The Daily Biotech Pulse: DermTech Soars On Contract, Fluidigm Plunges On Earnings, Decision Day For Regeneron, Bioventus Debuts

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.

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