Odonate Therapeutics, Inc. ODT, Opthea Limited OPT, ALX Oncology Holdings Inc. ALXO, Provention Bio, Inc. PRVB and Advaxis, Inc. ADXS are among the biggest biopharma movers Tuesday.
Odonate Gains On Institutional Stake: Shares of Odonate, a biopharma which recently announced discontinuation of development of an oral chemotherapy candidate named tesetaxel, are seeing renewed buying following disclosure of institutional stake.
The company said in a 13-G filing with the SEC that Ikarian Capital has built up a 5.2% stake in the company. A previous filing in late March showed that the biotech-focused investment had a 3.5% stake in the company.
The stock was up 8.04% at $3.76.
Opthea Rallies On Fast Track Designation: Australian biopharma Opthea said the FDA has granted fast track designation for the company's OPT-302, in combination with anti-VEGF-A therapy for the treatment of patients with neovascular wet age-related macular degeneration.
The designation vests advantages such as more frequent regulatory meeting and communications with the FDA, as well as a rolling review of completed sections of its biologic drug application.
Opthea is a clinical stage biopharma developing novel therapies to treat highly prevalent and progressive retinal diseases.
Opthea was adding 8.18% to $8.20.
Related Link: The Week Ahead In Biotech: Focus On Chemocentryx FDA Decision, Conference Presentations In A Light Week
ALX Oncology Advances On Positive Stomach Cancer Data: ALX Oncology, a clinical-stage immuno-oncology company, presented updated clinical data from its ASPEN-01 trial evaluating ALX148, in combination with Roche Holding AG's RHHBY Herceptin and chemotherapy for the treatment of gastric or gastroesophageal junction cancer, showing the combo is highly active and well-tolerated in patients with second-line or greater HER2 positive gastric cancer.
The new results were shared in an oral presentation at the 23rd World Congress on Gastrointestinal Cancer.
The stock was soaring 23.96% at $69.29.
Advaxis Jumps On Reverse Merger With Biosight: Advaxis, a clinical-stage biotech focused on the development and commercialization of proprietary Lm-based antigen delivery products, announced a reverse merger with privately-held Biosight Ltd.
Biosight is a biopharma developing innovative therapeutics for hematological malignancies and disorders.
The shareholders of Biosight will become the majority holders of the combined company immediately following completion of the transaction. The proposed merger will create a public company that will prioritize the clinical advancement and commercialization of Biosight's lead product, aspacytarabine.
Following the closing, which is expected to occur in the second half of 2021, Advaxis will be renamed Biosight Therapeutics and is expected to trade on the Nasdaq under the ticker symbol "BSTX."
The stock was surging up 30% to 61 cents.
Related Link: Neurodegenerative Disease, Cancer Stocks Among Top Biotech Gainers In 2021
Provention Bio Slumps On FDA Rejection of Diabetes Drug: Provention Bio announced that the FDA has issued a complete response letter for its biologics license application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals.
The FDA stated in the CRL that a single, low-dose pharmacokinetic/pharmacodynamic bridging study in healthy volunteers to compare planned commercial product with drug product originating from drug substance manufactured for historic clinical trials had failed to show PK comparability.
The company said it expects relevant additional PK/PD data being, or to be, collected from a PK/PD sub-study in patients receiving 12-days of therapy in the Phase 3 PROTECT trial in newly diagnosed T1D patients later this quarter.
The FDA had also raised issues related to product quality and required resolution of certain deficiencies conveyed during a recent general inspection at a fill/finish manufacturing facility used by the company.
The stock was sliding 25.97% to $6.14.
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