BioSpace News Archive

Novartis today announced results from the RIGHT Choice Phase II trial evaluating Kisqali® (ribociclib) plus endocrine therapy (ET) against combination chemotherapy (CT) in the first-line setting for pre- and perimenopausal patients with aggressive forms of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2−) metastatic breast cancer (MBC), including patients with visceral crisis.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from a post-hoc analysis from the Phase 3 TROPiCS-02 study evaluating Trodelvy® (sacituzumab govitecan-hziy; SG) versus comparator chemotherapy (physicians’ choice of chemotherapy, TPC) in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies.

A clinical study conducted with participation by Florida Cancer Specialists & Research Institute, LLC (FCS) has led to FDA approval of a new immunotherapy that improves chemotherapy treatment outcomes for patients with metastatic non small-cell lung cancer (mNSCLC).

Invivyd, Inc. announced the appointment of Jeremy Gowler as chief operating and commercial officer, effective December 16, 2022, and the promotion of Pete Schmidt, M.D. to chief medical officer, effective immediately.

ADMA Biologics, Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced preliminary estimates for its total revenue for the quarter- and year-ended December 31, 2022.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that investigational NBI-827104 did not meet its primary endpoint in the Phase 2 STEAMBOAT™ study evaluating the efficacy, safety, tolerability and pharmacokinetics of NBI-827104 compared to placebo in pediatric patients with epileptic encephalopathy with continuous spike-and-wave during sleep (EE-CSWS).

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that new data presentations supporting the clinical value of its Precision Oncology portfolio will be shared in ten abstracts and three presentations at the 2022 San Antonio Breast Cancer Symposium® (SABCS®).

TransCode Therapeutics, Inc. announced that it withdrew the Registration Statement on Form S-1 it filed with the U.S. Securities and Exchange Commission on November 28, 2022, and amended on November 30, 2022.

Albireo Pharma, Inc., a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, announced the grant of inducement restricted stock units to acquire 13,700 shares of Albireo’s common stock.

Vapotherm, Inc. announced that it was notified on November 30, 2022 by the New York Stock Exchange, Inc. that the Company is not in compliance with the NYSE’s continued listing standard set forth in Section 802.01C of the NYSE’s Listed Company Manual because the average closing price of the Company’s common stock was less than $1.00 per share over a consecutive 30 trading-day period.