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Here's a roundup of top developments in the biotech space over the last 24 hours:
Roche Holding AG (OTC:RHHBY) unit Spark Therapeutics, announced data from its Phase 1/2 clinical trial of investigational SPK-8011 in hemophilia A showing, at a median efficacy follow-up of 33.4 months, 16 of 18 study participants had sustained factor VIII, which permitted prophylaxis cessation and reduction in bleeding episodes. The latest results were published online in the New England Journal of Medicine.
The updated analysis of all 18 study participants demonstrated a 91.5% reduction in annualized bleed rate and a 96.4% reduction in annualized number of FVIII infusions.
Burning Rock Biotech Limited (NASDAQ:BNR) announced a strategic partnership with Germany's MERCK Kommanditgesellschaft auf Aktien (OTC:MKKGY) for developing companion diagnostics for the MET inhibitor tepotinib in the mainland China market.
The CDx test is based on Burning Rock's self-developed next generation sequencing-based liquid biopsy solution, the OncoCompass Target panel.
Wednesday before the market open, the company reported better-than-expected third-quarter results.
AstraZeneca plc (NASDAQ:AZN) announced new data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase 3 trials, both showing robust efficacy from a one-time intramuscular dose of the long-acting antibody combination.
The PROVENT trial evaluating a median six months of participant follow-up showed a 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%. Additionally, an exploratory analysis of the TACKLE outpatient treatment trial in patients with mild-to-moderate COVID-19 showed that one 600mg IM dose of AZD7442 reduced the risk of developing severe COVID-19 or death by 88% compared to placebo in patients who had been symptomatic for three days or less at the time of treatment.
Moderna, Inc. (NASDAQ:MRNA) announced that the first participant has been dosed in the Phase 2/3 study of mRNA-1345, its respiratory syncytial virus vaccine candidate. This study is known as ConquerRSV.
The stock was up 0.73% at $244 in premarket trading.
CureVac N.V. (NASDAQ:CVAC) announced the online publication in the journal Nature, extended preclinical study of the second-generation vaccine candidate, CV2CoV, jointly developed with GlaxoSmithKine plc (NYSE:GSK), showing results from a direct comparison of CV2CoV with Comirnaty, the licensed mRNA vaccine developed by Pfizer, Inc. (NYSE:PFE)/BioNTech SE (NASDAQ:BNTX).
"Neutralizing antibody levels measured following full vaccination of animals with either 12µg of CV2CoV or a 30µg standard dose of Comirnaty were shown to be highly comparable," CureVac said.
CureVac shares were up 4.43% at $40.51 in premarket trading.
Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, Paxlovid, for $5.29 billion, pending and contingent upon regulatory authorization. The company would begin delivering the drug later this year and concluding in 2022.
The company also said it has also entered into advance purchase agreements with several other countries and has initiated bilateral outreach to approximately 100 countries around the world.
Merck announced the U.S. Food and Drug Administration has approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Insider Transactions
Oncorus, Inc. (NASDAQ:ONCR) disclosed in a filing with the SEC that Stephen Harbin, its chief operating officer and chief of staff, bought 30,000 shares in the company.
The stock was up 2.84% at $5.71 in after-hours trading.
Progenity, Inc. (NASDAQ:PROG) said in a series of filings with the SEC that insiders, including Hutan Hashemi, chief compliance officer, and Matthew Cooper, chief compliance officer, disposed shares in the company.
The stock was slipping 2.46% to $4.76 in after-hours trading.
EDAP TMS S.A. (NASDAQ:EDAP) reported third-quarter revenues of $11.1 million, almost unchanged from a year-ago period, as lingering COVID-19 impact cut capital equipment sales. The net loss per share also remained flat at 3 cents per share. The results trailed expectations.
The stock was receding 2.35% to $5.81 in after-hours trading.
CymaBay Therapeutics, Inc. (NASDAQ:CBAY) announced that it has commenced an underwritten public offering of its common stock and pre-funded warrants. All shares of common stock and pre-funded warrants to be sold in the offering will be offered by CymaBay.
CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.
In premarket trading, the stock was slipping 2.48% to $3.94.
Click here to access Benzinga's FDA Calendar.
ProQR Therapeutics N.V. (NASDAQ:PRQR) will announce updated data from the Phase 1/2 InSight extension study of Sepofarsen in Leber congenital amaurosis type 10.
Itamar Medical Ltd. (NASDAQ:ITMR) (before the market open)
Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates
Posted In: AZN BNR BNTX CBAY CVAC EDAP GSK ITMR MKKGY MRNA ONCR PFE PROG PRQR RHHBY
