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 Jan. 25)
- Abbott Laboratories ABT
- Alexion Pharmaceuticals, Inc. ALXN
- Alnylam Pharmaceuticals, Inc. ALNY
- Antares Pharma Inc ATRS
- Applied Molecular Transport Inc. AMTI
- argenx SE – ADR ARGX
- Aurinia Pharmaceuticals Inc AUPH (announced FDA approval for its oral lupus nephritis drug)
- Axonics Modulation Technologies Inc AXNX
- Beigene Ltd BGNE
- BioNano Genomics Inc BNGO (reacted to positive sell-side commentary)
- Cassava Sciences Inc SAVA
- ChemoCentryx Inc CCXI
- Clearpoint Neuro Inc CLPT
- DarioHealth Corp DRIO
- DermTech Inc DMTK
- Edap Tms SAEDAP
- Eli Lilly And Co LLY (reacted to positive Phase 3 data for its COVID-19 antibody treatment bamlanivimab)
- Ekso Bionics Holdings Inc EKSO
- ENDRA Life Sciences Inc NDRA
- Evogene Ltd EVGN
- EXACT Sciences Corporation EXAS
- GW Pharmaceuticals PLC- ADR GWPH
- Halozyme Therapeutics, Inc. HALO
- Harvard Bioscience, Inc. HBIO
- Illumina, Inc. ILMN
- Inari Medical Inc NARI
- Insmed Incorporated INSM
- Ionis Pharmaceuticals Inc IONS
- Jazz Pharmaceuticals PLC (NASDAQ: JAZZ
- Jounce Therapeutics IncJNCE
- Kintara Therapeutics Inc KTRA
- Krystal Biotech IncKRYS
- LeMaitre Vascular Inc LMAT
- Ligand Pharmaceuticals Inc. LGND
- Merit Medical Systems, Inc. MMSI
- Mustang Bio Inc MBIO
- Omnicell, Inc. OMCL
- Oramed Pharmaceuticals, Inc. ORMP
- Penumbra Inc PEN
- Profound Medical CorpPROF
- Pulse Biosciences Inc PLSE (announced CE mark approval for the CellFX System for the treatment of general dermatologic conditions)
- Renalytix AI PLC RNLX
- Rhythm Pharmaceuticals Inc RYTM
- Seelos Therapeutics Inc SEEL
- SI-Bone Inc SIBN
- Silence Therapeutics ADR Representing 3 Ord Shs SLN
- SpringWorks Therapeutics Inc SWTX
- Supernus Pharmaceuticals Inc SUPN
- Titan Medical Inc. TMDI
- Vericel Corp VCEL
- Vistagen Therapeutics Inc VTGN
Down In The Dumps
None of the biotech/medical device/diagnostic stocks hit 52-week highs in the session.
Stocks In Focus
Novartis Q4 Results Trail Expectations
Novartis AG NVS reported a 3% year-over-year increase in fourth-quarter sales to $12.77 billion. The core EPS increased from $1.32 to $1.34. Analysts, on average, estimated EPS of $1.36 on revenue of $12.87 billion.
For 2021, the company expects constant currency sales growth in the low-to-mid single digit range and core operating income to rise in the mid-single digit range.
The stock was down 3.77% to $94.76 premarket Tuesday.
Amarin Includes HealthNet In Patent Infringement Lawsuit
Amarin Corporation plc AMRN said it has expanded the scope of its Vascepa patent infringement lawsuit against Hikma Pharma to include Health Net, a health care insurance provider in the U.S.
Amarin alleged that Health Net has actively induced pharmacies to dispense, and patients to use, Hikma generic icosapent ethyl capsules in infringement of three U.S. patents related to Vascepa.
A vast majority of Vascepa prescriptions are for use in cardiovascular risk reduction, and Hikma does not have an FDA-approved indication for that use, and inducement for such use would infringe the subject patents, Amarin said.
Amarin shares were rising 2.12% to $7.72 premarket Tuesday.
Spectrum Pharma Rises On Fund Stake Disclosure
Spectrum Pharmaceuticals, Inc. SPPI shares rallied after BlackRock, Inc. BLK revealed in a filing it beneficially owns an aggregate of 27.82 million shares in the company, giving it a 19.1% stake.
The stock was up 2.55% to $4.02 premarket.
Lilly's Antibody Combo Treatment Aces Late-Stage Study In High-Risk COVID-19 Patients
Lilly said its bamlanivimab, 2,800 mg, and etesevimab, 2,800 mg, together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19, meeting the primary endpoint of the Phase 3 BLAZE-1 trial.
"Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial," Lilly said.
In premarket trading Tuesday, the shares were advancing 1.18% to $214.85.
Morphosys Set For $1.5M Milestone Payment From I-Mab As Phase 1 Study Of Monoclonal Antibody In Solid Tumors Commences
I-Mab ADR IMAB and Morphosys Ag MOR announced the commencement of a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MOR210/TJ210 monotherapy in patients with relapsed or refractory advanced solid tumors in the U.S., with the first patient being dosed.
MOR210/TJ210 is a monoclonal antibody developed by MorphoSys that is directed against complement factor C5a receptor 1.
MorphoSys will receive a $1.5-million payment from I-Mab for achieving this milestone under the license agreement between the two companies. The licensing deal between the companies announced in November 2018 provides I-Mab exclusive rights to develop and commercialize MOR210/TJ210 in Greater China and South Korea, while MorphoSys retains rights in other parts of the world.
In premarket trading Tuesday, I-Mab shares were moving up 2.78% to $54.44.
Axonics Q4, FY20 Revenue Guidance Below Consensus Estimates
Axonics Modulation preannounced fourth-quarter revenue in the range of $34.7 million to $34.9 million, sharply higher than the $9.9 million in the year-ago quarter. For the full-year, the company expects revenue of about $111.5 million compared to the year-ago revenue of $13.8 million.
The guidance range trailed the consensus estimates that call for revenue of $35.48 million for the quarter and $112.31 million for the year.
Merck's Keytruda Gets Label Expansion In Europe
Merck & Co., Inc. MRK said the European Commission has approved its Keytruda as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
The stock was down 0.18% to $81 in premarket trading Tuesday.
German coronavirus vaccine developer CureVac BV CVAC announced an underwritten public offering of 5 million common shares.
The stock was down 2.6% to $101.78 premarket Tuesday.
Seelos said it has commenced a proposed underwritten public offering of shares of common stock. All of the shares of common stock in the offering will be sold by the company.
The stock was tumbling 9.02% to $2.42 premarket Tuesday.
Lipocine Inc LPCN said it intends to offer shares of its common stock in an underwritten public offering. All of the shares in the proposed offering are to be sold by Lipocine.
In premarket trading Tuesday, the stock was retreating 11.36% to $1.95.
On The Radar
Rhythm Pharma is hosting a virtual event from 8-10 a.m. Tuesday to provide an update on its ongoing exploratory Phase 2 Basket Study and genetic sequencing efforts.
The company will present data for setmelanotide in individuals living with heterozygous obesity due to genetic variants in one of two alleles of the POMC, PCSK1 or LEPR gene, as well as SRC1 and SH2B1 deficiency obesities.
It will also provide an update on data from its sequencing efforts, which now comprise samples from approximately 37,500 individuals with severe obesity.
Johnson & Johnson JNJ (Q4 revenue of $22.48 billion vs. $21.67-billion estimate, adjusted EPS $1.86 vs. $1.82 consensus, FY21 adjusted EPS guidance above consensus)
Varian Medical Systems, Inc. VAR (after the close)
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