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The Daily Biotech Pulse: Obseva Gets The Greenlight, Verastem Climbs On Licensing Deal, Merit Medical Earnings Disappoint

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 July 25)

  • Akero Therapeutics Inc (NASDAQ: AKRO)
  • Anika Therapeutics Inc (NASDAQ: ANIK)(reported better-than-expected second-quarter results)
  • Novocure Ltd (NASDAQ: NVCR)(reported strong second-quarter results)
  • Repligen Corporation (NASDAQ: RGEN)
  • Xenetic Biosciences Inc (NASDAQ: XBIO)
  • Baxter International Inc (NYSE: BAX) (reacted to strong second-quarter results)
  • West Pharmaceutical Services Inc. (NYSE: WST) (reacted to strong second-quarter results)
  • Myovant Sciences Ltd (NYSE: MYOV)

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 25)

  • Abeona Therapeutics Inc (NASDAQ: ABEO)(announced results from a Phase 1/2 trial of its ABO-102, its gene therapy candidate for San Filippo syndrome Type A)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)(announced initiation of trial dubbed SPEARHEAD-1 that is evaluating ADP-A2M4 SPEAR T cells for patients with synovial sarcoma or myxoid/round cell liposarcoma)
  • Aduro BioTech Inc (NASDAQ: ADRO)
  • Alkermes Plc (NASDAQ: ALKS)(reacted to Q2 results)
  • Alterity Therapeutics Ltd (NASDAQ: ATHE)
  • Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)
  • ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
  • Aquestive Therapeutics Inc (NASDAQ: AQST)
  • Assembly Biosciences Inc (NASDAQ: ASMB)
  • Atara Biotherapeutics Inc (NASDAQ: ATRA)
  • BENITEC BIOPHAR/S ADR (NASDAQ: BNTC)
  • ChemoCentryx Inc (NASDAQ: CCXI)
  • Dynavax Technologies Corporation (NASDAQ: DVAX)
  • Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
  • Gamida Cell Ltd (NASDAQ: GMDA)
  • GENFIT S A/ADR (NASDAQ: GNFT)
  • Innoviva Inc (NASDAQ: INVA)(reported below-consensus second-quarter results)
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
  • Kaleido Biosciences Inc (NASDAQ: KLDO)
  • Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Neuralstem, Inc. (NASDAQ: CUR)
  • NuCana PLC (NASDAQ: NCNA)
  • Organogenesis Holdings Inc (NASDAQ: ORGO)
  • Regulus Therapeutics Inc (NASDAQ: RGLS)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • Solid Biosciences Inc (NASDAQ: SLDB)
  • Surface Oncology Inc (NASDAQ: SURF)
  • Unity Biotechnology Inc (NASDAQ: UBX)
  • Wave Life Sciences Ltd (NASDAQ: WVE)

Stocks In Focus Obseva Gets Nod From Independent Data Monitoring Committee To Proceed With Trial Of Preterm Labor Drug

Obseva SA (NASDAQ: OBSV) said an independent data monitoring committee, or IDMC, that completed the unblinded review of data from the first 30 subjects randomized in Part B of the PROLONG trial in preterm labor with PGF2a receptor antagonist OBE022 recommended continuation of the trial without modification. The company said the next IDMC review is likely with data from 60 patients later this year.

J&J's Janssen Unit Aces Late-Stage Study Of Multiple Sclerosis Drug

Johnson & Johnson (NYSE: JNJ)'s Janssen unit announced positive top-line results from the Phase 3 OPTIMUM study that evaluated the safety and efficacy of ponesimod compared to Aubagio in adults with relapsing multiple sclerosis.

Ponesimod is a selective sphingosine-1-phosphate receptor 1 modulator, a class of drugs that is believed to functionally inhibit S1P activity and reduce the number of circulating lymphocytes by trapping them in the lymph nodes.

Janssen unit Actelion Pharma has a revenue sharing agreement with Idorsia Pharmaceuticals, and is liable to make certain payments to the latter related to the sales of ponesimod.

Verastem Out-licenses Cancer Drug to Sanofi In Select Territories For Up To $47M

Verastem Inc (NASDAQ: VSTM) announced an exclusive licensing agreement with Sanofi SA (NASDAQ: SNY) for the development and commercialization of its Copiktra in Russia, Turkey, the Middle East and Africa. Copiltra is an oral inhibitor of PI3K and was approved by the FDA in Sep. 2018 for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies.

The agreement calls upon Sanofi paying Verastem $5 million in upfront payment and potentially up to an additional $42 million in development and sales milestone payments, plus double-digit percentage royalties on future sales in licensed territories.

The stock jumped 16.79% to $1.53 in after-hours trading.

Offerings

Neuralstem priced its underwritten public offering of 2.78 million units at $2.70 per unit, raising gross proceeds of $7.50 million. Each unit corresponds to a common stock, one short-term warrant to purchase one common stock and one long-term warrant to purchase one common stock.

The stock 0.81% to $3.75 in after-hours trading.

Chiasma Inc (NASDAQ: CHMA) commenced an underwritten public offering of its common stock. All the shares earmarked for the offering are sold by the company. Chiasma said it intends to use the net proceeds primarily for the commercialization of Mycapssa in the U.S., if approved, and for working capital and other general corporate purposes.

The stock fell 1.06% to $5.60 in after-hours trading.

Earnings

Merit Medical Systems, Inc. (NASDAQ: MMSI) reported second-quarter earnings of 42 cents per share, trailing the year-ago's 43 cents per share and the consensus estimate of 50 cents per share. Revenues climbed 13.7% to $255.5 million. The company lowered its full-year guidance.

The stock fell 12.47% to $48 in after-hours trading.

Natus Medical Inc (NASDAQ: BABY)'s second-quarter EPS exceeded estimates and its revenues fell 4% year-over-year to $125.5 million. The third quarter revenue guidance is in line but EPS guidance was slightly below estimates. The company also narrowed its full-year guidance.

The stock added 4.67% to $28 in after-hours trading.

Harvard Bioscience, Inc. (NASDAQ: HBIO) reported in-line EPS for the second quarter but its revenues fell 6%. The company maintained its 2019 guidance.

The stock rallied 11.23% to $2.08 in after-hours trading.

On The Radar Earnings

AbbVie Inc (NYSE: ABBV) (before the market open)
Zimmer Biomet Holdings Inc (NYSE: ZBH) (before the market open)

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