Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Sept. 8)
- Akouos Inc (NASDAQ: AKUS)
- Albireo Pharma Inc (NASDAQ: ALB)(announced positive Phase 3 results for odevixibat in a liver disorder called progressive familial intrahepatic cholestasis)
- Castle Biosciences Inc (NASDAQ: CSTL)
- Harmony Biosciences Holdings Inc (NASDAQ: HRMY)
- Kura Oncology Inc (NASDAQ: KURA)
- Merit Medical Systems, Inc. (NASDAQ: MMSI)(announced sale of manufacturing equipment and associated assets used in its hypotube manufacturing business)
- X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Sept. 8)
- ADiTx Therapeutics Inc (NASDAQ: ADTX)
- AEterna Zentaris Inc. (NASDAQ: AEZS)(announced the presentation of data from pediatric study of macimorelin for childhood-onset growth hormone deficiency)
- AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ: ANPC)
- Ayala Pharmaceuticals Inc (NASDAQ: AYLA)
- Burning Rock Biotech Ltd (NASDAQ: BNR)
- Checkmate Pharmaceuticals Inc (NASDAQ: CMPI)
- Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)( reacted to a negative data readout)
- Immatics NV (NASDAQ: IMTX)
- Kymera Therapeutics Inc (NASDAQ: KYMR)
- Legend Biotech Corp (NASDAQ: LEGN)
- Regulus Therapeutics Inc (NASDAQ: RGLS)
- Royalty Pharma plc (NASDAQ: RPRX)
- Second Sight Medical Products Inc (NASDAQ: EYES)
- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS)
- Viveve Medical Inc (NASDAQ: VIVE)
Stocks In Focus AstraZeneca Halts Coronavirus Vaccine Study to Allow For Safety Review Following an Unexplained Illness
AstraZeneca plc (NYSE: AZN) shares are under pressure after the company said in a statement to STATNews it has voluntarily paused the study of the coronavirus vaccine candidate it is jointly developing with the Oxford University in order to allow review of safety data by an independent committee. The decision to pause came after there was a potentially unexplained illness in one of the trials.
The company said illnesses like this happens by chance in large trials, and that it is working to expedite the review of the single event to minimize any potential impact of the trial timeline.
In pre-market trading Wednesday, AstraZeneca shares were down 1.21% to $54.05. AstraZeneca’s setback has triggered buying in vaccine rivals.
Other vaccine makers advanced, with Moderna Inc (NASDAQ: MRNA) rising 4.34% to $56.70, BioNTech SE – ADR (NASDAQ: BNTX) gaining 3.30% to $61.70, Inovio Pharmaceuticals Inc (NASDAQ: INO) rallying 6.14% to $10.20, Vir Biotechnology Inc (NASDAQ: VIR) adding 3.73% to $29.75 and Novavax, Inc. (NASDAQ: NVAX) moving up 5.50% to $90.
Among big pharma companies, Sanofi SA (NASDAQ: SNY) was advancing 2.12% to $51.45, GlaxoSmithKline plc (NYSE: GSK) was surging up 1.77% to $39.66 and Pfizer Inc. (NYSE: PFE) was edging up 0.61% to $36.15.
Pfizer, BioNTech In Talks With the European Commission to Supply 200M Doses of Coronavirus Vaccine
Pfizer and partner BioNTech said they had concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to the European Union member states, with an option for further 100 million doses.
“Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization,” the companies said.
Trillium Gets $25M Equity Investment From Pfizer, Reports Positive Safety Data From Lymphoma Trials
Trillium Therapeutics Inc (NASDAQ: TRIL) said it has agreed to sell 2.298 million shares of its common shares in a registered direct offering to Pfizer at a price of $10.88 per share, for raising gross proceeds of $25 million.
Trillium said it intends to use the net proceeds to help fund its ongoing and planned clinical trials for its CD47 program, and for working capital and general corporate purposes.
Separately, Trillium announced updated data from its ongoing TTI-622 and TTI-621 dose escalation studies in relapsed and refractory lymphomas, showing the former demonstrated substantial monotherapy activity in highly pre-treated patients, with a broad therapeutic window, a rapid onset of action, and across a range of lymphoma indications. Since no safety signal was observed, the company said it is further escalating the dose.
TTI-621, meanwhile, showed a strong safety profile, with no dose limiting thrombocytopenia for doses up to 1.4 mg/kg.
The company said it expects to declare maximum tolerated doses or recommended phase 2 doses for both molecules either towards the end of this year or in the first half of 2021.
View more earnings on IBB
In pre-market trading, Trillium was jumping 37.63% to $13.02.
Chembio Submits Application For EUA For Its Rapid Antibody COVID-19 Test
Chembio Diagnostics Inc (NASDAQ: CEMI) said it has initiated the notification process and submission of an application for emergency use authorization to the FDA for its new rapid antibody test system, DPP SARS-CoV-2 IgM/IgG.
After granting an EUA earlier, the FDA revoked it in mid-June, citing concerns about the accuracy of the test.
DBV’s CFO, CCO to Depart as it Prepares to Resubmit Peanut Allergy Patch BLA
DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT) said Ramzi Benamar, CFO, and Kevin Trapp, Chief Commercial Officer, will leave the company, effective Oct. 2.
Sébastien Robitaille, a company insider, has been promoted to the CEO role, DBV said.
Merck’s Pneumococcal Vaccine Late-stage Studies Meet Goals
Merck & Co., Inc. (NYSE: MRK) said two Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, its investigational 15-valent pneumococcal conjugate vaccine, met their primary immunogenicity objectives.
Diffusion Pharma Appoints Board Member Robert Cobuzzi as CEO
Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) announced that Robert Cobuzzi Jr., who has served as a board member since January 2020, will succeed David Kalergis as President and CEO, effective immediately. Kalergis will retire from his operational responsibilities but continue to serve as Chairman of the Board, the company said.
The stock was rising 3.20% to 81 cents in pre-market trading.
Offerings
Athenex Inc (NASDAQ: ATNX) said it intends to offer and sell, subject to market conditions, 10 million shares of its common stock in an underwritten public offering.
The stock slid 9.41% to $13 in after-hours trading.
Albireo said it has commenced a proposed underwritten public offering of 3 million shares of its common stock.
The stock fell 4.09% to $38 in pre-market trading.
10X Genomics Inc (NASDAQ: TXG) said it has commenced an underwritten public offering of 3.5 million shares of its Class A common stock to be issued pursuant to a registration statement filed with the SEC. All of the shares are being offered by the company.
In pre-market trading, the stock was moving down 2.08% to $106.02.
On The Radar Clinical Readouts
Sutro Biopharma Inc(NASDAQ: STRO) is due to present at the International Gynecologic Cancer Society xDigital Annual Global Meeting, updated data from the Phase 1 study of STRO-002, its FRα-targeting antibody-drug conjugate, in ovarian cancer; The company will hold a conference call at 5:30 p.m. ET to discuss the updated data.
Earnings
MEI Pharma Inc (NASDAQ: MEIP)
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