Following a negative phase II/III study of an investigational treatment for major depressive disorder, Praxis Precision Medicines Inc. is dropping staff from the payroll and refocusing the company’s resources on tremor and epilepsy. The Aria study of PRAX-114, a positive allosteric modulator extrasynaptic GABA receptor, missed its primary endpoint, statistical significance as measured on the Hamilton Depression Rating Scale. It also missed the study’s secondary endpoints.
Five-year survival rates for people with metastatic colorectal cancer haven’t budged much in recent decades but new data presented at the American Society of Clinical Oncology’s annual conference pushed the boundary enough to be notable.
Could Merus NV be on course to get the fourth “tumor agnostic” drug approved, a groundbreaking approach to cancer that focuses on mutations rather than location of the disease? According to a trial update revealed at the American Society of Clinical Oncology (ASCO) conference the biotech from Utrecht, the Netherlands, could join Merck & Co Inc., Bayer AG/Eli Lilly and Co. and Roche Holding AG with its early-to-mid stage candidate, zenocutuzumab.
After weeks of mounting speculation by backers of Gilead Sciences Inc., data from the phase III Tropics-02 study testing Trodelvy (sacituzumab govitecan) vs. physicians’ choice of chemotherapy rolled out June 4 at the American Society of Clinical Oncology (ASCO) meeting in Chicago. Wall Street had hoped for better.
Affibody AB and its development partners, Acelyrin Inc. and Inmagene Biopharmaceuticals Co. Ltd., are accelerating plans to move the interleukin-17A inhibitor izokibep (formerly ABY-035) into phase III studies in psoriatic arthritis following better-than-expected phase II efficacy combined with an apparently clean safety profile.
As the American Society of Clinical Oncology (ASCO) meeting began, researchers discussed abstracts related to findings due to roll out during the course of the weekend event. On the table June 3 were primary results from the double‐blind, placebo‐controlled, phase III Shine study of Imbruvica (ibrutinib) from Abbvie Inc. and Johnson & Johnson (J&J) in combination with bendamustine‐rituximab and rituximab maintenance therapy as a first‐line treatment for patients ages 65 and over with mantle cell lymphoma.
The world’s biggest cancer-focused conference began June 3 as more than 40,000 attendees are expected at the American Society of Clinical Oncology’s (ASCO) annual gathering. The conference is being held in live in Chicago and is also available virtually. Among the more than 2,500 abstract presentations in about 120 subject subcategories are potential breakthroughs in treating non-small-cell lung cancer from Immutep Ltd., Cullinan Oncology Inc. and Surface Oncology Inc. Each company has seen upticks in their stock value, some as much as 10%, during the week as the conference approached and their data are presented.
Poor phase II top-line data for Immunic Inc.’s lead candidate, vidofludimus calcium (IMU-838) hammered the stock June 2 as the study of the selective oral DHODH inhibitor missed its primary endpoint of clinical remission in treating moderate to severe ulcerative colitis. The failure means Immunic won’t pursue a phase III study on its own in the indication, but it won’t affect the company’s planned phase III studies of IMU-838 in treating relapsing multiple sclerosis (MS) and a phase II in treating progressive MS.
I-Mab Biopharma Co. Ltd. chief medical officer John Hayslip said the firm is “moving forward at our best speed” in tandem with partner Shanghai Junshi Biosciences Co. Ltd. to produce a diagnostic test that could be used in further clinical work with anti-CD73 antibody uliledlimab, for which results from an ongoing phase II trial were disclosed May 26.
Pharnext SAS has completed recruitment of an FDA-requested second phase III trial of its lead product, PXT-3003, in Charcot-Marie-Tooth disease type 1A (CMT1A), but now needs to raise €50 million (US$53.9 million) to stay solvent until the data read out in Q4 2023.
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