The Daily Biotech Pulse: Puma, CareDx Soar On Earnings, Corcept Plunges On Bottom-Line Miss

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 Aug. 9)

• Acer Therapeutics Inc ACER(HC Wainwright reiterated its Buy rating and $55 price target)
• AstraZeneca plc (ADR) AZN
• Becton Dickinson and Co BDX
• BioCryst Pharmaceuticals, Inc. BCRX
• Celgene Corporation CELG
• Crinetics Pharmaceuticals Inc CRNX
• G1 Therapeutics Inc GTHX(reported a narrower loss for its Q2)
• Harvard Bioscience, Inc. HBIO
• Horizon Pharma PLC HZNP
• Medtronic PLC MDT
• Neurocrine Biosciences, Inc. NBIX
• Neuronetics Inc STIM
• Veracyte Inc VCYT
• Vital Therapies Inc VTL
• Xenon Pharmaceuticals Inc XENE

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 9)

• Adial Pharmaceuticals Inc ADIL
• Chiasma Inc CHMA
• CTI BioPharma Corp CTIC
• OHR Pharmaceutical Inc OHRP
• Osiris Therapeutics, Inc. OSIR
• Sonoma Pharmaceuticals Inc SNOA
• Synlogic Inc SYBX(reacted to Q2 results after the close on Wednesday)

Stocks In Focus

Stocks Reacting To Earnings

Arca Biopharma Inc ABIO reported a loss of 15 cents per share for Q2 compared to a loss of 59 cents per share a year ago. Analysts expected a wider loss of 22 cents per share. As of June 30, cash, cash equivalents and marketable securities totaled $9.6 million.

The stock fell 5.52 percent to $0.65 in after-hours trading.

Asterias Biotherapeutics Inc AST's net loss per share narrowed from 18 cents in Q217 to 13 cents in Q218. Analysts had looked ahead to a loss of 10 cents per share for the most recent second quarter. The company said it successfully lowered its cash burn rate, with cash, cash equivalents, and available-for-sale securities totaling $14.8 million as of June 30.

The stock moved up 9.68 percent to $1.70 in after-hours trading.

Regulus Therapeutics Inc RGLS reported a net loss of 13 cents per share for Q2, narrower than the loss of 41 cents reported last year. Analysts, on average, had estimated a loss of 16 cents per share. Cash, cash equivalents and short-term investments totaled $32.9 million as of June 30.

The stock soared 15.81 percent to $0.2549 in after-hours trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates

Caladrius Biosciences Inc CLBS's Q2 net loss widened from 22 cents per share in Q2'17 to 42 cents per share in Q2'18. Analysts had estimated a wider loss of 64 cents per share.

The stock advanced 7.59 percent to $5.67 in after-hours trading.

Organovo Holdings Inc ONVO said its fiscal-year 2019 first-quarter loss came in at 7 cents per share, wider than the loss of 10 cents per share last year . Revenues fell 30 percent year-over-year to $0.7 million. The loss per share is in line with expectations.

As of June 30, 2018, the Company had a cash and cash equivalents balance of $39.6 million, while it plans a net cash utilization rate of $22 million to $24 million in fiscal 2019

The stock declined 5.11 percent to $1.30 in after-hours trading.

Corcept Therapeutics CORT reported non-GAAP net income of 20 cents per share for Q2, trailing the 24 cents per share estimated by analysts.

The company lowered its FY18 revenue guidance from $275 million to $300 million to $250 million to $275 million.

The stock plunged 19.17 percent to $11.30 in after-hours trading.

Puma Biotechnology Inc PBYI reported a non-GAAP adjusted loss of 59 cents per share for Q2, narrower than the year-ago loss of $1.38 per share. On a GAAP basis the loss was $1.17 per share. Total revenues came in at $50.8 million.

The stock jumped 16.44 percent to $56.65 in after-hours trading.

Spectrum Pharmaceuticals, Inc. SPPI reported a non-GAAP net loss of 21 cents per share for Q2, while in the year-ago quarter, the company reported a loss of 11 cents per share. The company maintained its FY18 guidance at $95 million to $115 million. The loss was in line with expectations.

The stock climbed 8.67 percent to $21.80 in after-hours trading.

CareDx Inc CDNA reported a 48 percent increase in revenues to $17.8 million. The net loss per share narrowed from 17 cents in Q217 to 4 cents in Q218. The company raised its FY18 revenue guidance from $64 million to $66 million to $68 million to $70 million.

The stock rose 17.03 percent to $17.52 in after-hours trading.

On The Radar

PDUFA Dates

Regeneron Pharmaceuticals Inc REGN awaits FDA decision on its Eylea for treating wet age-related macular degeneration. The PDUFA date is set for Saturday.

Also on Saturday, Alnylam Pharmaceuticals, Inc. ALNY has a tryst with the FDA regarding the NDA for Patisiran, its investigational RNAi therapeutic targeting transthyretin, or TTR, for treating hATTR amyloidosis. Alnylam uses Arbutus Biopharma Corp ABUS's intellectual property in RNAi therapeutic products.