The Daily Biotech Pulse: Mylan Recalls Blood Pressure Drug, Heat Biologics Offering, New Novelion CEO

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 Nov. 20)

  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX
  • Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 20)

  • Fresenius Medical Care AG & Co. FMS
  • Adamas Pharmaceuticals Inc ADMS
  • Akebia Therapeutics Inc AKBA
  • Aquestive Therapeutics Inc AQST
  • Cancer Genetics Inc CGIX(reported a decline in its revenues and a wider loss for Q3)
  • Celgene Corporation CELG
  • Cellectis SA CLLS
  • Celsion Corporation CLSN
  • CTI BioPharma Corp CTIC
  • Cyclacel Pharmaceuticals Inc CYCC
  • CytomX Therapeutics Inc CTMX
  • DURECT Corporation DRRX
  • Endologix, Inc. ELGX
  • Erytech Pharma SA ERYP
  • Kala Pharmaceuticals Inc KALA
  • Keryx Biopharmaceuticals KERX
  • KITOV PHARMA LT/S ADR KTOV
  • Kodiak Sciences Inc KOD
  • Mersana Therapeutics Inc MRSN
  • Mesoblast limited MESO
  • Neos Therapeutics Inc NEOS
  • Neovasc Inc NVCN
  • Novan Inc NOVN
  • OptiNose Inc OPTN
  • PhaseBio Pharmaceuticals Inc PHAS
  • Revance Therapeutics Inc RVNC
  • SCYNEXIS Inc SCYX
  • Sutro Biopharma Inc STRO
  • Teligent IncTLGT
  • Tenax Therapeutics Inc TENX
  • Zynerba Pharmaceuticals Inc ZYNE

Stocks In Focus

Aquestive To Challenge Verdict On Opioid Addiction Drug

Following the U.S. Court of Appeals' ruling to overturn the preliminary injunction against Dr.Reddy's Laboratories Ltd RDY, Aquestive Therapeutics said it will continue to work with partner INDIVIOR PLC/S ADR INVVY to pursue the ongoing infringement cases against Dr. Reddy's Lab and other generic manufacturers to protect the Suboxone patent portfolio.

Suboxone film is a prescription medicine containing active ingredients buprenorphine and nalazone used to treat adults addicted to opioids.

Aquestive said it sees its near-term products, including Sympazan Oral Film, and the rest of its development pipeline offering promising future opportunity.

Dexcom Amends Glucose Monitoring Device Agreement With Google Unit Verily

DexCom, Inc. DXCM announced an amendment to the Collaboration and Licensing agreement with Alphabet Inc GOOGL's Verily, with the amendment meant to reinforce the mutual product development goals and also expand options for future collaborations. Dexcom also sees the new agreement to accelerate its advance into the Type 2 diabetes space.

The amendment includes strengthening product development timelines for second-gen CGM system, increasing synergy with Verily's Onduo franchise and expanding options to collaborate on development of products and software pertaining to Dexcom's products.

Additionally, the amendment agreement eliminates the royalty payments set forth in the original agreement, due to be paid by Dexcom.

On the financial side, Dexcom is due to pay an initial payment of $250 million in shares, and additional payments of up to $280 million, upon achievement of future product launch and revenue milestones.

Dexcom shares slipped 1.53 percent to $118 in after-hours trading.

Mylan Recalls Select Lots of High Blood Pressure Drug

Mylan NV MYL announced a nationwide recall of select lots of Valsartan containing products, citing the presence of trace amounts of N-nitrosodiethylamine, an impurity. The recalled products were manufactured by Mylan Pharma and Mylan Labs, and distributed in the U.S. between March 2017 and Nov. 2018. Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction

Mylan shares shed 2.57 percent to $33.04 in after-hours trading.

Heat Biologics To Offer Shares to Fund Clinical Programs

Heat Biologics Inc HTBX said it intends to offer shares as well as warrants to purchase shares of its common stock in an underwritten public offering. The company said it intends to use the proceeds for funding clinical and pre-clinical programs, among other things.

The stock slumped 26.83 percent to $1.50 in after-hours trading.

Novelion Appoints New Interim CEO

Novelion Therapeutics Inc NVLN announced the resignation of Jeffrey Hackman as interim CEO, although he would stay with the company in a transitional role until the end of November. The company appointed its General Counsel Mark Corrigan as interim CEO, effective immediately.

The stock rallied 9.92 percent to $0.94 in after-hours trading.

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