The Daily Biotech Pulse: Roche Snags Double Nod For Personalized Cancer Drug, Bellicum Offering, Nabriva Braces For Contepo Resubmission

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 Aug. 15)

• Novocure Ltd NVCR

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 15)

• AbbVie Inc ABBV
• Acer Therapeutics Inc ACER
• Adaptimmune Therapeutics PLC – ADR ADAP
• Aerpio Pharmaceuticals Inc ARPO
• Aldeyra Therapeutics Inc ALDX
• Amneal Pharmaceuticals Inc AMRX
• Alector Inc ALEC
• ANCHIANO THERAP/S ADR ANCN
• Bellicum Pharmaceuticals Inc BLCM
• BioCryst Pharmaceuticals, Inc. BCRX
• BioTelemetry Inc BEAT
• Cellectis SA CLLS
• Cyclerion Therapeutics Inc CYCN
• DelMar Pharmaceuticals Inc DMPI(announced pricing of its $6.5 million common stock offering at $1 per share)
• Eton Pharmaceuticals Inc ETON
• Fulcrum Therapeutics Inc FULC
• Gemphire Therapeutics Inc GEMP
• Genetic Technologies Limited GENE
• GENFIT S A/ADR GNFT
• HTG Molecular Diagnostics Inc HTGM
• Idera Pharmaceuticals Inc IDRA
• Innovate Biopharmaceuticals Inc INNT
• Ironwood Pharmaceuticals, Inc. IRWD
• Jaguar Health Inc JAGX(reacted to its second-quarter results)
• Kala Pharmaceuticals Inc KALA
• Kiniksa Pharmaceuticals Ltd (KNSA
• Mallinckrodt PLC MNK(fell despite reporting positive results for its drug to treat hepatorenal syndrome 1)
• MEI Pharma Inc MEIP
• Medigus ADR MDGS
• Meridian Bioscience, Inc. VIVO
• Mersana Therapeutics Inc MRSN
• MOTIF BIO PLC/S ADR MTFB
• Neuralstem, Inc. CUR(reacted to second-quarter results)
• Nuvectra Corp NVTR
• Organogenesis Holdings Inc ORGO
• Pluristem Therapeutics Inc. PSTI
• Plus Therapeutics Inc PSTV
• Progenics Pharmaceuticals, Inc. PGNX
• Prothena Corporation PLC PRTA
• Regenxbio Inc RGNX
• Rigel Pharmaceuticals, Inc. RIGL
• Rubius Therapeutics Inc RUBY
• Savara Inc SVRA
• Supernus Pharmaceuticals Inc SUPN
• Synlogic Inc SYBX
• Synthetic Biologics Inc SYN
• Teva Pharmaceutical Industries Ltd TEVA
• Titan Pharmaceuticals, Inc. TTNP (reported below-consensus earnings for the second quarter)
• Trevi Therapeutics Inc TRVI
• Unity Biotechnology Inc UBX
• Viking Therapeutics Inc VKTX
• Xenetic Biosciences Inc XBIO(reacted to second-quarter results)

Stocks In Focus

Nabriva To Resubmit Contepo NDA In Q4

Nabriva Therapeutics PLC – ADR NBRV announced, following the receipt of the final minutes of a Type A meeting it had with the FDA, it expects to resubmit the NDA for Contepo injection for treating complicated urinary tract infections, including acute pyelonephritis, early in the fourth quarter of 2019.

The Type A meeting was convened to resolve the issues identified in the complete response letter to the originally submitted NDA, which related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers. The FDA had not sought any additional clinical or non-clinical data.

The stock was seen rising 4.17% to $2.25 in pre-market trading Friday.

Roche Gets Nod For Its Personalized Cancer Medicine In Two Indications

Roche Holdings AG Basel ADR Common Stock RHHBY announced the FDA approved its entrectinib – brand name Rozlytrek – for the treatment of adults with ROS1-positive metastatic non-small cell lung cancer.

The regulatory agency has also granted accelerated approval for entrectinib for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase, or NTRK, gene fusion without a known acquired resistance mutation.

"Rozlytrek's FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting," said Sandra Horning, Roche's Chief Medical Officer.

Bellicum To Offer Preferred Stock and Warrants To Raise Gross Proceeds Of $53M

Bellicum said it would offer shares of its Series 1 preferred stock and warrants to purchase shares of its common stock in a public offering to raise gross proceeds of about $53 million.

Each share of Series 1 preferred stock is being sold together with one warrant to purchase 100 shares of common stock at a combined price to the public.

Th company also announced a concurrent private placement for raising $70 million.

The stock fell 5.01% to 95 cents in after-hours trading.

Masimo Makes Strategic Investment In Germany's TNI medical

Masimo Corporation MASI said it has closed a strategic investment with TNI medical AG, a privately-held commercial-stage medical device company based in Germany.

"TNI's novel softFlow technology is designed to provide high flow, warmed and humidified respiratory gases to spontaneously breathing patients suffering from pulmonary disease," Masimo said.

Earnings

Plus Therapeutics reported second-quarter contract revenues of $0.3 million in 2019, down from the $0.9 million revenues in 2018. The net loss per share from continuing operations narrowed from $18.53 to $5.12. The company ended the quarter with cash and cash equivalents of $4.5 million.

The stock soared 15.98% to $4.50 in after-hours trading.