The Daily Biotech Pulse: Nantkwest Reports Positive Cancer Vaccine Trial Results, Sarepta Offering

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Nov. 7)

• Allakos Inc ALLK
• BioTelemetry Inc BEAT
• Emergent Biosolutions Inc EBS
• Genomic Health, Inc. GHDX(reported beat-and-raise quarter)
• Gritstone Oncology Inc GRTS
• Horizon Pharma PLC HZNP(reported strong quarterly results)
• Merck & Co., Inc. MRK
• Oncobiologics Inc ONS

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 7)

• Achaogen Inc AKAO
• Adial Pharmaceuticals Inc ADIL
• Avalara Inc AVLR
• Audentes Therapeutics Inc BOLD(reported Q3 results)
• Five Prime Therapeutics Inc FPRX( reported Q3 results)
• Ironwood Pharmaceuticals, Inc. IRWD
• Kodiak Sciences Inc KOD
• Nemaura Medical Inc NMRD
• Neurometrix Inc NURO
• Novelion Therapeutics Inc NVLN
• Pieris Pharmaceuticals Inc PIRS(reported Q3 results)
• SUMMIT THERAPEU/S ADR SMMT
• Tenax Therapeutics Inc TENX(filed prospectus for an offering of Class A and Class B units)

Stocks In Focus

Nantkwest Reports Positive Results For Cancer Vaccine Trial

Releasing the first human clinical trial results of its cancer vaccine, Nantkwest Inc NK said all 30 patients with advanced metastatic cancer refractory to multiple previous therapies receiving NK cell fusion and novel cancer memory vaccine reported zero incidence of cytokinase release syndrome.

In highly refractory late-stage advanced metastatic pancreatic cancer about 90 percent disease control was achieved, with median overall survival of 9.5 months or greater, while 80 percent disease control was achieved in highly refractory late-stage advanced metastatic triple negative breast cancer.

In highly refractive patients with advanced metastatic head and neck cancer, the vaccine resulted in 67 percent disease control and a complete response in 1 patient.

The shares soared 53.14 percent to $4.15 in after-hours trading.

Voyager Reports Positive Early-Stage Results for Parkinson's Disease Therapy

Voyager Therapeutics Inc VYGR announced longer-term results of an open-label, dose escalating Phase 1b trial of its VY-AADC, which demonstrated sustained improvements in patient's motor function. VY-AADC is a gene therapy product being evaluated for Parkinson's disease.

"Patients in the two highest dose cohorts (Cohorts 3 and 2) experienced mean improvements in diary on-time without troublesome dyskinesia (good ON time) of 1.7 hours per day at 18 months and 2.7 hours per day at two years, respectively," the company said.

Separately, the company reported collaboration revenues of $2.09 million compared to $1.15 million last year. The net loss per share narrowed from 89 cents to 63 cents, while analysts expected a loss of 79 cents.

The stock plunged 12.08 percent to $12.30 in after-hours trading.

Sarepta, Endra Life Sciences To Offer Shares

Sarepta Therapeutics Inc SRPT said it will offer $500 million worth of shares in an underwritten public offering.

The stock fell 4.21 percent to $138 in after-hours trading.

ENDRA Life Sciences Inc NDRA said it is proposing to offer and sell shares of its common stock in an underwritten public offering. All the shares are to be offered by the company.

The stock fell 6.74 percent to $4.15 in after-hours trading.

See Also: The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates, Clinical Trial Results And IPOs

Earnings

Portola Pharmaceuticals Inc PTLA's Q3 total revenues rose from $3.8 million in Q3 2017 to $14.2 million, with the recent quarter's revenues including $7.7 million in product revenues and $7 million in collaboration revenues. Strong take off of the company's anticoagulant antidote Andexxa propped up the top-line. The net loss narrowed from $1.41 per share to $1.08 per share, and it was also narrower than the $1.62 per share loss estimated by analysts.

The company lowered its full-year guidance to reflect narrowed focus on a group of key hospitals for the launch of its Bevyxxa.

The stock jumped 16.21 percent to $22.15 in after-hours trading.

Verastem Inc VSTM reported Q3 total revenues of $15.51 million, comprising $15 million in upfront payment for the license and collaboration agreement with CSPC, and $508,000 in net product revenue from Copiktra, which was commercially sold in September following FDA approving the drug. The net loss per share narrowed from 61 cents to 29 cents, while analysts expected a wider loss of 42 cents per share.

The stock rallied 11.11 percent to $6.50 in after-hours trading.

Flexion Therapeutics Inc FLXN reported a narrower than expected loss for its Q3.

The stock gained 10.37 percent to $15.75 in after-hours trading.

TherapeuticsMD Inc TXMD reported net revenue of $3.5 million for Q3 compared to $4.4 million last year. The net loss of 14 cents per share was narrower than the 21 cents per share expected by analysts.

The stock climbed 8.35 percent to $5.06 in after-hours trading.

Hologic, Inc. HOLX's Q4 revenues rose 1.3 percent to $813.5 million and its non-GAAP EPS of 58 cents per share was in line with estimate. The company's full-year as well as fiscal-year first-quarter revenue guidance was in line, while non-GAAP EPS guidance was ahead of estimates.

The stock rose 4.58 percent to $43.15 in after-hours trading.

Ocular Therapeutix Inc OCUL reported a loss of 38 cents per share for its Q3, in line with the consensus. Revenue fell slightly year-over-year.

The stock declined 4.81 percent to $5.15 in after-hours trading.

OraSure Technologies, Inc. OSUR's Q3 net revenues rose 8 percent to $45.9 million and net income per share rose from 9 cents to 13 cents, while the consensus had called for earnings of 11 cents per share. The fourth-quarter guidance was better than expected.

The stock declined 6.59 percent to $13.75 in after-hours trading.

On The Radar

Earnings

• Karyopharm Therapeutics Inc KPTI (before the market open)
• Histogenics Corp HSGX (before the market open)
• Ligand Pharmaceuticals Inc. LGND (before the market open)
• Eloxx Pharmaceuticals Inc ELOX (before the market open)
• Endo International PLC ENDP (before the market open)
• Foamix Pharmaceuticals Ltd FOMX (before the market open)
• Misonix, Inc. MSON (after the market close)
• Assertio Therapeutics Inc ASRT (after the market close)
• BioDelivery Sciences International, Inc. BDSI (after the market close)
• BioTime, Inc. BTX (after the market close)
• Coherus Biosciences Inc CHRS (after the market close)
• CareDx Inc CDNA (after the market close)
• Synthetic Biologics Inc SYN (after the market close)
• Vermillion, Inc. VRML (after the market close)
• ICU Medical, Incorporated ICUI (after the market close)
• Inovio Pharmaceuticals Inc INO (after the market close)
• Transenterix Inc TRXC (after the market close)
• Collegium Pharmaceutical Inc COLL (after the market close)
• DENTSPLY SIRONA Inc XRAY (after the market close)
• HTG Molecular Diagnostics Inc HTGM (after the market close)
• Organovo Holdings Inc ONVO (after the market close)