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Benzinga's Daily Biotech Pulse: Valeant Earnings, Lipocine's FDA Watch, Invivo CFO Departure

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Benzinga's Daily Biotech Pulse: Valeant Earnings, Lipocine's FDA Watch, Invivo CFO Departure
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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 May 7)

  • Boston Scientific Corporation (NYSE: BSX)
  • DexCom, Inc. (NASDAQ: DXCM)
  • Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
  • G1 Therapeutics Inc (NASDAQ: GTHX)
  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH)
  • Integra Lifesciences Holdings Corp NASDAQ: IART)
  • STAAR Surgical Company (NASDAQ: STAA)

Down In The Dumps

(Stocks hitting 52-week lows on May 7)

  • Acasti Pharma Inc (NASDAQ: ACST)
  • DENTSPLY SIRONA Inc (NASDAQ: XRAY)

Stocks In Focus

Johnson & Johnson's Janssen Unit Secures FDA Nod for Yet Another Indication For Cancer Drug

Johnson & Johnson (NYSE: JNJ)'s Janssen unit announced FDA approval for its sBLA for darzalex, a monoclonal antibody, in combination with bortezomib, melphalan and prednisone, for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. This marked the fifth indication for darzalex.

Astellas Secures FDA Approval For Urinary Incontinence Drug-combo

ASTELLAS PHARMA/ADR (OTC: ALPMY) said the FDA approved its sNDA for myrbetriq in combination with solifenacin succinate for treating overactive bladder symptoms, manifesting as urge urinary incontinence and urinary frequency. Each of these compounds have already been approved as a monotherapy for OAB.

Invivo Announces CFO Departure, Narrower-than-expected FQ1 Loss

Invivo Therapeutics Holdings Corp (NASDAQ: NVIV) announced the resignation of CFO Christopher McNulty and the appointment of Jeff Modestino as principal financial officer and principal accounting officer. The company also announced a narrower-than-expected Q1 loss, which also narrowed year-over-year amid a decline in operating expenses, courtesy the restructuring efforts initiated in Q3 2017.

The stock slumped 11.45 percent to $7.35 after hours.

AEterna Zentaris'Q1 Beat

AEterna Zentaris Inc. (USA) (NASDAQ: AEZS) reversed to a profit of 87 cents per share in Q1 compared to a loss of 31 cents per share last year, as revenues increased to $24.66 million. The higher revenues were due to the recognition of an upfront payment of $24 million from Strongbridge Biopharma plc (NASDAQ: SBBP) for the license of macrilen.

The results exceeded the consensus estimates that called for a profit of 36 cents per share on revenues of $1.11 million.

The stock rallied 6.32 percent to $2.02 after hours.

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

PDUFA Dates

Lipocine Inc (NASDAQ: LPCN) awaits FDA ruling on its NDA for tlando, its hypogonadism treatment candidate. The decision assumes significance because, a FDA panel, which met in January, voted 13-6 against the benefit/risk profile of tlando.

On The Radar

The following are just a few of the companies scheduled to report earnings on Tuesday:

  • Acceleron Pharma Inc (NASDAQ: XLRN)
  • Valeant Pharmaceuticals (NYSE: VRX) Reported Q1 EPS $0.89 Beats $0.60 Estimate, Sales $1.995B Beat $1.95B Estimate; Raises Outlook
  • Myriad Genetics (NASDAQ: MYGN) Q3 EPS $0.31 Beats $0.27 Estimate, Sales $193.5M Beat $188.22M Estimate
  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
  • Opko Health Inc. (NASDAQ: OPK)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Alder Biopharmaceuticals Inc (NASDAQ: ALDR)
  • Amicus Therapeutics, Inc. (NASDAQ: FOLD)
  • ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP)
  • Applied Genetic Technologies Corp (NASDAQ: AGTC)
  • Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) Q1 EPS $(0.26) Misses $(0.19) Estimate, Made $3.976M Sales
  • Clovis Oncology Inc (NASDAQ: CLVS)
  • Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
  • Epizyme Inc (NASDAQ: EPZM)
  • Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)
  • Flexion Therapeutics Inc (NASDAQ: FLXN)
  • Haemonetics Corporation (NYSE: HAE) Q4 EPS $0.43 Beats $0.42 Estimate, Sales $233.552M Beat $227.12M Estimate
  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)
  • Kindred Biosciences Inc (NASDAQ: KIN)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
  • Loxo Oncology Inc (NASDAQ: LOXO)
  • Melinta Therapeutics, Inc. (NASDAQ: MLNT)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MAC) Q1 EPS $(1.33) Misses $(1.16) Estimate
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
  • Ocular Therapeutix Inc (NASDAQ: OCUL)
  • Oncomed Pharmaceuticals Inc (NASDAQ: OMED)
  • Prothena Corporation PLC (NASDAQ: PRTA)
  • Regenxbio Inc (NASDAQ: RGNX)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Sangamo Therapeutics Inc (NASDAQ: SGMO)
  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN)
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX)
  • T2 Biosystems Inc (NASDAQ: TTOO)
  • Vital Therapies Inc (NASDAQ: VTL)
  • Xenon Pharmaceuticals Inc (NASDAQ: XENE)

Posted-In: Biotech Earnings News FDA Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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