The Daily Biotech Pulse: Pfizer-BioNTech Receive FDA Panel Backing, Sanofi-GSK Disclose Delay In Vaccine Program, 4 Biotechs To Debut On Wall Street

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Dec. 10)

  • Adaptive Biotechnologies Corp ADPT
  • ALX Oncology Holdings Inc ALXO
  • Anixa Biosciences Inc ANIX
  • Arrowhead Pharmaceuticals Inc ARWR
  • Beam Therapeutics Inc BEAM
  • Bioanalytical Systems, Inc. BASI
  • BioLife Solutions Inc BLFS
  • BioNTech SE's – ADR BNTX
  • BioTelemetry Inc BEAT
  • Blueprint Medicines Corp BPMC
  • BridgeBio Pharma Inc BBIO
  • CareDx Inc CDNA
  • Castle Biosciences Inc CSTL
  • Checkmate Pharmaceuticals Inc CMPI
  • Corcept Therapeutics Incorporated CORT
  • Curis, Inc. CRIS
  • Denali Therapeutics Inc DNLI
  • Editas Medicine Inc EDIT (submitted an IND application to commence a Phase 1/2 study of drug to treat sickle cell disease)
  • Eidos Therapeutics Inc EIDX
  • Fate Therapeutics Inc FATE
  • Frequency Therapeutics Inc FREQ
  • Fulgent Genetics Inc FLGT
  • Immutep ADS Representing 10 Ord Shs IMMP (announced positive midstage breast cancer data)
  • Inhibrx Inc INBX
  • Intellia Therapeutics Inc NTLA
  • Iovance Biotherapeutics Inc IOVA
  • Kymera Therapeutics Inc KYMR
  • Merrimack Pharmaceuticals Inc MACK
  • Mirati Therapeutics Inc MRTX
  • Myovant Sciences Ltd MYOV
  • Natera Inc NTRA
  • Nkarta Inc NKTX
  • Novocure Ltd NVCR
  • Ocular Therapeutix Inc OCUL
  • Otonomy Inc OTIC
  • Paratek Pharmaceuticals Inc PRTK
  • Prelude Therapeutics Inc PRLD
  • Rocket Pharmaceuticals Inc. RCKT
  • Sangamo Therapeutics Inc SGMO
  • Seer Ord Shs Class A (Proposed) SEER (went public Friday)
  • Sellas Life Sciences Group Inc SLS
  • SI-Bone Inc SIBN
  • Silverback Therapeutics Inc SBTX
  • SpringWorks Therapeutics Inc SWTX
  • Tarsus Pharmaceuticals Inc TARS
  • TG Therapeutics Inc common stock TGTX (announced positive topline results from two global Phase 3 studies of ublituximab in patients with relapsing forms of multiple sclerosis)
  • Twist Bioscience Corp TWST (launched clonal-ready gene fragments, providing customers with a complete offering for genes)
  • Vericel Corp VCEL
  • Veru Inc VERU
  • XOMA Corp XOMA

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 10)

  • Bellicum Pharmaceuticals Inc BLCM
  • Nabriva Therapeutics PLC – ADR NBRV

Stocks In Focus

Pfizer-BioNTech COVID-19 Vaccine Gets FDA Panel Backing

Pfizer Inc. PFE and BioNTech SE – ADR BNTX said the FDA's Vaccines and Related Biological Products Advisory Committee voted 17 to 4 in support of the FDA granting emergency use authorization for the companies' COVID-19 mRNA vaccine, BNT162b2.

Pfizer shares added 2.76% to $42.88 in after-hours trading and BioNTech advanced 3.44% to $134.

Bio-Rad Issues Out-Year Guidance

Bio-Rad Laboratories, Inc. Class A Common Stock BIO announced 2023 guidance, expecting sales of $2.75 billion-$2.85 billion and a non-GAAP adjusted EBITDA margin of 23%-24%. The company sees sales getting a lift from its broad portfolio of products including Droplet Digital PCR, single-cell, clinical diagnostics and a focus on the bioproduction and biopharma channels.

Sonoma Strikes US Supply Deal For OTC Dermatological Products 

Sonoma Pharmaceuticals Inc SNOA announced an agreement with Crown Laboratories, a skin care company, for the exclusive rights to sell and market Sonoma's products for the over-the-counter dermatological market in the U.S.

Under the agreement, Crown will sell Sonoma's Microcyn technology dermal sprays and gels targeting itch and pain under the Sarna brand, with a unique variety of formulations to quickly relieve itch and skin irritations.

The stock was up 116.13% at $13.40 premarket Friday. 

Related Link: Week Ahead In Biotech: FDA To Decide On Emergency Use Of Pfizer's COVID Vaccine, Hematology Conference Presentations Pick Up Pace

EMA Committee Recommends Approval Of Dynavax Hepatitis B Vaccine

Dynavax Technologies Corporation DVAX said the European Medicines Agency's Committee For Medicinal Products For Human Use has issued a positive opinion on its marketing authorization application, recommending the granting of marketing authorization for the Heplisav-B vaccine.

The vaccine is for active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults 18 and older.

Dynavax shares were up 3.06% at $4.71 premarket. 

Passage Bio Gets UK Regulatory Clearance to Start Gene Therapy Trial For Inherited Neurological Disorder

Passage Bio Inc PASG said the U.K. Medicines Healthcare Products Regulatory Agency has approved the clinical trial authorization for PBGM01, its lead gene therapy candidate being studied for the treatment of GM1 gangliosidosis.

Patient enrollment for the UK clinical study site, which is part of the global program, is expected to start in the second quarter of 2021, the company said. 

In after-hours trading, the stock rose 4.09% to $28.99.

Innate Pharma To Return US, EU Rights For Leukemia Drug To AstraZeneca

Innate Pharma SA IPHA said it will return the U.S. and EU commercialization rights of Lumoxiti, which it acquired from AstraZeneca plc AZN in October 2018. Lumoxiti was approved by the FDA in 2018 to treat patients with relapsed and refractory hairy cell leukemia.

The U.S. rights will be transferred to AstraZeneca in 2021, with the company also remaining the marketing authorization applicant for the EU filing.

Innate also said it will immediately begin to reduce its U.S. commercial operations.

Roche Launches High-Throughput Coronavirus Antigen Test

Roche Holdings AG Basel ADR Common Stock RHHBY said it has launched a high-throughput SARS-CoV-2 antigen test to diagnose SARS-CoV-2 infections in markets accepting the CE Mark. The company said it has also filed for emergency use authorization from the FDA.

Sanofi, GSK Announce Delay In COVID-19 Vaccine Program

Sanofi SA SNY and GlaxoSmithKline plc GSK announced a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults.

The Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults ages 18-49, but a low immune response in older adults, likely due to an insufficient concentration of the antigen, the companies said.

The companies based the decision on the results from a recent challenge study in non-human primates performed with an improved antigen formulation, which demonstrated that the vaccine candidate could protect against lung pathology and lead to rapid viral clearance from the nasal passages and lungs within two to four days. 

Sanofi and GSK now plan to start a Phase 2b study in February 2021, with the study including a proposed comparison with an authorized COVID-19 vaccine. If the data is positive, a global Phase 3 study could start in the second quarter of 2021 and regulatory submissions could be made in the second half of 2021. The vaccine's potential availability is therefore delayed from mid-2021 to the fourth quarter of 2021.

Xeris' Glucagon Rescue Pen Gets Positive EMA Committee Recommendation

Xeris Pharmaceuticals Inc XERS said the EMA's CHMP has adopted a positive opinion for Ogluo, its RTU glucagon for injection. The CHMP recommends Ogluo for the treatment of severe hypoglycemia in adults, adolescents and children ages 2 years and older with diabetes mellitus.

If approved, the company said Ogluo could be launched in certain European countries in the second half of 2021.

In premarket trading Friday, the stock was up 6.6% to $4.36.

Offerings

Nabriva Therapeutics PLC – ADR NBRV priced its public offering of 6 million ordinary shares, or pre-funded warrants in lieu thereof, at an effective price of $2.50 per share or pre-funded warrant.

The gross proceeds to Nabriva Therapeutics from the offering are expected to be $15 million. The offering is expected to close on or about Dec. 15. 

The stock was down 29.71% premarket at $2.39. 

Aytu BioScience AYTU announced an increase in the size of its previously announced public offering and purchase on a firm commitment basis to 4.17 million shares, with the offering priced at $6 per share. The closing of the offering is expected to occur on or about Dec. 15.

9 Meters Biopharma Inc NMTR said it has commenced a proposed underwritten public offering of shares of its common stock. All of the shares in the proposed offering are to be sold by the company.

The stock slipped 9.4% to 77 cents in after-hours trading.

Opiant Pharmaceuticals Inc OPN said it has entered into a $50-million convertible note purchase and security agreement with a syndicate of Pontifax Medison Finance, a health care-dedicated venture and debt fund, and European growth debt firm Kreos Capital. 

The company said it expects to use the proceeds to fund the potential future commercialization of OPNT003, nasal nalmefene, an investigational treatment for opioid overdose, which it aims to file for approval by the FDA at the end of 2021.

The stock fell 1.93% to $8.15 in after-hours trading.

On The Radar

Clinical Readouts

Odonate Therapeutics Inc ODT will present at the San Antonio Breast Cancer Symposium with the results of CONTESSA, a Phase 3 study of tesetaxel in the treatment of patients with metastatic breast cancer.

Sellas Life Sciences Group Inc SLS Is scheduled to present at the SABCS with finalized data from the Phase 2 study of nelipepimut-S in combination with granulocyte-macrophage colony-stimulating factor in women with ductal carcinoma in situ of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+ or 3+ levels, and are pre- or post-menopausal.

IPOs

4D Molecular Therapeutics, Inc., a clinical-stage gene therapy company, priced its initial public offering of 8.4 million shares of its common stock at a price of $23 per share, for raising gross proceeds of $193.2 million.

All of the shares are being offered by the company. The shares are expected to begin trading on the Nasdaq under the ticker symbol "FDMT."

Certara, a biosimulation company, priced its upsized IPO of 29.055 million shares at $23 per share. Shares of Certara will begin trading on the Nasdaq under the ticker symbol "CERT." The gross proceeds from the offering will be about $336.5 million.

Abcellera Biologics, a technology company that searches, decodes and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease, priced its IPO of 24.15 million common shares at $20 per share. All of the common shares are being offered by AbCellera. The shares of the company are expected to begin trading on the Nasdaq under the ticker symbol "ABCL." The gross proceeds from the offering are expected to be $483 million.

Vivos Therapeutics, a medical technology company that offers novel and proprietary alternatives for treating mild-to-moderate obstructive sleep apnea, priced its IPO of 3.5 million shares of its common stock at a $6 per share. The shares of common stock are expected to begin trading on the Nasdaq under the ticker "VVOS."

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

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