The Daily Biotech Pulse: FDA Nod For AstraZeneca, AbbVie-Allergan Deal Clears Antitrust Hurdle

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 May 5)

• Adverum Biotechnologies Inc ADVM ( reacted to a positive clinical readout)
• Akebia Therapeutics Inc AKBA (announced positive topline results for a late-stage study of drug to treat anemia in chronic kidney disease patients)
• BIO-TECHNE Corp TECH
• ChemoCentryx Inc CCXI
• Cytokinetics, Inc. CYTK
• DexCom, Inc. DXCM
• GenMark Diagnostics, Inc GNMK(announced strong quarterly results)
• Immunomedics, Inc. IMMU
• Immunovant Inc IMVT
• Masimo Corporation MASI
• Minerva Neurosciences Inc NERV
• ORIC Pharmaceuticals Inc ORIC
• Regeneron Pharmaceuticals Inc REGN(reported quarterly results and announced positive results for its immuno-oncology therapy in treating skin cancer)
• Seattle Genetics, Inc. SGEN
• TG Therapeutics Inc common stock TGTX(announced positive late-stage readout for combo therapy in treating chronic lymphocytic leukemia)
• Vermillion, Inc. VRML
• Zynex Inc. ZYXI

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 5)

• Biofrontera AG BFRA
• Lyra Therapeutics Inc LYRA (IPOed May 1)

Stocks In Focus

AstraZeneca's Farxiga Gets Label Expansion to Treat Heart Failure

AstraZeneca plc AZN announced FDA approval for Farxiga oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure.

In after-hours trading, the stock edged up 0.52% to $53.75.

AbbVie Gets Antitrust Clearance For Allergan Buy

AbbVie Inc ABBV and Allergan plc AGN announced they have received clearance from the FTC for the pending acquisition of the latter by the former. The clearance was obtained following Allergan's decision to divest its autoimmune disorder treatment brazikumab to AstraZeneca as well as exocrine pancreatic insufficiency therapy Zenpep and another pancreatic enzyme preparation to Nestlé S.A. NSRGY.

Allergan has also decided that only one of its directors will join AbbVie board, and the companies have amended the transaction agreement accordingly. The closing of the deal is now contingent on the Irish High Court approval. A hearing for the same is scheduled today.

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

Qiagen Expects Q2 Results Above Consensus; Suspends Guidance

Qiagen NV QGEN pre-announced second-quarter results, expecting net sales growth of at least 12% at constant exchange rates and adjusted earnings per share of at least 40 cents at CER. The company said the sales growth for the quarter is likely to have benefited from the ongoing significant demand for various products and solutions in pandemic testing, partly offset by lower sales in other areas of its portfolio.

The company also suspended its full-year outlook. It is scheduled to release its first-quarter results after the close.

Cidara Announces Positive Data For Anti-fungal and Anti-viral Candidates

Cidara Therapeutics Inc CDTX announced publication of 10 abstracts reporting new clinical and preclinical data on the Company's antifungal rezafungin program and preclinical data on its Cloudbreak antiviral program that was to be present at the now cancelled European Congress of Clinical Microbiology and Infectious Diseases 2020 meeting.

Data from the STRIVE Phase 2 trial showed that a single dose of rezafungin has a Day 5 success rate of 62.3% compared to 55.7% for the approved echinocandin comparator, caspofungin. Additionally, preclinical data in a rabbit model of Candida endophthalmitis showed treatment with rezafungin significantly lowered fungal burden as compared to micafungin, azole as well as vehicle control in multiple eye tissues.

New findings on the company's Cloudbreak antiviral platform candidate CD377 showed the candidate's tolerability and stability in preclinical invitro and invivo studies. In animal testing, single doses of CD377 showed a greater decrease in lung viral burden and cytokine levels compared to oseltamivir, dosed for five days.

The stock added 3.68% to $3.10 in after-hours trading.

Offerings

Kura Oncology Inc KURA said it has commenced an underwritten public offering to sell shares of its common stock.

In after-hours trading, the stock fell 1.03% to $14.46.

Silk Road Medical Inc SILK said it has priced an underwritten public offering of 6.81 million shares of its common stock at $39 per share. About 4.89 million shares are being offered by the company and the remaining 1.92 million by certain selling shareholders. The company expects to generate gross proceeds of about $75 million from the offering. The offering is expected to close May 8.

The stock fell 7% to $40.25 in after-hours trading.

Earnings

Supernus Pharmaceuticals Inc's SUPN first-quarter revenues rose 11% to $95 million, ahead of the $83.48 million consensus estimate, and earnings per share, or, EPS, came in at 40 cents compared to the Street estimate of 28 cents. The company suspended its full-year guidance.

The stock jumped 22.69% to $27.20 in after-hours trading.

Clovis Oncology Inc CLVS reported Rubraca product revenues of $42.6 million compared to the consensus estimate of $41.41 million. The net loss, however, came in wider than expectations at $1.39 per share.

The stock gained 9.73% to $8.46 in after-hours trading.

Axonics Modulation Technologies Inc AXNX reported first-quarter revenues of $26.3 million, way ahead of the consensus of $15.16 million. The loss per share came in at 43 cents compared to the 61-cents consensus estimate.
In after-hours trading, the stock was up 7.42% to $35.75.

Myriad Genetics, Inc. MYGN reported below-consensus revenues and an unexpected loss for its first quarter.

The stock slipped 8.13% to $13.61 in after-hours trading.

Jazz Pharmaceuticals PLC's JAZZ first-quarter revenues climbed 5% to $535 million, trailing estimates of $544.55 million. The adjusted EPS came in at 45 cents, below the consensus estimate of 67 cents. The company lowered its full-year guidance.

In after-hours trading, the stock slipped 6.26% to $103.50.

Cytosorbents Corp CTSO reported first-quarter revenues of $8.7 million compared to the average analysts' estimate of $7 million. The loss came in at 10 cents per share compared to the 13 cents per share loss estimated by analysts. The company also hinted at higher second-quarter revenues relative to the first quarter, thanks to CytoSorb, which is used as a treatment of cytokine storm in many countries worldwide.

The stock gained 7.52% to $10.01 in after-hours trading.

T2 Biosystems Inc TTOO reported below-consensus first-quarter revenues and a wider-than-expected loss.

The stock slumped 9.67% to 54 cents in after-hours trading.

Agile Therapeutics Inc AGRX reported a wider-than-expected first-quarter loss.

In premarket trading, the stock declined 9.19% to $2.57.

Danish diabetes drug company Novo Nordisk A/S NVO said its first-quarter sales as well as EPS climbed 16%, thanks to pandemic-related stocking.

On The Radar

Axcella Health Inc AXLA is due to announce top-line data from a study that is assessing the impact of AXA1125 and AXA1957 on safety, tolerability and effects on structures and functions of the liver in adult subjects with nonalcoholic fatty liver disease, or NAFLD.

Earnings

• Eyepoint Pharmaceuticals Inc EYPT (before the market open)
• Horizon Therapeutics PLC HZNP (before the market open)
• Constellation Pharmaceuticals Inc CNST (before the market open)
• Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
• IVERIC bio Inc ISEE (before the market open)
• Blueprint Medicines Corp BPMC (before the market open)
• BioCryst Pharmaceuticals, Inc. BCRX (before the market open)
• Strongbridge Biopharma plc SBBP (before the market open)
• Evofem Biosciences, Inc. EVFM (before the market open)
• Neurocrine Biosciences, Inc. NBIX (before the market open)
• Jounce Therapeutics Inc JNCE (before the market open)
• PPD Inc PPD (before the market open)
• Zoetis Inc ZTS (before the market open)
• Ionis Pharmaceuticals Inc IONS (before the market open)
• TherapeuticsMD Inc TXMD (before the market open)
• Avanos Medical Inc AVNS (before the market open)
• Aerie Pharmaceuticals Inc AERI (after the close)
• Allogene Therapeutics Inc ALLO (after the close)
• ADMA Biologics Inc ADMA (after the close)
• Alexion Pharmaceuticals, Inc. ALXN (after the close)
• AxoGen, Inc Common Stock AXGN (after the close)
• Global Blood Therapeutics Inc GBT (after the close)
• Pacific Biosciences of California PACB (after the close)
• Theravance Biopharma Inc TBPH (after the close)
• BioTelemetry Inc BEAT (after the close)
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO (after the close)
• Veracyte Inc VCYT (after the close)
• Ligand Pharmaceuticals Inc. LGND (after the close)
• Precigen Inc PGEN (after the close)
• Ironwood Pharmaceuticals, Inc. IRWD (after the close)
• OraSure Technologies, Inc. OSUR (after the close)
• NuVasive, Inc. NUVA (after the close)
• Sarepta Therapeutics Inc SRPT (after the close)
• Natera Inc NTRA (after the close)
• Vanda Pharmaceuticals Inc. VNDA (after the close)
• Qiagen NV QGEN (after the close)
• Enanta Pharmaceuticals Inc ENTA (after the close)
• Esperion Therapeutics Inc ESPR (after the close)
• G1 Therapeutics Inc GTHX (after the close)
• Quidel Corporation QDEL (after the close)
• Cytokinetics (after the close)
• MannKind Corporation MNKD (after the close)
• Atara Biotherapeutics Inc ATRA (after the close)
• Cellular Biomedicine Group Inc CBMG (after the close)
• Opko Health Inc. OPK (after the close)
• VIVUS, Inc. VVUS (after the close)
• Ironwood Pharmaceuticals, Inc. IRWD (after the close)
• Ultragenyx Pharmaceutical Inc RARE (after the close)