Biotech Acquisitions Could Impact FDA Decisions to Watch in Q3 Authors: Proactive Investors

The Food and Drug Administration (FDA) is expected to make several groundbreaking decisions this quarter. While they may not have a direct impact on Australia or the decisions of the Therapeutic Goods Agency (TGA), they are certainly worth keeping an eye on.

The TGA is known to consider and monitor the use of real-world data and evidence to support regulatory decisions about medicines and biological products.

So what should we pay attention to over the next few months?

Two major biotech acquisitions last year involved innovative treatments for schizophrenia, and the first of those therapies could potentially receive FDA approval by the end of September. The milestone could underscore the growing interest in psychiatric drugs.

Additional novel psychiatric therapies are undergoing testing, including psychedelics such as MDMA and psilocybin. The FDA faces a difficult decision because its advisory panel recently criticized the use of MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD).

In the meantime, Gilead Sciences (NASDAQ:) could win approval for a drug acquired in its deal with CymaBay Therapeutics, and a new cell therapy could come to market.

MDMA-Based Therapy for PTSD

Lykos Therapeutics intends to develop a business based on MDMA, commonly known as ecstasy, for the treatment of PTSD.

Despite promising study results, FDA advisers have raised concerns about safety and conduct of the study, casting doubt on approval prospects. The FDA is expected to make a decision by Aug. 11.

KarXT for schizophrenia

The breakthrough antipsychotic drug KarXT, developed by Karuna Therapeutics, could become the first new treatment for schizophrenia in decades.

Clinical studies have shown significant reduction in symptoms and rapid onset of effects.

Although KarXT has side effects, it avoids the excessive weight gain and movement problems that come with older antipsychotic medications.

Analysts predict FDA approval will come on September 26, with potential annual sales exceeding $10 billion.

TransCon PTH for Hypothyroidism

Ascendis Pharma’s TransCon PTH, a replacement therapy for hypoparathyroidism, could be approved by August 14.

Despite previous setbacks due to manufacturing concerns, recent positive trial results and approvals in Europe and the UK bolster the drug’s prospects.

afami-target for synovial sarcomas

Adaptimmune’s afami-cel, a TCR cell therapy for the rare cancer synovial sarcoma, could receive FDA approval by Aug. 4.

While the company is struggling financially, a successful approval could validate its approach, although strong commercial performance will be key to maintaining success.

seladelpar in primary cholangitis

Thanks to Gilead’s acquisition of CymaBay, the company has expanded its offering with an experimental drug for liver disease – seladelpar.

Seladelpar, a drug used to treat a chronic condition called primary cholangitis, is expected to be approved by August 14.

Gilead emphasizes the product’s effectiveness in relieving itching and predicts moderate sales growth.