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Here's a roundup of top developments in the biotech space over the last 24 hours:
(Biotech Stocks Hitting 52-week Highs Aug. 16)
(Biotech Stocks Hitting 52-week Lows Aug. 16)
Eli Lilly and Company (NYSE:LLY) announced executive leadership changes and the creation of neuroscience and immunology business units to increase its focus on introducing breakthrough new medicines to millions of people with unmet needs.
Effective Sept. 5, Lilly Bio-Medicines will split into two business units, namely Lilly Neuroscience and Lilly Immunology. Anne White, currently SVP and president of Lilly Oncology, will lead Lilly Neuroscience as SVP and president. White will be responsible for Lilly's launched products and a Phase 3 portfolio in pain and neurodegeneration, including the potential launch of donanemab for the treatment of Alzheimer's disease.
Jacob Van Naarden, currently CEO of Loxo Oncology at Lilly, has been promoted to SVP and CEO of Loxo Oncology at Lilly and presiden of, Lilly Oncology and will be unifying these organizations. Patrik Jonsson will lead Lilly's launched products and Phase 3 portfolio of medicines in dermatology, gastroenterology and rheumatology as president of Lilly Immunology.
The shares were up 0.8% at $272.09 in premarket trading.
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) announced that an investigational new drug application submitted by its partner in China, Angel Pharma for the initiation of a Phase 1/1b clinical trial of Corvus' CPI-818 for the treatment of relapsed/refractory T cell lymphomas has been accepted by the Center for Drug Evaluation of the China National Medical Products Administration.
Angel Pharma plans to initiate the trial before the end of 2021 and will be responsible for all expenses related to executing the trial in China.
Corvus shares were up 5.83% at $2 in premarket trading.
Incyte Corporation (NASDAQ:INCY) announced a collaboration and license agreement with InnoCare for the development and commercialization of tafasitamab, a monoclonal antibody, in Greater China.
Under the terms of the agreement, InnoCare will pay Incyte $35 million upfront,and Incyte is eligible to receive up to an additional $82.5 million in potential development, regulatory and commercial milestones, as well as tiered royalties.
In turn, InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.
Pfizer, Inc. (NYSE:PFE) announced the pricing of a sustainability bond of $1 billion in aggregate principal amount of 1.75% senior notes due 2031.
The closing of the offering is expected to occur on Aug. 18. Pfizer intends to use the net proceeds to finance or refinance, in whole or in part, R&D expenses related to COVID-19 vaccine, capital expenditures in connection with the manufacture and distribution of COVID-19 vaccines and other projects of Pfizer or any of its subsidiaries that have environmental and/or social benefits.
Ra Medical Systems, Inc. (NYSE:RMED) announced the sale of its Pharos dermatology business to STRATA Skin Sciences, Inc. (NASDAQ:SSKN) for $3.7 million in cash. The Pharos excimer laser is FDA-cleared for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.
Separately, Ra Medical reported second-quarter results, showing a modest increase in revenues and a narrower loss.
In premarket trading, Ra Medical shares were slipping 7.36% to $2.77, while STRATA Skin shares were advancing 7.47% to $1.44.
Related Link: The Week Ahead In Biotech: Fate Therapeutics Data Readout, RenovoRx IPO In Focus Amid Tapering Earnings News Flo
Bristol-Myers Squibb Company (NYSE:BMY) announced the European Medicines Agency has validated its Type II variation marketing authorization applications for both Opdivo in combination with Yervoy and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
Validation of these applications confirm that the submissions are complete and begins the EMA's centralized review process.
Helius Medical Technologies, Inc. (NASDAQ:HSDT) announced it has received breakthrough designation from the Food and Drug Administration for its PoNS device with the proposed indication for use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over.
The stock was jumping 23.68% to $17.76 in premarket trading.
Gritstone bio, Inc. (NASDAQ:GRTS) announced that it has entered into a funding agreement of up to $20.6 million with the CEPI to advance the development of Gritstone's CORAL Phase 1 COVID-19 vaccine program with an initial focus in South Africa.
The stock was rising 2.63% to $8.21 in premarket trading.
Geron Corporation (NASDAQ:GERN) said 91% of the planned enrollment in IMerge Phase 3 evaluating imetelstat in lower risk myelodysplastic syndrome has been achieved. The company expects the trial to be fully enrolled in the fourth quarter of 2021.
In addition, the expected timing for top-line results in IMerge Phase 3 has been accelerated by three months to the first quarter of 2023, Geron said.
OncoSec Medical Incorporated (NASDAQ:ONCS) announced the establishment of a leadership committee consisting of three board members — Margaret Dalesandro, Herbert Kim Lyerly and Yuhang Zhao — to lead all development efforts, with a focus on the lead asset Tavo.
The company also said, effective immediately, OncoSec's interim CEO Brian Leuthner will be leaving the company. The search for a permanent CEO has been actively underway since late June.
Click here to access Benzinga's FDA Calendar
Tiziana announced publication of a peer-reviewed article on data from the clinical study of its intranasally administered monoclonal antibody Foralumab in the treatment of mild-to-moderate COVID-19 patients in Brazil.
The treatment was well-tolerated and produced significant reduction in lung inflammation as assessed by computerized tomography scanning, and this anti-inflammatory effect of treatment was strongly supported by a reduction in serum levels of pro-inflammatory biomarkers Interleukin-6, IL-18 and C-reactive protein, the company said.
Tiziana said it will shortly initiate a Phase 2 proof-of-concept study in Brazil to evaluate safety, tolerability and efficacy of intranasal Foralumab in a larger number of hospitalized patients with COVID-19.
The stock was up 7.1% at $1.80 in premarket trading.
Lumos Pharma, Inc. (NASDAQ:LUMO) said in a filing with the SEC that Kevin Lalande, a director, through the Sante Health Venture II fund, bought 93,000 shares in the company.
In premarket trading, the stock was adding 3.26% to $8.23.
Biocept, Inc. (NASDAQ:BIOC) said its second-quarter revenues climbed from $917,000 in 2020 to $12 million in 2021, thanks primarily to RT-PCR COVID-19 testing. The net loss per share narrowed from 51 cents to 14 cents.
The stock was down 7.39% at $3.51 in after-hours trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates
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