The Daily Biotech Pulse: Vaxart Rebounds On Strong Vaccine Data, Pfizer's Beat-And-Raise Quarter, BioLineRx Data

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 May 3)

• AbbVie Inc. ABBV
• BioNTech SE – ADR BNTX (moving on momentum imparted by vaccine news flow)
• GT Biopharma Inc GTBP
• GW Pharmaceuticals PLC- ADR GWPH
• Lantheus Holdings Inc LNTH
• Orthopediatrics Corp KIDS
• Quest Diagnostics Incorporated DGX
• West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 3)

• Adverum Biotechnologies Inc ADVM
• Aptinyx Inc. APTX
• Atea Pharmaceuticals, Inc. AVIR
• AVROBIO, Inc. AVRO (reacted to the need for conducting a registrational trial for its gene therapy candidate for Fabry disease)
• Aziyo Biologics, Inc. AZYO
• Celyad Oncology SA CYAD
• Cumberland Pharmaceuticals Inc. CPIX
• Cyclerion Therapeutics, Inc. CYCN
• Decibel Therapeutics, Inc. DBTX
• Flexion Therapeutics, Inc. FLXN
• GBS Inc. GBS
• GlycoMimetics, Inc. GLYC (reacted to first-quarter results)
• Gracell Biotechnologies Inc. GRCL
• Karyopharm Therapeutics Inc. KPTI (announced first-quarter results and the appointment of new CEO)
• iRhythm Technologies, Inc. IRTC
• Longboard Pharmaceuticals, Inc. LBPH
• Lucira Health, Inc. LHDX
• Mesoblast Limited MESO
• Olema Pharmaceuticals, Inc. OLMA
• Osmotica Pharmaceuticals plc OSMT
• Protara Therapeutics, Inc. TARA
• PTC Therapeutics, Inc. PTCT
• Quidel Corporation QDEL
• Sana Biotechnology, Inc. SANA
• Sigilon Therapeutics, Inc. SGTX
• Vaccitech plc VACC (went public Friday)
• Vallon Pharmaceuticals Inc VLON
• Werewolf Therapeutics Inc HOWL (went public Friday)

Stocks In Focus

Kymera To Present Positive Pre-Clinical Data For Inflammatory Disease Drug

Kymera Therapeutics, Inc. KYMR announced that it will present at the American Association of Immunologists' Virtual IMMUNOLOGY2021 annual meeting May 13, new preclinical data demonstrating KT-474's broad and potent anti-inflammatory activity in both mechanistic and disease models of inflammation.

"These data have broadened the potential clinical impact of KT-474 in diseases driven by IL-33/36, as well as Th17-driven inflammation, and continue to demonstrate superiority both in vitro and in vivo over clinically active IRAK4 kinase inhibitors," said CEO Nello Mainolfi. 

The stock added 4.11% to $45.55 in after-hours trading.

Vaxart Says COVID-19 Vaccine Candidate Has Broad Cross-Coronavirus Activity, Higher Immune Response Than Rival Vaccines

Vaxart Inc VXRT announced at its key opinion leader event that new data obtained from its Phase 1 COVID-19 trial added to the evidence suggesting that VXA-CoV2-1 — its first COVID-19 oral vaccine construct that triggers mucosal immunity and includes both the S and the N SARS-Cov-2 proteins — has broad cross-coronavirus activity.

The company said its oral vaccine induced higher CD8+ T-Cell responses than those seen with Moderna, Inc. MRNA or Pfizer, Inc. PFE vaccines in comparative experiments.

The stock was adding 21.57% to $9.75 in premarket trading Tuesday.

ObsEva Completes Enrollment In Phase 3 Yeslty Study 

ObsEVa SA OBSV announced that it has completed enrollment for the Phase 3 EDELWEISS 3 trial of Yeslty for patients with moderate to severe endometriosis-associated pain. Enrollment completion is an important milestone, and data from the primary endpoint readout is expected in the fourth quarter, the company said. 

Related Link: Week Ahead In Biotech (May 2-8): ChemoCentryx Adcom, Ophthalmology Conference Presentations, Earnings Deluge

BioLineRx Reports Positive Late-Stage Motixafortide Study Results In Multiple Myeloma

BioLineRx Ltd. BLRX announced positive top-line results from the GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor, the standard-of-care, for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.

An analysis of data on all 122 enrolled patients found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared to placebo plus G-CSF, the company said. The combination was found to be safe and well-tolerated. 

The stock was up 8.46% at $3.46 in premarket trading Tuesday.

Earnings

Ligand Pharmaceuticals Incorporated LGND said its first-quarter revenues increased from $33.2 million in 2020 to $55.2 million in 2021. The company's adjusted net income per share increased from 89 cents to $1.41, ahead of the $1.12 per share consensus estimate. The company reaffirmed its 2021 revenue guidance of around $291 million and adjusted EPS of $6.15, trailing the consensus estimates.

The stock was down 4.98% to $138 in after-hours trading.

Offerings

Syneos Health, Inc. SYNH priced its previously announced underwritten secondary offering by affiliates of Thomas Lee Partners and Advent International Corporation of an aggregate of 7 million shares of its common stock.

Syneos Health clarified that it is not selling any shares and will not receive any proceeds from the proposed sale of the shares by the selling stockholders in the offering. The offering is expected to close on May 6, subject to customary closing conditions.

The stock lost 3.49% to $80.44 in after-hours trading.

On The Radar

Earnings

• Pfizer Inc. PFE (Rev. $14.6B Vs. $13.6B Estimate, Adj. EPS 93 cents Vs 78-cent Consensus, Raises FY21 Guidance)
• Seres Therapeutics, Inc. MCRB (before the market open)
• Sage Therapeutics, Inc. SAGE (before the market open)
• Jounce Therapeutics, Inc. JNCE (before the market open)
• Incyte Corporation INCY (before the market open)
• Concert Pharmaceuticals, Inc. CNCE (before the market open)
• Repligen Corporation RGEN (before the market open)
• Catalent, Inc. CTLT (before the market open)
• Lantheus Holdings, Inc. LNTH (before the market open)
• Neuronetics, Inc. STIM (before the market open)
• Bausch Health Companies Inc. BHC (before the market open)
• Zimmer Biomet Holdings, Inc. ZBH (before the market open)
• Pacira BioSciences, Inc. PCRX (before the market open)
• Agile Therapeutics, Inc. AGRX (after the close)
• Aquestive Therapeutics, Inc. AQST (after the close)
• Atara Biotherapeutics, Inc. ATRA (after the close)
• Aptose Biosciences Inc. APTO (after the close)
• Aziyo Biologics, Inc. AZYO (after the close)
• Arrowhead Pharmaceuticals, Inc. ARWR (after the close)
• Theravance Biopharma, Inc. TBPH (after the close)
• Exact Sciences Corporation EXAS (after the close)
• Jazz Pharmaceuticals plc JAZZ (after the close)
• Silk Road Medical, Inc SILK (after the close)
• Ultragenyx Pharmaceutical Inc. RARE (after the close)
• PTC Therapeutics, Inc. PTCT (after the close)
• Sangamo Therapeutics, Inc. SGMO (after the close)
• Penumbra, Inc. PEN (after the close)
• Inspire Medical Systems, Inc. INSP (after the close)
• Globus Medical, Inc. GMED (after the close)
• Esperion Therapeutics, Inc. ESPR (after the close)
• Deciphera Pharmaceuticals, Inc. DCPH (after the close)
• Cerus Corporation CERS (after the close)
• Cytosorbents Corporation CTSO (after the close)
• Invitae Corporation NVTA (after the close)
• DURECT Corporation DRRX (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates