The Daily Biotech Pulse: Split Verdict For Chemocentryx, NKarta-CRISPR In Cell Therapy Collaboration, Orphazyme's Clinical Trial Setback, 2 IPOs

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 6)

• GT Biopharma, Inc. GTBP
• IRadimed Corporation IRMD
• PRA Health Sciences, Inc. PRAH
• Quest Diagnostics Incorporated DGX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 6)

• 4D pharma plc LBPS
• Acutus Medical, Inc. AFIB
• Adagene Inc. ADAG
• Akouos, Inc. AKUS
• Akoya Biosciences, Inc. AKYA
• Aprea Therapeutics, Inc. APRE
• Aptinyx Inc. APTX
• Aquestive Therapeutics, Inc. AQST
• ARCA biopharma, Inc. ABIO
• Arcturus Therapeutics Holdings Inc. ARCT
• Assembly Biosciences, Inc. ASMB
• Atea Pharmaceuticals, Inc. AVIR
• Athersys, Inc. ATHX
• Atreca, Inc. BCEL
• Autolus Therapeutics plc AUTL (reacted to its first-quarter results)
• AVROBIO, Inc. AVRO
• Axcella Health Inc. AXLA
• Aytu Biopharma, Inc. AYTU (announced its quarterly results)
• Baudax Bio, Inc. BXRX
• Bellerophon Therapeutics, Inc. BLPH
• BioXcel Therapeutics, Inc. BTAI
• Biomerica, Inc. BMRA
• Cara Therapeutics, Inc. CARA
• Celyad Oncology SA CYAD
• Concert Pharmaceuticals, Inc. CNCE
• ContraFect Corporation CFRX
• Cue Biopharma, Inc. CUE
• Decibel Therapeutics, Inc. DBTX
• Deciphera Pharmaceuticals, Inc. DCPH
• Dyadic International, Inc. DYAI
• Eloxx Pharmaceuticals, Inc. ELOX
• Epizyme, Inc. EPZM (announced its first-quarter results)
• Evofem Biosciences, Inc. EVFM
• Finch Therapeutics Group, Inc. FNCH
• Galecto, Inc. GLTO
• Galera Therapeutics, Inc. GRTX
• Galmed Pharmaceuticals Ltd. GLMD
• Global Blood Therapeutics, Inc. GBT (reacted to its first-quarter results)
• GlycoMimetics, Inc. GLYC
• Haemonetics Corporation HAE
• Homology Medicines, Inc. FIXX
• InflaRx N.V. IFRX
• Inhibrx, Inc. INBX
• Inovio Pharmaceuticals, Inc. INO
• Inozyme Pharma, Inc. INZY
• Intercept Pharmaceuticals, Inc. ICPT (announced its first-quarter results)
• Ionis Pharmaceuticals, Inc. IONS
• Kala Pharmaceuticals, Inc. KALA
• Karyopharm Therapeutics Inc. KPTI
• Kiniksa Pharmaceuticals, Ltd. KNSA
• Kinnate Biopharma Inc. KNTE
• Kiromic BioPharma, Inc. KRBP
• LogicBio Therapeutics, Inc. LOGC
• Longeveron Inc. LGVN
• Lucira Health, Inc. LHDX
• MediciNova, Inc. MNOV
• Mesoblast Limited MESO
• Metacrine, Inc. MTCR
• NeuBase Therapeutics, Inc. NBSE
• NeuroBo Pharmaceuticals, Inc. NRBO
• NuCana plc NCNA
• Odonate Therapeutics, Inc. ODT
• Olema Pharmaceuticals, Inc. OLMA
• OptiNose, Inc. OPTN
• OraSure Technologies, Inc. OSUR (reacted to its first-quarter results)
• Otonomy, Inc. OTIC
• Oyster Point Pharma, Inc. OYST
• PainReform Ltd. PRFX
• Pluristem Therapeutics Inc. PSTI
• Protara Therapeutics, Inc. TARA (announced its first-quarter results)
• Pulmatrix, Inc. PULM
• Relay Therapeutics, Inc. RLAY
• Sana Biotechnology, Inc. SANA
• Sensei Biotherapeutics, Inc. SNSE
• Soleno Therapeutics Inc SLNO (announced its first-quarter results)
• Sigilon Therapeutics Inc SGTX
• Sonnet BioTherapeutics Holdings, Inc. SONN
• Sotera Health Co SHC
• SQZ Biotechnologies Company SQZ
• Syros Pharmaceuticals, Inc. SYRS (announced its first-quarter results)
• Trevi Therapeutics, Inc. TRVI
• Universe Pharmaceuticals INC UPC
• Vaxcyte, Inc. PCVX
• VectivBio Holding AG VECT
• Vor Biopharma Inc. VOR
• VYNE Therapeutics Inc. VYNE (announced its first-quarter results)
• Werewolf Therapeutics, Inc. HOWL
• Windtree Therapeutics, Inc. WINT
• Yumanity Therapeutics, Inc. YMTX
• Zogenix, Inc. ZGNX

Stocks In Focus

Nkarta and CRISPR Enter R&D Collaboration For Gene-edited Cell Therapies For Cancer

CRISPR Therapeutics CRSP and Nkarta, Inc. NKTX announced a strategic partnership to research, develop and commercialize CRISPR/Cas9 gene-edited cell therapies for cancer.

Under the agreement, the companies will co-develop and co-commercialize two CAR NK cell product candidates, one targeting the CD70 tumor antigen and the other target to be determined. In addition, the companies will advance the development of a novel NK+T product candidate. Nkarta will also obtain a license to CRISPR gene editing technology to edit five gene targets in an unlimited number of its own NK cell therapy products.

Nkarta shares jumped 22.69% to $31.80 in after-hours trading.

Chemocentryx' Avacopan Gets Split Votes On Efficacy In ANCA-Associated Vasculitis

ChemoCentryx, Inc. CCXI said the FDA's Arthritis Advisory Committee that evaluated avacopan for the treatment of antineutrophil cytoplasmic autoantibody-associated vasculitis gave a split verdict on whether the efficacy data support approval of avacopan. The committee voted 9-7 in favor of safety and 10-8 that the benefit-risk profile is adequate to support approval of avacopan at the proposed dose of 30 mg twice daily.

A briefing document released earlier this week did not give a very favorable assessment of the drug, sending its shares down about 45% in one session.

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

Merck-Eisai's Combo Therapy Accepted For Review as Treatment Options For Kidney Cancer and Endometrial Cancer

Merck, Inc. MRK and Eisai Co. Ltd. ESALY said the FDA has accepted and granted priority review for applications seeking two new approvals for the combination of Eisai's Lenvima and Merck's Keytruda.

The first set of applications, a supplemental new drug application for Lenvima and a supplemental biologic license application for Keytruda, are for the first-line treatment of patients with advanced renal cell carcinoma, and the second set of applications are for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

The FDA has set PDUFA dates, or target action dates, of Aug. 25 and 26, for the advanced RCC sNDA and sBLA applications, respectively, and Sept. 3, for the advanced endometrial carcinoma applications.

Orphazyme Lead Drug Flunks Pivotal Trial In Amyotrophic Lateral Sclerosis

Orphazyme A/S ORPH said the ORARIALS-01 pivotal trial of arimoclomol in amyotrophic lateral sclerosis did not meet its primary and secondary endpoints to show benefit in people living with ALS. No important safety signals were reported in the trial.
The stock was plunging 22.41% to $6.64 in premarket trading Friday.

GlaxoSmithKline, Vir Say European Regulators Begins Rolling Review Application For COVID-19 Antibody Treatment Candidate

GlaxoSmithKline plc GSK and Vir Biotechnology, Inc. VIR today announced that the European Medicines Agency has started a rolling review of data on sotrovimab, an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents, aged 12 years and over and weighing at least 40 kg, with coronavirus disease 2019 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.

Earnings

Natera, Inc. NTRA said its first-quarter revenues climbed 62% to $152.3 million and the loss per share of 74 cents was narrower than the consensus loss estimate of $1.02 per share. The company issued above consensus guidance for 2021.

The stock lost 6.48% to $102.55 in after-hours trading.

Aurinia Pharmaceuticals Inc. AUPH reported first-quarter revenues of $914,000. The loss per share widened from 23 cents to 40 cents.

The stock plunged 21.80% to $9.65 in after-hours trading.

Fluidigm Corporation FLDM said its first-quarter revenues rose 19% to $32.8 million and the net loss per share widened from 23 cents to 25 cents. Analysts expected a narrower loss of 14 cents per share. The full-year revenue guidance was also below consensus.

In after-hours trading, the stock fell 11.11% to $4.08.

Evofem reported revenues of $1.105 million for the first quarter and its loss per share widened from 40 cents to 56 cents. Analysts, on average, estimated a loss of 49 cents per share.

The stock surged up 22.39% to $1.49 in after-hours trading.

T2 Biosystems, Inc.'s TTOO first-quarter revenues jumped 173% to $7 million, and the net loss per share narrowed from 22 cents to 7 cents. The company issued in-line revenue guidance for 2021.

Separately, the company said it has modified the terms of its existing contract with the BARDA to accelerate the development of multiple products that are being funded under the contract. This is done by modifying the contract to advance future deliverables into the currently funded Option 1 of the contract for some products,

The stock rose 16.38% to $1.35 in after-hours trading.

On The Radar

Earnings

Elanco Animal Health Incorporated ELAN (before the market open)
Amneal Pharmaceuticals, Inc. AMRX (before the market open)
ANI Pharmaceuticals, Inc. ANIP (before the market open)
Avanos Medical, Inc. AVNS (before the market open)
Meridian Bioscience, Inc. VIVO (before the market open)
Radius Health, Inc. RDUS (before the market open)

IPOs

Talaris Therapeutics, Inc., a late-clinical stage cell therapy company priced its initial public offering of 8.825 million shares of common stock at a price to the public of $17 per share. All shares are being offered by Talaris. The gross proceeds to Talaris from the offering are expected to be approximately $150 million. The shares are expected to begin trading on the Nasdaq "TALS."
Anebulo Pharmaceuticals, Inc., a clinical-stage biotechnology company developing novel solutions for people suffering from cannabinoid overdose and substance addiction, priced its IPO of 3 million shares of common stock at a public offering price of $7 per share. The gross proceeds from the offering are expected to be approximately $21 million. The common stock is expected to begin trading on the Nasdaq under the ticker symbol "ANEB."