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The Daily Biotech Pulse: AEterna Zentaris Explores Options, Verastem Plunges On Weak Copiktra Sales, FDA Nod For Aerie

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The Daily Biotech Pulse: AEterna Zentaris Explores Options, Verastem Plunges On Weak Copiktra Sales, FDA Nod For Aerie

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on March 12)

  • Elanco Animal Health Inc (NYSE: ELAN)
  • CareDx Inc (NASDAQ: CDNA)
  • Fulgent Genetics Inc (NASDAQ: FLGT)
  • Ionis Pharmaceuticals Inc (NASDAQ: IONS)
  • MeiraGTx Holdings PLC (NASDAQ: MGTX)

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 12)

  • Achaogen Inc (NASDAQ: AKAO)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • Zafgen Inc (NASDAQ: ZFGN)(decided against filing IND for ZGN-1258, its investigational candidate for rare metabolic disorders including Prader-Willi syndrome)

Stock In Focus

Eyepoint Launches Post-operative Eye Inflammation Drug In U.S.

Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) announced the commercial launch of Dexycu, chemically dexamethasone intraocular suspension 9 percent, in the United States.

"DEXYCU is the first and only FDA-approved intraocular steroid for the treatment of postoperative inflammation and is administered as a single dose at the end of cataract surgery," the company said.

The stock moved up 4.71 percent to $2.61 in after-hours trading.

Sonoma Pharma Announces Workforce Reduction And Cost Cuts

Following an extensive evaluation of its processes and financials under newly-joined CEO Bubba Sandford, Sonoma Pharmaceuticals Inc (NASDAQ: SNOA) announced substantial cost-cutting measures, including reductions to its workforce and management. This will help the company to reduce its cash burn and focus spending on growth.

"The primary reductions were in the company's consulting expenses, manufacturing force and manufacturing expenses," Sonoma said.

The stock rose 2.1 percent to $1.08 in after-hours trading.

FDA Approves Aerie's Eye Pressure Drug

Aerie Pharmaceuticals Inc (NASDAQ: AERI) said the FDA approved its Rocklatan, or netarsudil and latanoprost ophthalmic solution, 0.02%/0.05%, as a treatment option for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company said it plans to launch Rocklatan in the U.S. in the second quarter of 2019.

Separately, the company announced net cash burn and net revenue guidance for 2019, accounting for the Rocklatan launch, expecting net cash burn at $130 million to $140 million and net revenues at $110 million to $120 million.

The stock tacked on 2.58 percent to $47 in after-hours trading.

See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

AEterna Zentaris Explores Strategic Options, Including Sale

AEterna Zentaris Inc. (NASDAQ: AEZS) said its board has formed a special committee of independent directors to review strategic options. The company also said the committee has approved the appointment of the company of Torreya, a global investment bank specializing in life sciences as its financial advisor.

The options being considered include licensing of macimorelin outside of the United States and Canada, other monetization transactions relating to macimorelin or the potential sale of the company

The stock rallied 6.5 percent to $3.93 in after-hours trading.

Neovasc To Offer Shares

Neovasc Inc (NASDAQ: NVCN) commenced a proposed underwritten public offering of common shares. The company said it intends to use the net proceeds for the development and commercialization of the Neovasc Reducer, the development of the Tiara and general corporate and working capital purposes.

The stock fell 5.32 percent to 50 cents in after-hours trading.

J&J Submits sBLA For Approval of Expanded Indication For Multiple Myeloma Drug

Johnson & Johnson (NYSE: JNJ)'s Janssen unit said it has submitted a sBLA for Darzalex in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Darzalex has already been approved to treat previously-treated multiple myeloma patients.

NovaBay Trims U.S. Sales Force, Announces Departure Of Interim CEO

NovaBay Pharmaceuticals, Inc. (NYSE: NBY) announced a strategic shift in its U.S. commercialization strategy to support sales growth of eyecare product Avenova and maintain cost effectiveness.

To align with the strategic shift, the company reduced its U.S. commercial salesforce from 45 to 15 field sales representatives. The company also announced the resignation of interim CEO, CFO and Treasurer Jack McGovern, while it named its lead independent director Paul Freiman as Chairman of the board.

The company also named SVP and General Counsel Justin Hall as interim President and CEO, as well as Corporate Controller Jason Raleigh as interim CFO and Treasurer.

Earnings

Cara Therapeutics Inc (NASDAQ: CARA) reported a fourth-quarter loss of 52 cents per share on revenues of $5.5 million. In comparison, the company reported a loss of 43 cents per share in the year-ago period. Analysts had expected a wider loss of 58 cents per share.

The stock rose 11.82 percent to $19.49 in after-hours trading.

Verastem Inc (NASDAQ: VSTM) reported a loss of 37 cents per share for its fourth quarter compared to a loss of 43 cents per share last year. Revenues came in at $1.21 million.

Verastem's first commercial product Duvelisib, or Copiktra, was approved last September for treating adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies.

The net revenues for the fourth quarter, comprised fully of Copiktra sales, was less than half of what most analysts had expected.

The stock plunged 17.90 percent to $2.66 in after-hours trading.

On The Radar

Earnings

  • Trevena Inc (NASDAQ: TRVN) (before the market open)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) (before the market open)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI) (before the market open)
  • Apyx Medical Corp (NASDAQ: APYX) (after the market close)
  • Miragen Therapeutics Inc (NASDAQ: MGEN) (after the market close)
  • Melinta Therapeutics Inc (NASDAQ: MLNT) (after the market close)
  • Viking Therapeutics Inc (NASDAQ: VKTX) (after the market close)

Posted-In: Biotech Earnings News Offerings FDA Top Stories Trading Ideas Best of Benzinga

 

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