iShares NASDAQ Biotechnology Index Fund (NASDAQ: IBB), (ACIU) – The Daily Biotech Pulse: Valneva signs COVID-19 vaccine supply contract in Europe, I-Mab points to agreement with China, DermTech commits to its orientations
Here is an overview of the main developments in the field of biotechnology over the past 24 hours.
Focus on actions
MorphoSys COO to leave to pursue other opportunities
MorphoSys SA (NASDAQ: MOR) announced that Roland Wandeler has decided to step down as chief operating officer and board member, effective December 31, to pursue other opportunities. After Wandeler leaves, the sales organization headed by Joe Horvat, US Managing Director, will report directly to Managing Director Jean-Paul Kress.
The stock lost 2.35% to $ 11.20 in pre-market.
GeoVax In-licenses Phase 2 Candidate COVID-19 vaccine
GeoVax Labs Inc. (NASDAQ: GOVX) announced that it has entered into an exclusive licensing agreement with the City of Hope cancer research and treatment organization.
The agreement grants GeoVax the exclusive rights to further develop and commercialize an investigational multi-antigen SARS-CoV-2 vaccine, developed in City of Hope for immunocompromised patients, which is currently under investigation in an ongoing phase 2 clinical trial and shows high potential for use in the general population as a primary and / or general booster vaccine against COVID-19 worldwide.
The stock was up 3.82% to $ 4.35 in pre-trade.
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CodexDNA acquires synthetic biology products company Eton Bioscience
Codex DNA, Inc. (NASDAQ: DNAY) announced that it has agreed to acquire Eton Bioscience, a private provider of synthetic biology products and services. Under the terms of the agreement, Codex DNA will pay approximately $ 13 million in cash for the acquisition.
“Together with the Eton team, we will be able to accelerate our strategy of growing the BioXp system in the synthetic biology market,” said Todd Nelson, CEO of Codex DNA.
Separately, the company reported lower-than-consensus results for the third quarter.
In pre-market trade, Codex DNA increased 7.21% to $ 9.96.
I-Mab Announces Distribution Agreement for Pediatric Growth Hormone Drug Candidate for Growth Hormone Deficiency in China
I-Mab (NASDAQ: IMAB) announced that it has entered into a strategic collaboration agreement with Jumpcan Pharmaceutical Group, a Chinese pharmaceutical company, for the development, manufacture and commercialization of the highly differentiated, long-acting recombinant human growth hormone d ‘I-Mab, eftansomatropin alfa in mainland China.
Under the terms of the collaboration agreement, Jumpcan will make an upfront payment of 224 million yuan ($ 35.05 million) to I-Mab and, once the development, registration and sales milestones have been reached, certain milestone payments of up to 1.792 billion yuan, which royalty-free payments total up to 2.016 billion yuan. In addition, I-Mab and Jumpcan will share the profits generated by marketing the product in Mainland China on a 50/50 basis, under which I-Mab will be entitled to receive double-digit tiered royalties on net sales. .
The stock was up 8.08% to $ 62.10 in after-hours trading.
Nanobiotix Announces Positive Preclinical Data for Radiotherapy Activated NBTXR3
Nanobiotix (NASDAQ: NBTX) Preclinical data to be presented at the Society for Immunotherapy of Cancer meeting show that radiotherapy-activated NBTXR3 increases infiltration of CD8 + T cells and modulates the T cell receptor repertoire, as well as a marked modulation of the immunopeptidome in treated tumor cells in a mouse model.
KalVista to Begin Phase 3 Study of Angioedema Treatment Candidate Following Positive End-of-Phase Meeting
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) said it had a productive late-phase 2 meeting with the Food and Drug Administration regarding KVD900 under development for the oral on-demand treatment of hereditary angioedema. He recently received meeting minutes which confirmed that his Phase 3 trial design should be appropriate to support an NDA submission.
The company noted that its development team is finalizing the Phase 3 trial protocol and preparing for the start of the study, and it expects patients to be treated in the first quarter of 2022.
“KalVista is well capitalized, with funding until at least early 2024, which we hope will take us beyond the data from this Phase 3 trial and the Phase 2 trial currently underway. KVD824, ”the company said.
Valneva wins COVID-19 vaccine supply contract with European Commission
Valneva SE (NASDAQ: VALN) announced that the European Commission has approved an agreement under which Valneva will deliver up to 60 million doses of VLA2001, its inactivated COVID-19 vaccine candidate, over two years, including approximately 27 million doses in 2022.
Under the current terms of the agreement, the EC has the option to increase its initial purchase, in 2022, of VLA2001 to a total of 60 million doses by the end of 2023.
The stock jumped 19.61% to $ 48.36 in pre-market.
Inari Medical, Inc. (NASDAQ: NARI) reported third-quarter revenue of $ 72.99 million, up 88% year-over-year. The company returned to a net loss of 6 cents per share against a profit of 13 cents per share. The results have exceeded estimates. The company has raised its revenue forecast for the entire year.
The stock was up 13.09% to $ 98.25 in pre-trade.
TransMedics Group, Inc. (NASDAQ: TMDX) Third quarter revenue fell 24% to $ 5.4 million. The net loss per share fell from 19 cents to 47 cents. The company’s full-year revenue forecast was lower than the consensus estimate.
The stock slipped 9.94% to $ 28 in pre-market trading.
DermTech, Inc. (NASDAQ: DMTK) reported a larger loss for the third quarter, which was also larger than the consensus estimate. Revenue increased from $ 1.36 million to $ 3.03 million. Citing the unanticipated impacts of the Delta variant and Hurricane Ida, the company lowered its analysis revenue forecast for the year 2021.
The stock plunged 16.74% to $ 22.98 in pre-market trading.
AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) priced its public offering to subscribe for 1.301 million of its ADSs at a public offering price of $ 2.22 per share, for gross proceeds of approximately $ 2.9 million.
In pre-market, the title slipped 13.01% to $ 2.14.
Therapeutics Avenue, Inc. (NASDAQ: ATXI) priced its takeover bid with gross proceeds to the company. The offering is equivalent to 1.947 million shares at a public price of $ 1.34 per share.
The stock was down 12.66% to $ 1.38 in pre-market.
Mirati Therapeutics, Inc. (NASDAQ: MRTX) has announced its intention to offer and sell in a public offering subscribed for $ 500 million of shares of its common stock.
The stock was down 2.31% to $ 163.97.
On the radar
Clinical readings / presentations
Connective Tissue Oncology Society, or CTOS, 2021 Annual Meeting
Inhibrx, Inc. (NASDAQ: INBX): Update of the Phase 2 Expansion Cohort 1 for INBRX-109 in Patients with Conventional Chondrosarcoma
Presentations from the 14th clinical trial in Alzheimer’s disease
AC Immune SA (NASDAQ: ACIU): First Results of the Phase 2 Study of Semorinemab in Alzheimer’s Disease
Presentations at the SITC meeting
Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS): Data from its Phase 1 / 1b trial of mupadolimab in solid tumors, as well as the Phase 2 study of mupadolimab in squamous cell cancers of the head and neck positive for human papillomavirus
Nektar Therapeutics (NASDAQ: NKTR): Phase 1b data for NKTR-255 plus cetuximab in patients with solid tumors
Immutep Limited (NASDAQ: IMMP): Results from a Phase 2 study of eftilagimod alpha (and by Merck & Co., Inc. (NYSE: MRK) Keytruda in patients with unselected 2nd-line PD-L1 metastatic squamous cell carcinoma of the head and neck, and data from the phase 2 eftilagimod alpha and Keytruda study in patients not selected for PD-L1 expression in metastatic epidermoid head and neck first-line cell carcinoma
Genmab A / S (NASDAQ: GMAB) & BioNTech SE (NASDAQ: BNTX): Results of the Phase 1/2 trial evaluating the investigational bispecific antibody GEN1042 in patients with advanced solid tumors as well as Phase ½ data for GEN1046 in solid tumors
Fennec Pharma inc. (NASDAQ: FENC) (before market opens)
LumiraDx Limited (NASDAQ: LMDX) (before market opens)
HOOKIPA Pharma inc. (NASDAQ: HOOK) (before market opens)
Nuvalent, Inc. (NASDAQ: NUVL) (before market opens)
Verve Therapeutics, Inc. (NASDAQ: VERV) (before market opens)
Cerevel Therapeutics Holdings, Inc. (NASDAQ: CERE) (before market opens)
SA confirmed (NASDAQ: AFMD) (before market opens)
BioXcel Therapeutics, Inc. (NASDAQ: BTAI) (before market opens)
Bioceres Crop Solutions Corp. (NASDAQ: BIOX) (before market opens)
Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL) (before market opens)
TScan Therapeutics, Inc. (NASDAQ: TCRX) (before market opens)
Biotechnology company PDS (NASDAQ: PDSB) (before market opens)
Immunocore Holdings plc (NASDAQ: IMCR) (before market opens)
Ikena Oncology, Inc. (NASDAQ: IKNA) (before market opened)
Galera Therapeutics, Inc. (NASDAQ: GRTX) (before market opens)
Astria Therapeutics, Inc. (NASDAQ: ATXS) before the market opens)
Sotera Health Company (NASDAQ: SHC) (before market opens)
23andMe Holding Co. (NASDAQ: ME) (after closing)
Maravai LifeSciences Holdings, Inc. (NASDAQ: MRVI) (after closing)
Ampio Pharmaceuticals, Inc. (NYSE: AMPE) (after closing)
aTyr Pharma, Inc. (NASDAQ: VIE) (after closing)
ADMA Biologics, Inc. (NASDAQ: ADMA) (after closing)
Clearside Biomedical, Inc. (NASDAQ: CLSD) (after closing)
Daré Bioscience, Inc. (NASDAQ: DARE) (after close)
Navidea Biopharmaceuticals, Inc. (NASDAQ: NAVB) (after closing)
BIOLASE, Inc. (NASDAQ: BIOL) (after closing)
BioCardia, Inc. (NASDAQ: BCDA) (after closing)
Related Link: Attention Biotech Investors: Mark Your Calendar for November PDUFA Dates
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