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 (NASDAQ: ARQT)
- Aytu Bioscience Inc (NASDAQ: AYTU) (announced a deal to distribute COVID-19 test)
- Centogene NV (NASDAQ: CNTG)
- Forty Seven Inc (NASDAQ: FTSV)
Down In The Dumps
(Biotech Stocks Hitting 52-week lows on March 10)
- Accelerate Diagnostics Inc (NASDAQ: AXDX)
- Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
- Adaptive Biotechnologies Corp (NASDAQ: ADPT)
- ADMA Biologics Inc (NASDAQ: ADMA)
- Aeglea Bio Therapeutics Inc (NASDAQ: AGLE)
- AEterna Zentaris Inc. (NASDAQ: AEZS)
- Affimed NV (NASDAQ: AFMD)
- Akari Therapeutics PLC (NASDAQ: AKTX)
- Akcea Therapeutics Inc (NASDAQ: AKCA)
- Aldeyra Therapeutics Inc (NASDAQ: ALDX)
- Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)
- Alkermes Plc (NASDAQ: ALKS)
- Allena Pharmaceuticals Inc (NASDAQ: ALNA)
- ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
- AngioDynamics, Inc. (NASDAQ: ANGO)
- ANI Pharmaceuticals Inc (NASDAQ: ANIP)
- Anixa Biosciences Inc (NASDAQ: ANIX)
- AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ: ANPC)
- Aptevo Therapeutics Inc (NASDAQ: APVO)
- Aptinyx Inc (NASDAQ: APTX)
- Assertio Therapeutics Inc (NASDAQ: ASRT)
- Atara Biotherapeutics Inc (NASDAQ: ATRA)
- Atossa Therapeutics Inc (NASDAQ: ATOS)
- Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)
- AxoGen, Inc Common Stock (NASDAQ: AXGN)
- Axovant Gene Therapies Ltd (NASDAQ: AXGT)
- Bausch Health Companies Inc (NYSE: BHC)
- Bellicum Pharmaceuticals Inc (NASDAQ: BLCM)
- BENITEC BIOPHAR/S ADR (NASDAQ: BNTC)
- BioLife Solutions Inc (NASDAQ: BLFS)
- bluebird bio Inc (NASDAQ: BLUE)
- Black Diamond Therapeutics Inc (NASDAQ: BDTX)
- Capricor Therapeutics Inc (NASDAQ: CAPR)
- Celcuity Inc (NASDAQ: CELC)
- Cerecor Inc (NASDAQ: CERC)
- Chembio Diagnostics Inc (NASDAQ: CEMI)
- Eiger Biopharmaceuticals Inc (NASDAQ: EIGR)
- Enochian Biosciences Inc (NASDAQ: ENOB)
- Entasis Therapeutics Holdings Inc (NASDAQ: ETTX)
- Eton Pharmaceuticals Inc (NASDAQ: ETON)
- Evolus Inc (NASDAQ: EOLS)
- Exicure Inc (NASDAQ: XCUR)
- Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)
- Five Prime Therapeutics Inc (NASDAQ: FPRX)
- Gossamer Bio Inc (NASDAQ: GOSS)
- Gritstone Oncology Inc (NASDAQ: GRTS)
- GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH)
- Heron Therapeutics Inc (NASDAQ: HRTX)
- Incyte Corporation (NASDAQ: INCY)
- INmune Bio Inc (NASDAQ: INMB)
- Integra Lifesciences Holdings Corp (NASDAQ: IART)
- Invivo Therapeutics Holdings Corp (NASDAQ: NVIV)
- Jaguar Health Inc (NASDAQ: JAGX)
- Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)
- Kura Oncology Inc (NASDAQ: KURA)
- Lantheus Holdings Inc (NASDAQ: LNTH)
- TapImmune Inc. common stock (NASDAQ: MRKR)
- MediciNova, Inc. (NASDAQ: MNOV)
- Meridian Bioscience, Inc. (NASDAQ: VIVO)
- Misonix Inc (NASDAQ: MSON)
- Moleculin Biotech Inc (NASDAQ: MBRX)
- Myriad Genetics, Inc. (NASDAQ: MYGN)
- Neovasc Inc (NASDAQ: NVCN)
- Neurometrix Inc (NASDAQ: NURO)ccccc
- Neuronetics Inc (NASDAQ: STIM)
- Oncternal Therapeutics Inc (NASDAQ: ONCT)
- Orchard Therapeutics PLC – ADR (NASDAQ: ORTX)
- Organogenesis Holdings Inc (NASDAQ: ORGO)
- Pieris Pharmaceuticals Inc (NASDAQ: PIRS)
- Plus Therapeutics Inc (NASDAQ: PSTV)
- Polarityte Inc (NASDAQ: PTE)
- Portola Pharmaceuticals Inc (NASDAQ: PTLA)
- Precigen Inc (NASDAQ: PGEN)
- Precipio Inc (NASDAQ: PRPO)
- Radius Health Inc (NASDAQ: RDUS)
- Rhythm Pharmaceuticals Inc (NASDAQ: RYTM)
- Rubius Therapeutics Inc (NASDAQ: RUBY)
- SAGE Therapeutics Inc (NASDAQ: SAGE)
- Stealth BioTherapeutics Corp (NASDAQ: MITO)
- Stemline Therapeutics Inc (NASDAQ: STML)
- SurModics, Inc. (NASDAQ: SRDX)
- Synlogic Inc (NASDAQ: SYBX)
- T2 Biosystems Inc (NASDAQ: TTOO)
- Tcr2 Therapeutics Inc (NASDAQ: TCRR)
- Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)
- Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
- TFF Pharmaceuticals Inc (NASDAQ: TFFP)
- TRACON Pharmaceuticals Inc (NASDAQ: TCON)
- Unum Therapeutics Inc (NASDAQ: UMRX)
- Vericel Corp (NASDAQ: VCEL)
- X4 Pharmaceuticals Inc (NASDAQ: XFOR)
- Xeris Pharmaceuticals Inc (NASDAQ: XERS)
- X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)
- ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)
Stocks In Focus
Mallinckrodt's Global Opioid Settlement Agreement Endorsed By New York State
Mallinckrodt PLC (NYSE: 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. (NASDAQ: 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 (NYSE: 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 (OTC: BAYRY) and Onyx Pharma's Nexavar.
Phio Pharma Announces Agreement to Develop Immune Enhancers
Phio Pharmaceuticals Corp (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NYSE: 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 (OTC: 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 (NASDAQ: ALT) shares were sharply higher in after-hours trading, although there was no release from the company.
RA Medical Systems Inc (NYSE: 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 (NASDAQ: 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. (NASDAQ: 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.
Kala Pharmaceuticals Inc (NASDAQ: 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
• Xeris Pharma (before the market open)
• Liquidia Technologies Inc (NASDAQ: LQDA) (before the market open)
• Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
• INmune Bio Inc (NASDAQ: INMB) (before the market open)
• Clearside Biomedical Inc (NASDAQ: CLSD) (after the close)
• Calithera Biosciences Inc (NASDAQ: CALA) (after the close)
• Unity Biotechnology Inc (NASDAQ: UBX) (after the close)
• Navidea Biopharmaceuticals Inc (NYSE: NAVB) (after the close)
• Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the close)
• BioLife Solutions Inc (NASDAQ: BLFS) (after the close)
• Dynavax Technologies Corporation (NASDAQ: DVAX) (after the close)
• Miragen Therapeutics Inc (NASDAQ: MGEN) (after the close)
• Pfenex Inc (NYSE: PFNX) (after the close)
• Arcturus Therapeutics Ltd (NASDAQ: ARCT) (after the close)
• Novavax, Inc. (NASDAQ: NVAX) (after the close)
• Global Cord Blood Corp (NYSE: CO) (after the close)