Market Overview

The Daily Biotech Pulse: Menlo Flunks Midstage Trial, GW Pharma's Earnings, COVID-19 Updates

Share:
The Daily Biotech Pulse: Menlo Flunks Midstage Trial, GW Pharma's Earnings, COVID-19 Updates

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 Feb. 25)

Arcutis Biotherapeutics Inc (NASDAQ: ARQT) (Cowen initiated coverage of the stock at Outperform)

Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI)

Co-Diagnostics Inc (NASDAQ: CODX)(follow-on rally in reaction to CE mark approval for its COVI9-19 diagnostic kit)

Fate Therapeutics Inc (NASDAQ: FATE)

Halozyme Therapeutics, Inc. (NASDAQ: HALO)(reacted to its fourth-quarter results)

Iovance Biotherapeutics Inc (NASDAQ: IOVA)(reacted to reports of a potential sale)

Medpace Holdings Inc (NASDAQ: MEDP)

Mersana Therapeutics Inc (NASDAQ: MRSN)

PAVmed Inc (NASDAQ: PAVM)

Regeneron Pharmaceuticals Inc (NASDAQ: REGN)( upgraded by Jefferies to Buy)

TELA Bio Inc (NASDAQ: TELA)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Feb. 25)

  • AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)
  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • AngioDynamics, Inc. (NASDAQ: ANGO)
  • Aptevo Therapeutics Inc (NASDAQ: APVO)
  • Artelo Biosciences Inc (NASDAQ: ARTL)
  • Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)
  • Aytu Bioscience Inc (NASDAQ: AYTU)
  • Black Diamond Therapeutics Inc (NASDAQ: BDTX)
  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • Chembio Diagnostics Inc (NASDAQ: CEMI)
  • Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
  • Evolus Inc (NASDAQ: EOLS) (reacted to its fourth-quarter results)
  • Galectin Therapeutics Inc. (NASDAQ: GALT)
  • KITOV PHARMA LT/S ADR (NASDAQ: KTOV)
  • Lantheus Holdings Inc (NASDAQ: LNTH) (announced financial results for the fourth quarter)
  • MediciNova, Inc. (NASDAQ: MNOV)
  • Medigus Ltd. ADR (NASDAQ: MDGS)
  • Meridian Bioscience, Inc. (NASDAQ: VIVO)
  • Misonix Inc (NASDAQ: MSON)
  • Moleculin Biotech Inc (NASDAQ: MBRX)
  • Myriad Genetics, Inc. (NASDAQ: MYGN)
  • Neurometrix Inc (NASDAQ: NURO)
  • Neuronetics Inc (NASDAQ: STIM)
  • OncoSec Medical Inc (NASDAQ: ONCS)
  • Orthofix Medical Inc (NASDAQ: OFIX)(reacted to its fourth-quarter results)
  • Pacific Biosciences of California (NASDAQ: PACB)
  • PDS Biotechnology Corp (NASDAQ: PDSB)
  • Pfizer Inc. (NYSE: PFE)
  • Precipio Inc (NASDAQ: PRPO)
  • Predictive Oncology Inc (NASDAQ: POAI)
  • Pulse Biosciences Inc (NASDAQ: PLSE)
  • REDHILL BIOPHAR/S ADR (NASDAQ: RDHL)(acquired rights to opioid-induced constipation drug)
  • Sangamo Therapeutics Inc (NASDAQ: SGMO)
  • Sesen Bio Inc (NASDAQ: SESN)
  • Stealth BioTherapeutics Corp (NASDAQ: MITO)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Theratechnologies Inc (NASDAQ: THTX) (announced its fourth-quarter results)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • Zogenix, Inc. (NASDAQ: ZGNX)

See Also: The Week Ahead In Biotech: Biopharma Earnings Pick Up Pace

Stocks In Focus

Menlo Flunks In Itchy Skin Disease Study

Menlo Therapeutics Inc (NASDAQ: MNLO) said its Phase 2 study of serlopitant for the treatment of chronic pruritus of unknown origin did not meet the primary endpoint of showing a statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis.

Supernus Halts Development of ADHD Drug Following Second Failed Late-Stage Study

Supernus Pharmaceuticals Inc (NASDAQ: SUPN) said the Phase 3 P302 study of patients in the age group of 6 to 11 years did not meet the primary endpoint. The trial evaluated its SPN-810 for impulsive aggression, or IA, in patients with attention deficit hyperactivity disorder, or ADHD.

The company said it will halt all development activities on SPN-810 in IA.

The company also reported fourth quarter revenues of $100.4 million, down from $115.93 million. The earnings per share rose from 48 cents to 62 cents, and came in ahead of the 60-cent per share consensus. For the full-year 2020, the company expects net product sales in the range of $360 million to $390 million and operating earnings in the range of $70 million to $100 million.

The stock slipped 17.31% to $18.97 in after-hours trading.

Takeda Exercises Option to Acquire PvP Biologics For Up to $330M Following Phase 1 Celiac Disease Study

Takeda Pharmaceutical Co Ltd (NYSE: TAK) said it has acquired PvP Biologics Inc. following the conclusion of a Phase 1 proof-of-concept mechanism study of investigational drug TAK-062 for the treatment of uncontrolled celiac disease.

The company said it exercised its option to acquire PvP for a pre-negotiated upfront payment as well as development and regulatory milestones totaling up to $330 million. The companies earlier had a development and option agreement under which PvP was responsible for conduction R&D in exchange for funding by Takeda.

Takeda shares were rising 7.56% to $19.50 in pre-market trading.

Tonix To Develop COVID-19 Vaccine

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) announced a strategic collaboration with Southern Research to support development of a vaccine, codenamed TNX-1800, a live modified horsepox virus vaccine for percutaneous administration, to protect against COVID-19.

In premarket trading Wednesday, Tonix shares were advancing 47.13% to 60 cents.

Guardion Health Announces an Agreement to Develop an Immune-Supportive Formula

Guardion Health Sciences Inc (NASDAQ: GHSI) said it has been selected by Ho Wah Genting Berhad, a Malaysian listed company, to develop an immune- supportive formula for their consumer base.

In premarket trading Wednesday, the shares were spiking 22.03% to 36 cents.

Earnings

Insulet Corporation's (NASDAQ: PODD) fourth-quarter revenues climbed 27% to $209.4 million but EPS fell from 16 cents to 8 cents, while analysts estimated earnings of 11 cents per share. The company's revenue growth guidance was below consensus.

The stock ended down 11.55% to $174 in after-hours trading.

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) said its 2019 fourth-quarter revenues climbed 15% to $60.9 million. The EPS fell from 19 cents to 8 cents and also missed the consensus estimate of 11 cents. The company guided full-year 2020 revenues to $240 million to $260 million, below the consensus estimate of $274.55 million.

The stock slipped 7.59% to $10.60 in after-hours trading.

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) said its fourth quarter revenues increased from $6.65 million in 2018 to $109.08 million in year-ago quarter, ahead of the $105.3 million. CBD epilepsy medication Epidiolex came in at $104.5 million. The net loss per share narrowed from 20 cents to 7 cents, while analysts estimated a loss of 3 cents per share.

The stock declined 5.17% to $111 in after-hours trading.

Insmed Incorporated's (NASDAQ: INSM) fourth-quarter revenues surged 62% to $26.9 million. The net loss per share, however, widened from 22 cents to 38 cents, narrower than the consensus loss estimate of 40 cents per share. The company said it expects 2020 revenues in the range of $115 million to $119 million, ahead of the consensus estimate of $108.8 million.

The stock rallied 8.24% to $85 in after-hours trading.

Penumbra Inc (NYSE: PEN) reported fourth-quarter revenues of $145.3 million, up 20.3% year-over-year, and non-GAAP EPS climbed from 13 cents to 22 cents compared to the consensus estimate of 20 cents per share.

For 2020, the company expects revenues in the range of $635 million to $645 million, lower than the consensus estimate of $651.96 million,

The stock fell 6.90% to $164 in after-hours trading.

Aclaris Therapeutics Inc's (NASDAQ: ACRS) fourth-quarter net loss per share narrowed from 99 cents to 45 cents but revenues slipped from $1.77 million to $1.095 million. Analysts estimated a narrower loss of 39 cents per share.

The company said its cash, cash equivalents and marketable securities are sufficient to fund operations through the third quarter of 2021.

The stock advanced 8.03% to $1.48 in after-hours trading.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Esperion Therapeutics Inc's (NASDAQ: ESPR) bempedoic acid in combination with Merck & Co., Inc.'s (NYSE: MRK) Zetia for treating hypercholesterolemia. Last week, the FDA approved a monotherapy formulation of bempedoic acid for lowering LDL-cholesterol.

Adcom Meeting

FDA's Oncologic Drugs Advisory Committee is scheduled to discuss Eli Lilly And Co's (NYSE: LLY) sNDA for Cyramza injection for intravenous use in combination with Roche Holdings AG Basel ADR (OTC: RHHBY)'s Tarceva for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations.

Earnings

Harvard Bioscience, Inc. (NASDAQ: HBIO) (before the market open)
United Therapeutics Corporation (NASDAQ: UTHR) (before the market open)
Ionis Pharmaceuticals Inc (NASDAQ: IONS) (before the market open)
Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) (before the market open)
Endo International PLC (NASDAQ: ENDP) (before the market open)
Horizon Therapeutics PLC (NASDAQ: HZNP) (before the market open)
Amneal Pharmaceuticals Inc (NYSE: AMRX) (before the market open)
Moderna Inc (NASDAQ: MRNA) (before the market open)
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) (after the close)
Alimera Sciences Inc (NASDAQ: ALIM) (after the close)
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (after the close)
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the close)
Adaptive Biotechnologies Corp (NASDAQ: ADPT) (after the close)
Global Blood Therapeutics Inc (NASDAQ: GBT) (after the close)
BioTelemetry Inc (NASDAQ: BEAT) (after the close)
Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) (after the close)
Portola Pharmaceuticals Inc (NASDAQ: PTLA) (after the close)
Silk Road Medical Inc (NASDAQ: SILK) (after the close)
Editas Medicine Inc (NASDAQ: EDIT) (after the close)
G1 Therapeutics Inc (NASDAQ: GTHX) (after the close)
Opko Health Inc. (NASDAQ: OPK) (after the close)
Viking Therapeutics Inc (NASDAQ: VKTX) (after the close)

 

Related Articles (XBI + IBB)

View Comments and Join the Discussion!

Posted-In: Biotech Earnings M&A News Guidance FDA Top Stories Pre-Market Outlook

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com