FDA Decision Watch: What Investors Need To Know About Four Upcoming Drug Rulings

Investors are set to turn their focus on FDA decisions on experimental treatments for hepatitis B, RRP, sickle cell disease and psoriatic arthritis.

• GSK’s hepatitis B treatment achieved a functional cure in 19% of patients in two late-stage trials.
• Inovio’s therapy reduced the need for repeated surgeries in 81.3% of patients with recurrent respiratory papillomatosis.
• Agios is seeking accelerated approval for Mitapivat for patients aged 16 and older with sickle cell disease.

After clearing several new and expanded drug uses last week, most notably ImmunityBio’s (IBRX) Anktiva for an additional form of bladder cancer, all eyes now turn to the U.S. Food and Drug Administration’s (FDA) decisions on drugs to treat hepatitis B, respiratory disease, and sickle cell disease.

The momentum continues over the next couple of weeks, with the FDA set to issue decisions on GSK (GSK), Sun Pharmaceutical Industries (SUNPHARMA), Inovio Pharmaceuticals (INO), and Agios Pharmaceuticals (AGIO).

FDA’s Verdict On GSK’s Hepatitis B Treatment On Oct. 26

The FDA is likely to announce its decision on GSK’s Bepirovirsen, an experimental treatment for adults with chronic hepatitis B, on October 26. The drug is designed to reduce the production of proteins that allow the virus to multiply and help the immune system control the infection, potentially without the need for continuous treatment.

The application is supported by Phase 3 B-Well 1 and B-Well 2 trials, in which 19% of eligible patients receiving Bepirovirsen alongside standard treatment achieved a functional cure, compared with none receiving standard treatment alone. A functional cure means the hepatitis B virus remains suppressed without treatment.

Among patients with lower viral activity at the start of the study, the functional cure rate was 26%.

The FDA granted the application Priority Review and Breakthrough Therapy designation, as the disease affects about 1.7 million people in the United States, according to GSK.

Inovio’s RRP Therapy In Focus

Investors will then focus on Inovio Pharmaceuticals, whose INO-3107, an experimental treatment for adults with recurrent respiratory papillomatosis (RRP), is expected to receive a regulatory decision on October 30.

RRP is a rare disease caused by certain strains of human papillomavirus (HPV), which leads to recurring growths in the respiratory tract. Patients often require repeated surgeries to remove these growths.

INO-3107 is designed to help the immune system attack HPV-infected cells. Inovio is seeking an accelerated approval, with the disease reportedly affecting an estimated 14,000 people in the U.S.

In a Phase 1/2 study of 32 patients, 81.3% required fewer surgeries in the year following treatment, while 28.1% required no surgeries during or after treatment.

Agios Awaits Decision On Mitapivat

With Mitapivat already approved for certain inherited blood disorders, Agios is now seeking an accelerated approval for patients aged 16 and older with sickle cell disease, which can lead to anemia and potential organ damage. The decision is expected on November 1.

The oral drug activates an enzyme called pyruvate kinase, which helps red blood cells produce energy and function more effectively.

The Phase 3 Rise Up trial, which involved 207 patients, supports the application. In the study, 40.6% of patients receiving Mitapivat achieved a meaningful increase in hemoglobin levels, compared with 2.9% receiving placebo.

Additional analyses also showed that patients receiving Mitapivat were less likely to require blood transfusions.

Sun Pharma Wants To Expand Ilumya’s Use

India-based Sun Pharmaceutical Industries, which recently expanded its U.S. operations with the acquisition of Organon (OGN), is awaiting FDA’s decision on Ilumya, an injectable treatment that is being expanded for the treatment of active psoriatic arthritis.

Ilumya works by blocking interleukin-23 (IL-23), a protein involved in inflammation. The drug was first approved in the U.S. in 2018 to treat moderate-to-severe plaque psoriasis.

Sun Pharma is seeking approval to expand Ilumya’s use beyond skin symptoms to patients with joint-related disease, with a decision awaited on October 29.

How Have AGIO, INO, GSK And Sun Pharma Performed So Far This Year?

Retail sentiment surrounding AGIO, GSK and INO trended in the ‘bullish’ territory, and ‘neutral’ for Sun Pharma.

The stocks’ movement so far this year has been mixed, with Agios Pharma gaining 15.2%, while Sun Pharma has risen 1.8%. In contrast, GSK has edged 0.2% lower, while Inovio Pharmaceuticals has plunged 43.4%, the worst performer in this cohort.

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