The Daily Biotech Pulse: Pfizer-BioNTech COVID-19 Booster Data In Kids, Regeneron's COVID-19 Therapy Decision Pushed, Protagonist's Rusfertide Breakthrough Tag Update And More

Zinger Key Points
  • The FDA has extended the review of Regeneron Pharmaceuticals' marketing application of REGEN-COV (casirivimab and imdevimab) in non-hospitalized COVID-19 patients and as prophylaxis in certain individuals.
  • Protagonist Therapeutics received a letter from the FDA indicating the agency's intent to rescind Breakthrough Therapy Designation for the company's rusfertide product candidate in polycythemia vera.

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

Stocks In Focus

Pfizer-BioNTech's COVID-19 Vaccine Booster Shows High Immune Response In Kids Ages 5-11

Pfizer Inc PFE and BioNTech SE BNTX have announced results from a Phase 2/3 trial of a 10 µg booster (third) dose of COVID-19 vaccine in children ages 5-11.

Data from a subanalysis of 30 sera indicate that serum antibodies induced by a third dose neutralize the omicron variant. The shot demonstrated a 36-fold increase in neutralizing antibody titers compared to levels seen after two vaccine doses. 

PFE shares are down 0.15% at $53.02 and BNTX stock is down 0.65% at $178.21 during premarket trading.

FDA Extends Review Period For Regeneron's COVID-19 Therapy

The FDA has extended the review of Regeneron Pharmaceuticals Inc's REGN marketing application of REGEN-COV (casirivimab and imdevimab) in non-hospitalized COVID-19 patients and as prophylaxis in certain individuals.

The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data. The new target action date is July 13. 

The FDA has not requested any further studies.

Valneva's COVID-19 Vaccine Scores Conditional UK Approval 

The Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. has granted Conditional Marketing Authorization for Valneva SE's VALN COVID-19 vaccine candidate in adults 18 to 50 years of age.

MHRA found that VLA2001 meets safety, quality and effectiveness standards.

FDA Intends To Revoke Protagonist Therapeutics' Rusfertide Breakthrough Tag In Rare Form Of Blood Cancer

Protagonist Therapeutics Inc PTGX received a letter from the FDA indicating the agency's intent to rescind Breakthrough Therapy Designation for the company's rusfertide product candidate in polycythemia vera.

The company has submitted a meeting request to the FDA and a briefing document articulating why the company believes rusfertide continues to warrant Breakthrough Therapy Designation. 

Shares are slipping 29.1% at $18.10 during premarket trading.

AbbVie, Genmab Post Epcoritamab Data From Early Stage Blood Cancer Study

Genmab A/S GMAB and AbbVie Inc ABBV announced topline results from the first cohort of the EPCORE NHL-1 phase 1/2 trial of epcoritamab (DuoBody-CD3xCD20). 

The topline results demonstrated an overall response rate of 63.1%, exceeding the protocol prespecified efficacy threshold. 

The observed median duration of response was 12 months. The most common treatment-emergent adverse event was cytokine release syndrome with 49.7%, including 2.5% grade 3.

INmune Bio Starts Dosing In Midstage Alzheimer's Trial

INmune Bio Inc INMB has dosed the first patient enrolled in its Phase 2 trial using XPro1595 (XPro) to treat neuroinflammation as a cause of Alzheimer's disease. 

The Phase 2 trial is designed to evaluate XPro to treat cognition and function in patients with mild AD and biomarkers of inflammation.

Shares closed 3.35% higher at $8.65 during the after-market trading.

Amneal Scores Second US Biosimilars Approval with Alymsys

The FDA approved Amneal Pharmaceuticals Inc AMRX Biologics License Application for bevacizumab-maly, a biosimilar referencing Avastin.

The product will be marketed under the proprietary name Alymsys and represents the third bevacizumab biosimilar approved in the U.S.

The approval marks the second of three biosimilars approvals Amneal expects to receive this year in oncology.

Innovent Biologics' IBI310/Sintilimab Combo Gets Breakthrough Tag For Cervical Cancer.

The Center for Drug Evaluation of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to Innovent Biologics Inc's IVBXF IBI310 in combination with sintilimab for recurrent or metastatic cervical cancer.

The BTD for IBI310 was based on results from the first part of a Phase 2 trial. The safety profile in the study was consistent with that observed in previously reported studies, and no additional safety signals were identified for the combination of IBI310 and sintilimab. 

Related Link: The Week Ahead In Biotech (April 10-April 16): Regeneron FDA Decision, Cancer Conference Presentations And More.

Chimerix Confirms Ongoing Negotiations With BARDA On Smallpox Medicine Contract

Chimerix Inc CMRX confirms that it remains in active negotiations with the Biomedical Advanced Research and Development Authority (BARDA) regarding a sole-source contract to develop and procure up to 1.7 million treatment courses of the smallpox antiviral TEMBEXA.

The company expects to enter into the contract in the second quarter of FY22.

Insider Trading

Gemini Therapeutics Inc GMTX: Director Michael Leonard buys 955,000 shares at an average price of $1.40/share.

Shares are rising 6.92% at $1.70 during premarket trading.

Protalix BioTherapeutics Inc PLX: A form 4 filing showed the company CEO reported the purchase of 68,000 shares at $1.50 per share.

Shares are moving 6.72% higher at $1.43 during premarket trading.

Mersana Therapeutics Inc MRSN: Director Andrew Hack reported the purchase of 598,086 shares at an average price of $4.18/share.

Shares are moving 2.87% higher at $4.66 during premarket trading.

Trevi Therapeutics Inc TRVI: Shareholder Scott Sandell purchased 6.58 million shares at an average price of $1.90/share.

Shares closed 6.12% higher at $2.95 during aftermarket trading.

Offerings

Oncocyte Corporation OCX has priced a public offering of 26.3 million, together with warrants to purchase up to 13.1 million shares, for gross proceeds of $35 million.

Each common share is sold together with one warrant to purchase 0.5 common shares at a combined price of $1.3325

Shares closed 14.2% loewr at $1.09 during after-hours trading on Wednesday.

On The Radar

Earnings

Beyondspring Inc BYSI: fourth-quarter FY21 results before the market open.

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