The Daily Biotech Pulse: Novartis Stands By Zolgensma, GW Pharma Q2 Propelled By Epidiolex Sales, Ionis-Akcea Clinical Readout

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. 6)

• Allakos Inc ALLK(announced common stock offering)
• Cytokinetics, Inc. CYTK
• Insulet Corporation PODD( reacted to forecast-beating second-quarter results)
• Fulgent Genetics Inc FLGT(moved in reaction to second-quarter earnings)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 6)

• Abeona Therapeutics Inc ABEO
• Aerpio Pharmaceuticals Inc ARPO
• Alpine Immune Sciences Inc ALPN
• Bellicum Pharmaceuticals Inc BLCM(reacted to second-quarter results)
• Bicycle Therapeutics PLC BCYC
• BIOLINERX LTD/S ADR BLRX(reacted to second-quarter results)
• CELLECT BIOTECH/S ADR APOP
• ChemoCentryx Inc CCXI(reported below-consensus second-quarter revenues)
• Eloxx Pharmaceuticals Inc ELOX
• Endo International PLC ENDP(reacted to second-quarter results)
• Equillium Inc EQ
• Evogene Ltd EVGN
• Hepion Pharmaceuticals Inc HEPA
• Innovate Biopharmaceuticals Inc INNT
• MEI Pharma Inc MEIP
• Merit Medical Systems, Inc. MMSI
• Miragen Therapeutics Inc MGEN
• Oncolytics Biotech, Inc. ONCY
• Obseva SA OBSV
• Sienna Biopharmaceuticals Inc SNNA
• Tonix Pharmaceuticals Holding Corp TNXP
• Teva Pharmaceutical Industries Ltd TEVA
• Zoetis Inc ZTS

See Also: Biotech Stock On The Radar: Veru, A Catalyst-Rich Biopharma

Stocks In Focus

Novartis Reiterates Efficacy & Safety Of Zolgensma Following Data Integrity Issues

Following the FDA releasing a statement addressing data integrity issues with Novartis AG NVS's BLA for its gene therapy Zolgensma, the company said it is fully confident in the safety, quality and efficacy of Zolgensma.

"We maintain that the totality of the evidence demonstrating the product's effectiveness and its safety profile continue to provide compelling evidence supporting an overall favorable benefit-risk profile," the company said.

The stock shed 0.82% to $87.50 in after-hours trading.

Akcea, Ionis Report Positive Results For Drug To Treat Progressive Fat Loss Disorder

Akcea Therapeutics Inc AKCA, a unit of Ionis Pharmaceuticals Inc IONS, announced positive top-line results from the BROADEN study that evaluated Waylivra in patients with familial partial lipodystrophy. The study met the primary endpoint of showing a statistically significant reduction in triglyceride levels in patients with FPL treated with Waylivra compared to placebo-treated patients.

Additionally, the study achieved an important secondary endpoint of a statistically significant reduction in liver fat.

Ionis shares rose 2.33% to $65.56 in after-hours trading.

Reshape CFO To Quit

Reshape Lifesciences Inc RSLS said its CFO Scott Youngstrom will resign, effective Oct. 1, due to personal reasons. Youngstrom has agreed to assist in finding a replacement and in the orderly transition of responsibilities, the company said.

Silk Road Announces Secondary Offering Of Shares By Selling Shareholders

Silk Road Medical Inc SILK said certain selling shareholders are selling shares of its common stock through an underwritten public offering of 3.5 million shares.

The stock declined 1.11% to $37.28 in after-hours trading.

Allakos Upsizes Offering; Prices At $77/Share

Allakos upsized its previously announced underwritten public offering from $200 million to $350 million. The company has priced its 4.55-million common stock offering at $77 per share.

The stock rose 3.06% to $81.90 in after-hours trading.

Earnings

Cellectis SA CLLS reported a wider loss for its second quarter and a year-over-year decline in revenues.

The stock added 6.84% to $14.37 in after-hours trading.

Flexion Therapeutics Inc FLXN's second-quarter revenues jumped from $3.8 million in the second quarter of 2018 to $17 million in the second quarter of 2019. The loss narrowed form $2.27 to $2.05.

The stock jumped 10.50% to $10.10 in after-hours trading.

Obseva reported a wider loss of 80 cents for the second quarter compared to a loss of 49 cents per share in the year-ago period. Analysts expected a loss of 60 cents per share for the quarter. Separately, the company announced the closing of a $75 million senior secured credit facility with Oxford Finance, which it said it will use to advance its late-stage development pipeline.

TherapeuticsMD Inc TXMD reported a 62% year-over-year increase in second-quarter revenues to $6.1 million, with the bulk of the revenues coming from the sales of Imvexxy. The adjusted loss per share widened from 15 cents to 19 cents. The company raised its full-year revenue guidance.

The stock gained 8.02% to $2.02 in after-hours trading.

Guardant Health Inc GH reported a 178% year-over-year increase in second-quarter revenues and the net loss narrowed significantly from $1.75 per share to 13 cents.

The stock rallied 23.76% to $112 in after-hours trading.

GW Pharmaceuticals PLC- ADR GWPH reported second-quarter revenues of $72 million, a strong increase from the year-ago's $3.3 million, as its CBD epilepsy medication epidiolex sales came in at a robust $68.4 million. The company reversed from a loss of 25 cents per share to 21 cents per share.

The stock advanced 11.76% to $170.34 in after-hours trading.

Curis, Inc. CRIS reported a narrower second-quarter loss of 22 cents but its revenues fell from $2.4 million to $2.1 million.

The stock shed 5.60% to $2.19 in after-hours trading.

Supernus Pharmaceuticals Inc SUPN's second-quarter revenues climbed 5.2% year-over-year to $104.7 million. The earnings per share missed estimates by a penny. The company lowered its 2019 net product sales guidance.

The stock slipped 9.01% to $30.30 in after-hours trading.

On The Radar

Adcom Meeting

FDA's Antimicrobial Drugs Advisory Committee Meeting is scheduled to meet to discuss Gilead Sciences, Inc. GILD's sNDA for Descovy and enofovir alafenamide 25 mg for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. Briefing document released ahead of the meeting showed the regulatory agency may view the combo treatment amenable for men and not for women.

Earnings

• Athenex Inc ATNX (before the market open)
• ANI Pharmaceuticals Inc Common Stock ANIP (before the market open)
• AMAG Pharmaceuticals, Inc. AMAG (before the market open)
• Affimed NV AFMD (before the market open)
• ArQule, Inc. ARQL (before the market open)
• Eyepoint Pharmaceuticals Inc EYPT (before the market open)
• Eloxx Pharmaceuticals Inc ELOX (before the market open)
• Ionis Pharmaceuticals Inc IONS (before the market open)
• Intercept Pharmaceuticals Inc ICPT (before the market open)
• Horizon Therapeutics PLCHZNP (before the market open)
• Jounce Therapeutics Inc JNCE (before the market open)
• PDL BioPharma Inc PDLI (after the close)
• Cara Therapeutics Inc CARA (after the close)
• Sarepta Therapeutics Inc SRPT (after the close)
• Dynavax Technologies Corporation DVAX (after the close)
• Arena Pharmaceuticals, Inc. ARNA (after the close)
• Assertio Therapeutics Inc ASRT (after the close)
• Aerie Pharmaceuticals Inc AERI (after the close)
• Apyx Medical Corp NASDAQ: APYX (after the close)
• Unity Biotechnology Inc UBX (after the close)
• PDL BioPharma Inc PDLI (after the close)
• Cara Therapeutics Inc CARA (after the close)
• Celldex Therapeutics, Inc. CLDX (after the close)
• Collegium Pharmaceutical Inc COLL (after the close)
• Glaukos Corp GKOS (after the close)
• Foamix Pharmaceuticals Ltd FOMX
• Syndax Pharmaceuticals Inc SNDX (after the close)
• OptimizeRx Corporation OPRX (after the close)
• CytomX Therapeutics Inc CTMX (after the close)
• Catalyst Pharmaceuticals Inc CPRX (after the close)
• ICU Medical, Incorporated ICUI (after the close)
• Miragen Therapeutics Inc MGEN (after the close)
• OpGen Inc OPGN (after the close)
• Sunesis Pharmaceuticals, Inc. SNSS (after the close) Regenxbio Inc RGNX (after the close)
• Portola Pharmaceuticals Inc PTLA (after the close)
• Wright Medical Group NV WMGI (after the close)
• G1 Therapeutics Inc GTHX