By the end of this month, several pharmaceutical firms are set to receive a decision on their drug approval applications from the U.S. Food and Drug Administration (FDA), TipRanks’ FDA Calendar shows.
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In this article, we highlight all the companies awaiting a decision, the decision date, and what drugs are being considered.
- Agios Pharmaceuticals (AGIO) – Agios is a biopharma company based in Massachusetts. It develops medicines for rare genetic diseases and cancer. The FDA is set to decide on December 7 on Agios’s supplemental new drug application for the use of Pyrukynd (mitapivat) to treat adult patients with alpha- or beta-thalassemia, a genetic blood disorder. Pyrukynd helps red blood cells thrive longer and reduces anemia, a condition where the body lacks enough oxygen.
- Milestone Pharmaceuticals (MIST) – This pharma company focuses on developing drugs focused on the cardiovascular system. The FDA is set to decide on Cardamyst (etripamil) on December 13 after the company resubmitted its new drug application. The nasal spray is intended for at‑home use to rapidly bring sudden episodes of abnormally fast heart rate under control.
- Innoviva (INVA) – This California-based company produces treatments for respiratory and infectious diseases. The FDA is set to decide on Zoliflodacin on December 15. The drug is a new antibiotic pill being tailored to treat gonorrhea, including strains more resistant to older antibiotics.
- Aldeyra Therapeutics (ALDX) – This company develops medicines for inflammatory and immune‑related diseases, especially those of the eyes. The FDA is set to decide on Reproxalap on December 16 following the company’s resubmission. The eye drop is formulated to quickly relieve redness, irritation, and dryness in patients with dry eye disease or allergy‑related eye problems.
- Rhythm Pharmaceuticals (RYTM) – This firm focuses on rare genetic forms of obesity. The FDA is set to decide on Setmelanotide on December 20. The medication works on brain pathways that control hunger to help people with specific rare genetic disorders eat less and lose weight.
- Cytokinetics Inc. (CYTK) – Cytokinetics is working towards a medication that acts directly on muscle, including the heart. The FDA is set to decide on Aficamten on December 26 as part of a supplemental new drug application. The medication works to slightly ease the heart’s pumping action in conditions where the heart muscle is too thick and tight.
- Omeros Corporation (OMER) – This firm develops treatments that target the body’s inflammation pathways. The FDA is set to decide on Narsoplimab on December 26. The antibody drug aims to help protect blood vessels and organs from serious harm in certain inflammation‑driven and transplant‑associated conditions.
- Corcept Therapeutics (CORT) – This firm develops drugs that modulate the stress hormone cortisol. The FDA is set to decide on Relacorilant on December 30. This date is for the use of the tablet to manage Cushing’s syndrome, a condition where the body has excess cortisol levels.
- Vanda Pharmaceuticals (VNDA)– This biopharma company develops drugs for brain and rare disorders. The FDA is set to decide on Tradipitant on December 30. The medication is an oral drug designed to ease symptoms like vomiting in cases of gastroparesis — a disorder where the stomach takes too long to empty its contents into the small intestine — and itching in eczema.
- NRx Pharmaceuticals (NRXP) – This firm develops medicines for serious mental health and lung conditions. The FDA is set to decide on NRX‑100 on December 31. The therapy is an investigational brain‑acting drug that works on specific receptors to ease symptoms in patients with severe depression that has not responded to standard treatments.
- Outlook Therapeutics (OTLK) – This New Jersey-based firm makes eye‑focused versions of antibody drugs. The FDA is set to decide on ONS‑5010 (bevacizumab‑vikg) on December 31. This is an injection targeted at treating retinal diseases that threaten a person’s vision.