Benzinga's Daily Biotech Pulse: Novartis Earnings, J&J's HIV Combo Clears FDA Hurdle, Cara To Offer Shares

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 17)

• Avid Bioservices Inc CDMO(reversed to a profit in Q4)
• Becton Dickinson and Co BDX
• Eli Lilly And Co LLY(Cantor Fitzgerald affirmed its Overweight rating and $100 price target)
• Genomic Health, Inc. GHDX
• Haemonetics Corporation HAE
• IDEXX Laboratories, Inc. IDXX
• Kindred Biosciences Inc KIN
• Medtronic PLC MDT
• Momenta Pharmaceuticals, Inc. MNTA
• MORPHOSYS AG/S ADR MOR
• Reata Pharmaceuticals Inc RETA
• ResMed Inc. RMD
• Retrophin Inc RTRX
• Spectrum Pharmaceuticals, Inc. SPPI
• Vertex Pharmaceuticals Incorporated VRTX

Down In The Dumps

(Stocks hitting 52-week lows on July 17)

• Aileron Therapeutics Inc ALRN
• Altimmune Inc ALT
• Aralez Pharmaceuticals Inc ARLZ
• Arsanis Inc ASNS
• Clementia Pharmaceuticals Inc CMTA
• ContraVir Pharmaceuticals Inc CTRV
• Cytori Therapeutics Inc CYTX
• Neon Therapeutics Inc NTGN
• Scpharmaceuticals Inc SCPH
• Titan Medical Inc. TMDI

See Also: The Week Ahead In Biotech: Conferences, Clinical Trial Results, IPOs And More

Stocks In Focus

Novartis Q2 Profits, Sales Rise; Backs FY18 Outlook

Novartis AG (ADR) NVS reported a sharp increase in second-quarter profits, benefiting in part from gains on sale of its stake in the consumer health business joint venture with GlaxoSmithKline plc (ADR) GSK. Sales rose 7.5 percent year-over-year.

The Swiss pharma giant reiterated its FY2018 outlook and also said it will not hike drug prcies in the United States.

Roche's Liver Cancer Drug Combo Gets Breakthrough Designation

Roche Holdings AG Basel ADR RHHBY announced the FDA has accorded Breakthrough Designation for its Tecentriq in combination with Avastin as a first-line treatment for advanced or metastatic hepatocellular carcinoma patients. The designation was accorded based on data from a Phase 1b study.

Johnson & Johnson's AIDS Drug Cocktail Gets FDA Approval

Johnson & Johnson JNJ's Janssen unit said the FDA has approved it HIV-1 infection treatment candidate Symtuza, which is a concoction of darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg.

Symtuza is once daily single-tablet regimen, the company said.

Cobicistat, Emtricitabine and Tenofovir alafenamide are from Gilead Sciences, Inc. GILD.

Catalyst Biosciences Reports Positive Interim Data for Blood Disorder Drug

Catalyst Biosciences Inc CBIO released interim Phase 2/3 results of its hemophilia treatment Marzeptacog alfa, or MarzAA at the 64th Annual International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Meeting, which showed significant reductions in annualized bleed rate with daily subcutaneous injections of MarzAA.

The company also presented most recent data from Phase 1/2 trial of its CB 2679d/ISU304.

The stock was up about 15 percent at $13.95 in pre-market trading.

Coherus: Issues Raised By European Regulators For Neulasta Biosimilar Resolved

Coherus Biosciences Inc CHRS said in a SEC filing, following submission of a full response to issues identified by the Committee for Medicinal Products for Human Use regarding its pegfilgrastim biosimilar candidate CHS-1701 on July 3, it has received the co-Rapporteurs joint assessment report that suggested that all issues were addressed.

The company said it expects the CHS-1701 application to be included on the agenda for the July CHMP meeting.

The stock jumped 14.09 percent to $17 in after-hours trading.

Cara, Ac Immune Announce Stock Offerings

Cara announced commencement of a common stock offering of 4.5 million shares. The stock fell 5.32 percent to $20.45 in after-hours trading.

AC Immune SA ACIU announced a common stock offering of up to 10 million new common shares with a nominal value of 0.02 franc. AC Immune stock fell by 5.19 percent to $11.70 in after-hours trading.

On The Radar

Crinetics Pharmaceuticals, which develops therapies for rare endocrine diseases and endocrine-related tumors, priced its upsized 6-million-share IPO at $17. The shares will begin trading on the Nasdaq under the ticker symbol NASDAQ:CRNX.

Rubius Therapeutics said it has priced its upsized offering of 10.483 million shares at $23 per share, ahead of the estimated price range of $20-$22. The shares will begin trading on the Nasdaq under the ticker symbol NASDAQ:RUBY.

FDA Tidbits

FDA Commissioner Scott Gottlieb released a statement on the agency's efforts to provide greater access to non-prescription drugs. These steps include assessing if a medicine is right for them using innovative tools such as digital health technologies, that would support consumers in appropriately and safely self-selecting and using certain drugs.