The Daily Biotech Pulse: DermTech Soars On Contract, Fluidigm Plunges On Earnings, Decision Day For Regeneron, Bioventus Debuts - iShares Biotechnology ETF (NASDAQ:IBB)

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 Feb. 11)

10X Genomics Inc TXG
9 Meters Biopharma Inc NMTR
Abbott Laboratories ABT
Acasti Pharma Inc ACST (reacted to its quarterly results)
Advaxis, Inc. ADXS
Agios Pharmaceuticals Inc AGIO
Alimera Sciences Inc ALIM
Alkermes Plc ALKS
Allakos Inc ALLK
Anchiano Therapeutics Ltd – ADR (NASDAQ: ANCN
AngioDynamics, Inc. ANGO
Applied Molecular Transport Inc. AMTI
Apyx Medical Corp APYX
Arrowhead Pharmaceuticals Inc ARWR
Artelo Biosciences Inc ARTL
Aslan Pharmaceuticals Ltd ASLN
AtriCure Inc. ATRC
Avanos Medical Inc AVNS
Beigene Ltd BGNE
Bio-Path Holdings Inc BPTH (announced receipt of third patent related to manufacture of platform technology)
Bolt Biotherapeutics Inc BOLT
C4 Therapeutics Inc CCCC
Cancer Genetics Inc CGIX (reacted to an update to merger terms with StemoniX)
Cara Therapeutics Inc CARA
Celcuity Inc CELC
Cellular Biomedicine Group Inc CBMG
Clearpoint Neuro Inc CLPT
Clearside Biomedical Inc CLSD
Collegium Pharmaceutical Inc COLL
Collplant Biotechnologies Ltd – ADR CLGN
Edap Tms SA EDAP
Evogene Ltd EVGN
Eyenovia Inc EYEN
G1 Therapeutics Inc GTHX
Gamida Cell Ltd GMDA ( reacted to a positive late-stags readout)
Genetron Holdings Ltd – ADRGTH
Glaukos Corp GKOS
Guardion Health Sciences Inc GHSI
Ideaya Biosciences Inc IDYA
Illumina, Inc. ILMN
Immunocore Holdings PLC – ADR IMCR (IPOed Friday)
Inari Medical Inc NARI
iTeos Therapeutics Inc ITOS
Kintara Therapeutics Inc KTRA
Kodiak Sciences Inc KOD
Landos Biopharma Inc LABP
Leap Therapeutics Inc LPTX
Ligand Pharmaceuticals Inc. LGND
Lucira Health Inc LHDX (IPOed Friday)
Medpace Holdings IncMEDP
Merrimack Pharmaceuticals Inc MACK
Nantkwest Inc NK
NeoGenomics, Inc. NEO
Neubase Therapeutics Inc NBSE
Novocure Ltd NVCR
Opiant Pharmaceuticals Inc OPNT
Organogenesis Holdings Inc ORGO
Pacific Biosciences of California Inc PACB (announced a strategic investment from Japan's Softbank)
PDS Biotechnology Corp PDSB
Pharvaris BV PHVS
Plus Therapeutics Inc PSTV (reacted to insider buying)
PLx Pharma Inc PLXP
Prelude Therapeutics Inc PRLD
Prothena Corporation PLC PRTA
Pulmatrix Inc PULM
Purple Biotech ADR PPBT
Salarius Pharmaceuticals Inc SLRX
Sana Biotechnology Inc SANA (IPOed Feb. 4)
Seelos Therapeutics Inc SEEL
Sesen Bio Inc SESN
Solid Biosciences Inc SLDB
Supernus Pharmaceuticals Inc SUPN
SurModics, Inc. SRDX
Synlogic Inc SYBX
Syneos Health Inc SYNH
Veracyte Inc VCYT
Verrica Pharmaceuticals Inc VRCA
Xencor Inc XNCR
ZIOPHARM Oncology Inc. ZIOP
Zynerba Pharmaceuticals Inc ZYNE

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Feb. 11)

Galapagos ADR Representing Ord Shs GLPG (announced discontinuation of partnered late-stage trials testing experimental drug ziritaxestat in patients with pulmonary fibrosis)
Sensei Biotherapeutics Inc SNSE
Vallon Pharmaceuticals Inc VLON (IPOed Wednesday)

Stocks In Focus

Genmab, Seagen Files For Approval of Cervical Cancer Drug

Genmab 10 GMAB and Seagen Inc SGEN announced the submission of a biologics license application to the FDA, seeking accelerated approval for tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

DermTech Secures Contract From Texas State For Melanoma Gene Expression Test

DermTech Inc DMTK said it has contracted, effective Feb.1, with Blue Cross Blue Shield of Texas to make its pigmented lesion assay available to its approximately 6 million members in the state of Texas.

The company's gene expression-based PLA for the early detection of melanoma is now available as an in-network option for Blue Cross Blue Shield of Texas' Blue Essential, Traditional Indemnity and PPO/POS membership, the company said.

The stock soared 31.10% to $69.55 in after-hours trading.

Protalix Out-licenses Respiratory Disease Candidate

Protalix Biotherapeutics Inc PLX announced an exclusive worldwide license agreement with SarcoMed USA Inc. for alidornase alfa, or PRX–110, for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery.

SarcoMed will be responsible for the identification and selection of pharmaceutical candidates under the license, and the clinical research and development of such candidates.

Protalix is entitled to an initial cash payment of $3.5 million, subject to certain conditions, and to additional regulatory and commercial milestone payments and tiered royalties on net sales of products that are commercialized under the license agreement.

In premarket trading Thursday, Protalix shares were up 1.91% to $5.86.

Kaleido Rallies On Fund Buying

Kaleido Biosciences Inc KLDO shares rose after SEC filings revealed that Flagship Ventures Fund IV bought 215,001 shares in the company at a price of $11.5 apiece.

The stock added 15.17% to $12.68 in after-hours trading.

Lyra Gains Ground On Insider Transactions

Lyra Therapeutics Inc LYRA shares rose after a series of filings revealed that company insiders, including CEO Maria Palasis, and SVP Regulatory Affairs, Pamela Nelson, acquired shares through exercising of stock options.

The stock jumped 29.69% to $14.02 in after-hours trading.

Iveric Bio Retreats On Stake Selling By Fund

IVERIC bio Inc ISEE shares pulled back after BML Investment Partners liquidated some of its holdings in the company. The fund now owned 315,9207 shares, or a 3.5% stake, in the biopharma that focuses on developing therapies for retinal diseases.

The stock slid 4.25% to $5.63 in after-hours trading.

Earnings

Fluidigm Corporation FLDM reported fourth-quarter revenues and loss that missed the consensus estimates. The company's first-quarter revenue guidance was also below consensus.

The stock declined 17.35% to $5.86 in after-hours trading.

Vanda Pharmaceuticals Inc. VNDA reported fourth-quarter revenues of $67.65 million, higher than $60.93 million in the year-ago quarter. The EPS increased from 8 cents per share to 15 cents per share, a penny ahead of estimates. For the fiscal year 2021, the company guided to revenues of $270 million to $300 million, in line with the consensus estimate of $279.4 million.

The stock jumped 8.57% to $16.73 in after-hours trading.

Aethlon Medical, Inc. AEMD reported a wider-than-expected loss for its fourth quarter.

In after-hours trading, the stock fell 7.79% to $2.84.

Offerings

Kadmon Holdings Inc KDMN announced its intent to offer, subject to market conditions and other factors, $150 million aggregate principal amount of convertible senior notes due 2027 in a private offering to qualified institutional buyers.

In after-hours trading, the stock fell 7.1% to $4.97.

Pulmatrix announced that it has entered into definitive agreements with healthcare-focused institutional investors for the sale of 20 million shares of its common stock, at a purchase price of $2 per share, in a registered direct offering priced at-the-market.

The stock was plunging 18.49% to $2.16 in premarket trading Thursday.

Cancer Geneticsit said it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of an aggregate of approximately 4.22 million shares of its common stock, at a purchase price of $1.75 per share, for gross proceeds of approximately $7.4 million in a registered direct offering priced at-the-market.

The stock was slumping 18.49% to $7.01 in premarket trading Thursday.

Predictive Oncology Inc POAI said it has entered into securities purchase agreements with certain healthcare-focused institutional investors to raise about $17.5 million through the issuance of 2.78 million shares of its common stock at a purchase price of $6.30 per share in a registered direct offering priced at-the-market.

The stock was slipping 7.53% to $1.72 in premarket trading Thursday.

Onconova Therapeutics Inc ONTX priced its underwritten public offering of 25 million shares of its common stock at a public offering price of $1 per share, for raising gross proceeds of about $25 million.

In premarket trading Thursday, the stock was losing 4.31% to $1.11

Applied Therapeutics Inc APLT said it plans to make a public offering of 3 million shares of its common stock in an underwritten registered public offering.

The stock slipped 1.14% to $26.93 in after-hours trading.

TherapeuticsMD Inc TXMD announced an underwritten public offering of its common stock. All of the shares in the offering are to be sold by the company.

In after-hours trading, the stock was down 3.69% to $2.09.

Travere Therapeutics Inc TVTX said it intends to offer and sell, in an underwritten public offering and subject to market and other conditions, $150 million worth of its common stock. All of the shares are being offered by Travere.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Regeneron Pharmaceuticals Inc's REGN BLA for evinacumab for the treatment of homozygous familial hypercholesterolemia, an ultra-rare, inherited form of high cholesterol.

Clinical Readouts

Avrobio Inc AVRO will present at the 17th Annual WORLDSymposium, new phase 1/2 data for AVR-RD-02 ex vivo lentiviral vector, autologous gene therapy for Gaucher disease.

ASCO Genitourinary Cancers Symposium Presentations

Clovis Oncology Inc CLVS: Pharmacokinetics and safety data from the phase 1b RAMP study evaluating rucaparib plus enzalutamide in patients with metastatic castration-resistant prostate cancer

Infinity Pharmaceuticals Inc. INFI: Preliminary analysis of a phase 2 data for eganelisib in combination with and Bristol-Myers Squibb Co's BMY nivolumab compared to nivolumab monotherapy in patients with advanced urothelial carcinoma
BioXcel Therapeutics Inc BTAI: updated Phase 1b/2 data for BXCL701 in combination with Merck & Co., Inc.'s MRK in men with metastatic castration-resistant prostate cancer

Veru Inc VERU: updated clinical results for the Phase 1b and as well as an update on the Phase 2 clinical trial of VERU-111 in metastatic castration-resistant prostate cancer who failed an androgen receptor targeting agent

Earnings:

Karyopharm Therapeutics Inc KPTI (before the market open)
Genocea Biosciences Inc GNCA (before the market open)
Prothena Corporation PLC PRTA (before the market open)
Myovant Sciences Ltd MYOV (before the market open)
Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
Applied Genetic Technologies Corp AGTC (before the market open)
Alkermes Plc ALKS (before the market open)
Laboratory Corp. of America Holdings LH (before the market open)
AVITA Medical Inc RCEL (after the market close)
Aytu Bioscience Inc AYTU (after the market close)
Otonomy Inc OTIC (after the market close)
Illumina, Inc. ILMN (after the market close)
Ultragenyx Pharmaceutical Inc RARE (after the market close)
Bio-Rad Laboratories, Inc. Class A Common Stock BIO (after the market close)

IPOs

Durham, North Carolina-based Bioventus Inc. priced its upsized initial public offering of 8 million shares at $13, well below the estimated price range of $16-$18 apiece. The medical device company's shares will begin trading on the Nasdaq under the ticker symbol BVS.

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