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The Daily Biotech Pulse: Mirati Tastes Success With KRAS Inhibitor, Roche-Spark Deal Delayed Further, Morphosys Halts Study

Shanthi Rexaline

The following is a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs Oct. 28.)

  • AstraZeneca plc (NYSE: AZN) (reported positive clinical readout for triple combo lung cancer drug)
  • Bioanalytical Systems, Inc. (NASDAQ: BASI)
  • Cabaletta Bio Inc (NASDAQ: CABA) (went public Oct. 25)
  • ESSA Pharma Inc (NASDAQ: EPIX)
  • IGM Biosciences Inc (NASDAQ: IGMS)
  • Novo Nordisk A/S (NYSE: NVO)
  • Reata Pharmaceuticals Inc (NASDAQ: RETA)
  • Seattle Genetics, Inc. (NASDAQ: SGEN)
  • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB) (reacted to a positive clinical readout)

Down In The Dumps

(Biotech stocks that hit 52-week lows Oct. 28.)

  • Agile Therapeutics Inc (NASDAQ: AGRX) (reported negative comments from FDA staff in the briefing document posted ahead of Twirla Adcom meeting)
  • Bellerophon Therapeutics Inc (NASDAQ: BLPH)
  • CytomX Therapeutics Inc (NASDAQ: CTMX)
  • Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • Endologix, Inc. (NASDAQ: ELGX (FDA issued a safety communication to physicians and patients regarding Endologix AFX endovascular grafts)
  • Hoth Therapeutics Inc (NASDAQ: HOTH)
  • KemPharm Inc (NASDAQ: KMPH)
  • Miragen Therapeutics Inc (NASDAQ: MGEN)
  • Mirum Pharmaceuticals Inc (NASDAQ: MIRM)
  • MOTIF BIO PLC/S ADR (NASDAQ: MTFB)
  • Myovant Sciences Ltd (NYSE: MYOV)
  • Orgenesis Inc (NASDAQ: ORGS)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)

Stocks In Focus Mirati's KRAS Inhibitor Shows Tumor Shrinkage

Mirati Therapeutics Inc (NASDAQ: MRTX) announced the first Phase 1/2 trial results for MRTX849, an investigational KRAS G12C inhibitor, in patients with solid tumors expressing KRAS G12C mutations.

The midstage asset demonstrated clinical activity, including objective responses, in patients with non-small cell lung cancer, or NSCLC, and colorectal cancer, or CRC.

At the highest dose of 600mg BID, three of five evaluable patients with NSCLC and one of the two evaluable patients with CRC achieved a partial response, with the remaining patients experiencing stable diseases, the company said in a statement.

The stock rallied 14.15% to $93 in after-hours trading.

See also: The Week Ahead In Biotech: Adcom Test For Agile; Pfizer, Merck Lead Earnings

Roche's Spark Deal Deadline Extended Yet Again

Roche Holdings AG Basel ADR (OTC: RHHBY) announced an extension to the offering period for its previously announced tender offer to buy all outstanding shares of Spark Therapeutics Inc (NASDAQ: ONCE) for $114.50 per share.

The offer, which was previously scheduled to expire at 5 p.m. Wednesday, Oct. 30, has now been extended until 5 p.m. Monday, Nov. 25.

Roche said the extension provides additional time for the U.S. FTC and the U.K. CMA to complete their previously disclosed reviews.

View more earnings on IBB

The deadline has been extended multiple times.

Morphosys Halts Clinical Development Of Midstage Atopic Dermatitis Asset

Morphosys Ag (NASDAQ: MOR) said it has decided to end the clinical development of MOR106 in atopic dermatitis following an interim analysis for futility that was performed in the Phase 2 IGUANA trial.

The company said the decision was taken in concurrence with partners GALAPAGOS NV/S ADR (NASDAQ: GLPG) and Novartis AG (NYSE: NVS).

The futility analysis detected a low probability to meet the primary endpoint of the study, defined as the percentage change in the eczema area and severity index score, according to Morphosys.

Morphosys shares were falling 2.49% to $26.24 in Tuesday's premarket session. 

Earnings

Medical device maker Orthofix Medical Inc (NASDAQ: OFIX) reported 1.6% net sales growth to $113.5 million and non-GAAP earnings per share of 41 cents, lower than 44 cents in the year-ago period.

The company reduced its full-year 2019 net sales and earnings outlook.

The stock was down 12.28% at $43 in Tuesday's premarket session. 

On The Radar Adcom Meeting

The Bone, Reproductive and Urologic Drug Advisory Committee is scheduled to meet to discuss AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)'s sNDA for Makena, which is being evaluated for reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity.

Clinical Trial Readouts AACR-NCI-EORTC Presentations

Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) is scheduled to present Phase 1 data for DCC-3014 in solid tumors or hematologic malignancies; and updated Phase 1 data for DCC-2618 in the second to fourth line setting for gastrointestinal stromal tumors.

Sutro Biopharma Inc (NASDAQ: STRO) will present initial safety data from a Phase 1 trial of STRO-002 in ovarian and endometrial cancer.

Kura Oncology Inc (NASDAQ: KURA) is due to present Phase 2 data for Tipifarnib in head and neck squamous cell carcinomas with HRAS Mutations.

World Vaccine Congress Presentations

VBI Vaccines Inc (NASDAQ: VBIV) is scheduled to present Phase 1/2a Part A immuno-oncology data for VBI-1901 in recurrent glioblastoma multiforme.

Earnings

  • BIO-TECHNE Corp (NASDAQ: TECH) (before the market open)
  • Incyte Corporation (NASDAQ: INCY) (before the market open)
  • Medpace Holdings Inc (NASDAQ: MEDP) (before the market open)
  • Merck & Co., Inc. (NYSE: MRK) (before the market open)
  • NeoGenomics, Inc. (NASDAQ: NEO) (before the market open)
  • Pfizer Inc. (NYSE: PFE) (before the market open)
  • Alimera Sciences Inc (NASDAQ: ALIM) (after the market close)
  • Amgen, Inc. (NASDAQ: AMGN) (after the market close)
  • EXACT Sciences Corporation (NASDAQ: EXAS) (after the market close)
  • Seattle Genetics (after the market close)
  • Silk Road Medical Inc (NASDAQ: SILK) (after the market close)
  • PTC Therapeutics, Inc. (NASDAQ: PTCT (after the market close)
  • Cardiovascular Systems Inc (NASDAQ: CSII) (after the market close)
  • Verastem Inc (NASDAQ: VSTM) (after the market close)

Related Link: Gilead Falls On Uninspiring Q3 Print: 3 Analyst Takes

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