The Daily Biotech Pulse: CureVac Close To Coronavirus Vaccine Deal With EU, Entera Bio's Positive Readout, Patent Protection For Co-Diagnostics

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 19)

  • 10X Genomics Inc TXG
  • ALX Oncology Holdings Inc ALXO
  • Avenue Therapeutics Inc ATXI
  • Cardiff Oncology Inc CRDF
  • Castle Biosciences Inc CSTL
  • Checkmate Pharmaceuticals Inc CMPI
  • DarioHealth Corp DRIO
  • Harmony Biosciences Holdings, Inc. HRMY (went public Wednesday)
  • Immunovant Inc IMVT (moved in sympathy with a M&A deal)
  • Inhibrx, Inc. INBX (went public Wednesday)
  • Keros Therapeutics Inc KROS
  • Kura Oncology Inc KURA
  • Mirati Therapeutics Inc MRTX
  • Momenta Pharmaceuticals, Inc. MNTAannounced a deal to be bought by Johnson & Johnson JNJ
  • Natera Inc NTRA
  • Nurix Therapeutics Inc NRIX
  • Orthopediatrics Corp KIDS
  • Pacific Biosciences of California Inc PACB
  • Pacira Biosciences Inc PCRX
  • PDL BioPharma Inc PDLI
  • Qiagen NV QGEN
  • Sangamo Therapeutics Inc SGMO
  • Shockwave Medical Inc SWAV
  • Syros Pharmaceuticals Inc SYRS
  • TFF Pharmaceuticals Inc TFFP

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 19)

  • Burning Rock Biotech Ltd BNR
  • Entera Bio Ltd ENTX
  • Eyepoint Pharmaceuticals Inc EYPT
  • Histogen Inc HSTO
  • Iterum Therapeutics PLC ITRM
  • NanoVibronix Inc NAOV
  • Recro Pharma Inc REPH
  • Teligent Inc (NEW JERSEY) TLGT (reacted to second-quarter results)
  • Unity Biotechnology Inc UBX

Stocks In Focus

Centogene, Evotec To Collaborate On Drug Discovery For Gaucher Disease

Centogene NV CNTG, a commercial-stage company focused on rare diseases, and Germany's Evotec announced that the companies have expanded their existing drug discovery partnership related to the protein target glucocerebrosidase, with a focus on Gaucher disease, a genetic and relatively common lysosomal storage disorder.

The companies said they intend to develop a treatment option for the majority of patients.

Currently available treatments are individualized for each patient depending on the type of Gaucher disease and are focused on symptomatic relief.

Co-Diagnostics Technology Gets Additional Patent Protection

Co-Diagnostics Inc CODX said the U.S. Patent and Trademark Office has granted increased patent protection for the its novel CoPrimer technology used in its COVID-19 test kit and its other molecular diagnostic tests. This new patent further validates the uniqueness of the CoPrimer molecule, and provides even more comprehensive protection for all of its potential applications, the company said. 

In premarket trading, the stock was adding 2.55% to $14.90.

See also: The Week Ahead In Biotech: Spotlight On Gilead, BioMarin FDA Decisions, IPOs

Entera Bio Reports Positive Results For Midstage Osteoporosis Study, Wider Q2 Loss

Entera Bio reported positive interim six-month data from the Phase 2 study that evaluated its EB 613 in osteoarthritis.

EB 613 produced a meaningful and positive impact on lumbar spine bone mineral density in a dose-dependent manner, the company said.

Entera said it expects to report interim biomarker data from the 2.5mg dose in the first quarter of 2021, with the final data expected in the second quarter of 2021.

The company's revenue rose from $74,000 in the first six months of 2019 to $94,000 in the first six months of 2020. 

The second-quarter loss per share widened from 12 cents to 17 cents.

The stock was rising 8.57% to $1.52 in premarket trading Thursday.

CureVac In Advanced Talks To Supply Up To 405M Coronavirus Vaccine Doses 

CureVac N.V. CVAC said it is in advanced discussions with the European Commission to supply up to 225 million doses with an option for an additional purchase of 180 million doses, to be supplied once the company's mRNA-based vaccine has proven to be safe and effective against COVID-19.

In premarket trading Thursday, CureVac shares were advancing 11.34% to $62.24.

Immunic Begins Phase 1 Study In Gastrointestinal Disorders

Immunic Inc IMUX announced the dosing of the first healthy volunteer in its Phase 1 clinical program of IMU-856, an orally available, small molecule modulator that targets a yet-undisclosed protein that serves as a transcriptional regulator of intestinal barrier function.

In preclinical studies, the compound appeared to represent a novel and paradigm-shifting approach to the treatment of gastrointestinal diseases by potentially restoring intestinal barrier function while maintaining immunocompetency, Immunic said.

Axsome Says Migraine Drug On Track For Q4 NDA

Axsome Therapeutics Inc AXSM said it has completed a successful pre-NDA meeting with the FDA for AXS-07 for the acute treatment of migraine.

Based on the feedback from the FDA, the company said it believes its regulatory data package will be sufficient to support an NDA for AXS-07 for the acute treatment of migraine. It also said it remains on track to submit the planned NDA in the fourth quarter of 2020.

EyePoint Gets $9.5M Payment For Expanded Licensing Agreement For Eye Inflammation Treatments

EyePoint said Ocumension has made a one-time $9.5 million payment for an expansion to its exclusive license agreements for the development and commercialization of Yutiq and Dexycu in certain Asian markets.

In premarket trading Thursday, the stock was jumping 30.77% to 68 cents. 

Earnings

NuCana PLC NCNA reported a wider loss for the second quarter of 2020.

In after-hours trading, the stock slipped 3.14% to $5.25.

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

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