Benzinga's Daily Biotech Pulse: AbbVie Files sNDA For Leukemia Drug, AcelRx Offering, Aurinia Starts Mid-Stage Trial

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling the Peaks

(Stocks hitting 52-week highs on July 11)

• AC Immune SA ACIU
• Arbutus Biopharma Corp ABUS
• DexCom, Inc. DXCM
• Eagle Pharmaceuticals Inc EGRX
• Illumina, Inc. ILMN
• Intuitive Surgical, Inc. ISRG
• Krystal Biotech Inc KRYS
• Myriad Genetics, Inc. MYGN (Morgan Stanley analyst Steve Beuchaw upgraded shares to Overweight and hiked his price target to $55.

Down In The Dumps

(Stocks hitting 52-week lows on July 11)

• Advaxis, Inc. ADXS(announced withdrawal of Conditional Marketing Authorization ApplIcation in Europe for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy. This follows EMA's determination that additional data is required for conditional approval.)
• Autolus Therapeutics Ltd – ADR AUTL
• Calithera Biosciences Inc CALA
• Catabasis Pharmaceuticals Inc CATB
• Cytori Therapeutics Inc CYTX
• Idera Pharmaceuticals Inc IDRA((terminated merger agreement with BioCryst Pharmaceuticals, NASDAQ:BCRX))
• Reshape Lifesciences Inc RSLS(announced $2.7 million registered direct offering)
• Sellas Life Sciences Group Inc SLS

See Also: Zynerba Pops On Positive Phase 2 Data For ZYN002 In Fragile X

Stocks In Focus

AbbVie Files For Expanded Indication For Its Blood Cancer Drug

AbbVie Inc ABBV said it has submitted a sNDA for its Venetoclax n combination with a hypomethylating agent or in combination with low-dose cytarabine for treating newly diagnosed acute myeloid leukemia, or AML, patients ineligible for intensive chemotherapy. The treatment option has already been approved for chronic lymphocytic leukemia.

The application has been submitted based on a Phase 1b as well as a Phase 1/2 trial.

Final Mid-stage Results of Sanofi's TB Vaccines Published In NEJM

A Phase 2 proof-of-concept study of two vaccinations, namely the existing BCG vaccine as well as an investigational vaccine, H4:IC31, developed by Sanofi SA (ADR)SNY along with Aeras, a NGO, showed that BCG significantly reduced sustained TB infections in adolescents with a 45.4 percent vaccine efficacy. H4:IC31 also reduced sustained infections, although not at statistically significant levels, showing 30.5% vaccine efficacy.

"However, the trend observed for H4:IC31 is the first time a subunit vaccine has shown any signal that it may be able to protect against TB infection or disease in humans," the company said.

The final results were published in the New England Journal of Medicine.

Illumina's Leverages Its Technology to OrigiMed

OrigiMed announced an agreement with Illumina, Inc. ILMN that provides for the former developing and promoting its advanced molecular clinical tumor applications to the public in China using the latter's Next Generation Sequencing, or NGS, technology.

"It also signals that genomics technology will play an increasingly important future role in the fast-developing market of precise diagnosis of cancer," OrigiMed said.

Aurinia Initiates Mid-stage Trial For Dry Eye Syndrome

Aurinia Pharmaceuticals Inc AUPH announced that it has commenced a Phase 2 trial evaluating voclosporin ophthalmic solution,or VOS, for the treatment of dry eye syndrome, or DES.

The company said the trial is evaluating the tolerability of VOS 0.2 percent versus Restasis at four weeks in subjects with mild to moderate DES.

The stock rose 2.8 percent to $5.87 in after-hours trading.

AcelRx, Myovant Announce Common Stock Offerings

AcelRx Pharmaceuticals Inc ACRX announced the commencement of an underwritten public offering of its common stock, with all the shares to be sold the company. The company did not divulge the size of the offering.

Myovant Sciences Ltd MYOV said it has commenced a $75 million common stock offering. The company intends to use the proceeds for the commercial launch of relugolix, its pipeline candidate for endometriosis and uterine fibroids, as well as for working capital and other general corporate purposes.

AcelRx shares fell 7.35 percent to $3.15 in after-hours trading and Myovant slumped 17.01 percent to $20.

On The Radar

FDA's Antimicrobial Drugs Advisory Committee is set to discuss GlaxoSmithKline plc (ADR) GSK's NDA for tafenoquine tablet, 150 milligram indicated for radical cure, ie prevention of relapse, of Plasmodium vivax malaria on July 12.

FDA Tidbits

FDA Commissioner Scott Gottlieb issued a statement, wherein he discussed the agency's efforts to advance development of gene therapies, which according to the agency, have the potential treat intractable and vexing diseases. The FDA released a suite of six scientific guidance documents in draft form, meant to serve as the building blocks of a comprehensive framework.