The Daily Biotech Pulse: Athenex, NeoGenomics And Amryt In M&A Mix, European Nod For Roche's Cancer Immunotherapy, Earnings Deluge Continues

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 4)

• AbbVie Inc. ABBV
• BioLineRx Ltd. BLRX (reacted to a positive data readout)
• BioNTech SE – ADR BNTX
• Celcuity Inc. CELC
• Cocrystal Pharma, Inc. COCP (moved on continuing momentum imparted by the company's update on its COVID-19 program)
• Lantheus Holdings Inc LNTH(announced its first-quarter results)
• PRA Health Sciences, Inc. PRAH
• Precipio, Inc. PRPO (announced its COVID-19 rapid antibody test is now available on Amazon, Inc. AMZN)
• Quest Diagnostics Incorporated DGX (reacted to an analyst upgrade)
• SI-BONE, Inc. SIBN (reacted to its first-quarter results)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 4)

• ACADIA Pharmaceuticals Inc. ACAD
• Acutus Medical, Inc. AFIB
• Adverum Biotechnologies Inc ADVM
• Agile Therapeutics, Inc. AGRX
• Akoya Biosciences, Inc. AKYA
• Aptinyx Inc. APTX
• Aquestive Therapeutics, Inc. AQST
• Assembly Biosciences, Inc. ASMB
• Atea Pharmaceuticals, Inc. AVIR
• Athenex, Inc., ATNX,
• AVROBIO, Inc. AVRO
• Aziyo Biologics, Inc. AZYO
• Bellerophon Therapeutics, Inc. BLPH
• BioXcel Therapeutics, Inc. BTAI
• Cara Therapeutics, Inc. CARA
• Celyad Oncology SA CYAD
• ChemoCentryx, Inc. CCXI (moved in reaction to mixed review by FDA staffers regarding its investigational asset to treat anti-neutrophil cytoplasmic auto-antibody-associated vasculitis)
• Concert Pharmaceuticals, Inc. CNCE (announced its first quarter results)
• Decibel Therapeutics, Inc. DBTX
• Emergent BioSolutions Inc. EBS
• Evofem Biosciences, Inc. EVFM
• Flexion Therapeutics, Inc. FLXN
• Galecto, Inc. GLTO (announced first-quarter results)
• GlycoMimetics, Inc. GLYC
• Gracell Biotechnologies Inc. GRCL
• Haemonetics Corporation HAE
• Hoth Therapeutics, Inc. HOTH
• InflaRx N.V. IFRX
• Inovio Pharmaceuticals, Inc. INO
• iRhythm Technologies, Inc. IRTC
• Karyopharm Therapeutics Inc. KPTI
• Kinnate Biopharma Inc. KNTE
• Kiromic BioPharma, Inc. KRBP
• LogicBio Therapeutics, Inc. LOGC
• Longboard Pharmaceuticals, Inc. LBPH
• Lucira Health, Inc. LHDX
• MediciNova, Inc. MNOV
• Mesoblast Limited MESO
• Metacrine, Inc. MTCR
• NeuroPace, Inc. NPCE
• NuCana plc NCNA
• Olema Pharmaceuticals, Inc. OLMA
• Pluristem Therapeutics Inc. PSTI
• Protara Therapeutics, Inc. TARA
• PTC Therapeutics, Inc. PTCT
• Quidel Corporation QDEL
• Relay Therapeutics, Inc. RLAY
• Sana Biotechnology, Inc. SANA
• Seagen Inc. SGEN
• Sigilon Therapeutics, Inc. SGTX
• Syros Pharmaceuticals, Inc. SYRS
• Vaccitech plc VACC (IPOed Friday)
• Vallon Pharmaceuticals Inc VLON
• Vor Biopharma Inc. VOR
• Voyager Therapeutics, Inc. VYGR
• VYNE Therapeutics Inc. VYNE

Stocks In Focus

Amryt Pharma to Buy Chiasma In an All-Stock Deal

Amryt AMYT announced the signing of a definitive agreement to acquire Chiasma, Inc. CHMA in an all-stock combination. The transaction has been approved and recommended by the boards of both Amryt and Chiasma.

Under the terms of the transaction, each share of Chiasma common stock will be exchanged for 0.396 Amryt ADSs, each representing five Amryt ordinary shares. As of the close of trading on May 4, Amryt's ordinary shares on AIM were 2 pounds ($2.78) per share and Amryt's ADS's on Nasdaq were $12.95 per ADS.

The acquisition, according to the companies, leverages Amryt's proven commercial execution ability, global infrastructure and integration capabilities to accelerate Mycapssa launch in the U.S. and international markets

Athenex Acquires CAR-NKT Cell Immunotherapy Company Kuur For Up to $185M

Athenex announced that it has acquired Kuur Therapeutics, Inc., a developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies.

Under the terms of the agreement, Athenex will pay $70 million upfront to Kuur shareholders and certain of its former employees and directors, comprised primarily of equity in Athenex common stock. Additionally, they are eligible to receive up to $115 million of milestone payments, which may be paid, at Athenex's sole discretion, in either cash or additional Athenex common stock, or a combination of both.

The stock was up 24.26% to $4.61 in after-hours trading.

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

NeoGenomics to Buy Remainder of Stake It Doesn't Already Own In Liquid Biopsy Platform Company Inivata For $390M

NeoGenomics, Inc. NEO, a provider of cancer-focused genetic testing services, announced it has agreed to acquire Inivata Ltd, a commercial-stage liquid biopsy platform company headquartered in Cambridge, England.

The acquisition follows a $25 million minority equity investment by NeoGenomics in Inivata in May 2020, at which time NeoGenomics was granted a fixed price option to purchase the remainder of Inivata for $390 million prior to Dec. 31, 2021.

The cash purchase price will be funded with balance sheet cash and through a private placement of equity. The acquisition is subject to satisfaction of certain customary closing conditions and is expected to close concurrently with the private placement in June 2021.

Tiziana Strikes Deal to Scout Clinical Partner For Liver Cancer Therapy In Japan

Tiziana Life Sciences plc TLSA said it has executed an agreement with Takanawa Japan for a strategic business development plan to Identify a clinical partner in Japan and other Asian countries for further clinical development of Milciclib for treatment in advanced hepatocellular carcinoma patients.

Tiziana shares were adding 1.96% to $2.6 in premarket trading.

Roche's Tecentriq Gets European Regulatory Nod For Certain Type of Lung Cancer

Roche Holding AG RHHBY said the European Commission has approved Tecentriq as a first-line treatment for adults with metastatic non-small cell lung cancer, whose tumors have high PD-L1 expression, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumour aberrations.

Tarsus Says FDA Accepts Its Regulatory Application For TP-05 as a Preventative Option For Lyme Disease

Tarsus Pharmaceuticals, Inc. TARS said the FDA has accepted its investigational new Drug application for TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease.

With this IND acceptance, the company expects to initiate a Phase 1 single ascending dose and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of TP-05 in healthy volunteers. Study initiation is anticipated in July.

Earnings

Esperion Therapeutics, Inc. ESPR reported first-quarter revenues of $8 million, up from $1.8 million in the year-ago period. The net loss per share widened from $2.84 from $3.50. Analysts, on average, estimated a loss of $2.52 per share.

The stock fell 20.28% to $20.40 in after-hours trading.

Cytosorbents Corporation's CTSO first-quarter revenues increased 10% year-over-year to $10.6 million. The loss per share remained flat at 10 cents per share. The consensus estimate had called for a loss of 3 cents per share.

In after-hours trading, the stock was down 6.49% to $8.50.

Inspire Medical Systems, Inc. INSP reported first-quarter revenues of $40.4 million, up 89% year-over-year. The loss per share narrowed from 67 cents to 60 cents. Citing positive trends, the company raised its full-year guidance.

The stock lost 6.19% to $212.50 in after-hours trading.

Offerings

Cocrystal Pharma announced that it has entered into an underwriting agreement with H.C. Wainwright & Co, under which the underwriter has agreed to purchase on a firm commitment basis 26 million shares of common stock at a price to the public of $1.54 per share. The closing of the offering is expected to occur on or about May 7, subject to satisfaction of customary closing conditions.

The stock plunged 19.16% to $1.73 in after-hours trading.

On The Radar

Clinical Readouts

Veru Inc. VERU will present at the European Society for Medical Oncology Breast Cancer Virtual Congress 2021, clinical results from the Phase 2 clinical study of enobosarm in heavily pretreated women with AR+ER+HER2- advanced breast cancer.

Earnings

Horizon Therapeutics Public Limited Company HZNP (before the market open)
EyePoint Pharmaceuticals, Inc. EYPT (before the market open)
Editas Medicine, Inc. EDIT (before the market open)
United Therapeutics Corporation UTHR (before the market open)
Clovis Oncology, Inc. CLVS (before the market open)
Vericel Corporation VCEL (before the market open)
10x Genomics, Inc. TXG (before the market open)
Passage Bio, Inc. PASG (before the market open)
Ionis Pharmaceuticals, Inc. IONS (before the market open)
NeoGenomics, Inc. (NEO) (before the market open)
OraSure Technologies, Inc. OSUR (after the close)
Ampio Pharmaceuticals, Inc. AMPE (after the close)
Arbutus Biopharma Corporation ABUS (after the close)
Aerie Pharmaceuticals, Inc. AERI (after the close)
Arena Pharmaceuticals, Inc. ARNA (after the close)
Aeglea BioTherapeutics, Inc. AGLE (after the close)
Allogene Therapeutics, Inc. ALLO (after the close)
Adaptive Biotechnologies Corporation ADPT (after the close)
AxoGen, Inc. AXGN (after the close)
ACADIA Pharmaceuticals Inc. ACAD (after the close)
Global Blood Therapeutics, Inc. GBT (after the close)
Synthetic Biologics, Inc. SYN (after the close)
Neurocrine Biosciences, Inc. NBIX (after the close)
Sarepta Therapeutics, Inc. SRPT (after the close)
REGENXBIO Inc. RGNX (after the close)
Rigel Pharmaceuticals, Inc. RIGL (after the close)
Vanda Pharmaceuticals Inc. VNDA (after the close)
Ocular Therapeutix, Inc. OCUL (after the close)
Glaukos Corporation GKOS (after the close)
Celcuity Inc. CELC (after the close)
CareDx, Inc CDNA (after the close)
Nevro Corp. NVRO (after the close)
Tandem Diabetes Care, Inc. TNDM (after the close)
OrthoPediatrics Corp. KIDS (after the close)
DiaMedica Therapeutics Inc. DMAC (after the close)
Turning Point Therapeutics, Inc. TPTX (after the close)
Outset Medical, Inc. OM (after the close)
TRACON Pharmaceuticals, Inc. TCON (after the close)
Lumos Pharma, Inc. LUMO (after the close)
NuVasive, Inc. NUVA (after the close)
Supernus Pharmaceuticals, Inc. SUPN (after the close)