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The Daily Biotech Pulse: Reata Leaps On Positive Readout, Takeda Divests, FDA Nod For Akorn, J&J Earnings

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The Daily Biotech Pulse: Reata Leaps On Positive Readout, Takeda Divests, FDA Nod For Akorn, J&J Earnings

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. 14.)

  • Natera Inc (NASDAQ: NTRA)
  • Ra Pharmaceuticals Inc (NASDAQ: RARX)
  • Reata Pharmaceuticals Inc (NASDAQ: RETA)

Down In The Dumps

(Biotech stocks that hit 52-week lows on Oct. 14.)

  • Adaptive Biotechnologies Corp (NASDAQ: ADPT)
  • Aileron Therapeutics Inc (NASDAQ: ALRN)
  • Akers Biosciences Inc (NASDAQ: AKER)
  • Albireo Pharma Inc (NASDAQ: ALBO)
  • Aptinyx Inc (NASDAQ: APTX)
  • Assertio Therapeutics Inc (NASDAQ: ASRT)
  • Atreca Inc (NASDAQ: BCEL)
  • Auris Medical Holding Ltd (NASDAQ: EARS)
  • AzurRx BioPharma Inc (NASDAQ: AZRX)
  • BioNano Genomics Inc (NASDAQ: BNGO)
  • BioNTech SE – ADR (NASDAQ: BNTX (went public last week)
  • BioSpecifics Technologies Corp. (NASDAQ: BSTC)
  • Cerus Corporation (NASDAQ: CERS)
  • Chimerix Inc (NASDAQ: CMRX)
  • Cleveland BioLabs, Inc. (NASDAQ: CBLI)
  • Clovis Oncology Inc (NASDAQ: CLVS)
  • Cocrystal Pharma Inc (NASDAQ: COCP)
  • Dermira Inc (NASDAQ: DERM)
  • Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)
  • Fulcrum Therapeutics Inc (NASDAQ: FULC)
  • Helius Medical Technologies Inc (NASDAQ: HSDT)
  • Homology Medicines Inc (NASDAQ: FIXX)
  • ICU Medical, Incorporated (NASDAQ: ICUI)
  • INmune Bio Inc (NASDAQ: INMB)
  • Iterum Therapeutics PLC (NASDAQ: ITRM)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • Karuna Therapeutics Inc (NASDAQ: KRTX)
  • Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)
  • Morphic Holding Inc (NASDAQ: MORF)
  • MOTIF BIO PLC/S ADR (NASDAQ: MTFB)
  • Nektar Therapeutics (NASDAQ: NKTR)
  • Novus Therapeutics Inc (NASDAQ: NVUS)
  • Orgenesis Inc (NASDAQ: ORGS)
  • Precision BioSciences Inc (NASDAQ: DTIL)
  • Plus Therapeutics Inc (NASDAQ: PSTV)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • Satsuma Pharmaceuticals Inc (NASDAQ: STSA)
  • Selecta Biosciences Inc (NASDAQ: SELB)
  • Strongbridge Biopharma plc (NASDAQ: SBBP)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • Trinity Biotech plc (NASDAQ: TRIB)
  • Verastem Inc (NASDAQ: VSTM)
  • Vir Biotechnology Inc (NASDAQ: VIR (went public last week)
  • Viveve Medical Inc (NASDAQ: VIVE)

See also: The Week Ahead In Biotech: FDA Decisions, Johnson & Johnson Among Big Pharma Earnings

Stocks In Focus

Immutep Drug Combo Produces Positive Results In Skin Cancer Study

IMMUTEP LTD/S ADR (NASDAQ: IMMP) announced positive data from a pPhase 1 study, dubbed TACTI-mel that evaluated its product candidate eftilagimod alpha in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda for melanoma.

The company noted deep and durable responses with tumor shrinkage in 56% and 66% of patients in Part A and B studies, respectively. Also, a disease control rate of 66% in patients in the Part A and B studies was observed, Immutep said.

"Patients are responding well to the combination treatment, their tumors are shrinking and not growing back over a long follow-up period. In addition, we have seen the complete disappearance of all target tumor lesions for six patients plus one patient with a metabolic complete response on the PET-scan," the company said. 

Reata Reports Positive Results For Neurological Disorder Drug

Reata announced positive results from the registrational part 2 portion of a Phase 2 study dubbed MOXIe for omaveloxolone in patients with Friedreich ataxia, a rare inherited disorder that leads to a progressive loss of neurological function.

The study met the primary endpoint of a statistically significant placebo-corrected 2.4-point improvement in the modified Friedreich's Ataxia Rating Scale, or mFARS, relative to placebo after 48 weeks of treatment.

Based on the positive results and subject to discussions with regulatory authorities, Reata said it plans to proceed with the submission of regulatory filings in the U.S. and internationally.

The stock rallied 39.18% $140 in Tuesday's premarket session. 

FDA Approves Akorn's Generic Inflammation Lotion

Specialty pharma company Akorn, Inc. (NASDAQ: AKRX) said it has received an abbreviated new drug approval from the FDA for its betamethasone dipropionate lotion USP (augmented), 0.05%. It is a corticosteroid indicated for the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 and older.

The company's stock added 5.26% to $4 in the premarket session. 

Takeda Divests Select Prescription, OTC Assets In Asia, Africa For $200M

Takeda Pharmaceutical Co Ltd (NYSE: TAK) said it has agreed to divest a portfolio of select over-the-counter and prescription pharma assets in a number of Near East, Middle Eastern and African countries to Swiss pharma company Acino for a total value of over $200 million.

The divestment is the third transaction in 2019 that is expected to help Takeda focus on business areas core to its long-term growth and facilitate rapid leveraging following its acquisition of Shire, according to the company

On The Radar

Clinical Trial Readouts

Relmada Therapeutics Inc (NASDAQ: RLMD) will present Phase 2 data for REL-1017in treatment-resistant depression.

Earnings

Johnson & Johnson (NYSE: JNJ)

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