NUVB - Nuvation stock falls as NUV-422 cancer program gets axed 35% workforce cut

Nuvation Bio ( NYSE: NUVB ) said it is discontinuing the clinical development of NUV-422 and reducing its workforce by 35% to save cost and focus on other programs.

The company said the decision to discontinue NUV-422 factored in feedback from the U.S. Food and Drug Administration (FDA) on a partial clinical hold on its monotherapy phase 1/2 study (Protocol NUV-422-02) and clinical hold letters for its combination phase 1b/2 studies (Protocols NUV-422-03 and NUV-422-04).

Nuvation announced in June the FDA had verbally placed a partial clinical hold on a phase 1 dose-escalation study of NUV-422 after the emergence of an eye inflammation called uveitis.

The company added that it had paused enrollment of new patients following the emergence of the uveitis, but the FDA requested a mitigation plan to address the adverse event of uveitis.

Nuvation said that it would be difficult to form an effective mitigation plan without significant further research as the causes of uveitis associated with NUV-422 was not understood and its development appeared unpredictable.

"Following an extensive analysis of the Phase 1 dose escalation study of NUV-422 in solid tumors, we made the determination that uveitis cannot be safely managed," said Nuvation Founder, President, and CEO David Hung.

Nuvation added that a reduction in work force of 35% and other cost savings linked with discontinuing NUV-422 program will extend its cash runway through 2028.

The company expects to report a balance of ~$703.8M in cash, cash equivalents and marketable securities as of June 30.

Nuvation intends to now focus its resources on developing NUV-868, for which enrollment is ongoing in a phase 1 monotherapy study. The company noted that it has planned phase 1b studies of NUV-868 in combination with olaparib ( sold as Lynparza by AstraZeneca and Merck) or enzalutamide (marketed as Xtandi by Pfizer and Astellas) to enhance the potential value of the program across multiple tumor types.

NUVB -5.43% to $2.61 premarket Aug. 1

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