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The Daily Biotech Pulse: Trevana Pain Drug Resubmission Accepted For Review, Can-Fite To Explore Treatment For COVID-19

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 on March 4)

Benzinga · 03/05/2020 13:14

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 on March 4)

  • 89bio Inc (NASDAQ: ETNB)
  • Arcus Biosciences Inc (NYSE: RCUS)
  • Arcturus Therapeutics Ltd (NASDAQ: ARCT)(announced a partnership with Duke-NUS Medical School to develop a COVID-19 vaccine for Singapore)
  • Cue Biopharma Inc (NASDAQ: CUE)
  • IGM Biosciences Inc (NASDAQ: IGMS)
  • Inovio Pharmaceuticals Inc (NASDAQ: INO)
  • Ocular Therapeutix Inc (NASDAQ: OCUL)(reacted to its preliminary fourth-quarter results and interim data from a Phase 1 study evaluating its eye implant OTX-TKI in patients with wet age-related macular degeneration)
  • Quest Diagnostics Inc (NYSE: DGX)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN)(CEO Leonard Schleifer reportedly told CNBC the company hopes to produce COVID-19 treatment candidate that could be ready for human testing by August)
  • Revolution Medicines Inc (NASDAQ: RVMD) (IPOed mid-February)
  • SpringWorks Therapeutics Inc (NASDAQ: SWTX)
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX)(reacted to the company's fourth-quarter results)
  • Syneos Health Inc (NASDAQ: SYNH)
  • Viela Bio Inc (NASDAQ: VIE)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on March 4)

  • Alterity Therapeutics Ltd (NASDAQ: ATHE)
  • AngioDynamics, Inc. (NASDAQ: ANGO)
  • Aptevo Therapeutics Inc (NASDAQ: APVO)
  • CASI Pharmaceuticals Inc (NASDAQ: CASI)
  • Enlivex Therapeutics Ltd (NASDAQ: ENLV)
  • Evogene Ltd (NASDAQ: EVGN)(reacted to fourth-quarter results)
  • Evolus Inc (NASDAQ: EOLS)(reacted to comments by Korean drug maker Medytox about an ITC case brought up by the company against Daewoong and partner Evolus on intellectual property related to Medytox' botulinum toxin)
  • Mylan NV (NASDAQ: MYL)
  • Orthofix Medical Inc (NASDAQ: OFIX)
  • Passage Bio Inc (NASDAQ: PASG)(IPOed last week)
  • Titan Medical Inc. (NASDAQ: TMDI)

See also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Stocks In Focus

Co-Diagnostics' COVID-19 Detection Kit Demand Surges

Co-Diagnostics Inc (NASDAQ: CODX) said demand, both domestic and international, surged for its COVID-19 detection kits in recent weeks, leading to increased product shipments. The increase comes after the FDA changed its policy Feb. 20 and the number of cases testing positive for the disease burgeoned worldwide.

The stock was surging 27.17% to $15.26 in pre-market trading.

Castle Biosciences Gets First Patent For Skin Cancer Gene Expression Profile Test

Skin cancer diagnostic company Castle Biosciences Inc (NASDAQ: CSTL) said the U.S. patent office has issued it the first U.S. patent related to the DecisionDx -Melanoma gene expression profile test for patients with cutaneous melanoma.

FDA Accepts Trevena's Resubmitted NDA for Pain Drug

Trevena Inc (NASDAQ: TRVN) said the FDA has acknowledged the receipt of and accepted the resubmitted NDA for intravenous oliceridine, its lead investigational asset, for the management of moderate-to-severe acute pain. The PDUFA date has been set for Aug. 7.

In pre-market trading, shares were rising 12.35% to 91 cents.

Can-Fite To Explore Treatment For COVID-19

Can-Fite BioPharma Ltd. (NASDAQ: CANF) said it is exploring a collaboration to explore if its investigational asset Piclidenoson, being evaluated for autoimmune inflammatory disease, is effective against coronavirus following reports that rheumatoid arthritis drugs have been introduced for the treatment of the same.

The stock was jumping 26.28% to $1.97 in pre-market trading.

RA Medical Says NYSE Accepts Plan to Regain Compliance

RA Medical Systems Inc (NYSE: RMED) said the NYSE has accepted the company's business plan to regain compliance with the NYSE listing standards. Late last year, the company was notified by the NYSE regarding flouting of listing standards pertaining to average market capitalization being less than $50 million over a recent consecutive 30 days.

MacroGenomics' Chief Medical Officer Resigns to Pursue Another Opportunity

MacroGenics Inc (NASDAQ: MGNX) announced the resignation of Jon Wigginton as its SVP, Clinical Development & Chief Medical Officer, effective March 27, as he pursues a new opportunity. The role will be assigned on an interim basis to Ezio Bonvini, who is currently serving as SVP, Research and Chief Scientific Officer, the company said.

Morphosys To Issue Additional Shares For Subscription By Incyte As Part of Tafasitamab Licensing Deal

Morphosys Ag (NASDAQ: MOR) said its Management Board has resolved to increase the share capital of the company by issuing 907,441 new ordinary shares from the authorized capital to facilitate purchase of 3.63 million ADSs by Incyte Corporation (NASDAQ: INCY). The newly issued shares represent about 2.84% of the registered share capital of MorphoSys prior to the consummation of the capital increase.

Incyte's purchase of ADSs amounting to $150 million or $41.32 per ADS is part of the consideration due to MorphoSys for the former acquiring licensing rights to develop and commercialize the latter's investigational compound tafasitamab.

In pre-market trading, MorphoSys shares were slipping 3.70% to $28.89.

Earnings

Specialty pharma company Opiant Pharmaceuticals Inc (NASDAQ: OPNT), which develops treatment for treating addictions and drug overdose, reported fourth-quarter revenues of $7.7 million compared to $4.8 million in the fourth quarter of 2018. The company reversed to a profit of 20 cents per share from a loss of $2.49 per share last year, while analysts had estimated a loss of $2.13 per share, on average.

The stock rallied 17.09% to $13.70 in after-hours trading.

Offerings

BridgeBio Pharma Inc (NASDAQ: BBIO) priced the upsized offering of $475 million aggregate principal amount of 2.50% convertible senior notes due 2027 in a private offering to qualified institutional buyers. The company said the notes will bear interest at a rate of 2.50% per year, payable semi-annually in arrears on March 15 and Sept. 15 of each year. Beginning Sept. 15, 2020.

The company estimates to raise net proceeds of about $463.7 million from the offering.

On The Radar

Earnings

  • Arbutus Biopharma Corp (NASDAQ: ABUS) (before the market open)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (before the market open)
  • Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) (before the market open)
  • Xtant Medical Holdings Inc (NYSE: XTNT) (before the market open)
  • Fulcrum Therapeutics Inc (NASDAQ: FULC) (before the market open)
  • Syros Pharmaceuticals Inc (NASDAQ: SYRS) (before the market open)
  • Obseva SA (NASDAQ: OBSV) (before the market open)
  • OptiNose Inc (NASDAQ: OPTN) (before the market open)
  • Caladrius Biosciences Inc (NASDAQ: CLBS) (after the close)
  • Eton Pharmaceuticals Inc (NASDAQ: ETON) (after the close)
  • BioNano Genomics Inc (NASDAQ: BNGO) (after the close)
  • Corvus Pharmaceuticals Inc (NASDAQ: CRVS) (after the close)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) (after the close)