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 ADVM
- Affimed NV 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 BHVN
- BioMarin Pharmaceutical Inc. BMRN (announced additional data from Phase 1/2 study of investigational gene therapy for severe hemophilia A)
- BioXcel Therapeutics Inc BTAI
- Brainstorm Cell Therapeutics Inc BCLI
- Cytokinetics, Inc. CYTK
- DiaMedica Therapeutics Inc DMAC
- Fennec Pharmaceuticals Inc FENC
- GENMAB A/S/S ADR GMAB
- Ideaya Biosciences Inc IDYA
- ITAMAR MED LTD/S ADR ITMR
- MannKind Corporation MNKD
- Meridian Bioscience, Inc. VIVO
- Neubase Therapeutics Inc NBSE
- NGM Biopharmaceuticals Inc NGM
- Novo Nordisk A/S NVO
- Ocular Therapeutix Inc OCUL
- Odonate Therapeutics Inc ODT
- Passage Bio Inc PASG
- Quidel Corporation QDEL
- Sanofi SA SNY (announced positive results for a Phase 3 study of its enzyme replacement therapy avalglucosidase alfa in late-onset Pompe disease)
- Sarepta Therapeutics Inc SRPT
- SpringWorks Therapeutics Inc SWTX
- TELA Bio Inc TELA
- TFF Pharmaceuticals Inc TFFP (announced orphan drug designation for tacrolimus for prophylaxis of lung allograft rejection)
- Vaxcyte Inc PCVX (went public Friday)
- Zai Lab Ltd ZLAB
- Zentalis Pharmaceuticals Inc ZNTL
- Zynex Inc. ZYXI
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows June 17)
- BioCardia Inc BCDA
- Hoth Therapeutics Inc HOTH
- Lantern Pharma Inc LTRN (went public Thursday)
Stocks In Focus
Eloxx Resumes Midstage Cystic Fibrosis Study In Europe, Israel
Eloxx Pharmaceuticals Inc 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 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 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. 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 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 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. 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 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 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 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 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 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 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 EPZM regulatory application for label expansion for tazemetostat, this time for follicular lymphoma.
Earnings
- BioNano Genomics Inc BNGO (after the close)
- Urovant Sciences Ltd UROV (after the close)
Related Link: Sinovac Makes Headway In Coronavirus Vaccine Race With Positive Preliminary Phase 1/2 Results
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