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

Down In The Dumps

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

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

Stock In Focus

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

Chiasma Inc 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 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 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 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 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 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 SESN has a pre-BLA meeting scheduled with the FDA for Vicinium that is evaluated for severe adult eosinophilic asthma patients.