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The Daily Biotech Pulse: Takeda Pulls Plug On Amyloidosis Drug Trial, Chiasma Preps For Drug Launch With New CEO Appointment, Orchard Prices Offering

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The Daily Biotech Pulse: Takeda Pulls Plug On Amyloidosis Drug Trial, Chiasma Preps For Drug Launch With New CEO Appointment, Orchard Prices Offering

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 June 5)

  • Array Biopharma Inc (NASDAQ: ARRY)
  • Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
  • BIOFRONTERA AG/ADR (NASDAQ: BFRA)
  • EXACT Sciences Corporation (NASDAQ: EXAS)
  • Mirati Therapeutics Inc (NASDAQ: MRTX)
  • Misonix, Inc. (NASDAQ: MSON)
  • Repligen Corporation (NASDAQ: RGEN)
  • Uniqure NV (NASDAQ: QURE)
  • Zoetis Inc (NYSE: ZTS)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on June 5)

  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • Akebia Therapeutics Inc (NASDAQ: AKBA)
  • Arbutus Biopharma Corp (NASDAQ: ABUS)
  • Caladrius Biosciences Inc (NASDAQ: CLBS)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • ChemoCentryx Inc (NASDAQ: CCXI)(moved in sympathy with its rival, which has a competing drug)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL)
  • ContraVir Pharmaceuticals Inc (NASDAQ: CTRV)
  • Cyclerion Therapeutics Inc (NASDAQ: CYCN)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX)
  • Harvard Bioscience, Inc. (NASDAQ: HBIO)
  • IMMUTEP LTD/S ADR (NASDAQ: IMMP)
  • Inflarx NV (NASDAQ: IFRX)(skin inflammation drug did not meet the primary endpoin in a mid-stage study)
  • Neuronetics Inc (NASDAQ: STIM)
  • Psychemedics Corp. (NASDAQ: PMD)
  • Seres Therapeutics Inc (NASDAQ: MCRB)
  • Sierra Oncology Inc (NASDAQ: SRRA)
  • Solid Biosciences Inc (NASDAQ: SLDB)
  • T2 Biosystems Inc (NASDAQ: TTOO)
  • Theravance Biopharma Inc (NASDAQ: TBPH)
  • Trinity Biotech plc (NASDAQ: TRIB)
  • Xenetic Biosciences Inc (NASDAQ: XBIO)
  • Zafgen Inc (NASDAQ: ZFGN)

Stock In Focus

Chiasma Ropes In Pharma Commercialization Veteran as CEO Ahead of Mycapssa Launch

Chiasma Inc (NASDAQ: CHMA) announced the appointment of Raj Kannan, a pharma commercial veteran, as its CEO, replacing Mark Fitzpatrick. Fitzpatrick will continue to serve as president of the company. The transition is expected to occur no later than June 17.

"I look forward to working with Raj and the rest of the Chiasma team as we plan for an expected mid-2020 PDUFA date for Mycapssa® and develop our longer-term commercialization strategy in the E.U. and in other markets," said Fitzpatrick.

Mycapssa is an oral somatostatin analog candidate currently in a Phase 3 trial under a Special Protocol Assessment agreement with the FDA for the maintenance therapy of adult patients with acromegaly, a hormonal disorder disease of the pituitary gland.

Novartis Says Iscalimab Extends Survival Of Transplanted Organs

Novartis AG (NYSE: NVS) announced histology data with its investigational compound iscalimab, which suggested that 60 percent of iscalimab-treated transplant patients have normal kidney histology at least 1 year after transplant vs 0 percent with tacrolimus, which is the current standard-of-care. Novartis presented the data at the American Transplant Congress as a late-breaking abstract.

Iscalimab is a fully human, monoclonal antibody preventing cluster of differentiation 40 (CD40) pathway signaling and activation of CD40+ cell types.

Orchard Therapeutics Prices Common Stock Offering

Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) priced its public offering of 9 million ADSs, representing 9 million shares, to generate gross proceeds of $1.28 million. The offering is expected to close June 10.

Reata Gets Orphan Drug Designation For Rare Kidney Disease Drug

Reata Pharmaceuticals Inc (NASDAQ: RETA) said the FDA accorded orphan drug designation to its bardoxolone methyl for the treatment of autosomal dominant polycystic kidney disease, which is an inherited form of kidney disease affecting 140,000 patients in the U.S.

Takeda Shelves Amyloidosis Drug Study After Ninlaro Flunks Late-Stage Trial

Takeda Pharmaceutical Co Ltd (NYSE: TAK) said its Phase 3 study dubbed TOURMALINE-AL-1 that evaluated its Ninlaro in combination with dexamethasone in patients with relapsed or refractory systemic light-chain amyloidosis did not meet the first of the two primary endpoints, of showing a statistically significant improvement in overall hematologic response compared to the standard-of-care regimens. The company said it's discontinuing the trial.

The stock fell 5.53 percent to $15.90 in after-hours trading.

Itamar Home Sleep Apnea Test Receives FDA Nod

ITAMAR MED LTD/S ADR (NASDAQ: ITMR) said it has received 501(k) clearance from the FDA for WatchPAT One, its first and only fully disposable Home Sleep Apnea Test. The company said the device incorporates the technology of WatchPAT 300, which received 510(k) clearance in August 2018 and was launched in March 2019.

On The Radar

Sesen Bio Inc (NASDAQ: SESN) has a pre-BLA meeting scheduled with the FDA for Vicinium that is evaluated for severe adult eosinophilic asthma patients.

Posted-In: Biotech News Offerings FDA Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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