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The Daily Biotech Pulse: Translate Bio Halts mRNA Therapy Trial, Roche Multiple Sclerosis Biomarker Data, D-Day For Xeris

Shanthi Rexaline

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 on Sept. 9.)

  • ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (reacted to positive Nuplazid data)
  • Bioanalytical Systems, Inc. (NASDAQ: BASI)
  • Protagonist Therapeutics Inc (NASDAQ: PTGX)
  • Scpharmaceuticals Inc (NASDAQ: SCPH)
  • ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)
  • Pfenex Inc (NYSE: PFNX)

Down In The Dumps

(Biotech stocks that hit 52-week lows on Sept. 9.)

  • Advaxis, Inc. (NASDAQ: ADXS) (reacted to third-quarter results)
  • Agios Pharmaceuticals Inc (NASDAQ: AGIO)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Gemphire Therapeutics Inc (NASDAQ: GEMP)
  • Illumina, Inc. (NASDAQ: ILMN)
  • Neurotrope Inc (NASDAQ: NTRP) (Alzheimer's disease drug did not meet the primary endpoint)
  • Obalon Therapeutics Inc (NASDAQ: OBLN)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
  • Retrophin Inc (NASDAQ: RTRX)
  • Stealth BioTherapeutics Corp (NASDAQ: MITO)
  • Surface Oncology Inc (NASDAQ: SURF)
  • Trinity Biotech plc (NASDAQ: TRIB)
  • Transenterix Inc (NYSE: TRXC)

See also: Biotech Stock On The Radar: Ardelyx Gears Up For FDA Decision Day

Stocks In Focus Translate Bio Discontinues Development Of mRNA Therapy

Translate Bio Inc (NASDAQ: TBIO) said in a clinical pipeline update that it has decided to discontinue the development of MRT5201, a liver-targeted treatment for ornithine transcarbamylase, or OTC, deficiency.

The decision to discontinue was due to data from recently completed preclinical studies that do not support the desired pharmacokinetic and safety profile for advancement of the program.

The company said it has decided to prioritize the development of its pulmonary disease programs, including the ongoing development of MRT5005 for cystic fibrosis as well as the evaluation of targets in additional pulmonary diseases.

The stock was down 7.3% at $9.25 in premarket trading Tuesday. 

Roche Presents New Ocrevus Biomarker Data 

Roche Holdings AG Basel ADR (OTC: RHHBY) announced new data from its Ocrevus trials in relapsing and primary progressive multiple sclerosis at the European Committee for Treatment and Research in Multiple Sclerosis held in Stockholm, Sweden.

Following OCREVUS treatment, blood neurofilament light chain — a protein providing structural support to nerve fibers in brain —levels were lowered to a healthy donor range in relapsing MS and primary progressive MS patients, Roche said.

An increase in the protein is associated with nerve cell damage, with the detection of the protein in blood or cerebrospinal fluid serving as a biomarker of nerve cell damage.

Flexion In-Licenses Xenon's Pain Drug For Up To $127.75M

Flexion Therapeutics Inc (NASDAQ: FLXN) announced a definitive agreement with Xenon Pharmaceuticals Inc (NASDAQ: XENE) under which the former will acquire the global rights to develop and commercialize XEN4-2, a NaV1.7 inhibitor for the management of post-operative pain.

Flexion's new preclinical program, dubbed FX301, will consist of XEN402 formulated for extended release from a thermosensitive hydrogel.

For the global rights to XEN402 program, including a broad patent estate as well as the associated non-clinical, clinical and manufacturing components, Flexion paid $3 million upfront, with the potential payment of another $9 million through initiation of a proof-of-concept clinical trial in the form of CMC, development and regulatory milestones.

Following the proof of concept trial initiation, Xenon is eligible to receive further future clinical development and global regulatory approval milestone payments of up to $40.75 million, commercialization milestone payments of up to $75 million and future sales royalties ranging from mid-single to low-double digit percentages.

Mesoblast Licenses European, Latin American Rights To Back Pain Cell Therapy

Mesoblast limited (NASDAQ: MESO) said it has entered into a strategic partnership with Grünenthal to develop and commercialize MPC-06-ID, a late-stage allogeneic cell therapy candidate for the treatment of chronic low back pain due to degenerative disc disease in patients who have exhausted conservative treatment options.

Grünenthal will acquire exclusive commercialization rights to MPC-06-1D for Europe and Latin America by paying up to $150 million in upfront and milestone payments prior to product launch, as well as further commercialization milestone payments.

Zoetis Reports Positive Efficacy Data For Triple Combo Parasiticide

Zoetis Inc (NYSE: ZTS) announced positive efficacy data for its investigational triple combination parasiticide product at the 2-19 Triennial meeting of the American Heartworm Society in New Orleans, Louisiana. T

he company's triple combo investigational asset consists of sarolaner, moxidectin and pyrantel that is administered orally once a month as a preventative for heartworm disease and to treat and control ticks, fleas and intestinal nematodes in dogs.

On The Radar PDUFA Dates

Xeris Pharmaceuticals Inc (NASDAQ: XERS) awaits the FDA verdict on its NDA for Gvoke, a ready-to-use glucagon injection for the treatment of severe hypoglycemia.

Clinical Trial Readouts

Concert Pharmaceuticals Inc (NASDAQ: CNCE) will present Phase 1 data for CTP-692 in schizophrenia at the 32nd European College of Neuropsychopharmacology Congress held in Copenhagen, Denmark.

Related Link: The Week Ahead In Biotech: Focus On Earnings Deluge, Mid-Year Clinical Trial Readouts

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