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Celldex Jumps on Phase 1b Progress With Skin-Disorder Drug

Celldex reported progress in a Phase 1b trial of CDX-0159, which treats the two most common forms of an inflammatory skin ailment.
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Celldex Therapeutics  (CLDX)  shares on Monday blasted higher after the biotech reported progress in a Phase 1b clinical trial of a skin-condition drug and H.C. Wainwright boosted its price target on the shares.

The trial is for CDX-0159, which treats the two most suffered forms of chronic inducible urticaria, an inflammatory skin ailment.

“All 19 patients who received a single full dose of CDX-0159 experienced a clinical response to provocation testing,” Celldex said.

“Responses were rapid, profound, and durable and correlated with a depletion of skin mast cells. CDX-0159 was generally well tolerated.”

Celldex recently traded at $45.34, up 40%. It had soared 87% in the six months through Friday.

As for H.C. Wainwright, analyst Joseph Pantginis lifted his price target to $50 from $36 and affirmed a buy rating. 

He’s “encouraged” by the test results and the CDX-0159 drug could be transformational, he said, according to Bloomberg

In other health-care news, the FDA notified Sigilon Therapeutics  (SGTX)  that its Phase 1/2 study of SIG-001 for hemophilia A has been placed on clinical hold.

“The clinical hold was initiated following the company’s submission of a serious adverse event and temporary enrollment halt to the FDA,” Sigilon said.

“To date, three patients have been dosed with SIG-001. The third patient, who received the highest dose of study drug, developed inhibitors to Factor VIII — a well-known complication of FVIII therapy,” Sigilon said.

Among other things, the FDA has requested additional information or data on factors potentially contributing to the development of inhibitors in this patient, the company said.