The Daily Biotech Pulse: Pfizer Strikes $5.29B COVID Pill Supply Deal With US, Roche's Spark Therapeutics Reports Positive Gene Therapy Readout, EDAP Earnings

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Roche's Spark Subsidiary Reports Positive Phase 1/2 Data For Hemophilia Gene Therapy Candidate

Roche Holding AG 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 Partners With Germany's Merck For Developing Companion Diagnostics For Lung Cancer Drug In China

Burning Rock Biotech Limited BNR announced a strategic partnership with Germany's MERCK Kommanditgesellschaft auf Aktien 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 Announces Positive Phase 3 Data For COVID-19 Antibody Treatment As Preventative, Curative Treatments

AstraZeneca plc 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 Commences Phase 1 Study Of RSV Vaccine Candidate

Moderna, Inc. 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.

Related Link: The Week Ahead In Biotech (Nov. 14-Nov. 20): BioMarin FDA Decision, Tapering Earnings News Flow, Conference Presentations And More

CureVac's Second-Gen COVID-19 Vaccine Candidate Found Comparable With Pfizer/BioNTech's Comirnaty In Preclinical Studies

CureVac N.V. CVAC announced the online publication in the journal Nature, extended preclinical study of the second-generation vaccine candidate, CV2CoV, jointly developed with GlaxoSmithKine plc GSK, showing results from a direct comparison of CV2CoV with Comirnaty, the licensed mRNA vaccine developed by Pfizer, Inc. PFE/BioNTech SE 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 To Supply 10M Courses Of Oral COVID Pill To US For About $5.29B

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's Keytruda Gets FDA Nod As Adjuvant Treatment For Kidney Cancer

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. 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. 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. 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. 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.

On The Radar

Clinical Readouts

ProQR Therapeutics N.V. PRQR will announce updated data from the Phase 1/2 InSight extension study of Sepofarsen in Leber congenital amaurosis type 10.


Itamar Medical Ltd. ITMR (before the market open)

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

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