Cardinal Health up 4% premarket on FQ4 beat

Cardinal Health (NYSE:CAH) fiscal Q4 results:

Revenues: $37.4B (+6%).

Net income: $194M (+116%); non-GAAP net income: $334M (+6%); EPS: $0.65 (+117%); non-GAAP EPS: $1.11 (+10%).

Fiscal 2020 guidance: Non-GAAP EPS: $4.85 – 5.10.

Shares are up 4% premarket on light volume.

Previously: Cardinal Health EPS beats by $0.17, beats on revenue (Aug. 8)

https://seekingalpha.com/news/3489481-cardinal-health-4-percent-premarket-fq4-beat

Wright Medical down 18% premarket on guidance cut

Wright Medical Group (WMGI) Q2 results: Revenues: $229.7M (+11.8%).

Net Loss: ($18.9M) (+79.1%); Loss Per Share: ($0.15) (+82.4%); Non-GAAP Net Income: $2.2M (+161.1%); Non-GAAP EPS: $0.02 (+166.7%).

2019 guidance: Sales: $925M – 930M from $954M – 966M; non-GAAP EBITDA: $157M – 163M from $160M – 170M; non-GAAP EPS: $0.15 – 0.20 from $0.17 – 0.25.

Shares are down 18% premarket.

Previously: Wright Medical EPS beats by $0.01, misses on revenue (Aug. 7)

https://seekingalpha.com/news/3489472-wright-medical-18-percent-premarket-guidance-cut

DBV Tech up 17% premarket on Viaskin Peanut application in U.S.

Thinly traded DBV Technologies (NASDAQ:DBVT) is up 17% premarket on modest volume following the resubmission of its U.S. marketing application for Viaskin Peanut for the treatment of peanut allergy in children ages 4-11 years.

The company withdrew its initial filing in December 2018 in order to generate additional data on manufacturing procedures and quality control.

https://seekingalpha.com/news/3489494-dbv-tech-17-percent-premarket-viaskin-peanut-application-u-s

Pacira up 4% premarket on Q2 beat

Pacira Pharmaceuticals (PCRX) Q2 results: Revenues: $102.6M (+22.0%); Exparel sales: $98.9M (+23.0%); Iovera: $2M; Royalty revenue: $0.8M (+100.0%).

Net Income: $2.7M (+3.8%); EPS: $0.06 (unch); Non-GAAP Net Income: $17.5M (+76.8%); Non-GAAP EPS: $0.41 (+70.8%).

2019 Guidance: Exparel net product sales: $400M – 410M (unch); iovera net product sales: $8M – 10M (unch).

Shares are up 4% premarket.

Previously: Pacira Pharmaceuticals EPS beats by $0.07, beats on revenue(Aug. 8)

https://seekingalpha.com/news/3489499-pacira-4-percent-premarket-q2-beat

Agenus up 8% on AGEN2373 IND, milestone payment

Agenus (AGEN +8%) is up on light volume in early trade on the heels of its announcement that the FDA has accepted its IND filing for immuno-oncology (I-O) candidate AGEN2373, triggering a $7.5M milestone payment from collaboration partner Gilead Sciences (GILD).

AGEN2373 is a fully human monoclonal antibody that inhibits (binds to) an immune checkpoint protein called CD137.

The companies established their partnership in December 2018 to develop five I-O therapies.

https://seekingalpha.com/news/3489550-agenus-8-percent-agen2373-ind-milestone-payment

Sarepta down 14% on safety concerns with DMD gene therapy

Sarepta Therapeutics (SRPT -14.2%) is down on more than double normal volume as selling accelerates from this morning when the company announced its plan to increase enrollment in a study of DMD gene therapy SRP-9001 that will extend its development timeline.

The culprit appears to be the appearance of SRP-9001 on the FDA’s Adverse Event Reporting System, although more information is needed to assess whether it means anything since this is a customary requirement for drug makers and healthcare providers.

Update: In a statement, the company says that the one adverse event, rhabdomyolysis, from Study 102 was erroneously reported. The DMD patient presented with dark urine and elevated creatine phosphokinase levels two weeks after infusion with SRP-9001 and was otherwise asymptomatic. He was hospitalized for observation, discharged the next day and test results returned to normal. Rhabdomyolysis, a condition resulting from muscle injury in which the kidneys cannot remove waste and concentrated urine, is a risk associated with DMD.

Shares are currently down 8% after a brief halt of trading.

https://seekingalpha.com/news/3489632-sarepta-14-percent-safety-concerns-dmd-gene-therapy

Amicus down 5% on Pompe study questions

Amicus Therapeutics (FOLD -5.2%) slips on below-average volume in apparent response to an analyst’s question during its Q2 conference call this morning about its late-stage study, PROPEL, evaluating the combination of of ATB200 and AT2221 in patients with late-onset Pompe disease (LOPD). The BofA analyst questioned whether the primary endpoint of the 6-minute walk test (6MWT) is better than Sanofi’s lung function primary endpoint in its Phase 3 LOPD study, COMET, of enzyme replacement therapy avalglucosidase alfa (neoGAA), adding that Sanofi may announce preliminary data sooner.

Pompe disease is a rare inherited disorder in which the sugar molecule glycogen builds up in cells due to the absence or dysfunction in an enzyme called glucosidase. Symptoms include weak muscles, enlarged liver and breathing difficulties. It is typically diagnosed in infants, but late-onset Pompe can occur in adults who have less severe Pompe (more glucosidase activity) hence the question about the 6MWT since symptoms develop slowly over time. Respiratory difficulties are frequently the first signs of the disease.

https://seekingalpha.com/news/3489643-amicus-5-percent-pompe-study-questions