MRNA, LNTH, BMY, CAPR, RARE Stocks In Focus — These FDA Decisions Could Shape August Trading

• Moderna is seeking approval for mRNA-1010, its experimental mRNA-based seasonal flu vaccine for adults 50 and older.
• Capricor is seeking full approval for Deramiocel, a cell therapy aimed at heart damage caused by Duchenne muscular dystrophy, after an earlier rejection. 
• Ultragenyx is seeking approval for DTX401, a one-time gene therapy for glycogen storage disease type Ia, a rare inherited metabolic disorder, by August 23.

The U.S. Food and Drug Administration is set to rule on five closely watched treatments in August from Moderna, Lantheus Holdings, Bristol Myers Squibb, Capricor Therapeutics and Ultragenyx Pharmaceutical.

Decisions are due by August 23 at the latest on therapies ranging from an mRNA flu vaccine to a gene therapy for a rare metabolic disorder, putting biotech investors on high alert as the outcomes could drive sharp near-term moves across the sector.

August 5: Moderna’s Flu Shot (MRNA)

Moderna is seeking approval for mRNA-1010, its experimental mRNA-based seasonal flu vaccine for adults 50 and older. An FDA advisory panel already voted unanimously in favor of the shot in June, and the FDA is slated to decide on its application by August 5.

The FDA initially refused to file Moderna’s application in early February 2026, citing concerns that the comparator vaccine used in the main trial did not reflect the best available care for older adults. Moderna revised its plan, and now the company is seeking a traditional approval for adults aged 50-64 and an accelerated approval for adults 65 and older. If granted accelerated approval in the patient population, Moderna will be required to conduct another study to confirm effectiveness in the group.

August 13: Lantheus’ Alzheimer’s Scan (LNTH)

Lantheus wants approval for MK-6240, a PET imaging agent that detects tau protein tangles in the brain, a hallmark of Alzheimer’s disease. Doctors would use the scan to help confirm the presence of tau pathology, stage the disease, and guide treatment decisions.

The FDA accepted the company’s application seeking approval in October and granted it a fast-track designation. The application is based on two late-stage trials in people with early Alzheimer’s disease. In both trials, the scan identified patients with tau pathology and ruled out people without it, to support the application. The FDA will decide on the application by August 13 at the latest.

August 17: Bristol Myers Squibb’s Myeloma Drug (BMY)

Bristol Myers Squibb is seeking approval for iberdomide, an oral drug combined with existing medicines for patients whose multiple myeloma has returned or stopped responding, by August 17. It works by helping the immune system attack cancer cells more effectively while also directly killing myeloma cells.

Bristol Myers’ application was accepted by the FDA in February and granted priority review. The application relies on the large late-stage trial where iberdomide, together with Daratumumab and Dexamethasone, showed a statistically significant improvement in minimal residual disease (MRD) negativity rates compared to control arms. MRD negativity means no detectable cancer cells remain after treatment — an early sign of deep response.

August 22: Capricor’s Duchenne Therapy (CAPR)

Capricor is seeking full approval for Deramiocel, a cell therapy aimed at heart damage caused by Duchenne muscular dystrophy. After an earlier rejection, the company submitted new data from its late-stage HOPE-3 trial to the FDA.

However, in July, an advisory committee voted 9–3 against the claim that the available evidence provides substantial proof of effectiveness for treating DMD cardiomyopathy. The vote is non-binding, meaning the FDA could still approve the therapy.

August 23: Ultragenyx’s Gene Therapy (RARE)

Ultragenyx is seeking approval for DTX401, a one-time gene therapy for glycogen storage disease type Ia, a rare inherited metabolic disorder, by August 23. People with GSDIa cannot release stored sugar from the liver, leading to dangerous drops in blood sugar (hypoglycemia) during fasting, excess glycogen buildup in the liver and kidneys, and other long-term complications.  

The FDA granted priority review to Ultragenyx’s application in February. There are currently no approved treatments that address the underlying cause of GSDIa.

How Did Retail Traders React?

On Stocktwits, retail sentiment around MRNA trended in the ‘bearish’ territory at the time of writing, while sentiment around RARE and LNTH stayed at ‘neutral’ levels. Sentiment around CAPR and BMY was ‘extremely bullish’ at the time of writing.

While MRNA stock has gained 87% year-to-date, LNTH has added 52%, BMY 21%, and RARE 9%, while CAPR fell 85%. 

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