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 ARQT (Cowen initiated coverage of the stock at Outperform)

Brainstorm Cell Therapeutics Inc BCLI

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

Fate Therapeutics Inc FATE

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

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

Medpace Holdings Inc MEDP

Mersana Therapeutics Inc MRSN

PAVmed Inc PAVM

Regeneron Pharmaceuticals Inc REGN( upgraded by Jefferies to Buy)

TELA Bio Inc TELA

Down In The Dumps

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

• AcelRx Pharmaceuticals Inc ACRX
• Acorda Therapeutics Inc ACOR
• AngioDynamics, Inc. ANGO
• Aptevo Therapeutics Inc APVO
• Artelo Biosciences Inc ARTL
• Autolus Therapeutics Ltd – ADR AUTL
• Aytu Bioscience Inc AYTU
• Black Diamond Therapeutics Inc BDTX
• Blueprint Medicines Corp BPMC
• Chembio Diagnostics Inc CEMI
• Enanta Pharmaceuticals Inc ENTA
• Evolus Inc EOLS (reacted to its fourth-quarter results)
• Galectin Therapeutics Inc. GALT
• KITOV PHARMA LT/S ADR KTOV
• Lantheus Holdings Inc LNTH (announced financial results for the fourth quarter)
• MediciNova, Inc. MNOV
• Medigus Ltd. ADR MDGS
• Meridian Bioscience, Inc. VIVO
• Misonix Inc MSON
• Moleculin Biotech Inc MBRX
• Myriad Genetics, Inc. MYGN
• Neurometrix Inc NURO
• Neuronetics Inc STIM
• OncoSec Medical Inc ONCS
• Orthofix Medical Inc OFIX(reacted to its fourth-quarter results)
• Pacific Biosciences of California PACB
• PDS Biotechnology Corp PDSB
• Pfizer Inc. PFE
• Precipio Inc PRPO
• Predictive Oncology Inc POAI
• Pulse Biosciences Inc PLSE
• REDHILL BIOPHAR/S ADR RDHL(acquired rights to opioid-induced constipation drug)
• Sangamo Therapeutics Inc SGMO
• Sesen Bio Inc SESN
• Stealth BioTherapeutics Corp MITO
• Tetraphase Pharmaceuticals Inc TTPH
• Theratechnologies Inc THTX (announced its fourth-quarter results)
• Tonix Pharmaceuticals Holding Corp TNXP
• Zogenix, Inc. 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 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 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 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 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 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 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. 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 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 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 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 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 ESPR bempedoic acid in combination with Merck & Co., Inc.'s 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 LLY sNDA for Cyramza injection for intravenous use in combination with Roche Holdings AG Basel ADR 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. HBIO (before the market open)
• United Therapeutics Corporation UTHR (before the market open)
• Ionis Pharmaceuticals Inc IONS (before the market open)
• Momenta Pharmaceuticals, Inc. MNTA (before the market open)
• Endo International PLC ENDP (before the market open)
• Horizon Therapeutics PLC HZNP (before the market open)
• Amneal Pharmaceuticals Inc AMRX (before the market open)
• Moderna Inc MRNA (before the market open)
• Arena Pharmaceuticals, Inc. ARNA (after the close)
• Alimera Sciences Inc ALIM (after the close)
• ACADIA Pharmaceuticals Inc. ACAD (after the close)
• BioMarin Pharmaceutical Inc. BMRN (after the close)
• Adaptive Biotechnologies Corp ADPT (after the close)
• Global Blood Therapeutics Inc GBT (after the close)
• BioTelemetry Inc BEAT (after the close)
• Cyclacel Pharmaceuticals Inc CYCC (after the close)
• Portola Pharmaceuticals Inc PTLA (after the close)
• Silk Road Medical Inc SILK (after the close)
• Editas Medicine Inc EDIT (after the close)
• G1 Therapeutics Inc GTHX (after the close)
• Opko Health Inc. OPK (after the close)
• Viking Therapeutics Inc VKTX (after the close)