(RTTNews) - The following biotech stocks are seeing significant moves in premarket trading on Monday, ranging from surges of over 98% to drops of over 50%, following regulatory announcements or results from ongoing clinical trials.
IDEAYA Climbs Over 20%
IDEAYA Biosciences Inc. (IDYA), a precision medicine oncology company, is up over 20% in premarket trading on Monday, trading at $36.99. The company has reported positive topline results from its Phase 2/3 registrational trial (OptimUM-02) of darovasertib in combination with crizotinib in first-line HLA-A*02:01-negative metastatic uveal melanoma.
Virax Surges 98% Following ISO Certification
Virax Biolabs Group Ltd. (VRAX), a biotechnology company, is up over 98% in the premarket trade at $0.20. The company specializes in developing in vitro diagnostic (IVD) tools. Last month, it was granted ISO certification for its quality management systems by Lloyd's Regulatory Quality Assurance (LRQA). This certification supports the company's plans to establish a T-cell profiling platform in IVDs for post-acute infection syndromes (PAIS), like long-COVID.
Zentalis Spikes Amid Trials For Ovarian Cancer Treatment
Zentalis Pharmaceuticals Inc. (ZNTL), a clinical oncology company, rose 48.77% and closed at $6.61 on Friday. This followed an announcement on Thursday that emerging DENALI Part 2a interim data showed a favourable benefit-risk profile for the 400 mg once-daily (5:2) dose compared with the 300 mg once-daily (5:2) dose. DENALI Part 2a is the dose-confirmation stage of its Phase 2 registration-intent trial evaluating Azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The optimal dose of 400 mg will be further tested in the DENALI Phase 2b and Phase 3 ASPENOVA trials.
Organon Rises Over 25% In Premarket
Organon & Co. (OGN), a global healthcare company, saw shares rise to $8.83 on Friday, marking an increase of 27.29%. The Economic Times on Saturday reported that Sun Pharmaceutical Industries is close to acquiring Organon for about $12 billion.
MacroGenics On Watch
MacroGenics Inc. (MGNX), a clinical-stage biopharmaceutical company, hit a 52-week high of $3.88 in the premarket, up 4.65%. Last week, the FDA lifted the clinical hold on the company's Phase 2 LINNET study for lorigerlimab, a monoclonal antibody being developed for treating platinum-resistant ovarian cancers (PROC), and clear cell gynecologic cancers (CCGC). The company is also developing multiple antibody drug conjugates (ADCs) for treating solid tumours.
Replimune Plunges To 52-Week Low After CRL From FDA
Replimune Group Inc. (REPL), a clinical-stage biotechnology company, reached a 52-week low of $2.13 in the premarket trade, plunging 55.25%. This follows the receipt of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on Friday for its investigational biologic, RP1, proposed for the treatment of melanoma.
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