The Daily Biotech Pulse: Agile Gives Regulatory Update On Contraceptive Patch, Advaxis Misses Estimates, Ocular Submits sNDA

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

The following biotech stocks hit 52-week highs Jan. 10: 

• Takeda Pharmaceutical Co Ltd TAK
• Veracyte Inc VCYT

None of the biotech stocks hit 52-week lows Thursday.

Stocks In Focus

Agile Confident In Twirla Approval By Year's End 

Agile Therapeutics Inc AGRX said it expects to complete the comparative wear study for Twirla in the first quarter and resubmit the NDA in the first half of 2019. This renders a potential approval timeframe of the end of 2019.

Twirla is Agile's investigational low-dose, once-weekly contraceptive patch. The FDA previously issued a complete response letter to Agile's NDA for Twirla in December 2017.

The announcement followed the company's meeting with FDA's Division of Bone, Reproductive, and Urologic Products, where it discussed the specific design and success criteria of the comparative wear study intended to demonstrate adequate adhesion via non-inferiority of Twirla to Xulane, a generic version of the Ortho Evra contraceptive patch.

The company said it has sufficient cash to meet its projected operating requirements into Q2. 

The stock rose 1.57 percent to 80 cents in after-hours trading Thursday.

Advaxis Results Trail Expectations

Advaxis, Inc. ADXS reported a decline in its 2018 revenue from $12.03 million a year ago to $6.06 million. The net loss narrowed from $2.31 to $1.29 as the company reined in expenses.

Analysts expected a loss of $1.09 per share on revenue of $6.28 million for the year.

Ocular Therapeutix Files For Expanded Indication For Eye Pain Drug

Ocular Therapeutix Inc OCUL said it has submitted a sNDA for Dextenza, seeking an expansion in indication to include the treatment of ocular inflammation following ophthalmic surgery.

Dextenza was approved in November to treat post-surgical ocular pain for up to 30 days with a single administration. It is a preservative-free ophthalmic insert meant to be placed in the lower lacrimal punctum and into the canaliculus of the eye.

The company expects the review of the sNDA to be completed in the second half of the year. 

The stock rallied 2.5 percent to $4.10 in after-hours trading Thursday.

Related Links:

The Week Ahead In Biotech: Conferences, Clinical Trials

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