Benzinga’s Daily Biotech Pulse: FDA Panel Nod For Akcea, Synergy’s Revenue Miss, FDA Warns E-Liquid Makers Again

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 May 10)

• ABIOMED, Inc. (NASDAQ: ABMD)
• Bio-Rad Laboratories, Inc. (NYSE: BIO)
• AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
• Aptevo Therapeutics Inc (NASDAQ: APVO)(reported Q1 results before Thursday’s open)
• argenx NV – ADR (NASDAQ: ARGX)
• AxoGen, Inc (NASDAQ: AXGN)
• BioTelemetry Inc (NASDAQ: BEAT)
• Genomic Health, Inc. (NASDAQ: GHDX)
• Merit Medical Systems, Inc. (NASDAQ: MMSI)
• Novocure Ltd (NASDAQ: NVCR)
• Regenxbio Inc (NASDAQ: RGNX)
• Stemline Therapeutics Inc (NASDAQ: STML)(reported Q1 results after Wednesday’s close)
• Penumbra Inc (NYSE: PEN)

Down In The Dumps

(Stocks hitting 52-week lows on May 10)

• Alimera Sciences Inc (NASDAQ: ALIM)
• Altimmune Inc (NASDAQ: ALT) (announced resignation of CFO)
• Cesca Therapeutics Inc (NASDAQ: KOOL)
• Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)(fell ahead of Q1 results released after Thursday’s close)
• Stellar Biotechnologies Inc (NASDAQ: SBOT)

Stocks In Focus

Omeros Q1 Misses Estimate

Omeros Corporation (NASDAQ: OMER) reported below-consensus revenues of $1.59 million and a wider-than-expected loss of 62 cents per share.

Notwithstanding the sub-par results, the stock rallied 6.08 percent to $17.11 in after-hours trading.

Fate Posts Below-Consensus Results

Fate Therapeutics Inc (NASDAQ: FATE) reported a Q1 loss of 27 cents per share on revenues of $1.03 million. Analysts, on average, estimated a loss of 22 cents per share on revenues of $1.68 million.

The stock shed 5.57 percent to $10.35 after hours.

Geron Q1 Revenues Fall Sharply

Geron Corporation (NASDAQ: GERN) reported a loss of 4 cents per share in Q1, while analysts estimated a loss of 5 cents per share.

Revenues fell about 41 percent to $537,000.

Geron shares pulled back by 5.51 percent to $3.43 in after-hours trading.

See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates

Akcea Gets FDA Panel Nod

Akcea Therapeutics Inc (NASDAQ: AKCA), an affiliate of Ionis Pharmaceuticals Inc (NASDAQ: IONS) announced that the Endocrinologic and Metabolic Drugs Advisory Committee, which met to discuss the safety and efficacy of subcutaneously injected volanesoren solution for patients with familial chylomicronemia syndrome, voted 12-8 to support its approval.

The PDUFA goal date is set to for August.

Akcea shares soared 16.17 percent to $3.34 percent after hours, while Ionis saw its stock climb by 4.56 percent to $1.95.

Synergy Pharma Q1 Revenues Light On Soft Constipation Drug Sales

Synergy Pharmaceuticals Inc (NASDAQ: SGYP) reported Q1 net loss of 15 cents per share, narrower than the 16 cents loss estimated by analysts. Revenues of $8.6 million trailed the Street estimate of $11.5 million.

Shares slumped 11.04 percent to $1.45 after hours.

BioLife Posts In-line Q1

BioLife Solutions Inc (NASDAQ: BLFS) reported a loss of 1 cent per share on revenues of $3.815 million. The results were in line with estimates. The company increased its gross margin guidance for FY18 and reaffirmed its biopreservation media revenue forecast.

The stock moved up 5.94 percent to $8.74 after hours.

BioTime’s Below-par Q1

BioTime, Inc. (NYSE: BTX) reported a Q1 loss of 50 cents per share, wider than the 7 cents loss expected by analysts. Revenues of $701,000 were also below expectations.

The stock fell 4.98 percent to $2.10 in after hours trading, Thursday.

HTG Molecular

HTG Molecular Diagnostics Inc (NASDAQ: HTGM) reported a narrower-than-expected Q1 loss of 22 cents per share. However, revenues of $4.16 million trailed the $4.97 million consensus estimate. The company raised the low-end of its FY18 revenue guidance.

The stock slipped 6.99 percent to $3.59 after hours.

ZIOPHARM Q1 Trails Estimates

ZIOPHARM Oncology Inc. (NASDAQ: ZIOP) reported a Q1 loss of 15 cents per share compared to the 13 cents per share loss expected by economists. The company reported revenues of $146,000, notably lower than the $1.5 million consensus estimate.

ZIOPHARM shares slumped 8.43 percent to $4.13 after hours.

Other Stocks That Reacted to Earnings

(after hours Thursday’s quote)

• Adamis Pharmaceuticals Corp (NASDAQ: ADMP) – Up 1.83 percent to $3.895
• Halozyme Therapeutics, Inc. (NASDAQ: HALO) – Down 2.80 percent to $19.41
• Athersys, Inc. (NASDAQ: ATHX) – Up 2.38 percent to $2.15
• Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) – Down 1.14 percent to $5.20
• Pernix Therapeutics Holdings Inc (NASDAQ: PTX) – Up 2.90 percent to $2.48
• Aptose Biosciences Inc (NASDAQ: APTO) – Down 3.72 percent to $3.11

FDA Tidbits

After a recent clamp down, the FDA sent out four new warnings letters to manufacturers and retailers for selling e-liquids used in e-cigars with labels that mislead into thinking they are kid-friendly products such as cereal, soda and pancakes.