Important Updates from Medicare, FDA, and Biotech Companies

Today, we have some important news from Medicare, the Food and Drug Administration (FDA), and updates from several biotech companies that you might have missed. Let’s break it down for you. Medicare and Cancer Drugs: Medicare has announced that the under-the-skin versions of cancer drugs Keytruda (by Merck & Co.) and Opdivo (by Bristol Myers Squibb) won’t be subject to price negotiations in 2028. However, they might be included in 2029. This news comes as a relief to investors who were concerned about the potential impact on these drugs, which were initially given as intravenous infusions and later converted into under-the-skin injections using technologies developed by companies like Halozyme. Some drug companies had argued that Medicare didn’t have the authority to group these different types of drugs together, and that doing so might discourage drug research. Medicare has said they need more time to develop clear rules for this issue. FDA Approves Second Generic Version of Abortion Pill: The FDA has approved a second generic version of the abortion pill mifepristone. This approval has sparked backlash from some conservative politicians and anti-abortion groups. Mifepristone is one of two pills commonly used to terminate a pregnancy within the first trimester. The approval comes after recent promises from health officials to reevaluate the safety of mifepristone, which has been consistently proven safe in studies since its initial approval over two decades ago. Ovid Therapeutics’ Experimental Drug Shows Promise: Ovid Therapeutics, a New York-based biotech company, announced that its most advanced experimental drug, OV329, succeeded in an early-stage study of healthy volunteers. This drug is designed to inhibit enzymes that break down GABA, a neurotransmitter that calms brain cells. The study found significant enzyme inhibition, giving the company confidence to further study the medicine as a potential seizure therapy. Ovid also reported favorable safety data and no evidence of changes in participants’ visual health. The company’s share price rose nearly 12% on this news. Cidara Therapeutics Receives Major Award for Flu Prevention Therapy: Cidara Therapeutics received a $339 million award from the Biomedical Advanced Research and Development Authority to support the development of CD388, a preventive therapy for flu infections. This drug could be an alternative to flu vaccines. The award will help with manufacturing and additional studies needed for U.S. approval. Taysha Gene Therapies Aligns with FDA on Rett Syndrome Study: Shares of Taysha Gene Therapies surged 50% after the company aligned with the FDA on the design of a pivotal study for its experimental treatment for Rett syndrome, a rare disease. The study will include an interim analysis that could lead to a speedy approval if the results are positive. This news is also a boost for Neurogene, another company working on a gene therapy for Rett syndrome. Bolt Biotherapeutics Cuts Workforce: Bolt Biotherapeutics is cutting its workforce in half for the second time in two years. The company is delaying the results of a study of its cancer antibody drug, BDC-4182, to the third quarter of 2026 and is restructuring to extend its cash runway into 2027. Cirrus Therapeutics Raises Funds for Gene Therapy: Cirrus Therapeutics announced a $11 million seed financing round to bring a gene therapy for the ‘dry’ form of age-related macular degeneration into preclinical testing. The treatment aims to reverse a recently identified cause of dry AMD, the loss of an immune-regulating protein called IRAK-M.

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