Attention Biotech Investors: Mark Your Calendar For These February PDUFA Dates

Biotech stocks have come under some selling pressure in the new year. However, January did witness some strong stock-specific upward moves, especially with stocks leveraged to the Wuhan coronavirus epidemic.

PDUFA dates are binary events that invariably serve as make-or-break catalysts for stocks. These dates are deadlines by which the FDA reviews a new drug application before announcing its decision concerning the approvability/non-approvability of the drug.

Epizyme Inc's EPZM tazemetostat for the treatment of epithelioid sarcoma and Horizon Therapeutics PLC's HZNP thyroid eye disease drug Tepezza were among the key FDA approvals that came through in January.

The following are the key PDUFA dates to watch for in February.

Can Third Time Be Charm For Agile?

• Company: Agile Therapeutics Inc AGRX
• Type of Application: NDA
• Candidate: Twirla
• Indication: hormonal contraceptive patch
• Date: Feb. 16

Twirla is an experimental, once-weekly combined hormonal contraceptive patch that contains the active ingredients ethinyl estradiol, a type of estrogen, and levonorgestrel, a type of progestin.

The FDA had shot down the originally submitted NDA in February 2013 following which Agile resubmitted the application in June 2017. The regulatory agency issued a second CRL in December 2017, citing deficiencies relating to quality adhesion test methods and issues identified during an inspection of the facility of a third-party manufacturer. The FDA also raised concerns about the in vivo adhesion properties of Twirla and their potential relationship to the late-stage clinical trial.

Following the second CRL, the company resubmitted the NDA May 2019. An Adcom that discussed the NDA issued a verdict favoring approval of the drug. In November, the company announced a three-month extension to the PDUFA date, moving it from Nov. 16, 2019 to Feb. 16.

See Also: Acceleron Hits All-Time High On Positive Readout For Pulmonary Arterial Hypertension Drug

Merck Seeks Label Expansion For Keytruda To Include 6-Week Dosing Schedule

• Company: Merck & Co., Inc. MRK
• Type of Application: sBLAs
• Candidate: Keytruda
• Indication: Updation of dosing schedules
• Date: Feb. 18

The six sBLAs submitted by Merck were accepted for review July 2019, with the applications seeking updation of dosing frequency for Keytruda to include a 400mg, every-six weeks dosing schedule option, in melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma.
The currently approved dosing schedule is 200mg every three weeks infused over 30 minutes.

Can Baudax Bio's Non-Opioid Pain Drug Soothe Investors?

• Company: Baudax Bio Inc BXRX
• Type of Application: NDA
• Candidate: intravenous formulation of meloxicam
• Indication: moderate-to-severe pain
• Date: Feb. 20

Baudax Bio's IV meloxicam, a non-opioid pain drug, stumbled at the FDA altar twice in the past, with the latest rejection coming in March 2019. The CRL suggested delayed onset of IV meloxicam fails to meet the prescriber expectations for IV drugs.

Following the FDA's acceptance of Baudax' complete response package, the agency set a PDUFA goal date of Feb. 20.

Esperion Awaits Twin Approvals

• Company: Esperion Therapeutics Inc ESPR
• Type of Application: NDA
• Candidate: Bempedoic acid
• Indication: elevated low-density lipoprotein-cholesterol, or LDL-C
• Date: Feb. 21

Bempedoic acid is an oral, once-daily ATP citrate lyase inhibitor that reduces cholesterol and fatty acid synthesis in the liver. It's meant to treat patients with elevated LDL-C, who need additional LDL-C lowering despite the use of currently accessible therapies.

• Company: Esperion Therapeutics
• Type of Application: NDA
• Candidate: Bempedoic acid and ezetimibe
• Indication: elevated LDL-C
• Date: Feb. 26

In the bempedoic acid and ezetimibe combo treatment, the former inhibits cholesterol synthesis and the latter cholesterol absorption.

Adcom Meetings

FDA's Tobacco Products Scientific Advisory Committee is scheduled to meet Feb. 14 to discuss the modified risk tobacco product applications submitted by 22nd Century Group Inc XXII for VLN King and VLN Menthol King combusted, filtered cigarettes. The company is projecting these tobacco products as "very low nicotine content" cigarettes.