Daily Biotech Pulse: Allergan's Depression Drug Flunks Late-Stage Trial, Apellis Offering, ShockWave Medical IPO

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on March 6)

• Chiasma Inc CHMA
• Magenta Therapeutics Inc MGTA
• Proteon Therapeutics Inc PRTO
• Stealth BioTherapeutics Corp MITO

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 6)

• AMAG Pharmaceuticals, Inc. AMAG
• CytomX Therapeutics Inc CTMX
• Elanco Animal Health Inc ELAN
• Evolent Health Inc EVH
• Inovio Pharmaceuticals Inc INO
• MEDNAX Inc MD
• Novavax, Inc. NVAX
• OncoSec Medical Inc ONCS
• Unity Biotechnology Inc UBX (reacted to its fourth-quarter results released ahead of the market open)
• Urogen Pharma Ltd URGN

Stock In Focus

Allergan's Major Depressive Disorder Drug Fails In a Late-stage Study

Close on heels of Johnson & Johnson JNJ's Janssen unit securing FDA nod for its treatment-resistant depression drug, Allergan plc AGN released top-line results from three pivotal Phase 3 studies that evaluated its rapastinel as an adjunctive treatment of major depressive disorder, which showed that pipeline candidate did not meet primary and secondary endpoints in the relapse prevention study. However, rapastinel was well tolerated without any signal of psychotomimetic side effects.

The stock fell 2.55 percent to $134 in after-hours trading.

Pfenex Says Licensee Reports Positive Late-stage trial For Vaccine

Pfenex Inc PFNX said the Serum Institute of India, which has licensed its Pneumosil 10-valent pneumococcal conjugate vaccine, reported positive results for a pivotal Phase 3 study, with all primary and secondary endpoints met.

"Pneumosil contains the recombinant carrier protein CRM197 produced by Serum Institute under a license to the Pfēnex Expression Technology," Pfenex said.

Pfenex is eligible to receive annual fees, milestone payments and a tiered low-single-digit royalty based on net sales for all products developed by the Serum Institute that use the CRM197 carrier protein produced via the Pfēnex Expression Technology.

Based on the study results, the Serum Institute has received an export license to Pneumosil. The institute has already initiated the process of WHO prequalification form vaccine, which could take up to 12 months to be completed.

The stock rallied 10.59 percent to $4.70 in after-hours trading.

See Also: Jefferies Sees Opportunity In Marinus Pharmaceuticals: 4 Reasons Why

Offerings

Apellis Pharmaceuticals Inc APLS commenced an underwritten public offering of $75 million worth of shares. All the shares are being offered by the company.

The stock slid 8.47 percent to $16.75 in after-hours trading.

Epizyme Inc EPZM announced its intention to offer its common stock and Series A convertible preferred stock in two concurrent but separate underwritten public offerings. All the shares in the proposed offerings are to be sold by the company.

The stock declined 2.08 percent to $11.78 in after-hours trading.

Earnings

China Biologic Products Holdings Inc CBPO reported non-GAAP adjusted earnings per share, or EPS, of 76 cents compared to 90 cents last year. Sales rose 27.5 percent to $114.9 million. The company forecast 4-6 percent growth in 2019 non-GAAP adjusted net income in RMB terms.

The stock moved down 4.53 percent to $80 in after-hours trading.

CareDx Inc CDNA reported a 88 percent jump in fourth-quarter revenues to $23.5 million. The company reversed to a profit of 1 cent per share on a non-GAAP basis from a loss of 9 cents in the year-ago period. Foe 2019, the company expects revenues of $105 million to $107 million.

The fourth-quarter EPS was in line and the full-year revenue guidance was above the consensus estimate.

The stock fell 1.94 percent to $30.30 in after-hours trading.

Idera Pharmaceuticals Inc IDRA reported a narrower loss of 45 cents per share compared to a loss of 66 cents per share last year. Analysts expected a wider loss of 51 cents per share.

The stock lost 4.20 percent to $2.51 in after-hours trading.

On The Radar

Earnings

• Orthopediatrics Corp KIDS (before the market open)
• BioXcel Therapeutics Inc BTAI (before the market open)
• Trinity Biotech plc TRIB (before the market open)
• Albireo Pharma Inc ALBO (before the market open)
• ArQule, Inc. ARQL (before the market open)
• Zai Lab Ltd ZLAB (before the market open)
• Syros Pharmaceuticals Inc SYRS (before the market open)
• Celldex Therapeutics, Inc. CLDX (after the market close)
• Kindred Biosciences Inc NKIN (after the market close)
• Pure Bioscience, Inc. Common Stock PURE (after the market close)
• Ocular Therapeutix Inc OCUL (after the market close)
• Aeglea Bio Therapeutics Inc AGLE (after the market close)
• T2 Biosystems Inc TTOO (after the market close)
• AcelRx Pharmaceuticals Inc ACRX (after the market close)
• Aravive Inc ARAV
• Arbutus Biopharma Corp ABUS (after the market close)
• Geron Corporation GERN (after the market close)
• HTG Molecular Diagnostics Inc HTGM (after the market close)
• Syndax Pharmaceuticals Inc SNDX (after the market close)
• Calithera Biosciences Inc CALA (after the market close)
• Navidea Biopharmaceuticals Inc NAVB (after the market close)
• Geron Corporation GERN (after the market close)
• DURECT Corporation DRRX (after the market close)
• Sunesis Pharmaceuticals, Inc. SNSS (after the market close)

IPO

ShockWave Medical, which sells medical devices to treat cardiovascular diseases, priced its upsized offering of 5.70 million shares at $17, ahead of the estimated price range of $14-$16.

The shares are to be listed on the Nasdaq under the ticker symbol SWAV.