Why Morphic, Athenex, Lixte Biotech Are Moving Today

Morphic Holding Inc MORF, Athenex Inc ATNX and Lixte Biotechnology Holdings Inc LIXT are among the healthcare movers on Monday.

Morphic Jumps On Data: Morphic, a biopharma developing oral integrin therapies for treating chronic diseases, reported positive Phase 1 data for its MORF-057, which is being evaluated for inflammatory bowel disease.

In the Phase 1 single ascending dose study, MORF-057 was found to be well tolerated in all five cohorts receiving MORF-057 in single doses, ranging from 25mg to 400mg, with no serious adverse events and no significant lab abnormalities in any subject, the company said.

The data provides early proof-of-concept for MORF-057 as an oral, selective α4β7 inhibitor, it added.

The company noted that the Phase 1 multiple ascending dose and food effect trials are ongoing.

Separately, the company reported below-consensus revenues and a wider-than-expected loss for the fiscal year 2020.

Morphic shares were rallying 108.79% to $75.50.

Lixte Shares Pulls Back On Pricing Direct Offering at a Discount: Lixte, which manufactures pharmacologically active drugs used in cancer treatment, said it has entered into definitive agreements for the sale of 1.133 million shares at 3.70 per share, in a registered direct offering. The closing of the offering is expected to occur on or about March 2, subject to the satisfaction of customary closing conditions.

Lixte shares were sliding 17.95% to $4.58.

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Athenex Plunges On Adverse FDA Ruling: Oncology-focused biopharma Athenex said the Food and Drug Administration has issued a complete response letter for its NDA for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer.

Paclitaxel is a commonly used chemotherapy medication and it is given as an injection or intravenous infusion.

In the CRL, the FDA raised safety risk stemming from an increase in neutropenia-related sequelae on the oral paclitaxel arm compared with the IV paclitaxel arm. The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate at week 19, conducted by blinded independent central review.

The agency recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S.

Athenex said it plans to request a meeting with the FDA to discuss the agency's response, engage in a dialogue on the design and scope of a clinical trial to address the FDA's requirements and align on the next steps required to obtain approval.

Separately, the company reported a wider-than-expected loss for the fourth quarter, while its revenues exceeded estimates.
Athenex was seen plunging 51.42% to $5.88.

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