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The Daily Biotech Pulse: Obseva Reports Positive Endometriosis Drug Trial, Assembly Biosciences Execs Depart, Coherus Settles With Amgen

Shanthi Rexaline

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 May 2)

  • Alcon AG (NYSE: ALC)
  • Dr.Reddy's Laboratories Ltd (NYSE: RDY)

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 2)

  • EXACT Sciences Corporation (NASDAQ: EXAS)
  • KemPharm Inc (NASDAQ: KMPH)
  • NeoGenomics, Inc. (NASDAQ: NEO)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Strongbridge Biopharma plc (NASDAQ: SBBP)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Verastem Inc (NASDAQ: VSTM)
  • Vistagen Therapeutics Inc (NASDAQ: VTGN) (reported negative trial results )
  • Xenetic Biosciences Inc (NASDAQ: XBIO)

Stock In Focus Obseva Reports Positive Results For Long-Term Study Of Endometriosis Drug

Obseva SA (NASDAQ: OBSV) reported follow-up results from the Phase 2b EDELWEISS clinical trial of its oral gonadotropin-releasing hormone receptor antagonist linzagolix for treating endometriosis-related pelvic pain, showing that patients treating with linzagolix for 52 weeks saw maintenance of pelvic pain response rates, with the 75mg or the 200mg dose. Bone mineral density remained within safe limits, the company added.

The data, according to the company, support long-term therapeutic potential of linzagolix and supports the currently-starting Phase 3 program for endometriosis.

Assembly Biosciences CFO, COO Depart

Assembly Biosciences Inc (NASDAQ: ASMB) announced the departure of CFO and COO, and the appointment of David Houck as SVP, Product Development and Portfolio Management.

Coherus Settles With Amgen on Neulasta Biosimilar

Coherus Biosciences Inc (NASDAQ: CHRS) settled the trade secret action brought by Amgen, Inc. (NASDAQ: AMGN) against it that was pending in the Superior Court of California Court of Ventura. Coherus did not disclose the terms of the settlement but said it will continue to market Udenyca, an FDA-approved biosimilar for Amgen's Neulasta, and will pay a single-digit royalty for Amgen for five years.

Coherus shares rose 2.29 percent to $16.13 in after-hours trading.

Earnings

Endologix, Inc. (NASDAQ: ELGX) reported 15.8 percent year-over-year revenue growth for its first quarter to $35.6 million. The net loss per share narrowed from $2.36 to $2.12. The company reaffirmed its previous annual guidance for revenues of at least $140 million in 2019, in line with the consensus.

The stock climbed 10.76 percent to $7 in after-hours trading.

Ligand Pharmaceuticals Inc. (NASDAQ: LGND)'s first-quarter revenues fell from $56.2 million in the year-ago period to $45.3 million. The net income, on an adjusted basis, fell from $1.55 per share to $1.16, exceeding the $1.02 per share consensus. The company reaffirmed its adjusted earnings per share guidance of $3.20 on revenues of $118 million for 2019. The guidance were below estimates.

The stock fell 5.67 percent to $119.90 in after-hours trading.

T2 Biosystems Inc (NASDAQ: TTOO) reported first-quarter revenues of $1.314 million compared to $1.048 million in the year-ago period. The net loss per share narrowed from 36 cents to 34 cents, while analysts expected a loss of 30 cents per share. The company reiterated its full-year guidance of $10.5 million in revenues. It expects second quarter revenues of $1.8 million to $2.1 million. The guidance were below the consensus estimates.

The stock fell 3.57 percent to $2.43 in after-hours trading.

Gilead Sciences, Inc. (NASDAQ: GILD) reported first-quarter adjusted net income of $1.76 per share on revenues of $5.3 billion. The bottom line exceeded estimates. This compared to $1.48 per share in adjusted net income and revenues of $5.1 billion last year. The company reaffirmed its 2019 guidance of net product sales in the range of $21.3 billion - $21.8 billion.

View more earnings on IBB

The stock was up 0.83 percent to $65.84 in after-hours trading.

Alder Biopharmaceuticals Inc (NASDAQ: ALDR)'s first-quarter net loss narrowed from $1.73 share to $1.63 per share. Analysts estimated a loss of $1.03 per share. Cash, cash equivalents, investments and restricted cash came in at $498.5 million at the end of March compared to $412.4 million at the end of Dec. 2018.

"Alder believes its available cash, cash equivalents, investments and restricted cash will be sufficient to meet its projected operating requirements through the anticipated launch of eptinezumab and into the latter part of 2020," the company said.

The stock added 4.58 percent to $12.80 in after-hours trading.

Globus Medical Inc (NYSE: GMED) reported 4.9 percent year-over-year first-quarter revenue growth to $182.9 million and non-GAAP EPS of 36 cents, down 13.4 percent. Analysts estimated EPS of 41 cents. The company confirmed its full-year sales guidance of $770 million and non-GAAP EPS guidance of $1.72. The guidance was about in line.

The stock fell 7.96 percent to $42.30 in after-hours trading.

Novo Nordisk A/S (NYSE: NVO) reported 9 percent revenue growth and a 3 percent drop in net profit for the first quarter. The company reiterated its 2019 outlook for 2-5 percent sales growth in constant exchange rate and 2-6 percent operating profit growth, also in constant currency.

On The Radar Clinical Trial Readouts Abstracts Of American Academy of Neurology annual meeting Presentations (to be made public Friday)

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) – Phase 3 data for Epidiolex (Dravet Syndrome)

Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) – Phase 3 data for Zydis ODT formulation of rimegepant (migraine)

Ovid Therapeutics Inc (NASDAQ: OVID) - Phase 2 data for OV101 (for adolescents with Angelman syndrome)

Earnings

ImmunoGen, Inc. (NASDAQ: IMGN)(before the market open)

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