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)

• 89bio Inc ETNB
• Arcus Biosciences Inc RCUS
• Arcturus Therapeutics Ltd ARCT(announced a partnership with Duke-NUS Medical School to develop a COVID-19 vaccine for Singapore)
• Cue Biopharma Inc CUE
• IGM Biosciences Inc IGMS
• Inovio Pharmaceuticals Inc INO
• Ocular Therapeutix Inc 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 DGX
• Regeneron Pharmaceuticals Inc 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 RVMD (IPOed mid-February)
• SpringWorks Therapeutics Inc SWTX
• Syndax Pharmaceuticals Inc SNDX(reacted to the company's fourth-quarter results)
• Syneos Health Inc SYNH
• Viela Bio Inc VIE

Down In The Dumps

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

• Alterity Therapeutics Ltd ATHE
• AngioDynamics, Inc. ANGO
• Aptevo Therapeutics Inc APVO
• CASI Pharmaceuticals Inc CASI
• Enlivex Therapeutics Ltd ENLV
• Evogene Ltd EVGN(reacted to fourth-quarter results)
• Evolus Inc 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 MYL
• Orthofix Medical Inc OFIX
• Passage Bio Inc PASG(IPOed last week)
• Titan Medical Inc. 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 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 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 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. 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 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 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 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 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 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 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 ABUS (before the market open)
• BioCryst Pharmaceuticals, Inc. BCRX (before the market open)
• Eyepoint Pharmaceuticals Inc EYPT (before the market open)
• Xtant Medical Holdings Inc XTNT (before the market open)
• Fulcrum Therapeutics Inc FULC (before the market open)
• Syros Pharmaceuticals Inc SYRS (before the market open)
• Obseva SA OBSV (before the market open)
• OptiNose Inc OPTN (before the market open)
• Caladrius Biosciences Inc CLBS (after the close)
• Eton Pharmaceuticals Inc ETON (after the close)
• BioNano Genomics Inc BNGO (after the close)
• Corvus Pharmaceuticals Inc CRVS (after the close)
• Eloxx Pharmaceuticals Inc ELOX (after the close)