Benzinga's Daily Biotech Pulse: ARMO Skyrockets On Eli Lilly Deal, Akcea Meets FDA Panel, vTv Alzheimer's Trial Results

Down In The Dumps

(Stocks hitting 52-week lows on May 9)

• Aralez Pharmaceuticals Inc ARLZ
• BioDelivery Sciences International, Inc. BDSI
• Lipocine Inc LPCN(FDA issued a complete response letter to the NDA for its testosterone replacement therapy)
• RXi Pharmaceuticals Corp RXII
• Sanofi SA (ADR) SNY
• THERAPIX BIOSCI/S ADR TRPX

Stocks In Focus

ARMO-Eli Lilly

ARMO Biosciences Inc ARMO announced a deal to be bought by Eli Lilly And Co LLY for $50 per share or $1.6 billion in total in an all-cash deal.

The stock was skyrocketing 67.57 percent to $49.97 in Thursday's pre-market trading.

Exelixis' Late-Stage Study of Colorectal Cancer Combo Drug Fails

Exelixis, Inc. EXEL announced that a Phase 3 pivotal trial dubbed IMblaze370 that tested cotellic, its MEK inhibitor, and Roche's Genentech unit's tencentriq did not meet the primary endpoint of improving overall survival versus regorafenib. The combo drug was evaluated for use by patients with difficult-to-treat, locally advanced or metastatic colorectal cancer, whose disease had progressed or who were intolerant to at least two systemic chemotherapy regimens.

Integra Lifesciences Pulls Back On Pricing Of Common Stock Offering

Integra Lifesciences Holdings Corp IART announced it has priced its offering of 5.25 million shares at $58.50 per share.

The stock fell 4.45 percent to $61 in after-hours trading Wednesday.

Sellas Gains On Orphan Drug Status

Sellas Life Sciences Group Inc SLS said the FDA has granted orphan drug designation to its galinpepimut-S for treating multiple myeloma. The designation is given to develop therapies for rare diseases or disorders affecting fewer than 200,000 in the U.S. It vests the company some advantages, such as a 7-year market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

The stock added 2.34 percent to $5.69 after hours Wednesday.

vTv Therapeutics' Alzheimer's Therapy Found Effective In Subpopulation

vTv Therapeutics Inc VTVT said post-hoc analyses of data from Part A of it Phase 3 STEADFAST study that evaluated its Alzheimer's therapy azeliragon threw up a subpopulation that showed statistically significant benefit relative to placebo.

The subpopulation consisted of participants with peak azeliragon blood plasma concentration of less than 7.5 ng/ml.

Based on this, the company said it will submit to the FDA a revised study plan for the Part B study.

Topline efficacy results from the Part B study based on 12-month data is due in June.

The stock jumped 20.47 percent to $2.06 after hours.

Catalyst Pharma Posts In-line Loss

Catalyst Pharmaceuticals Inc CPRX reported a Q1 non-GAAP loss of 6 cents per share, in line with estimates.

The stock jumped 17.86 percent to $3.30 in after-hours trading.

Wright Medical Loss Narrows

Wright Medical Group NV WMGI reported a narrower Q1 loss of 1 cent per share and revenues of $198.54 million, ahead of the consensus estimates. The company reiterated its FY18 guidance.

The stock gained 8.44 percent to $22.75 after hours.

Inovio Q1 Misses Estimate

Inovio Pharmaceuticals INO reported a Q1 loss of 36 cents per share, wider than the 14 cents per share loss estimated by analysts.

Inovio slid 6.83 percent to $4.50 after hours trading.

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

Adverum'a Q1 Revenues Light

Adverum Biotechnologies Inc ADVM reported a narrower-than-expected Q1 loss, while its revenues were slightly below estimates.

The stock shed 5.90 percent to $5.50.

Mannkind Disappoints With Q1 Results

MannKind Corporation MNKD reported a wider-than-expected Q1 loss and below-consensus revenues. MannKind stock declined 5.03 percent to $1.70.

PDL Biopharma Q1 Trails Estimates

PDL BioPharma Inc PDLI announced Q1 results, showing a profit of 1 cent per share compared to 6 cents per share expected by analysts. Revenues of $38.52 million also missed the consensus estimate of $50.4 million.

The stock receded 6.45 percent to $2.90 in after-hours trading.

Cara's Q1 Miss

Cara Therapeutics Inc CARA reported below-consensus Q1 results.

Cara fell 6.42 percent to $12.10 in after-hours trading.

Other Stocks That Reacted to Earnings

(Thursday after-hours quote)

Portola Pharmaceuticals Inc PTLA – Up 2.41 percent to $43.30
Novavax, Inc. NVAX – Down 2.92 percent to $1.66
Puma Biotechnology Inc PBYI – Down 1.99 percent to $64
Savara Inc SVRA – Down 1.94 percent to $9.60
Immunomedics, Inc. IMMU – Down 3.55 percent to $18.20

On The Radar

The following companies are scheduled to report earnings on Thursday:

• Depomed Inc DEPO
• Fate Therapeutics Inc FATE
• Karyopharm Therapeutics Inc KPTI
• Nektar Therapeutics NKTR
• Athersys, Inc. ATHX
• BioDelivery Sciences International, Inc BDSI
• Eagle Pharmaceuticals Inc EGRX
• BioTime, Inc. BTX
• CareDx Inc CDNA
• Halozyme Therapeutics, Inc. HALO
• Strongbridge Biopharma plc SBBP
• Synergy Pharmaceuticals Inc SGYP
• Catabasis Pharmaceuticals Inc CATB
• RXi Pharmaceuticals Corp RXII
• Catalyst Pharmaceuticals Inc CPRX
• Fibrocell Science Inc FCSC

Adcom Meeting Schedule

The Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet to discuss the safety and efficacy of Akcea Therapeutics Inc AKCA subcutaneously injected volanesoren solution for patients with familial chylomicronemia syndrome.

FDA Tidbits

The FDA filed with the federal court, seeking permanent injunctions against two stem cell clinics for deviating from current good manufacturing practice requirements. These clinics are also prohibited from marketing stem cell products without the agency's approval.