The Daily Biotech Pulse: European Nod For Roche, Takeda Recall, Neon Exults On Journal Publication

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 Sept. 5)

• Bioanalytical Systems, Inc. BASI
• NextCure Inc NXTC
• Pfenex Inc PFNX
• Protagonist Therapeutics Inc PTGX
• ResMed Inc. RMD
• West Pharmaceutical Services Inc. WST

Down In The Dumps

(Biotech stocks hitting 52-week lows on Sept. 5)

• Adamis Pharmaceuticals Corp ADMP
• BioNano Genomics Inc BNGO
• Endologix, Inc. ELGX
• Mallinckrodt PLC MNK (retreated amid reports of restructuring ahead of Cleveland opioid litigation)
• Merit Medical Systems, Inc. MMSI
• VBI Vaccines Inc VBIV
• Zafgen Inc ZFGN (announced decision to explore strategic options)

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

Stocks In Focus

Neon's Process To Predict Neoantigens To Control Tumor Growth Published In Scientific Journal

Neon Therapeutics Inc NTGN announced publication in the scientific journal "Immunity," a breakthrough process for predicting which neoantigens will be presented by MHC Class II molecules in the tumor microenvironment.

The company's proprietary mono-allelic profiling technology called MAPTAC facilitated the development of convolutional neural network-based predictors, which achieved up to a 61-fold improvement in predicting MHC class II peptides compared to publicly available tools.

"This MHC class II technology will be integrated into Neon's RECON bioinformatics platform and is expected to improve the efficacy of immunotherapies developed by Neon by predicting recruitment of CD4+ T cells, which are believed to be important in controlling tumor growth," the company said.

The stock rallied 23.71% to $3.60 in after-hours trading.

Roche Tecentriq-Chemo Combo Approved As First-line Treatment For Lung Cancer in Europe

Roche Holdings AG Basel ADR RHHBY said the European Commission has approved and granted marketing authorization for its Tecentriq in combination with chemotherapy – carboplatin and etoposide – for the first-line treatment of adults with extensive-stage small cell lung cancer.

Immunic's Ulcerative Colitis Drug Found To Be Safe, With Broad Effective Dose Range

Immunic Inc IMUX said following an pre-planned interim dosing analysis of data from the phase 2 CALDOSE-1 study of IMU-838 in patients with moderate-to-severe ulcerative colitis, the lowest dosing of 10 mg hasn't been found ineffective, while the highest dose of 45 mg hasn't been found to be intolerable. The deduction was done by an unblinded and independent data review committee, which reviewed the data.

While confirming the broader-than-initially-expected effective dose range in patients with ulcerative colitis, the study also vouched for the safety profile.

The company said it intends to continue the trial with all three dosing arms.

The stock jumped 24.81% to $16.10 in after-hours trading.

Takeda Recalls Parathyroid Hormone Injection On Rubber Particulate Issues

Takeda Pharmaceutical Co Ltd TAK announced a U.S. recall of all doses of Natpara, or parathyroid hormone, injection of doses 25 mcg, 50 mcg, 75 mcg and 100 mcg, following discussions with the FDA. The recalls, which are effective immediately, are due to a potential issue related to rubber particulates originating from the rubber septum of the NATPARA cartridge.

"Takeda is committed to supply integrity, and we are working closely with the FDA to resolve the issue and resume supply as soon as possible," the company said.

Pfenex Receives $11M Milestone Payment From Jazz For Chemo Drug

Pfenex said it has earned an $11 million development milestone under its development and license agreement with Jazz Pharmaceuticals PLC JAZZ regarding PF745, a recombinant crisantaspase with half-life extension technology – a chemotherapy drug used to treat acute lymphoblastic leukemia.

Recently, Jazz announced completion of the Phase 1 study of PF743, with the company planning to initiate a Phase 2/3 study later in 2019.

Out of the total development and sales milestone payment of $224.5 million, $177.5 million is yet to be realized, Pfenex said.

Myovant Parent Sells Stake In 5 Subsidiaries To Japan's Dainippon Pharma

Myovant Sciences Ltd MYOV said its founding shareholder Roivant Sciences entered into a non-binding memorandum of agreement to create a broad strategic alliance with Sumitomo Dainippon Pharma Co Ltd DNPUF under which Roivant will turn over the ownership interest in 5 of the biopharma companies under its fold, including Myovant, to the Japanese firm.

Dainippon Pharma will also receive options to acquire up to 6 additional companies and Roivant's proprietary technology platforms DrugOme and Digital Innovation.

Additionally, Dainippon Pharma will take a 10% equity stake in Roivant. Roivant is to get $3 billion from the Japanese company for ceding the ownership rights and the sale of options.

The companies expect to sign a definitive agreement in this regard by the end of October.

Myovant shares added 4.35% to $8.39 in after-hours trading.