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The Daily Biotech Pulse: Eloxx Resumes Cystic Fibrosis Study, Rexahn's Reverse Merger, Ultragenyx, Epizyme Await FDA Decisions

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The Daily Biotech Pulse: Eloxx Resumes Cystic Fibrosis Study, Rexahn's Reverse Merger, Ultragenyx, Epizyme Await FDA Decisions

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 June 17)

  • Adverum Biotechnologies Inc (NASDAQ: ADVM)
  • Affimed NV (NASDAQ: AFMD) (announced completion of dosing of first cohort in Phase 1/2A study of AFM24 in treating advanced EGFR-expressing solid tumors)
  • Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN)
  • BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (announced additional data from Phase 1/2 study of investigational gene therapy for severe hemophilia A)
  • BioXcel Therapeutics Inc (NASDAQ: BTAI)
  • Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI)
  • Cytokinetics, Inc. (NASDAQ: CYTK)
  • DiaMedica Therapeutics Inc (NASDAQ: DMAC)
  • Fennec Pharmaceuticals Inc (NASDAQ: FENC)
  • GENMAB A/S/S ADR (NASDAQ: GMAB)
  • Ideaya Biosciences Inc (NASDAQ: IDYA)
  • ITAMAR MED LTD/S ADR (NASDAQ: ITMR)
  • MannKind Corporation (NASDAQ: MNKD)
  • Meridian Bioscience, Inc. (NASDAQ: VIVO)
  • Neubase Therapeutics Inc (NASDAQ: NBSE)
  • NGM Biopharmaceuticals Inc (NASDAQ: NGM)
  • Novo Nordisk A/S (NYSE: NVO)
  • Ocular Therapeutix Inc (NASDAQ: OCUL)
  • Odonate Therapeutics Inc (NASDAQ: ODT)
  • Passage Bio Inc (NASDAQ: PASG)
  • Quidel Corporation (NASDAQ: QDEL)
  • Sanofi SA (NASDAQ: SNY) (announced positive results for a Phase 3 study of its enzyme replacement therapy avalglucosidase alfa in late-onset Pompe disease)
  • Sarepta Therapeutics Inc (NASDAQ: SRPT)
  • SpringWorks Therapeutics Inc (NASDAQ: SWTX)
  • TELA Bio Inc (NASDAQ: TELA)
  • TFF Pharmaceuticals Inc (NASDAQ: TFFP) (announced orphan drug designation for tacrolimus for prophylaxis of lung allograft rejection)
  • Vaxcyte Inc (NASDAQ: PCVX) (went public Friday)
  • Zai Lab Ltd (NASDAQ: ZLAB)
  • Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)
  • Zynex Inc. (NASDAQ: ZYXI)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 17)

  • BioCardia Inc (NASDAQ: BCDA)
  • Hoth Therapeutics Inc (NASDAQ: HOTH)
  • Lantern Pharma Inc (NASDAQ: LTRN) (went public Thursday)

Stocks In Focus

Eloxx Resumes Midstage Cystic Fibrosis Study In Europe, Israel

Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) said enrollment in its Phase 2 clinical trial for ELX-02 in cystic fibrosis has resumed in Israel and Europe after being temporarily paused in response to the COVID-19 pandemic.

Enrollment in the U.S. trial remains paused due to safety concerns, Eloxx said. The company said it's looking to complete enrollment in its Phase 2 proof-of-concept trial and report top-line data as soon as feasible.

The stock was soaring 21.31% to $3.70 premarket Thursday. 

Adamas Pharma Confirms Shelving Of Gocovri Study In Multiple Sclerosis Patients With Walking Impairment

Adamas Pharmaceuticals Inc (NASDAQ: ADMS) said that following a comprehensive analysis of Phase 3 data from the INROADS study of ADS-5102 in multiple sclerosis patients with walking impairment, it has reconfirmed its decision not to initiate further late-stage development in MSW.

The company noted that further engagement with the FDA regarding a potential path to submission confirmed the need of an additional pivotal Phase 3 confirmatory study.

The stock was down 9.09% at $2.60 premarket. 

Emergent Bio To Invest $75M In Expansion Of CDMO Capabilities

Emergent Biosolutions Inc (NYSE: EBS) said it will further strengthen its contract development and manufacturing capabilities by expanding into viral vector and gene therapy by investing $75 million in its Canton, Massachusetts facility.

The facility is focused on the development and manufacturing of drug substances for live viral vaccines, including the company's smallpox vaccine.

In premarket trading Thursday, the stock was up 1.76% to $71.18.

Illumina Buys Cloud-Based Genomic Analysis Software Company

Illumina, Inc. (NASDAQ: ILMN) announced the acquisition of Netherlands-based BlueBee, a cloud-based software company that provides genomics analysis solutions for research and clinical customers.

The deal will enhance Illumina's capabilities to analyze and interpret the data produced by its sequencing systems, the company said. 

See also: The Week Ahead In Biotech: FDA Decisions In The Cards For Merck, Epizyme, Evoke And Ultragenyx

Roche Reports Positive Results For Late-Stage Breast Cancer Study

Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) said the Phase 3 IMpassion031 study evaluating Tecentriq in combination with chemotherapy met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response for the treatment of people with early triple-negative breast cancer regardless of PD-L1 expression.

The study is comparing the combination to placebo plus chemotherapy. 

In the study, fewer patients who received the Tecentriq combination as a neoadjuvant treatment had evidence of tumor tissue detectable at the time of surgery regardless of PD-L1 expression in comparison to the control arm.

Tonix Announces Expansion Of Vaccine Collaboration Agreement

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) announced an expansion of its strategic collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19.

The research is part of an ongoing a collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix's TNX-1800, a live replicating virus vaccine designed to protect against COVID-19.

The data will support the interpretation of animal trial results with TNX-1800, which are expected in the fourth quarter of 2020 and subsequent human trials.

In premarket trading Thursday, Tonix shares were jumping 28.39% to 80 cents.

Rexahn To Reverse Merge With Ocuphire Pharma

Rexahn Pharmaceuticals, Inc. (NASDAQ: REXN) announced an agreement to merge with privately held Ocuphire Pharma in an all-stock deal. The transaction is expected to close in the second half of 2020.

Following the consummation of the deal, the combined company will change its name to Ocuphire Pharma Inc, and will likely to trade on the Nasdaq under the ticker symbol "OCUP."

The combined company will focus on the advancement of its pipeline of ophthalmic drug candidates, Rexahn said.

Hutchison Gets Fast Track Designation For Drug To Treat Colorectal Cancer

HUTCHISON CHINA/S ADR (NASDAQ: HCM) said the FDA has granted Fast Track Designation for the development of fruquintinib for patients with previously treated metastatic colorectal cancer. 

The company said it is initiating a Phase 3 registration study, known as the FRESCO-2 study, in refractory mCRC in the U.S., Europe and Japan, with enrollment set to begin in mid-2020.

Offerings

Leap Therapeutics Inc (NASDAQ: LPTX) said it has commenced an underwritten public offering of its common stock and pre-funded warrants to purchase shares of its common stock.

All shares of common stock and pre-funded warrants to be sold in the offering will be offered by the company.

The stock slipped 15.08% to $2.14 in after-hours trading.

IVERIC bio Inc (NASDAQ: ISEE) priced its upsized underwritten public offering of 24.54 million shares of its common stock at $4.10 per share and the pre-funded warrants to purchase 1.9143 million shares at $4.099 per pre-funded warrant, in each case less underwriting discounts and commissions. All of the securities are being offered by the company.

The stock was down 2.03% at $4.35 premarket. 

IDEAYA, which recently announced an oncology collaboration, priced an underwritten public offering of 6.67 million shares at $15 per share to generate gross proceeds of $100 million. The offering is expected to close on or about June 22.

The stock fell was down 9.42% at $16.82 premarket Thursday.

Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) announced a common stock offering, with all the shares earmarked for the offering sold by the company.

The stock was down 0.33% at $4.49 premarket. 

Orthopediatrics Corp (NASDAQ: KIDS) said it is commencing an underwritten public offering of its common stock.

The stock was down 3.06% at $48.15 premarket. 

On The Radar

PDUFA Dates

Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) and its Japanese partner Kyowa Kirin have a tryst with the FDA, as the agency is set to rule on hypophosphatemia treatment candidate burosumab.

The regulatory agency will also decide on Epizyme Inc's (NASDAQ: EPZM) regulatory application for label expansion for tazemetostat, this time for follicular lymphoma.

Earnings

  • BioNano Genomics Inc (NASDAQ: BNGO) (after the close)
  • Urovant Sciences Ltd (NASDAQ: UROV) (after the close)

Related Link: Sinovac Makes Headway In Coronavirus Vaccine Race With Positive Preliminary Phase 1/2 Results

 

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