Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates

Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates

Photo by Martin Lopez from Pexels

Year-end reviews by the Food and Drug Administration produced mostly positive outcomes, with most therapies passing the regulatory hurdle without any hiccups. Despite the problems posed by the pandemic for the conduct of clinical trials and regulatory inspections of facilities, the biopharma sector continued to innovate at a brisk pace this past year. New molecular entity approvals, considered a measure of innovation, totaled 53 in 2020 compared to 48 in 2019.

Notable among the NME approvals for December were BioCryst Pharmaceuticals, Inc. (BCRX)'s heredity angioedema treatment Orladeyo, MacroGenics Inc. (MGNX)'s Margenza for treating breast cancer, and Myovant Sciences Ltd (MYOV)'s Orgovyx to treat prostate cancer.

The FDA also accorded emergency use authorizations for the investigational vaccines of Pfizer Inc. (PFE), BioNTech SE – ADR (BNTX), and Moderna Inc. (MRNA). Here are the key PDUFA goal dates for the unfolding month.

Merck Seeks Approval For Heart Failure Drug

  • Company: Merck & Co., Inc. (MRK).
  • Type of Application: NDA.
  • Candidate: Vericiguat.
  • Indication: Heart failure.
  • Date: Jan. 20.

Vericiguat is an orally administered soluble guanylate cyclase stimulator that is being evaluated, in combination with existing heart failure therapies, as a treatment option to reduce the risk of cardiovascular death and heart failure hospitalization in patients with symptomatic chronic heart failure with reduced ejection fraction, or HFrEF.

HFrEF occurs due to the inability of heart to eject blood sufficiently during the contraction phase. About 6.5 million people in the U.S. have heart failure, and approximately 40-50% of these patients have HFrEF, Merck said.

Aurinia's Kidney Inflammation Drug Awaits Nod

  • Company: Aurinia Pharmaceuticals Inc. (AUPH).
  • Type of Application: NDA.
  • Candidate: Voclosporin.
  • Indication: Lupus nephritis.
  • Date: Jan. 22.
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