Benzinga's Daily Biotech Pulse: FDA Nods For Teligent And Keytruda, Sonoma's Q4 Miss, Sage Inks Deal With Japan's Shionogi

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

Scaling the Peaks

(Stocks hitting 52-week highs on June 13)

• ABIOMED, Inc. ABMD
• AngioDynamics, Inc. ANGO
• Arrowhead Pharmaceuticals Inc ARWR
• BioLife Solutions Inc BLFS
• BIO-TECHNE Corp TECH
• CAS Medical Systems Inc CASM
• Edwards Lifesciences Corp EW
• Galectin Therapeutics Inc. GALT
• Helius Medical Technologies Inc HSDT
• Insulet Corporation PODD
• Kindred Biosciences Inc KIN
• MORPHOSYS AG/S ADR MOR
• Neogen Corporation NEOG
• ResMed Inc. RMD
• Qiagen NV QGEN
• Viking Therapeutics Inc VKTX
• Xenon Pharmaceuticals Inc XENE

Down In The Dumps

(Stocks hitting 52-week lows on June 13)

• Achieve Life Sciences Inc ACHV
• Evelo Biosciences Inc EVLO
• Flex Pharma Inc FLKS
• MiMedx Group Inc MDXG
• Scpharmaceuticals Inc SCPH

Stocks In Focus

Teligent Says FDA Approved Generic Skin Ointment

Teligent Inc TLGT said it has received FDA approval for its abbreviated new drug application for diflorasone diacetate ointment 0.05 percent, a high-potency corticosteriod used to treat a variety of skin conditions. The company plans to launch the product in the third quarter of 2018. Citing IQVIA data, the company said the product has total addressable market of $14.1 million.

The stock rallied 10.09 percent to $3.60 after hours.

Sage Inks Deal With Japan's Shionogi For Depressive Disorder Drug

SAGE Therapeutics Inc SAGE announced a strategic collaboration with Japan's Shionogi & Co for the clinical development and commercialization of its SAGE-217 for treating major depressive disorder, or MDD, and other indications in Japan, Taiwan and South Korea. The pipeline candidate has got Breakthrough Therapy Designation in the U.S., with the FDA recently announcing an expedited development plan for it.

The agreement provides for Shionogi assuming responsibility of clinical development, regulatory filings and commercialization of SAGE-217 for MDD, and potentially other indications, in Japan, Taiwan and South Korea.

Sage gets to receive an upfront payment of $90 million, and potential milestone payments up to $485 million, while also receiving tiered royalties on sales in these countries.

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

Merck's Keytruda Secures FDA Approval For Another Indication

Merck & Co., Inc. MRK's Keytruda received FDA approval for treating refractory, or relapsed primary mediastinal large B-cell lymphoma, a type of non-Hodgkin lymphoma.

Sonoma Q4 Misses Estimates

Sonoma Pharmaceuticals Inc SNOA reported Q4 2018 revenues of $3.7 billion, below the $4.49 million consensus estimate. The net loss per share was a wider-than-expected 93 cents per share.

The stock plunged 20.45 percent to $3.19 after hours.

FDA Identifies Deficiencies In Mylan's Generic Drug

Mylan NV MYL said the FDA has communicated to it minor deficiencies in its ANDA for Advair Diskus, with a complete response letter likely to be received on June 27, 2018. Advair is GlaxoSmithKline plc (ADR) GSK's inhaled lung drug.

"Upon receipt of the official Complete Response Letter, we will determine what, if any, impact that it could have on our full year 2018 outlook," the company said.

The stock fell 4.61 percent to $39.75 after hours.