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

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)