second-quarter financial results and provided an update on recent progress.

For an analyst ratings summary and ratings history on Cardiff Oncology click

Cardiff Oncology, Inc. (CRDF) Misses Q2 EPS by 2c

Tue, 11 Aug 2026 16:38:50 -0400

Cardiff Oncology, Inc. (NASDAQ: CRDF) reported Q2 EPS of ($0.14), $0.02 worse than the analyst estimate of ($0.12). Revenue for the quarter came in at $100 thousand versus the consensus estimate of $62.78 thousand.

For earnings history and earnings-related data on Cardiff Oncology, Inc. (CRDF) click here.

Form 8-K Cardiff Oncology, Inc. For: Aug 11

Tue, 11 Aug 2026 16:11:00 -0400

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Form 8-K Cardiff Oncology, Inc. For: Aug 11

Tue, 11 Aug 2026 16:11:00 -0400

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Cardiff Oncology Reports Second Quarter 2026 Results and Provides Business Update

Tue, 11 Aug 2026 16:10:00 -0400

Positive Phase 2 CRDF-004 data presented in an oral session at ASCO support advancement of 30 mg onvansertib plus FOLFIRI/bevacizumab into planned registrational program for first-line RAS-mutated mCRC