Biotech Stocks Facing FDA Decision In May 2024

(RTTNews) - As April comes to an end, attention shifts to biotech stocks poised for regulatory events in May. The FDA approved eight novel drugs last May, contributing to a total of 55 approvals in 2023.

So far this year, 15 novel drugs have secured the regulatory nod. Can 2024 surpass the count achieved last year?

Let's take a look at the biotech companies awaiting FDA decisions in May.

Pfizer Inc. (PFE)

The FDA will decide whether or not to convert the accelerated approval of Pfizer and Genmab's Tivdak to full approval on May 9, 2024.

Tivdak, an antibody-drug conjugate, was granted accelerated approval by the FDA for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy on Sep.20, 2021.

Cervical cancer remains a disease with high unmet need despite improvements in vaccination and screening methods aimed at preventing and detecting pre- and early-stage cervical cancers.

In a pivotal clinical trial, Tivdak demonstrated superior overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR) in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.

Moderna Inc. (MRNA)

Moderna's investigational respiratory syncytial virus vaccine mRNA-1345 is under FDA review, with a decision due on May 12, 2024.

Respiratory syncytial virus (RSV) is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia in infants and older adults. Each year in the U.S., roughly 60,000 to 120,000 older adults are hospitalized, and 6,000 to 10,000 of them die due to RSV infection.

GlaxoSmithKline Biologicals' Arexvy is the first RSV vaccine approved for use in the United States for individuals 60 years of age and older.

Dynavax Technologies Corp. (DVAX)

Dynavax Technologies has sought FDA approval to expand the use of its hepatitis B vaccine Heplisav-B for adults on hemodialysis and a decision is due on May 13, 2024.

The Heplisav-B vaccine, which combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG 1018, was approved by the FDA in November 2017, for prevention of infection caused by all known subtypes of hepatitis B virus in adults of age 18 years and older.

In a clinical trial that evaluated a 4-dose regimen of Heplisav-B in adults with end-stage renal disease undergoing hemodialysis, a seroprotection rate of 89.3% was observed with high levels of anti-HBs antibodies, which are critical to maintain protection in patients undergoing hemodialysis, according to the company.

The vaccine generated net product revenue of $213.3 million in 2023, representing a 69% growth year-over-year.

Ascendis Pharma A/S (ASND)

Ascendis Pharma's once-daily hormone replacement therapy TransCon PTH is at the FDA altar again, with a decision expected on May 14, 2024.

TransCon PTH is proposed for the treatment of adult patients with hypoparathyroidism, a rare endocrine disorder characterized by a deficiency or absence of parathyroid hormone.

This is the company's second attempt to get FDA approval for TransCon PTH. The U.S. regulatory agency had declined to approve TransCon PTH in May 2023, citing concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product.

TransCon PTH is approved in the European Union and other territories under the brand name Yorvipat.

Bristol Myers Squibb (BMY)

Bristol Myers Squibb has sought FDA approval for the expanded use of its drug Breyanzi in two more indications.

Breyanzi, a CD19-directed CAR T cell therapy, is already approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma and chronic lymphocytic leukemia or small lymphocytic lymphoma.

The proposed new indications for Breyanzi seek to include the treatment of adult patients with relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma.

The FDA decision on the drug in relapsed or refractory follicular lymphoma is expected on May 23, 2024, and that in refractory mantle cell lymphoma is due on May 31, 2024.

Breyanzi generated total annual sales of $364 million in 2023 compared to $182 million in the prior year.

Novo Nordisk A/S (NVO)

An FDA panel is slated to review Novo Nordisk's Awiqli for the proposed treatment of diabetes in adults on May 24, 2024.

Awiqli is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection.

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of Awiqli for the treatment of diabetes in adults.

Awiqli was approved in Canada in March 2023.