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) (reportedpositive 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

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.” data-reactid=”49″ type=”text”>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.

companysaid in a statement.” data-reactid=”51″ type=”text”>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, thecompanysaid in a statement.

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

The Week Ahead In Biotech: Adcom Test For Agile; Pfizer, Merck Lead Earnings” data-reactid=”53″ type=”text”>See also:The Week Ahead In Biotech: Adcom Test For Agile; Pfizer, Merck Lead Earnings

Roche’s Spark Deal Deadline Extended Yet Again

RHHBY) announced an extension to the offering period for its previously announced tender offer to buy all outstanding shares ofSpark Therapeutics Inc(NASDAQ:ONCE) for $114.50 per share.” data-reactid=”55″ type=”text”>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 ofSpark 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” data-reactid=”58″ type=”text”>View more earnings on IBB

multiple times.” data-reactid=”59″ type=”text”>The deadline has been extendedmultiple times.

Morphosys Halts Clinical Development Of Midstage Atopic Dermatitis Asset

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.” data-reactid=”61″ type=”text”>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.

GLPG) andNovartis AG(NYSE:NVS).” data-reactid=”62″ type=”text”>The company said the decision was taken in concurrence with partnersGALAPAGOS NV/S ADR(NASDAQ:GLPG) andNovartis 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

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.” data-reactid=”66″ type=”text”>Medical device makerOrthofix 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

AMAG)’s sNDA for Makena, which is being evaluated for reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity.” data-reactid=”70″ type=”text”>The Bone, Reproductive and Urologic Drug Advisory Committee is scheduled to meet to discussAMAG 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

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.” data-reactid=”72″ type=”text”>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 i

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