The Daily Biotech Pulse: J&J Announces CEO Transition, FibroGen's Roxadustat Approved In Europe, GeoVax, Sorrento Announce COVID-19 Vaccine Data

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 Aug. 19)

• Alkermes plc ALKS
• Edwards Lifesciences Corporation EW
• Monte Rosa Therapeutics, Inc. GLUE
• Novo Nordisk A/S NVO
• Intuitive Surgical, Inc. ISRG
• Regeneron Pharmaceuticals, Inc. REGN
• ResMed Inc. RMD
• West Pharmaceutical Services, Inc. WST
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 19)

• ABVC BioPharma, Inc. ABVC
• ACADIA Pharmaceuticals Inc. ACAD
• Accelerate Diagnostics, Inc. AXDX
• Adicet Bio, Inc. ACET
• ADMA Biologics, Inc. ADMA
• Adverum Biotechnologies, Inc. ADVM
• Akouos, Inc. AKUS
• Annexon, Inc. ANNX
• Applied Genetic Technologies Corporation AGTC
• Aptinyx Inc. APTX
• Aptose Biosciences Inc. APTO
• Aravive, Inc. ARAV
• Ardelyx, Inc. ARDX
• Arena Pharmaceuticals, Inc. ARNA
• Aridis Pharmaceuticals, Inc. ARDS
• Assertio Holdings, Inc. ASRT
• Atara Biotherapeutics, Inc. ATRA
• AVROBIO, Inc. AVRO
• Axsome Therapeutics, Inc. AXSM
• Biomea Fusion, Inc. BMEA
• BioSig Technologies, Inc. BSGM
• bluebird bio, Inc. BLUE
• Candel Therapeutics, Inc. CADL (IPOed July 27)
• Catabasis Pharmaceuticals, Inc. CATB
• Catalyst Biosciences, Inc. CBIO
• Cellectar Biosciences, Inc. CLRB
• Cellectis S.A. CLLS
• Checkmate Pharmaceuticals, Inc. CMPI
• Chemomab Therapeutics Ltd. CMMB
• Clovis Oncology, Inc. CLVS
• CNS Pharmaceuticals, Inc. CNSP
• Codex DNA, Inc. DNAY
• CymaBay Therapeutics, Inc. CBAY
• CytomX Therapeutics, Inc. CTMX
• Deciphera Pharmaceuticals, Inc. DCPH
• Edgewise Therapeutics, Inc. EWTX
• Eiger BioPharmaceuticals, Inc. EIGR
• Epizyme, Inc. EPZM
• FibroGen, Inc. FGEN
• Flexion Therapeutics, Inc. FLXN
• Gemini Therapeutics, Inc. GMTX
• Global Blood Therapeutics, Inc. GBT
• GlycoMimetics, Inc. GLYC
• Graphite Bio, Inc. GRPH
• Harpoon Therapeutics, Inc. HARP
• HCW Biologics Inc. HCWB
• Hepion Pharmaceuticals, Inc. HEPA
• Heron Therapeutics, Inc. HRTX
• Histogen Inc. HSTO
• Immunocore Holdings plc IMCR
• IN8bio, Inc. INAB (IPOed July 30)
• InflaRx N.V. IFRX
• InMed Pharmaceuticals Inc. INM
• iRhythm Technologies, Inc. IRTC
• Kala Pharmaceuticals, Inc. KALA
• Karyopharm Therapeutics Inc. KPTI
• Keros Therapeutics, Inc. KROS
• Kinnate Biopharma Inc. KNTE
• Kiromic BioPharma, Inc. KRBP
• Kronos Bio, Inc. KRON
• Kura Oncology, Inc. KURA
• Lantern Pharma Inc. LTRN (announced preclinical data for LP-184 in glioblastoma)
• Liminal BioSciences Inc. LMNL
• Madrigal Pharmaceuticals, Inc. MDGL
• MaxCyte, Inc. MXCT
• Metacrine, Inc. MTCR
• Nektar Therapeutics NKTR
• Neoleukin Therapeutics, Inc. NLTX
• NuCana plc NCNA
• Oncorus, Inc. ONCR
• OncoSec Medical Incorporated ONCS
• Orchard Therapeutics plc ORTX
• Otonomy, Inc. OTIC
• Passage Bio, Inc. PASG
• Pliant Therapeutics, Inc. PLRX
• PMV Pharmaceuticals, Inc. PMVP
• Protara Therapeutics, Inc. TARA
• PTC Therapeutics, Inc. PTCT
• Qualigen Therapeutics, Inc. QLGN
• Recursion Pharmaceuticals, Inc. RXRX
• Regencell Bioscience Holdings Limited RGC
• Rhythm Pharmaceuticals, Inc. RYTM
• Rockwell Medical, Inc. RMTI
• RxSight, Inc. RXST (IPOed July 30)
• Sage Therapeutics, Inc. SAGE
• Sangamo Therapeutics, Inc. SGMO
• Scopus BioPharma Inc. SCPS
• Seres Therapeutics, Inc. MCRB
• SI-BONE, Inc. SIBN
• Sigilon Therapeutics, Inc. SGTX
• Sio Gene Therapies Inc. SIOX
• Spectrum Pharmaceuticals, Inc. SPPI
• Stoke Therapeutics, Inc. STOK
• Syros Pharmaceuticals, Inc. SYRS
• T2 Biosystems, Inc. TTOO
• Talis Biomedical Corporation TLIS
• Titan Pharmaceuticals, Inc. TTNP
• Tiziana Life Sciences PLC TLSA
• Trevi Therapeutics, Inc. TRVI
• Trillium Therapeutics Inc. TRIL
• Unicycive Therapeutics, Inc. UNCY
• UroGen Pharma Ltd. URGN
• VYNE Therapeutics Inc. VYNE
• X4 Pharmaceuticals, Inc. XFOR
• ZIOPHARM Oncology, Inc. ZIOP

Stocks In Focus

Marker Therapeutics Announces Award of $13.1M Funding for Blood Cancer Research

Marker Therapeutics, Inc. MRKR announced it received notice of a ‘product development research' award totaling about $13.1 million from the Cancer Prevention and Research Institute of Texas to support its Phase 2 clinical trial of its lead MultiTAA-specific T cell product MT-401.

The CPRIT award is intended to support the adjuvant arm of the Phase 2 clinical trial evaluating MT-401 when given as an adjuvant therapy to patients with acute myeloid leukemia following a hematopoietic stem cell transplant. The primary objectives of the adjuvant arm of the trial are to evaluate relapse-free survival after MT-401 treatment when compared with a randomized control group.

The stock was soaring 15.48% to $1.94 in premarket trading.

Click here to access Benzinga's FDA Calendar

FibroGen's Roxadustat Approved to Treat Anemia In Chronic Kidney Disease Patients

FibroGen, Inc. FGEN and Japanese partner Astellas Pharma Inc ALPMY announced that the European Commission has approved roxadustat, under the brand name Evrenzo, for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease.

The FDA earlier this month refused to approve roxadustat.

FibroGen shares were up 7.93% at $12.38 in premarket trading.

Fate Announces Positive Phase 1 Data For NK Cell Cancer Immunotherapy Candidates

Fate Therapeutics, Inc. FATE positive interim clinical data from its FT516 and FT596 programs for patients with relapsed / refractory B-cell lymphoma.

The company noted that 10 of 14 Patients in FT596 single-dose escalation cohorts 2 and 3 achieved objective response, 7 patients achieved complete response, including 2 of 3 patients treated with FT596 in combination with rituximab following autologous CD19 CAR T-cell therapy.

The company also said 8 of 11 Patients in FT516 multi-dose escalation cohorts 2 and 3 achieved objective response, including 6 patients that achieved complete response. Additionally, 5 of 8 responders continue in the ongoing response at median time of 5.2 months.

The stock was slipping 8.93% to $77.98 in premarket trading.

Sorrento Says Its COVID-19 Vaccine Candidate Proved Effective Against Original and Variant Strains In Animal Studies

Sorrento Therapeutics, Inc. SRNE announced preprint publication of preclinical data for its protein-based COVID-19 vaccine candidate, showing the candidate has potential to elicit potent neutralizing B-cell immune responses against the original SARS-CoV-2 strain and its emerging variants, including beta and delta.

The stock was up 5.40% at $8.70 in premarket trading.

J&J CEO Alex Gorsky to Transition to Role of Chairman, Joaquin Duato Named CEO

Johnson & Johnson JNJ announced Alex Gorsky, currently Chairman and chief executive officer, will serve as Executive Chairman of the company and transition the CEO role to Joaquin Duato, currently vice chairman of the company's executive committee, effective Jan. 3, 2022. Following the transition of the CEO role, Duato will also be appointed as a member of the company's board.

J&J shares were down 0.57% at $177.55 in premarket trading.

Impel NeuroPharma Gains On Insider Buying

Impel NeuroPharma, Inc. IMPL revealed in a filing that Adrian Adams, its CEO and President, acquired 20,000 shares in the company.

In premarket trading, the stock was gaining 6.81% to $4.12.

Kadmon Announces Commercial Availability of Recently-approved Graft-versus-host Disease Treatment

Kadmon Holdings, Inc. KDMN announced that Rezurock, 200 mg once daily tablets, is now commercially available for shipment to prescribed patients in the U.S.

Rezurock was approved on July 16 by the Food and Drug Administration for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease, after failure of at least two prior lines of systemic therapy.

GeoVax Presents Data Showing Broader Immunity Provided By Vaccines Manufactured Using Its MVA Platform

GeoVax Labs, Inc. GOVX presented data from ongoing studies of its preventive vaccine against COVID-19, showing its modified virus Ankara - virus like particle platform, has a design strategy for vaccines that is expected to induce broader immunity through inclusion of multiple structural and nonstructural proteins from the target pathogen.

Expression of the SARS-CoV-2 spike, membrane and envelope proteins by MVA supports the in vivo formation of virus like particles, which induce both antibody and T-cell responses. The incorporation of sequence-conserved nonstructural proteins can provide targets for T-cell responses to increase the breadth and function of vaccine-induced immune responses.

The stock was jumping 84.65% to $7.95 in premarket trading.

Tiziana Sets Forth On Plan to Transform Into a Bermuda-listed Corporation

Tiziana said it has formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences Ltd, a Bermuda-incorporated company, as the ultimate parent company of the of the Tiziana Group.

The decision follows the company's determination that the interests of its business and shareholders are best served by aligning the place of the listing with the principal business activities of the Tiziana Group, which are predominately based in the U.S.

If the plan is approved, the shares of the company will be delisted from London and the shares of the new parent company of the Tiziana group will be directly listed on the Nasdaq.

Offerings

Progenity, Inc. PROG priced its previously announced underwritten public offering of 40 million shares of its common stock and warrants to purchase up to 40 million shares of its common stock.

Progenity expects to receive gross proceeds from the underwritten public offering of approximately $40 million.

The stock was slumping 49% to 76 cents in premarket trading.

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