The Daily Biotech Pulse: Minerva, InflaRx Report Positive Data Readouts, Lucira COVID-19 Test Kit Available On Amazon, Decision Day For Heron

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 11)

• HOOKIPA Pharma Inc. HOOK
• Novo Nordisk A/S NVO
• West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 11)

• 4D Molecular Therapeutics, Inc. FDMT
• 4D pharma plc LBPS
• Acutus Medical, Inc. AFIB
• Adagene Inc. ADAG
• Adaptive Biotechnologies Corporation ADPT
• ADC Therapeutics SA ADCT
• Agile Therapeutics, Inc. AGRX
• Akouos, Inc. AKUS (reacted to presentation of non-clinical data on gene therapy candidates at the American Society of Gene and Cell Therapy meeting)
• Akoya Biosciences, Inc. AKYA
• Aprea Therapeutics, Inc. APRE
• Aptinyx Inc. APTX
• Aquestive Therapeutics, Inc. AQST
• ARCA biopharma, Inc. ABIO
• Arcturus Therapeutics Holdings Inc. ARCT (reacted to its first-quarter results)
• Assembly Biosciences, Inc. ASMB
• Atea Pharmaceuticals, Inc. AVIR
• Atreca, Inc. BCEL
• Athersys, Inc. ATHX
• Aurinia Pharmaceuticals Inc. AUPH
• Autolus Therapeutics plc AUTL
• AVROBIO, Inc. AVRO
• Axcella Health Inc. AXLA (announced initiation of Phase 2b trial of non-alcoholic steatohepatitis study)
• Aytu Biopharma, Inc. AYTU
• Baudax Bio, Inc. BXRX
• BioXcel Therapeutics, Inc. BTAI
• Biomerica, Inc. BMRA
• Bolt Biotherapeutics, Inc. BOLT
• Brainstorm Cell Therapeutics Inc. BCLI
• Calithera Biosciences, Inc. CALA
• Capricor Therapeutics, Inc. CAPR
• Cara Therapeutics, Inc. CARA (announced its first-quarter results)
• Celyad Oncology SA CYAD
• Centogene N.V. CNTG
• Cidara Therapeutics, Inc. CDTX
• Co-Diagnostics, Inc. CODX
• Concert Pharmaceuticals, Inc. CNCE
• Connect Biopharma Holdings Limited CNTB
• Corvus Pharmaceuticals, Inc. CRVS
• Deciphera Pharmaceuticals, Inc. DCPH
• Dyadic International, Inc. DYAI
• Emergent BioSolutions Inc. EBS
• Enveric Biosciences, Inc. ENVB
• Evofem Biosciences, Inc. EVFM
• Finch Therapeutics Group, Inc. FNCH
• Flexion Therapeutics, Inc. FLXN
• Gain Therapeutics, Inc. GANX (announced its first-quarter results)
• Galecto, Inc. GLTO
• Galmed Pharmaceuticals Ltd. GLMD
• Gemini Therapeutics, Inc. GMTX
• Geron Corporation GERN (reacted to its first-quarter results)
• GlycoMimetics, Inc. GLYC
• Gossamer Bio, Inc. GOSS
• Graybug Vision, Inc. GRAY
• Haemonetics Corporation HAE
• Harmony Biosciences Holdings, Inc. HRMY
• Hoth Therapeutics, Inc. HOTH
• HTG Molecular Diagnostics, Inc. HTGM
• Idera Pharmaceuticals, Inc. IDRA
• InflaRx N.V. IFRX
• Inhibrx, Inc. INBX
• Inovio Pharmaceuticals, Inc. INO (announced its first-quarter results)
• Intercept Pharmaceuticals, Inc. ICPT
• Ionis Pharmaceuticals, Inc. IONS
• Kinnate Biopharma Inc. KNTE
• Kiromic BioPharma, Inc. KRBP
• Larimar Therapeutics, Inc. LRMR (reacted to an early-stage clinical readout)
• Lucira Health, Inc. LHDX
• Lyra Therapeutics, Inc. LYRA
• Mesoblast Limited MESO
• MorphoSys AG MOR
• Nabriva Therapeutics plc NBRV
• NeuBase Therapeutics, Inc. NBSE
• NextCure, Inc. NXTC
• OptiNose, Inc. OPTN
• Otonomy, Inc. OTIC
• Oyster Point Pharma, Inc. OYST
• PainReform Ltd. PRFX
• Pluristem Therapeutics Inc. PSTI
• PMV Pharmaceuticals, Inc. PMVP
• Protara Therapeutics, Inc. TARA
• Provention Bio, Inc. PRVB
• Pulmatrix, Inc. PULM
• PTC Therapeutics, Inc. PTCT
• Qualigen Therapeutics, Inc. QLGN
• Reata Pharmaceuticals, Inc. RETA
• Recursion Pharmaceuticals, Inc. RXRX
• RedHill Biopharma Ltd. RDHL
• Relay Therapeutics, Inc. RLAY
• Sarepta Therapeutics, Inc. SRPT
• Sensei Biotherapeutics, Inc. SNSE
• Sigilon Therapeutics Inc SGTX (announced its first-quarter results)
• Soleno Therapeutics Inc SLNO
• Soligenix, Inc. SNGX
• Sonnet BioTherapeutics Holdings, Inc. SONN
• SQZ Biotechnologies Company SQZ
• Syros Pharmaceuticals, Inc. SYRS
• Talaris Therapeutics, Inc. TALS
• Talis Biomedical Corporation TLIS
• Terns Pharmaceuticals, Inc. TERN
• TherapeuticsMD, Inc. TXMD
• UroGen Pharma Ltd. URGN
• Vaxcyte, Inc. PCVX
• VectivBio Holding AG VECT
• Vor Biopharma Inc. VOR
• VYNE Therapeutics Inc. VYNE
• Werewolf Therapeutics, Inc. HOWL

Stocks In Focus

Minerva Announces Positive Results From Phase 3 Open-label Extension Study of Schizophrenia Treatment Candidate

Minerva Neurosciences, Inc. NERV announced results from the 40-week open-label extension of its phase 3 trial of roluperidone for the treatment of negative symptoms of schizophrenia, showing mean improvement in positive symptoms.

This improvement is measured by Positive and Negative Syndrome Scale and Negative Symptom Factor Score observed over one year in patients receiving both 64 mg and 32 mg doses.

"Results provide additional support for continued development of roluperidone and submission of NDA following completion of bioequivalence study and other work to address FDA comments from the Type C meeting held on Nov. 10," the company said.

The stock jumped 34.53% to $3 in after-hours trading.

InflaRx's Vilobelimab Aces Mid-stage Study In Inflammation of Blood Vessels

InflaRx announced positive topline results from its U.S. Phase 2 IXPLORE study with vilobelimab in patients with anti-neutrophil cytoplasmic auto-antibody -associated vasculitis, or AAV.

"Although the sample size of the trial was small and it is difficult to interpret results not powered to show statistical significance, patients across all three treatment groups demonstrated a strong response at week 16, and more patients treated with SOC plus vilobelimab had clinical remissions at various timepoints throughout the study compared to SOC plus placebo," the company said.

The stock rose 1.44% to $3.52 in after-hours trading.

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

Lucira Health Announces Availability of COVID-19 Test Kit On Amazon

Lucira said its Lucira CHECK IT COVID-19 test kit is now available on Amazon, Inc. AMZN in the US.

Each LUCIRA CHECK IT test kit provides a PCR quality test result at home in 30 minutes or less. After testing, users can also receive a free, text based digital LUCI PASS verified test result on their phone for work or travel. The product costs $55 and includes free standard shipping.

Morphosys, Incyte Commence Late-stage Study of Combo Treatment In First-line Setting In Diffuse Large B-cell Lymphoma Patients

Morphosys and Incyte INCY announced that the first patient has been dosed in the pivotal Phase 3 study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, or R-CHOP, a current standard-of-care, compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma.

Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation.

Sanofi, Cellectis Reach Deal For Alemtuzumab to Be Used as Lymphodepleting Agent In Latter's Clinical Trials

Cellectis S.A. CLLS and Sanofi SNY announced a partnership agreement and a supply agreement regarding alemtuzumab, an anti-CD52 monoclonal antibody, to be used as part of a lymphodepleting regimen in certain Cellectis sponsored UCART clinical trials.

Patients' lymphodepleting regimens reduce host immune cells and should improve allogeneic CAR T-cell expansion and persistence.

As part of the agreement, Sanofi will supply alemtuzumab to support Cellectis' clinical trials and the parties agreed to enter into discussions to execute a commercial supply of alemtuzumab under pre-agreed financial conditions.

Earnings

VolitionRx Limited VNRX reported a loss for its first quarter that was in line with the consensus.

The stock rose 11.50% to $3.49 in after-hours trading.

Ra Medical Systems, Inc. RMED said its first-quarter revenues fell from $1.4 million in 20202 to $1.1 million in 2021, and the net loss per share narrowed from $13.98 to $2.48. Analysts had estimates revenues of 990,000 and a loss of $2.94.

The stock moved up 14.46% to $3.80 in after-hours trading.

ClearPoint Neuro, Inc.'s CLPT first-quarter revenues climbed 29% year-over-year to $4 million and the loss per share was 13 cents, flat with the year-ago quarter. Analysts had estimated a loss of 14 cents per share.

The company guided to fiscal year 2021 revenues of $16 million to $17.5 million, ahead of the $15.83 million consensus estimate.

The stock gained 10.42% to $19.50 in after-hours trading.

Offerings

Praxis Precision Medicines, Inc. PRAX said it has commenced an underwritten public offering of 4 million shares of its common stock.. All shares in the offering are to be sold by Praxis. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

The stock fell 6.19% to $24.25 in after-hours trading.

Axonics, Inc. AXNX priced its public offering of 3.5 million shares of its common stock at a price of $50 per share. The gross proceeds from the offering to Axonics are expected to be $175 million. The offering is expected to close on May 14, subject to the satisfaction of customary closing conditions.

In after-hours trading, the stock was down 4.57% to $50.33.

On The Radar

PDUFA Dates

The Food and Drug Administration is scheduled to rule on Heron Therapeutics, Inc.'s HRTX new drug application for HTX001, which is being evaluated for postoperative pain. This is Heron's third attempt at gaining approval for the investigational drug.

Clinical Readouts

Graybug Vision will host a conference call and webcast to discuss the full-data analysis of the 12-month treatment phase of its Phase 2b ALTISSIMO trial Wednesday, at 8 am. The mid-stage trial is evaluating its investigational asset GB-102 in wet age-related macular degeneration.

ASGCT Meeting Presentations

Rocket Pharmaceuticals, Inc. RCKT: Updated results of a global Phase 1 study of lentiviral mediated gene therapy for adult and pediatric patients with pyruvate kinase deficiency

Cellectis: translational data obtained from the first patients enrolled prior to clinical hold, in the Phase 1 study of UCARTCS1, an allogeneic CAR T-Cell therapy targeting CS1 in patients with relapsed or refractory multiple myeloma

Earnings

PolyPid Ltd. PYPD (before the market open)
Minerva Neurosciences, Inc. NERV (before the market open)
IMV Inc. IMV (before the market open)
Veru Inc. VERU (before the market open)
Strongbridge Biopharma plc SBBP (before the market open)
Apyx Medical Corporation APYX (before the market open)
Curis, Inc. CRIS (after the close)
Acutus Medical, Inc. AFIB (after the close)
ADMA Biologics, Inc. ADMA (after the close)
Biocept, Inc. BIOC (after the close)
Cyclacel Pharmaceuticals, Inc. CYCC (after the close)
MannKind Corporation MNKD (after the close)
Eyenovia, Inc. EYEN (after the close)
Flexion Therapeutics, Inc. FLXN (after the close)
Panbela Therapeutics, Inc. PBLA (after the close)
Repro Med Systems, Inc. KRMD (after the close)
STRATA Skin Sciences, Inc. SSKN (after the close)
Salarius Pharmaceuticals, Inc. SLRX (after the close)
Marker Therapeutics, Inc. MRKR (after the close)