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The Daily Biotech Pulse: Pfizer, BioNTech Begin European Filing For Coronavirus Vaccine, Y-mAbs BLA Rejected, GlycoMimetics Granted Rare Pediatric Disease Designation

The Daily Biotech Pulse: Pfizer, BioNTech Begin European Filing For Coronavirus Vaccine, Y-mAbs BLA Rejected, GlycoMimetics Granted Rare Pediatric Disease Designation

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 Oct. 5)

  • 10X Genomics Inc (NASDAQ: TXG)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • argenx SE – ADR (NASDAQ: ARGX) (presented positive new data from a Phase 3 trial evaluating efgartigimod in patients with generalized myasthenia gravis)
  • Ascendis Pharma A/S (NASDAQ: ASND)
  • Beigene Ltd (NASDAQ: BGNE)
  • BioLife Solutions Inc (NASDAQ: BLFS)
  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • C4 Therapeutics, Inc. (NASDAQ: CCCC) (went public Friday)
  • Castle Biosciences Inc (NASDAQ: CSTL)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • CTI BioPharma Corp (NASDAQ: CTIC)
  • Cytokinetics, Inc. (NASDAQ: CYTK) (reacted to presentations at the Heart Failure Society of America virtual meeting)
  • Eidos Therapeutics Inc (NASDAQ: EIDX) - announced a deal to be bought by BridgeBio Pharma Inc (NASDAQ: BBIO)
  • EXACT Sciences Corporation (NASDAQ: EXAS)
  • Horizon Therapeutics PLC (NASDAQ: HZNP)
  • Kura Oncology Inc (NASDAQ: KURA)
  • LifeSci Acquisition Corp (NASDAQ: LSAC)
  • Myokardia Inc (NASDAQ: MYOK) - announced a deal to be bought by Bristol-Myers Squibb Co (NYSE: BMY) for $13.1 billion
  • Novocure Ltd (NASDAQ: NVCR)
  • Pacific Biosciences of California Inc (NASDAQ: PACB)
  • ProPhase Labs Inc (NASDAQ: PRPH)
  • Pulse Biosciences Inc (NASDAQ: PLSE)
  • Qiagen NV (NYSE: QGEN)
  • Repligen Corporation (NASDAQ: RGEN)
  • Seattle Genetics, Inc. (NASDAQ: SGEN)
  • Shockwave Medical Inc (NASDAQ: SWAV)
  • TG Therapeutics Inc common stock (NASDAQ: TGTX)
  • Turning Point Therapeutics Inc (NASDAQ: TPTX)
  • Twist Bioscience Corp (NASDAQ: TWST)
  • Vericel Corp (NASDAQ: VCEL)
  • Zealand Pharma A S ADR (NASDAQ: ZEAL)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 5)

  • AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ: ANPC)
  • Dyne Therapeutics Inc (NASDAQ: DYN)
  • Fusion Pharmaceuticals Inc (NASDAQ: FUSN)
  • Immunome Inc (NASDAQ: IMNM) (went public Friday)
  • Polypid Ltd (NASDAQ: PYPD)
  • Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN)
  • Taysha Gene Therapies Inc (NASDAQ: TSHA) (listed on Sept. 24)

Stocks In Focus

GlycoMimetics's Sickle Cell Disease Drug Gets Rare Pediatric Disease Designation

GlycoMimetics Inc (NASDAQ: GLYC) said the FDA has granted rare pediatric disease designation for rivipansel in the treatment of sickle cell disease in patients 18 and younger.

The stock was gaining 8.56% to $3.55 premarket Tuesday.

Iovance BLA For Skin Cancer Therapy Delayed

Following a recent Type B meeting with the FDA, Iovance Biotherapeutics Inc (NASDAQ: IOVA) said it has not been able to agree with the FDA on the required potency assays to fully define its tumor-infiltrating lymphocyte therapy lifileucel in metastatic melanoma, which is required as part of a BLA submission.

As the company is continuing to refine the information from its potency assays and simultaneously developing additional assays, it said a BLA submission is not expected by the end of 2020.

In premarket trading, Iovance was slumping by 20.4% to $25.52.

Y-mAbs Regulatory Application For Neuroblastoma Drug Rejected 

Y-mAbs Therapeutics, Inc (NASDAQ: YMAB) said it has received a refusal-to-file letter from the FDA regarding the BLA for omburtamab in the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The application was submitted in August.

The FDA determined that certain parts of the chemistry, manufacturing and control module and the clinical module of the BLA require further details, the company said.

Y-mAbs said it will request a Type A meeting with the FDA as soon as possible and plans to work closely with the agency, with the goal of resubmitting the BLA before the end of 2020

The stock slipped 18.59% to $33.95 in after-hours trading.

Pfizer, BioNTech Begin Regulatory Submission For Coronavirus Vaccine Candidate In Europe

Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: BNTX) said they have initiated a rolling submission to the European Medicines Agency for their coronavirus vaccine candidate BNT162b2.

The EMA's decision to start a rolling review follows the encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2, the companies said.

BioNTech and Pfizer said they plan to work with the EMA's Committee for Medicinal Products for Human Use to complete the rolling review process to facilitate the final marketing authorization application.

In premarket trading Tuesday, BioNTech shares were rallying 9.05% to $88 and Pfizer was advancing 1.22% to $37.20.

See also: The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO

Gamida Cell Reports Positive Late-stage Results For Cell Therapy In Patients With Hematological Malignancies

Gamida Cell Ltd (NASDAQ: GMDA) said the Phase 3 study of omidubicel, an investigational advanced cell therapy in development as a potential life-saving treatment option for patients in need of bone marrow transplant, met all three of its secondary endpoints.

The Phase 3 study evaluated the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.

The stock was soaring 9.52% to $4.60 in premarket trading Tuesday.

Miragen's Lead Cancer Drug Flunks Midstage Lymphoma Study

Miragen Therapeutics Inc (NASDAQ: MGEN) said preliminary data from the Phase 2 SOLAR clinical trial of cobomarsen in patients with cutaneous T-Cell lymphoma suggest that cobomarsen lacks a compelling result for the study's primary endpoint — objective skin response of at least four months duration relative to the vorinostat control arm.

The company said it will continue to analyze the final topline data and other secondary SOLAR data as it seeks a partner for cobomarsen. The focus continues to be on the advancement of the lead program MRG-229 for idiopathic pulmonary fibrosis, Miragen said.

The stock was down 26.45% at 56 cents premarket Tuesday.

10x Genomics to Buy ReadCoor For $350M

10x Genomics said that it has entered into a definitive agreement to acquire Boston-based ReadCoor, Inc., developer of foundational In Situ technologies, for cash and stock consideration of $350 million.

This, along with the late August acquisition of CartaNA AB, will give the company comprehensive and foundational intellectual property, key technology advances and deep talent and expertise in the emerging In Situ field, which helps measure large numbers of molecules directly in tissue by capturing the precise location of those molecules at sub-cellular resolution.

The stock added 2.11% to $133.50 in after-hours trading.

AMAG Receives FDA Notice On Preterm Birth Drug

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) said it has received an FDA notice regarding withdrawal of approval for Makena — hydroxyprogesterone caproate injection — a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth.

The FDA said in its letter that the company can request a hearing on the withdrawal.

"We are reviewing our options, including the opportunity to request an oral hearing, and will respond to the agency within the allotted time. We continue to expect the transaction with Covis to close in November 2020," said Amag CEO Scott Myers.

The stock was was trading 0.92% higher to $13.20 premarket Tuesday.

Halozyme, argenx Deepen Drug Delivery Technology Deal

Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced an expansion to its existing collaboration agreement with argenx, giving the latter exclusive access to Halozyme's Enhanze drug delivery technology for three additional targets upon nomination for a total of up to six targets under the existing and newly expanded collaboration.

To date, agenx has nominated two targets including the human neonatal Fc receptor FcRn and complement component C2.

On The Radar

Clinical Readouts

Axovant Gene Therapies Ltd (NASDAQ: AXGT) will announce at the Chardan 4th Annual Genetic Medicines Conference six-month safety and efficacy data from the second cohort of its AXO-Lenti-PD program, which is evaluating its AXO-Lenti-PD gene therapy in Parkinson's disease. The presentation is scheduled for 2:30 pm ET.

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


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