The Daily Biotech Pulse: Daiichi's Positive Breast Cancer Trial, Supernus Slumps, Axovant Reverse Split

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 May 7)

• Axsome Therapeutics Inc AXSM
• BioSig Technologies Inc BSGM
• GW Pharmaceuticals PLC- ADR GWPH (announced positive trial results for Epidiolex and strong Q1 results)
• Zynex Inc. ZYXI

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 7)

• AMAG Pharmaceuticals, Inc. AMAG (reacted to its Q1 results)
• Emergent Biosolutions Inc EBS
• Enochian Biosciences Inc ENOB
• KemPharm Inc KMPH
• Mylan NV MYL(reported Q1 results and did not issue any update on its strategic review)
• NGM Biopharmaceuticals Inc NGM
• Novavax, Inc. NVAX
• Strongbridge Biopharma plc SBBP
• Verastem Inc VSTM

Stock In Focus

Daiichi, AstraZeneca Report Positive Breast Cancer Trial Data

DAIICHI SANKYO/S ADR DSNKY and AstraZeneca plc AZN announced positive topline results for the pivotal Phase 2 study dubbed DESTINY-Breast01 trial of [fam-] trastuzumab deruxtecan, codenamed DS-8201, in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.

The companies said these results are likely to support planned global regulatory submissions, including the BLA with the FDA, which is expected to be done in the first half of 2019.

Roche Releases Positive Long-Term Results For Multiple Sclerosis Drug

Roche Holdings AG Basel ADR RHHBY announced new data for its Ocrevus being indicated for relapsing and primary progressive multiple sclerosis, which showed its effect on reducing the risk of disability progression is associated with higher exposure to the medicine and lower B-cell levels. It also showed the positive impact of Ocrevus in significantly reducing disability progression.

Ocrevus was approved both for relapsing form and primary progressive multiple sclerosis at diagnosis.

"These are the first data to show that higher OCREVUS exposure is associated with greater control of disability progression without impacting safety," said Stephen Hauser, chair of the Scientific Steering Committee of the OPERA studies.

The Week Ahead In Biotech: Conferences, Clinical Trial Readouts, Earnings And IPOs

Durect Aces Alcoholic Hepatitis Drug Mid-StageTrial, Posts Mixed Q1 Results

DURECT Corporation DRRX announced preliminary data from the ongoing Phase 2a trial of DUR-928 in alcoholic hepatitis, which showed that 10 patients have completed dosing to-date in the dose-escalation study, with eight patients treated at 30mg dose and two patients at 90mg dose.

"Seventy-eight percent (7/9) of the DUR-928 treated AH patients with Lille scores are classified as complete responders, 22% (2/9) are partial responders and none (0/9) were null responders," the company said.

Separately, the company reported a wider than expected loss for its first quarter but its revenues exceeded estimates.
The stock slid 13.58 percent to 69.49 cents in after-hours trading.

DelMar, Axovant Announce Reverse Stock Splits

DelMar Pharmaceuticals Inc DMPI said it will effect a 1-for-10 reverse stock split of its outstanding shares, with the split taking effect from May 8. The reverse split, done to satisfy the Nasdaq continued listing standards, has been approved by the board and doesn't require shareholder approval.

The stock slipped 2.75 percent to 36.8 cents in after-hours trading.

Axovant Sciences Ltd AXGT also announced a reverse stock split at a 1-for-8 ratio, The shares will begin to trade on a split-adjusted basis on the Nasdaq on May 8. On account of the split, the number of outstanding shares will be reduced from 182.2 million to 22.8 million.

The stock fell 1.83 percent to $1.07 in after-hours trading.

Earnings

Supernus Pharmaceuticals Inc SUPN reported first-quarter EPS of 34 cents on revenues of $85.47 million. The results trailed expectations. Supernus guided 2019 net product sales to $435 million to $455 million.

The stock fell 13.42 percent to $32 in after-hours trading.

Aerie Pharmaceuticals Inc AERI reported a narrower-than-expected loss for the first quarter, while revenues trailed expectations.

The stock moved down 8.24 percent to $35.10 in after-hours trading.

Myriad Genetics, Inc. MYGN's third-quarter revenues rose 18 percent to $216.6 million, trailing the $217.46 million consensus estimate. The adjusted earnings increased from 34 cents per share to 46 cents per share, while analysts estimated EPS of 42 cents per share.

The company's fiscal-year 2019 and fourth-quarter revenue guidance were below estimates but full-year adjusted EPS guidance was above consensus.

The stock declined 6.79 percent to $32 in after-hours trading.

Opko Health Inc. OPK's first-quarter revenues were below estimates and its net loss per share was wider than expectations.

The stock slipped 5.93 percent to $2.22 in after-hours trading.

Dermira Inc DERM's first-quarter revenues trailed expectations, while the net loss per share was narrower than expectations.

The stock ended down 4.76 percent to $10 in after-hours trading.

On The Radar

Earnings

Before the Market Open

• Amicus Therapeutics, Inc. FOLD
• Aquestive Therapeutics Inc AQST
• Avadel Pharmaceuticals PLC AVDL
• BioCryst Pharmaceuticals, Inc. BCRX
• Clearside Biomedical Inc CLSD
• Horizon Pharma PLC HZNP
• Radius Health Inc RDUS
• Jounce Therapeutics Inc JNCE
• Portola Pharmaceuticals Inc PTLA
• Intercept Pharmaceuticals Inc ICPT
• Moderna Inc MRNA
• Eyepoint Pharmaceuticals Inc EYPT

After the Close

• Akcea Therapeutics Inc AKCA
• Athersys, Inc. ATHX
• Aclaris Therapeutics Inc ACRS
• AcelRx Pharmaceuticals Inc ACRX
• Arena Pharmaceuticals, Inc. ARNA
• Assertio Therapeutics Inc ASRT
• Aimmune Therapeutics Inc AIMT
• Arrowhead Pharmaceuticals Inc ARWR
• Aileron Therapeutics Inc ALRN
• AxoGen, Inc Common Stock AXGN
• Apyx Medical Corp APYX
• Biocept Inc BIOC
• Bio-Rad Laboratories, Inc. BIO
• Dynavax Technologies Corporation DVAX
• Nektar Therapeutics NKTR
• Tricida Inc TCDA
• Revance Therapeutics Inc RVNC
• Miragen Therapeutics Inc MGEN
• Tetraphase Pharmaceuticals Inc TTPH
• Paratek Pharmaceuticals Inc PRTK
• Sangamo Therapeutics Inc SGMO
• Misonix, Inc. MSON
• Sarepta Therapeutics Inc SRPT
• ZIOPHARM Oncology Inc. ZIOP
• NewLink Genetics Corp NLNK
• CareDx Inc CDNA
• CymaBay Therapeutics Inc CBAY
• OptimizeRx Corporation OPRX
• Glaukos Corp GKOS
• Collegium Pharmaceutical Inc COLL
• Five Prime Therapeutics Inc FPRX
• Flexion Therapeutics Inc FLXN