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

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

Down In The Dumps

(Stocks hitting 52-week lows on May 7)

• Acasti Pharma Inc ACST
• DENTSPLY SIRONA Inc XRAY

Stocks In Focus

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

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