The Daily Biotech Pulse: Priority Review For Amgen's Asthma Treatment, Evaxion Reports Positive Skin Cancer Readout, Quidel Recalls Lyra COVID-19 Test

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 July 7)

  • Ambrx Biopharma Inc. AMAM
  • Alkermes plc ALKS
  • AtriCure, Inc. ATRC
  • Bio-Rad Laboratories, Inc. BIO
  • Bio-Techne Corporation TECH
  • Biohaven Pharmaceutical Holding Company Ltd. BHVN (pre-announced better-than-expected Q2 sales of migraine drug)
  • BioLife Solutions, Inc. BLFS
  • Edwards Lifesciences Corporation EW
  • Globus Medical, Inc. GMED
  • Intuitive Surgical, Inc. ISRG
  • IVERIC bio, Inc. ISEE
  • Laboratory Corporation of America Holdings LH
  • Novo Nordisk A/S NVO
  • Opiant Pharmaceuticals, Inc. OPNT (announced positive topline pharmacokinetic data for nasal spray of opioid overdose drug)
  • ResMed Inc. RMD
  • Syneos Health, Inc. SYNH
  • Virpax Pharmaceuticals, Inc. VRPX (provided a progress update on its pipeline of product candidates)
  • West Pharmaceutical Services, Inc. WST
  • Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 7)

  • 89bio, Inc. ETNB
  • AbCellera Biologics Inc. ABCL
  • Achilles Therapeutics plc ACHL
  • Adverum Biotechnologies, Inc. ADVM
  • Akouos, Inc. AKUS
  • Aerovate Therapeutics, Inc. AVTE (went public June 30)
  • Akouos, Inc. AKUS
  • Alzamend Neuro, Inc. ALZN
  • Angion Biomedica Corp. ANGN
  • Assembly Biosciences, Inc. ASMB
  • Ayala Pharmaceuticals, Inc. AYLA
  • Aytu Biopharma, Inc. AYTU
  • Aziyo Biologics, Inc. AZYO
  • Baudax Bio, Inc. BXRX
  • Biodesix, Inc. BDSX
  • Biophytis SA BPTS
  • BioXcel Therapeutics, Inc. BTAI
  • Black Diamond Therapeutics, Inc. BDTX
  • Bolt Biotherapeutics, Inc. BOLT
  • Calithera Biosciences, Inc. CALA
  • Cellectis S.A. CLLS
  • Celyad Oncology SA CYAD
  • Checkmate Pharmaceuticals, Inc. CMPI
  • Chembio Diagnostics, Inc. CEMI
  • Cogent Biosciences, Inc. COGT
  • Cullinan Oncology, Inc. CGEM
  • CytomX Therapeutics, Inc. CTMX
  • CVRx, Inc. CVRX (IPOed June 30)
  • DiaMedica Therapeutics Inc. DMAC
  • Exelixis, Inc. EXEL
  • Freeline Therapeutics Holdings plc FRLN
  • Galapagos NV GLPG
  • Galecto, Inc. GLTO
  • Gemini Therapeutics, Inc. GMTX
  • GlycoMimetics, Inc. GLYC
  • IMV Inc. IMV
  • Inhibikase Therapeutics, Inc. IKT
  • Kala Pharmaceuticals, Inc. KALA
  • Kiromic BioPharma, Inc. KRBP
  • Madrigal Pharmaceuticals, Inc. MDGL
  • Mersana Therapeutics, Inc. MRSN
  • Miromatrix Medical Inc. MIRO
  • Molecular Templates, Inc. MTEM
  • Nabriva Therapeutics plc NBRV
  • NeuBase Therapeutics, Inc. NBSE
  • NRx Pharmaceuticals, Inc. NRXP (announced training of physicians to use COVID-19 treatment in Georgia)
  • Oyster Point Pharma, Inc. OYST
  • Protara Therapeutics, Inc. TARA
  • Provention Bio, Inc. PRVB
  • Rockwell Medical, Inc. RMTI
  • Sensei Biotherapeutics, Inc. SNSE
  • Sonnet BioTherapeutics Holdings, Inc. SONN
  • Terns Pharmaceuticals, Inc. TERN
  • uniQure N.V. QURE
  • VectivBio Holding AG VECT
  • Vor Biopharma Inc. VOR
  • Voyager Therapeutics, Inc. VYGR
  • VYNE Therapeutics Inc. VYNE
  • Yumanity Therapeutics, Inc. YMTX

Stocks In Focus

Amgen-AstraZeneca's Regulatory Application For Asthma Treatment Accepted For Priority Review

Amgen, Inc. AMGN announced the FDA has accepted a biologics license application and granted priority review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca plc AZN.

The PDUFA goal date for a decision by the FDA is set for the first quarter of 2022.

Amgen shares were up 0.11% at $243.49 in premarket trading.

BeiGene's Chinese Regulatory Application Seeking Label Expansion For Tislelizumab In Esophageal Cancer Accepted For Review

BeigGene, Ltd. BGNE announced the Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental BLA for the anti-PD1 antibody tislelizumab for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma who have disease progression following or are intolerant to first-line standard chemotherapy.

This is the eighth marketing application for tislelizumab, of which five have been approved in China, the company said.

SI-Bone Announces Publication Of Positive Results For Implant System To Treat Joint Pain

SI-BONE, Inc., SIBN announced the publication of two-year results from the SALLY study, a prospective multicenter clinical trial of the iFuse-3D Implant System, showing marked and sustained improvements in sacroiliac joint pain, patient function and quality of life that are consistent with results from three prior multicenter prospective clinical trials using the iFuse implant.

The results also demonstrated a significant reduction in the proportion of study subjects taking opioids for SI joint pain. The three objective physical function tests, namely active straight leg raise, five times sit-to-stand and transitional timed up-and-go, included in the study, all of which showed statistically significant improvements from baseline.

The stock was up 1.28% at $29.20 in premarket trading.

Can-Fite Gears Up To Begin Pivotal Late-Stage Study of Namodenoson In Liver Cancer

Can-Fite BioPharma Ltd. CANF announced it has completed preparatory work ahead of the anticipated initiation of patient enrollment for its pivotal Phase 3 registration trial of Namodenoson in the treatment of hepatocellular carcinoma, the most common form of liver cancer.

The company also said it has received agreement from both the FDA and European Medicines Agency on the protocol and plans to submit it for Institutional Review Board approvals in the coming weeks.

The stock was adding 3.57% to $2.32 in premarket trading.

Lilly Inks R&D Collaboration With Privately Held Verge Genomics To Develop ALS Therapies

Eli Lilly and Company LLY and Verge Genomics, a biotech company that has created an all-in-human, artificial-intelligence-powered drug discovery and development platform focused on therapies for serious genetic diseases, announced a three-year collaboration to research and develop novel therapies for the treatment of amyotrophic lateral sclerosis.

Under the terms of the three-year agreement, Verge will receive up to $25 million in upfront, equity investment and potential near-term payments, with additional milestone value of $694 million and potential downstream royalties.

Related Link: The Week Ahead In Biotech: Focus On Chemocentryx FDA Decision, Conference Presentations In A Light Week

Evaxion Announces Positive Readouts From Early Stage Melanoma Studies

Evaxion Biotech A/S EVAX announced results from both its Phase 1/2a trial of cancer immunotherapy EVX-01 in metastatic melanoma and interim Phase 1/2a trial of cancer immunotherapy EVX-02 in adjuvant melanoma.

Data from the trial of EVX-01 in combination with a PD-1 checkpoint inhibitor showed a safety profile with only Grade 1 and 2 adverse events observed. Combined therapy with EVX-01 demonstrated an objective response rate of 67% across all nine patients compared with historical data of 40% with anti-PD1 treatment alone. The company expects to initiate a Phase 2b trial in December.

Data from the first patients in the EVX-02 trial showed T-cell activation, even in assays that had not been pre-stimulated. Based on this readout, Evaxion said it will continue to generate more data from the trial with the aim of initiating a Phase 2 trial with EVX-02 in an adjuvant setting in the second quarter of 2022.

In premarket trading, the stock was advancing 11.32% to $7.57.

Quidel Recalls Lyra COVID-19 Test Due To Potential False Negative Results

Quidel Corporation QDEL announced the recall of its Lyra SARS-CoV-2 Assay due to a significant risk of false negative results for patients with relatively high amounts of SARS‐CoV‐2 virus potentially causing the PCR amplification to occur before a cycle‐threshold value less than or equal to 5 when using certain thermocyclers.

The stock was down 1.88% at $118 in premarket trading.

On The Radar

Clinical Readouts

Morphic Holding, Inc. MORF will host a webcast and conference call at 8 a.m. Friday, July 9 to discuss results from the Phase 1 study of MORF-057 in inflammatory bowel disease. The company will also present the data at the European Crohn's and Colitis Organization 16th Annual Congress.

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

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