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 NTRA
• Ra Pharmaceuticals Inc RARX
• Reata Pharmaceuticals Inc RETA

Down In The Dumps

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

• Adaptive Biotechnologies Corp ADPT
• Aileron Therapeutics Inc ALRN
• Akers Biosciences Inc AKER
• Albireo Pharma Inc ALBO
• Aptinyx Inc APTX
• Assertio Therapeutics Inc ASRT
• Atreca Inc BCEL
• Auris Medical Holding Ltd EARS
• AzurRx BioPharma Inc AZRX
• BioNano Genomics Inc BNGO
• BioNTech SE – ADR BNTX
• BioSpecifics Technologies Corp. BSTC
• Cerus Corporation CERS
• Chimerix Inc CMRX
• Cleveland BioLabs, Inc. CBLI
• Clovis Oncology Inc CLVS
• Cocrystal Pharma Inc COCP
• Dermira Inc DERM
• Diffusion Pharmaceuticals Inc DFFN
• Fulcrum Therapeutics Inc FULC
• Helius Medical Technologies Inc HSDT
• Homology Medicines Inc FIXX
• ICU Medical, Incorporated ICUI
• INmune Bio Inc INMB
• Iterum Therapeutics PLC ITRM
• Jaguar Health Inc JAGX
• Kala Pharmaceuticals Inc KALA
• Karuna Therapeutics Inc KRTX
• Kiniksa Pharmaceuticals Ltd KNSA
• Morphic Holding Inc MORF
• MOTIF BIO PLC/S ADR MTFB
• Nektar Therapeutics NKTR
• Novus Therapeutics Inc NVUS
• Orgenesis Inc ORGS
• Precision BioSciences Inc DTIL
• Plus Therapeutics Inc PSTV
• Puma Biotechnology Inc PBYI
• Satsuma Pharmaceuticals Inc STSA
• Selecta Biosciences Inc SELB
• Strongbridge Biopharma plc SBBP
• TRACON Pharmaceuticals Inc TCON
• Trinity Biotech plc TRIB
• Verastem Inc VSTM
• Vir Biotechnology Inc VIR
• Viveve Medical Inc 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 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. 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. 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 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 RLMD will present Phase 2 data for REL-1017in treatment-resistant depression.

Earnings

Johnson & Johnson JNJ

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