Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates

Regulatory decisions by the U.S. Food and Drug Administration in December turned out to be mostly positive. Among the treatment options that were greenlighted in the month were two new molecular entities.

The number of new molecular entities approved is considered an indicator of innovation that is occurring in the drug industry. With the year almost grinding to a close, NME approvals total 48 compared to the 53 NMEs that received the nod in 2020.

Here are the key PDUFA dates scheduled for January.

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Xeris Awaits Approval Of Acquired Cushing's Syndrome Drug

• Company: Xeris Biopharma Holdings, Inc. XERS
• Type of Application: NDA
• Candidate: Recorlev (levoketoconazole)
• Indication: endogenous Cushing's syndrome.
• Date: Jan. 1

Recorlev came into Xeris's fold through its acquisition of Strongbridge Biopharma, which was announced in May.

Recorlev is an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing's syndrome. Cushing's syndrome is a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure, which is often the result of a benign tumor of the pituitary gland.

The NDA filed by Strongbridge was accepted for review in May 2021.

Can Eon's Epilepsy Clear FDA Hurdle After Initial Hiccups?

• Company: Eton Pharmaceuticals, Inc. ETON
• Type of Application: NDA
• Candidate: zonisamide oral suspension
• Indication: epilepsy
• Date: Jan. 29

The NDA for zonisamide oral suspension for the treatment of partial seizures in patients with epilepsy was accepted for review in Oct. 2020, with a PDUFA date of May 29. Eton announced in February that it has sold its neurology portfolio, including lamotrigine, zonisamide and topiramate to privately held Azurity Pharma for up to $45 million, including upfront and milestone payments.

The application was hit with a complete response letter and subsequently, Azurity filed a response to the FDA's communication in August following which a new PDUFA goal date was announced.

Eton will receive a $5-million milestone payment upon the approval and launch of zonisamide.

In a mid-November update, Eton said it believes the only item holding up FDA approval of the zonisamide oral suspension product application is the FDA inspection of the product's European manufacturer.

‘Go' or ‘No-Go' For Roche Retinal Disorder

• Company: Roche Holding AG RHHBY
• Type of Application: biologic license application
• Candidate: faricimab
• Indication: retinal disorders
• Date: Jan. 29 (estimated)

The FDA accepted the BLA for faricimab for priority review on July 29 as a treatment option for wet age-related macular degeneration and diabetic macular edema. Assuming a six-month review period, a decision could be expected in late January.

Faricimab is a bispecific antibody targeting the vascular endothelial growth factor and angiopoietin 2 pathways.

Regeneron/Sanofi Seek Label Expansion For Cancer Drug Libtayo

• Company: Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY
• Type of Application: supplemental BLA
• Candidate: Libtayo
• Indication: cervical cancer.
• Date: Jan. 30

Regeneron's application seeking expanding the label of Libtayo to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy was accepted for priority review on Sept. 28. Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T-cells. It currently has been approved three indications, involving difficult to treat cancers.

Related Link: After Much Criticism, Biogen Slashes Aduhelm Price In Half

Can Pfizer Snag Approval For Pediatric Growth Hormone Deficiency Treatment?

• Company: Pfizer, Inc. PFE/OPKO Health, Inc. OPK
• Type of Application: BLA
• Candidate: Somatrogon
• Indication: pediatric patients with growth hormone deficiency
• Date: January

Somatrogon is an investigational new biologic product, which is being co-developed by Pfizer and OPKO under a 2014 agreement. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

The investigational asset is a once-weekly, long-acting recombinant human growth hormone, for the treatment of growth hormone deficiency in pediatric patients.

The application was accepted for review in January with a PDUFA date in October. Later in late September, Pfizer said the FDA communicated a three-month extension in the review period to January.