The Daily Biotech Pulse: NY State Endorses Mallinckrodt's Opioid Settlement, Kamada To Work On COVID-19 Treatment

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 10)

• Arcutis Biotherapeutics Inc ARQT
• Aytu Bioscience Inc AYTU (announced a deal to distribute COVID-19 test)
• Centogene NV CNTG
• Forty Seven Inc FTSV

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on March 10)

• Accelerate Diagnostics Inc AXDX
• Adamas Pharmaceuticals Inc ADMS
• Adaptive Biotechnologies Corp ADPT
• ADMA Biologics Inc ADMA
• Aeglea Bio Therapeutics Inc AGLE
• AEterna Zentaris Inc. AEZS
• Affimed NV AFMD
• Akari Therapeutics PLC AKTX
• Akcea Therapeutics Inc AKCA
• Aldeyra Therapeutics Inc ALDX
• Alexion Pharmaceuticals, Inc. ALXN
• Alkermes Plc ALKS
• Allena Pharmaceuticals Inc ALNA
• ANCHIANO THERAP/S ADR ANCN
• AngioDynamics, Inc. ANGO
• ANI Pharmaceuticals Inc ANIP
• Anixa Biosciences Inc ANIX
• AnPac Bio-Medical Science Co Ltd – ADR ANPC
• Aptevo Therapeutics Inc APVO
• Aptinyx Inc APTX
• Assertio Therapeutics Inc ASRT
• Atara Biotherapeutics Inc ATRA
• Atossa Therapeutics Inc ATOS
• Autolus Therapeutics Ltd – ADR AUTL
• AxoGen, Inc Common Stock AXGN
• Axovant Gene Therapies Ltd AXGT
• Bausch Health Companies Inc BHC
• Bellicum Pharmaceuticals Inc BLCM
• BENITEC BIOPHAR/S ADR BNTC
• BioLife Solutions Inc BLFS
• bluebird bio Inc BLUE
• Black Diamond Therapeutics Inc BDTX
• Capricor Therapeutics Inc CAPR
• Celcuity Inc CELC
• Cerecor Inc CERC
• Chembio Diagnostics Inc CEMI
• Eiger Biopharmaceuticals Inc EIGR
• Enochian Biosciences Inc ENOB
• Entasis Therapeutics Holdings Inc ETTX
• Eton Pharmaceuticals Inc ETON
• Evolus Inc EOLS
• Exicure Inc XCUR
• Eyepoint Pharmaceuticals Inc EYPT
• Five Prime Therapeutics Inc FPRX
• Gossamer Bio Inc GOSS
• Gritstone Oncology Inc GRTS
• GW Pharmaceuticals PLC- ADR GWPH
• Heron Therapeutics Inc HRTX
• Incyte Corporation INCY
• INmune Bio Inc INMB
• Integra Lifesciences Holdings Corp IART
• Invivo Therapeutics Holdings Corp NVIV
• Jaguar Health Inc JAGX
• Jazz Pharmaceuticals PLC JAZZ
• Kura Oncology Inc KURA
• Lantheus Holdings Inc LNTH
• TapImmune Inc. common stock MRKR
• MediciNova, Inc. MNOV
• Meridian Bioscience, Inc. VIVO
• Misonix Inc MSON
• Moleculin Biotech Inc MBRX
• Myriad Genetics, Inc. MYGN
• Neovasc Inc NVCN
• Neurometrix Inc NUROccccc
• Neuronetics Inc STIM
• Oncternal Therapeutics Inc ONCT
• Orchard Therapeutics PLC – ADR ORTX
• Organogenesis Holdings Inc ORGO
• Pieris Pharmaceuticals Inc PIRS
• Plus Therapeutics Inc PSTV
• Polarityte Inc PTE
• Portola Pharmaceuticals Inc PTLA
• Precigen Inc PGEN
• Precipio Inc PRPO
• Radius Health Inc RDUS
• Rhythm Pharmaceuticals Inc RYTM
• Rubius Therapeutics Inc RUBY
• SAGE Therapeutics Inc SAGE
• Stealth BioTherapeutics Corp MITO
• Stemline Therapeutics Inc STML
• SurModics, Inc. SRDX
• Synlogic Inc SYBX
• T2 Biosystems Inc TTOO
• Tcr2 Therapeutics Inc TCRR
• Teligent Inc (NEW JERSEY) TLGT
• Tetraphase Pharmaceuticals Inc TTPH
• TFF Pharmaceuticals Inc TFFP
• TRACON Pharmaceuticals Inc TCON
• Unum Therapeutics Inc UMRX
• Vericel Corp VCEL
• X4 Pharmaceuticals Inc XFOR
• Xeris Pharmaceuticals Inc XERS
• X T L Biopharmaceuticals Ltd XTLB
• ZIOPHARM Oncology Inc. ZIOP

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

Stocks In Focus

Mallinckrodt's Global Opioid Settlement Agreement Endorsed By New York State

Mallinckrodt PLC MNK said the New York State Attorney General Letitia James lent support to the company's previously announced global opioid settlement, joining 47 other states and U.S. Territory Attorneys General.

The State of New York and Suffolk County, together with Mallinckrodt and SpecGx LLC, have jointly filed a motion to remove the companies from the New York State opioid trial.

In pre-market trading, shares were rising 13.24% to $2.48.

Kamada to Work On Treatment for Severely Ill COVID-19 Patients

Israeli plasma-derived biopharma Kamada Ltd. KMDA said it plans to initiate the development of an Anti-COVID-19 polyclonal immunoglobin using is its proprietary plasma derived IgG platform technology as a potential treatment for severely ill coronavirus patients.

"We are working with the Israeli regulatory authorities and local medical institutions to advance our program," said Amir London, CEO of Kamada.

In pre-market trading, shares were up 6.23% to $5.80.

FDA Approves Bristol-Myers' Opdivo-Yervoy Combo For Liver Cancer

Bristol-Myers Squibb Co's BMY said the FDA approved its sBLA for Opdivo + Yervoy as a treatment option for patients with advanced hepatocellular carcinoma, previously treated with Bayer AG BAYRY and Onyx Pharma's Nexavar.

Phio Pharma Announces Agreement to Develop Immune Enhancers

Phio Pharmaceuticals Corp PHIO has reached a new agreement with Medigene relating to its previously announced research collaboration with Helmholtz Zentrum München to develop novel candidates for the use of Intasyl compounds in adoptive cell therapy to enhance immune function.

The new agreement provides for Medigene contributing expertise regarding clinical development and proprietary research material. The company also has an option to an exclusive license for potential immune cell enhancers against certain fee payments.

Phio shares rallied 15.30% to $3.24 in after-hours trading.

NuCana's Ovarian Cancer Drug Shows Favorable Disease Control In Midstage Study

NuCana PLC NCNA announced preliminary results from part one of the Phase 2 study of single-agent Acelarin in difficult-to-treat patients with platinum-resistant ovarian cancer, which showed that out of the 45 evaluable patients, one patient achieved a complete response and two patients achieved partial responses, while 16 achieved stable disease.

"We are pleased with this favorable disease control rate and Acelarin's ability to achieve confirmed complete and partial responses in this very heavily pre-treated patient population," said Hugh Griffith, CEO of NuCana.

Separately, the company reported fourth-quarter results showing a wider loss.

NuCana shares rose 7.25% to $7.25 in after-hours trading.

Sophiris Bio Shares to Be Delisted From Nasdaq, Effective March 12

Sophiris Bio Inc SPHS, which is evaluating its topsalysin in late-stage clinical trials for urological diseases, said the Nasdaq Officer of General Counsel informed the company that the Nasdaq Hearing Panel has determined to delist its shares from the Nasdaq. Trading in the company's shares are to be suspended, effective at the open of business March 12.

The company said it expects its shares to be eligible for trading on the OTC.

The delisting comes in the wake of the company flouting listing standards pertaining to the minimum $2.5 million stockholder's equity requirement.

The stock plummeted 39.58% to 35 cents in the after-hours trading.

J&J's Lung Cancer Therapy Gets Breakthrough Designation

Johnson & Johnson JNJ said its Janssen unit's JNJ-61186372 has been granted Breakthrough Therapy Designation by the FDA for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

Roche's Biomarker-based Screening Test For Cervical Cancer Approved by FDA

Roche Holdings AG Basel ADR RHHBY said the FDA approved its CINtec PLUS Cytology, as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for HPV using the cobas 4800 HPV Test.

Altimmune Soars Despite No News

Altimmune Inc ALT shares were sharply higher in after-hours trading, although there was no release from the company.

Earnings

RA Medical Systems Inc RMED reported a decline in is fourth-quarter revenues from $2 million in 2018 to $1.4 million in 2019. The net loss per share narrowed from $1.18 to 72 cents. Analysts estimated a loss of $1.15 per share.

The stock plunged 39.72% to 85 cents in after-hours trading.

Fulgent Genetics Inc's FLGT fourth-quarter revenues climbed 48% year-over-year to $8.4 million and the company reported non-GAAP EPS of 4 cents, in line with the consensus estimate.

The stock 4.92% to $14.50 in after-hours trading.

Sunesis Pharmaceuticals, Inc. SNSS reported fourth-quarter revenues of $2.07 million in 2019 compared to no revenues a year ago. The net loss per share narrowed from 16 cents to 5 cents, while analysts estimated a loss of 7 cents per share.

The stock slipped 5.21% to 91 cents in after-hours trading.

Offerings

Kala Pharmaceuticals Inc KALA said it has priced its underwritten public offering of 16 million shares at $7.89 per share, for generating gross proceeds of $126.2 million. The company expects the offering to close March 13.

In premarket trading Wednesday, Kala shares were adding 11.53% to $8.80.

On The Radar

Earnings

• Xeris Pharma (before the market open)
• Liquidia Technologies Inc LQDA (before the market open)
• Galmed Pharmaceuticals Ltd GLMD (before the market open)
• INmune Bio Inc INMB (before the market open)
• Clearside Biomedical Inc CLSD (after the close)
• Calithera Biosciences Inc CALA (after the close)
• Unity Biotechnology Inc UBX (after the close)
• Navidea Biopharmaceuticals Inc NAVB (after the close)
• Cumberland Pharmaceuticals, Inc. CPIX (after the close)
• BioLife Solutions Inc BLFS (after the close)
• Dynavax Technologies Corporation DVAX (after the close)
• Miragen Therapeutics Inc MGEN (after the close)
• Pfenex Inc PFNX (after the close)
• Arcturus Therapeutics Ltd ARCT (after the close)
• Novavax, Inc. NVAX (after the close)
• Global Cord Blood Corp CO (after the close)