The Daily Biotech Pulse: Axovant In-Licenses 2 Gene Therapies, Agile To Undertake Additional Study Of Contraceptive Patch

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Dec. 13)

• Kezar Life Sciences Inc KZR

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 13)

• Aileron Therapeutics Inc ALRN
• Altimmune Inc ALT(announced disappointing data for Anthrax vaccine NasoShield)
• Ardelyx Inc ARDX
• Bellicum Pharmaceuticals Inc BLCM(announced appointment of Atabak Mokari as its CFO)
• Biocept Inc BIOC
• BioXcel Therapeutics Inc BTAI
• Cellectis SA CLLS
• CTI BioPharma Corp CTIC(announced restructuring program that includes the elimination of 50 percent of workforce)
• Cytori Therapeutics Inc CYTX
• DURECT Corporation DRRX
• Eagle Pharmaceuticals Inc EGRX
• Epizyme Inc EPZM
• Five Prime Therapeutics Inc FPRX
• Forward Pharma A/S FWP
• Genetic Technologies Limited GENE
• GlycoMimetics Inc GLYC
• Insys Therapeutics Inc INSY
• Leap Therapeutics Inc LPTX
• Mustang Bio Inc MBIO
• Neovasc Inc NVCN
• Oncomed Pharmaceuticals Inc OMED
• Onconova Therapeutics Inc ONTX
• Ophthotech Corp OPHT
• Orgenesis Inc ORGS
• Ovid Therapeutics Inc OVID
• Paratek Pharmaceuticals Inc PRTK
• Prana Biotechnology Limited PRAN
• SCYNEXIS Inc SCYX
• Second Sight Medical Products Inc EYES
• Sienna Biopharmaceuticals Inc SNNA
• TherapeuticsMD Inc TXMD
• Titan Medical Inc. TMDI
• TrovaGene Inc TROV
• Unum Therapeutics Inc UMRX
• Zynerba Pharmaceuticals Inc ZYNE

See Also: The Week Ahead In Biotech: Conferences, Clinical Trials And Earnings

Stocks In Focus

Axovant In-licenses Two Gene Therapies For Pediatric Lysosomal Disorder, To Offer Shares

Axovant Sciences Ltd AXON announced acquisition of exclusive rights for developing and commercializing two novel gene therapy programs to address GM1 gangliosidosis and GM2 gangliosidosis, both of which are pediatric lysosomal storage disorders, from the University of Massachusetts Medical School.

The two gene therapy candidates, dubbed AXO-AAV-GM1 and AXO-AAV-GM2, would introduce copies of the respective genes encoding the critical enzymes impacted in these diseases.

Separately, the company said it has commenced an underwritten public offering of its common shares, with all shares being sold by the company.

The stock slid 6.19 percent to $1.06 in after-hours trading.

ZioPharma Promotes Mauney to President

ZIOPHARM Oncology Inc. ZIOP said it has promoted Chief Business Officer David Mauney to the role of President, effective immediately. Mauney's new role involves leading the company's corporate and business development strategies and overseeing all operations.

The stock rose 3.09 percent to $3 in after-hours trading.

Agile To Go Ahead With Comparative Study Of Investigational Contraceptive Patch Following Meeting With FDA

Following its meeting with the FDA's Division of Bone, Reproductive, and Urologic Products on Dec. 11, Agile Therapeutics Inc AGRX said it expects to conduct a crossover wear study in healthy woman with a body mass index less than 35 kg/square meter, who will be randomized either to Twirla, its investigational low-dose once-weekly contraceptive patch, or Xulane.

Twirla was handed down a complete response letter, or CRL, in December 2017, with FDA raising concerns over deficiencies related to, among other things, the in vivo adhesion properties and their potential relationship to the Phase 3 clinical trial results.

Agile said it will provide additional details on the study following the receipt of the final meeting minutes from the FDA in January. The company plans to complete the study in Q1'19 and resubmit the NDA in H1 2019, which leaves the possibility of a potential approval by the end of 2019.

Hologic Launches Non-Surgical Facelift Device In North America

Hologic, Inc. HOLX said its Cynosure division has launched FDA-cleared TempSure Surgical RF Technology – a platform for providing clinicians ability to perform both surgical and non-surgical aesthetic procedures on a single device – in North America.

The company also said it has relaunched Tempsure Vitalia hand pieces and probes, while also continuing to market MonaLisa Touch CO2 laser.

On The Radar

Clinical Trial Results

Bellicum Pharmaceuticals Inc BLCM is expected to report preliminary results from the lower-dose cohorts of the Phase 1/2 study of BPX-601 in patients with advanced pancreatic cancer at the ESMO Immuno-oncology conference.

Beigene Ltd BGNE will release Phase 1/2 data for bladder cancer treatment candidate Tislelizumab, at the ESMO Immuno-oncology conference.