Benzinga's Daily Biotech Pulse: Biogen, AC Immune Slip Despite Positive Trials, Sarepta Slapped With Clinical Hold

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 July 25)

• Allakos Inc ALLK(shares were listed on July 19)
• Baxter International Inc BAX
• Becton Dickinson and Co BDX
• Biogen Inc BIIB
• Bio-Rad Laboratories, Inc. BIO
• Edwards Lifesciences Corp EW(shares rose ahead of earnings due Thursday)
• Eli Lilly And Co LLY(reported better-than-expected Q2 earnings and announced plans to spin-off its Animal Health business)
• Endo International PLC ENDP
• Illumina, Inc. ILMN
• Medtronic PLC MDT
• Neurocrine Biosciences, Inc. NBIX

Down In The Dumps

(Stocks hitting 52-week lows on July 25)

• Agile Therapeutics Inc AGRX(FDA turned down the company's appeal regarding Twirla)
• ContraVir Pharmaceuticals Inc CTRV
• Cytori Therapeutics Inc CYTX
• Diffusion Pharmaceuticals Inc DFFN
• Genocea Biosciences Inc GNCA
• Immune Pharmaceuticals Inc IMNP
• MeiraGTx Holdings PLC MGTX
• Neurometrix IncNURO
• Orgenesis Inc ORGS
• Reshape Lifesciences Inc RSLS
• RXi Pharmaceuticals Corp RXII
• Surface Oncology Inc SURF
• TESARO Inc TSRO
• Titan Medical Inc. TMD
• VBI Vaccines Inc VBIV

Stocks In Focus

Biogen Falls As Street Adopts Caution On Alzheimer's Candidate

After presenting a poster on mid-stage trial results for its Alzheimer's disease candidate elenbecestat, Biogen and partner Eisai made an oral presentation of detailed results from a Phase 2 study of another AD treatment candidate BAN2401 at the Alzheimer's Association International Conference.

BAN2401 is an anti-amyloid beta protofibril antibody, which was evaluated in an 856-patient, placebo-controlled, double-blind, parallel-group, randomized trial. The patients suffered from mild cognitive impairment due to AD, or mild Alzheimer's dementia, with confirmed amyloid pathology in the brain.

Among the doses tested, the highest doses of 10 mg/kg monthly and 10 mg/kg biweekly were found to have higher efficacy, and the 10 mg/kg biweekly dose slowed cognitive decline by 30 percent compared to placebo at 18 months.

Notwithstanding the positive results, investors bid down the stock amid caution regarding the success.

Biogen fell 11.42 percent to $340 after hours.

AC Immune Reports Positive Results For Alzheimer's Drug Candidate

AC Immune SA ACIU, which also has an AD drug candidate crenezumab  it develops with Roche Holdings AG Basel ADR Common Stock RHHBY, also presented new exploratory Phase 2 data for the candidate at the AAIC.

The results showed that crenezumab significantly reduced Abeta oligomers in cerebrospinal fluid in patients with AD.

"These first of their kind data are very promising as they support the proposed mechanism of action of crenezumab to preferentially bind to and promote removal of neurotoxic oligomers, a form of Abeta," the company said. Crenezumab is currently in two Phase 3 trials.

The stock slid 11.94 percent to $14.49 in after-hours trading.

Sarepta's Duchenne Muscular Dystrophy Trial Put On Clinical Hold

Sarepta Therapeutics Inc SRPT announced the Phase 1/2a clinical trial of its Duchenne Muscular Dystrophy Micro-Dystrophin Gene Therapy has been put on clinical hold by the FDA. The FDA cited the presence of a trace amount of DNA fragment in research-grade third-party supplied plasmid as reason for the action.

"We intend to rapidly respond to the FDA's clinical hold letter, including a commitment to the Agency to only use GMP-s plasmid," the company said.

Sarepta shares declined 6.26 percent to $123 in after-hours trading.

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

Gilead's CEO To Step Down; Q2 Results Beat Estimates

Gilead Sciences, Inc. GILD reported Q2 non-GAAP earnings of $1.91 per share, ahead of the $1.56 consensus estimate. Revenues of $5.648 billion also surpassed the $5.21 billion consensus estimate.

The company raised its full-year non-GAAP product gross margin guidance.

Separately, the company said its president and CEO John Milligan will step down after being with the company for 28 years.

The stock fell 1.48 percent to $77.75 in after-hours trading.

Vertex Report Strong Q2 Results

Vertex Pharmaceuticals Incorporated VRTX reported Q2 non-GAAP earnings of 94 cents per share, and a 46 percent increase in its cystic fibrosis, or CF, revenues to $750 million. Analysts, on average, estimated earnings of 75 cents per share and revenues of $680.98 million.

The company also raised its full-year CF product revenue guidance to $2.9 billion to $3 billion.

Roche First-Half Results Beat Estimates; Raises Guidance

Roche reported better-than-expected first-half results, helped by strong performances by new drugs, and also raised its full-year sales growth outlook.

Nabriva Announces Common Stock Offering

Nabriva Therapeutics PLC NBRV said it has commenced an underwritten public offering of $50 million shares. All the shares are to be sold by the company. Nabriva announced Tuesday a deal to buy Zavante Therapeutics.

The stock fell 8.22 percent to $3.24 in after-hours trading.

On The Radar

Earnings

Allergan plc AGN Q2 EPS $4.42 Beats $4.12 Estimate, Sales $4.124B Beat $3.91B Estimate
ABIOMED, Inc. ABMD Q1 EPS $0.78 Misses $0.82 Estimate, Sales $180.01M Beat $173.27M Estimate
Alexion Pharmaceuticals, Inc. ALXN Q2 EPS $2.07 Beats $1.70 Estimate, Sales $1.045B Beat $977.89M Estimate
Amgen, Inc. AMGN (after the market close)
Alkermes Plc ALKS Q2 EPS $0.29 Beats $0.14 Estimate, Sales $304.642M Beat $247.08M Estimate
Baxter International Inc BAX Q2 EPS $0.77 Beats $0.71 Estimate, Sales $2.842B Beat $2.83B Estimate
Cytokinetics, Inc. CYTK
Edwards Lifesciences Corp EW (after the market close)
Celgene Corporation CELG Q2 EPS $2.16 Beats $2.10 Estimate, Sales $3.814B Beat $3.7B Estimate
Seattle Genetics, Inc. SGEN (after the market close)
Retrophin Inc RTRX (after the market close)

IPO

Liquidia Technologies said it priced its initial public offering of 4.55 million shares at $11 per share. The shares will be listed on the Nasdaq under the ticker symbol LQDA.