Odonate Therapeutics, Inc. (NASDAQ: ODT), Dyadic International, Inc. (NASDAQ: DYAI) and Marker Therapeutics, Inc. (NASDAQ: MRKR) are among the early biotech movers in Monday’s session.
Odonate to Shut Shop: Odonate, an oncology-focused pharma company, said it is discontinuing the development of tesetaxel following feedback from the Food and Drug Administration in a pre-New Drug Application meeting.
Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. It was being evaluated in a late-stage study in metastatic breast cancer, and the company was hoping to file an NDA in mid-2021.
Following the FDA feedback, the company said it concluded that the clinical data package for tesetaxel is unlikely to support FDA approval. It also said it will wind down its operations.
Odonate intends to work with clinical sites to transition patients in ongoing tesetaxel clinical studies to appropriate alternative therapies.
Odonate shares were plunging 73.78% to $4.99.
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Dyadic Soars On Vaccine News: Dyadic, a biotech that leverages its proprietary C1-cell protein production platform for the development of biologic vaccines and therapeutics, said it is expanding its partnership with South Korea’s Medytox to co-develop C1 manufactured COVID-19 vaccines and/or boosters.
If successful, it can be used to immunize people against two or more of the current and future COVID-19 variants, the company said.
Dyadic shares were soaring 47.65% to $7.87.
Marker Moving On Momentum: Shares of Marker, a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, came under pressure for much of last week following an announcement concerning common-stock offering.
Friday, the stock rebounded after Cantor Fitzgerald initiated coverage of the stock with an Overweight rating and $6 price target and the company disclosed in a series of filings buying by insiders. The upward momentum is continuing into Monday’s shares, with the shares moving sharply higher on above-average volume.
Marker was surging up 33.88% to $3.24.
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