The Daily Biotech Pulse: European Nod For Amgen, miRagen Overhauls Clinical Pipeline, Tonix Snags Patent Win

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 Dec. 11)

Acceleron Pharma Inc XLRN
Aimmune Therapeutics Inc AIMT
Aprea Therapeutics Inc APRE
Aptose Biosciences Inc APTO
argenx SE – ADR ARGX
ArQule, Inc. ARQL
Arvinas Inc ARVN
Audentes Therapeutics Inc BOLD
Axsome Therapeutics Inc AXSM
Avadel Pharmaceuticals PLC AVDL
Bausch Health Companies Inc BHC
BioNTech SE – ADR BNTX
Bio-Rad Laboratories, Inc. BIO
Bristol-Myers Squibb Co BMY
Cue Biopharma Inc CUE
Deciphera Pharmaceuticals Inc DCPH
Eidos Therapeutics Inc EIDX
Flexion Therapeutics Inc FLXN
Forty Seven Inc FTSV
GlaxoSmithKline plc GSK
Gossamer Bio Inc GOSS
Immunomedics, Inc. IMMU
Incyte Corporation INCY
IVERIC bio Inc ISEE
Kadmon Holdings Inc KDMN
Ra Pharmaceuticals Inc RARX
Repro-Med Systems, Inc. KRMD
Sanofi SA SNY
Tricida Inc TCDA

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 11)

AEterna Zentaris Inc. AEZS
Brickell Biotech Inc BBI
Correvio Pharma Corp CORV( announced negative FDA panel verdict for its Brinavess)
Endologix, Inc. ELGX
Genprex Inc GNPX
Idera Pharmaceuticals Inc IDRA
Lipocine Inc LPCN
MEREO BIOPHARMA/ADR MREO
Tetraphase Pharmaceuticals Inc TTPH
Therapix Biosciences Ltd – ADR TRPX
Tonix Pharmaceuticals Holding Corp TNXP
Unum Therapeutics Inc UMRX

Stocks In Focus

Tonix Wins European Patent For Sublingual Formulation of Neurological Drug Combo

Tonix said the European Patent Office has issued it a patent titled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Mannitol," which relates to compositions comprising eutectics of cyclobenzaprine hydrochloride and mannitol, and methods of making those compositions. The combo, codenamed TNX-102 SL is being developed as a treatment for four indications: posttraumatic stress disorder, fibromyalgia, agitation in Alzheimer's disease and alcohol use disorder.

The patent allows market exclusivity for Tonix until 2034.

The stock jumped 25.24% to $1.22 in after-hours trading.

Roche's Subcutaneous Formulation Of Breast Cancer Drug Combo Found Non-inferior to Intravenous Formulation

Roche Holdings AG Basel's RHHBY Genentech announced new data from the Phase 3 study dubbed FeDeriCa, which evaluated the fixed dose combo of Perjeta and Herceptin with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, which showed non-inferiority of the subcutaneous formulation of Perjeta, with comparable efficacy and safety to standard intravenous infusions of Perjeta plus Herceptin and chemotherapy in eligible people with HER2-positive breast cancer.

Subcutaneous administration reduces the timing of administration versus intravenous formulation, the company said.

Amgen's Bone-Building Osteoporosis Drug Approved In Europe

Amgen, Inc. AMGN said the European Commissions has granted marketing authorization for its Evenity for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. With the European nod, Evenity is now approved in 37 countries, including the U.S., Japan, Canada and Australia.

Puma's Breast Cancer Combo Treatment Aces Mid-Stage Trial

Puma Biotechnology Inc PBYI presented at the San Antonio Breast Cancer Symposium, or SABCS, results from a Phase 2 study of its neratinib in combination with Roche's Herceptin and fulversant in heavily pre-treated patients with HER2 mutations and hormone receptor-positive disease, which showed that for the 17 efficacy evaluable patients, nine patients experienced a confirmed objective response, all of which are partial responses, and 10 patients experienced clinical benefit. The median progression-free survival wad 9.8 months.

The safety profile was consistent with that observed previously in metastatic patients with HER2 amplified tumors.

The stock added 3.80% to $9.02 in after-hours trading.

Gilead Submits BLA For Cell Therapy to Treat Mantle Cell Lymphoma

Gilead Sciences, Inc.'s GILD Kite unit said it has submitted a BLA to the FDA for the investigational CAR T-cell therapy KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. The company said it plans to submit a Marketing Authorization Application for the compound in early 2020.

miRagen to Pursue Changed Clinical Development Strategy, To Trim Jobs

Miragen Therapeutics Inc MGEN announced a series of strategic changes, including a reduction in the enrollment planned for the Phase 2 SOLAR study that is evaluating cobomarsen in cutaneous T-cell lymphoma. The company expects to announce top-line data from the amended trial in the third quarter of 2020.

The company also plans to consult with the FDA to define a development path for cobomarsen in T-cell leukemia/lymphoma, and focus future pipeline development efforts, primarily on MRG-229 in idiopathic pulmonary fibrosis.

miRagen is also streamlining operations and reallocating existing resources, with a planned elimination of about 18 jobs. With these, the company said it believes its cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2020.

The company said its VP of R&D Paul Rubin is leaving the company, effective Dec. 31 to spend more time with his family and it named Dr. Diana Escolar, who joined the company in Jan. 2018, as its chief medical officer.

The stock slid 6.75% to 64 cents in after-hours trading.

Twist Bioscience Q2 Loss Wider Than Expected

Twist Bioscience Corp's TWST fourth quarter revenues climbed from $8.4 million in 2018 to $15.7 million in 2019. The net loss per share narrowed from $6.59 to 96 cents per share but was wider than the 83-cent per share consensus estimate.

The revenue guidance for the first quarter of 2020 and the fiscal year 2020 surrounded the consensus estimates.

The stock fell 9.62% to $23.50 in after-hours trading.

Offerings

Forty Seven priced its previously announced underwritten public offering of 4.86 million shares at $35 apiece. The company expects to raise gross proceeds of $170.1 million from the offering. The offering is expected to close on Dec. 16.

The stock edged up 0.70% to $36.21 in after-hours trading.

Assembly Biosciences Inc ASMB said it intends to sell shares of its common stock in an underwritten public offering. All the shares earmarked for the offering are to be sold by the company.

The stock fell 5.03% to $16.82 in after-hours trading.

On The Radar

San Antonio Breast Cancer Symposium Presentations

OncoSec Medical Inc ONCS: interim Phase 2 data for tavo in combination with Keytruda in triple-negative breast cancer

Oncternal Therapeutics Inc ONCT: Phase 1 data for cirmtuzumab, in combination with Bristol-Myers Squibb's Abraxane

European Society of Medical Oncology-Immuno-Oncology Congress Presentations

Gritstone Oncology Inc GRTS – initial safety data from the Phase 1 study of GRANITE-001 in solid tumors as well as initial safety data from the Phase 1 data for SLATE-001 in solid tumors