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The Daily Biotech Pulse: AstraZeneca Faces Setback In Ovarian Cancer Study, Mallinckrodt To Explore COVID-19 Treatment, Imara IPO

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 11)

Benzinga · 03/12/2020 11:37

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 11)

  • Bicycle Therapeutics PLC (NASDAQ: BCYC) (reacted to its fourth-quarter results)
  • Centogene NV (NASDAQ: CNTG)
  • Tiziana Life Sciences PLC (NASDAQ: TLSA) ( announced plans to develop its investigational monoclonal antibody for treating COVID-19)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on March 11)

  • Accelerate Diagnostics Inc (NASDAQ: AXDX)
  • Achieve Life Sciences Inc (NASDAQ: ACHV)
  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Adaptive Biotechnologies Corp (NASDAQ: ADPT)
  • Aeglea Bio Therapeutics Inc (NASDAQ: AGLE)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Affimed NV (NASDAQ: AFMD)
  • Aileron Therapeutics Inc (NASDAQ: ALRN)
  • Akari Therapeutics PLC (NASDAQ: AKTX)
  • Akcea Therapeutics Inc (NASDAQ: AKCA)
  • Akorn, Inc. (NASDAQ: AKRX)
  • Aldeyra Therapeutics Inc (NASDAQ: ALDX)
  • Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)
  • Alkermes Plc (NASDAQ: ALKS)
  • AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
  • Amarin Corporation plc (NASDAQ: AMRN)
  • ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
  • AngioDynamics, Inc. (NASDAQ: ANGO)
  • ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP)
  • Anixa Biosciences Inc (NASDAQ: ANIX)
  • Aquestive Therapeutics Inc (NASDAQ: AQST)
  • Aravive Inc (NASDAQ: ARAV)
  • Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
  • Atara Biotherapeutics Inc (NASDAQ: ATRA)
  • Atossa Therapeutics Inc (NASDAQ: ATOS)
  • Autolus Therapeutics Ltd – ADR (NASDAQ: AUTL)
  • AVEO Pharmaceuticals, Inc. ((NASDAQ: AVEO)
  • AxoGen, Inc Common Stock (NASDAQ: AXGN)
  • Axovant Gene Therapies Ltd (NASDAQ: AXGT)
  • Bellicum Pharmaceuticals Inc (NASDAQ: BLCM)
  • BioCardia Inc (NASDAQ: BCDA)
  • BioSig Technologies Inc (NASDAQ: BSGM)
  • BioTelemetry Inc (NASDAQ: BEAT)
  • Black Diamond Therapeutics Inc (NASDAQ: BDTX)
  • CASI Pharmaceuticals Inc (NASDAQ: CASI)
  • Catabasis Pharmaceuticals Inc (NASDAQ: CATB)
  • CELYAD SA/ADR (NASDAQ: CYAD)
  • Cerecor Inc (NASDAQ: CERC)
  • Champions Oncology Inc (NASDAQ: CSBR)
  • Chiasma Inc (NASDAQ: CHMA)
  • CNS Pharmaceuticals Inc (NASDAQ: CNSP)
  • Corvus Pharmaceuticals Inc (NASDAQ: CRVS)
  • Edap Tms SA (NASDAQ: EDAP)
  • Ekso Bionics Holdings Inc (NASDAQ: EKSO)
  • 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)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH)
  • Heron Therapeutics Inc (NASDAQ: HRTX)
  • Ideaya Biosciences Inc (NASDAQ: IDYA)
  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)
  • Illumina, Inc. (NASDAQ: ILMN)
  • ImmuCell Corporation (NASDAQ: ICCCv
  • Integra Lifesciences Holdings Corp (NASDAQ: IART)
  • Ionis Pharmaceuticals Inc (NASDAQ: IONS)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)
  • Kalvista Pharmaceuticals Inc (NASDAQ: KALV)
  • Kamada Ltd. (NASDAQ: KMDA)
  • KITOV PHARMA LT/S ADR (NASDAQ: KTOV)
  • Kura Oncology Inc (NASDAQ: KURA)
  • Lantheus Holdings Inc (NASDAQ: LNTH)
  • MacroGenics Inc (NASDAQ: MGNX)
  • TapImmune Inc. common stock (NASDAQ: MRKR)
  • MediciNova, Inc. (NASDAQ: MNOV)
  • Medigus Ltd. (NASDAQ: MDGS)
  • MeiraGTx Holdings PLC (NASDAQ: MGTX)
  • Meridian Bioscience, Inc. (NASDAQ: VIVO)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MACK)
  • Misonix Inc (NASDAQ: MSON)
  • Moleculin Biotech Inc (NASDAQ: MBRX)
  • Monopar Therapeutics Inc (NASDAQ: MNPR)
  • Mustang Bio Inc (NASDAQ: MBIO)
  • Myriad Genetics, Inc. (NASDAQ: MYGN)
  • Neovasc Inc (NASDAQ: NVCN)
  • Neurometrix Inc (NASDAQ: NURO)
  • NuVasive, Inc. (NASDAQ: NUVA)
  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX)
  • Organogenesis Holdings Inc (NASDAQ: ORGO)
  • Oxford Immunotec Global PLC (NASDAQ: OXFD)
  • Pacira Biosciences Inc (NASDAQ: PCRX)
  • Pfizer Inc. (NYSE: PFE)
  • Phio Pharmaceuticals Corp (NASDAQ: PHIO)
  • Pieris Pharmaceuticals Inc (NASDAQ: PIRS)
  • Plus Therapeutics Inc (NASDAQ: PSTV)
  • Polarityte Inc (NASDAQ: PTE)
  • Precigen Inc (NASDAQ: PGEN)
  • Predictive Oncology Inc (NASDAQ: POAI)
  • Psychemedics Corp. (NASDAQ: PMD)
  • Pulse Biosciences Inc (NASDAQ: PLSE)
  • Rhythm Pharmaceuticals Inc (NASDAQ: RYTM)
  • Rubius Therapeutics Inc (NASDAQ: RUBY)
  • SAGE Therapeutics Inc (NASDAQ: SAGE)
  • Salarius Pharmaceuticals Inc (NASDAQ: SLRX)
  • Spero Therapeutics Inc (NASDAQ: SPRO)
  • Stealth BioTherapeutics Corp (NASDAQ: MITO)
  • Stemline Therapeutics Inc (NASDAQ: STML)
  • Stoke Therapeutics Inc (NASDAQ: STOK)
  • SurModics, Inc. (NASDAQ: SRDX)
  • Synlogic Inc (NASDAQ: SYBX)
  • T2 Biosystems Inc (NASDAQ: TTOO)
  • Tcr2 Therapeutics Inc (NASDAQ: TCRR)
  • Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)
  • TFF Pharmaceuticals Inc (NASDAQ: TFFP)
  • Theratechnologies Inc (NASDAQ: THTX)
  • Titan Medical Inc. (NASDAQ: TMDI)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • Unum Therapeutics Inc (NASDAQ: UMRX)
  • Vericel Corp (NASDAQ: VCEL)
  • Viking Therapeutics Inc (NASDAQ: VKTX)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • VIVUS, Inc. (NASDAQ: VVUS)
  • Voyager Therapeutics Inc (NASDAQ: VYGR)
  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)
  • Xencor Inc (NASDAQ: XNCR)
  • ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)
  • Zimmer Biomet Holdings Inc (NYSE: ZBH)

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

Stocks In Focus

AstraZeneca-Merck's Ovarian Cancer Combo Therapy Fails To Meet Primary Endpoint In Late-stage study

AstraZeneca plc (NYSE: AZN) and Merck & Co., Inc. (NYSE: MRK) said the Phase 3 study dubbed GY004 that evaluated cediranib in combination with Lynparza versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer did not meet the primary endpoint of progression-free survival.

Achieve Life Sciences Says Investigational Smoking Cessation Drug Showed Efficacy In Midstage Trial

Ahead of a planned presentation of additional analyses of results from the ORCA-1 Phase 2b trial of cytisinicline at the SRNT annual meeting being held in New Orleans, Achieve Life Sciences said new analyses demonstrated cytisinicline's biochemical efficacy through measurement of serum cotinine as well as the previously treated carbon monoxide efficacy.

"The additional analyses further validate our belief that cytisinicline could be an effective aid to smoking cessation regardless of demographics, prior smoking history, or numerous quit attempts," said Dr. Cindy Jacobs, Chief Medical Officer of Achieve.

The stock was seen adding 3.98% to 43 cents in pre-market trading.

Mallinckrodt To Explore Inhaled Nitric Oxide As Supportive Treatment Option For COVID-19

Mallinckrodt PLC (NYSE: MNK) said it's currently evaluating a potential role of inhaled nitric oxide as a supportive measure for treating patients infected with SARS-CoV-2 and having associated pulmonary complications. The company said it has engaged with the U.S. FDA, NIH and BARDA.

The company currently markets iNO as INOmax gas for inhalation in the U.S. for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.

In pre-market trading, Mallinckrodt shares were rallying 12.13% to $3.42.

AbbVie Gets European Nod For Leukemia Combo Regimen

AbbVie Inc (NYSE: ABBV) said the European Commission has approved its Venclyxto in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia who were previously untreated. AbbVie is partnering with Roche Holdings AG Basel ADR (OTC: RHHBY) for developing Venclyxto.

Clearside Confirms George Lasezkay As CEO

Clearside Biomedical Inc (NASDAQ: CLSD) has appointed George Lasezkay as CEO, effective March 1. Lasezkay had held the position on an interim basis ahead of the recent appointment. Separately, the company reported flat revenues of $1.9 million and a narrower loss of 7 cents per share, in line with the consensus.

The stock eased 0.77% to $2.57 in after-hours trading.

Teva's Ajovy Recommended by U.K.'s Health Advisory Body

Teva Pharmaceutical Industries Ltd (NYSE: TEVA) said the National Institute for Health and Care Excellence, or NICE, has recommended its Ajovy in its Final Appraisal Document for the prevention of migraine in adults with chronic migraine and who have not responded to at least three prior preventive drug treatments.

NICE is an independent public body that provides national guidance and advice to improve health and social care in the U.K.

Amneal Announces New CFO

Amneal Pharmaceuticals Inc (NYSE: AMRX) has appointed pharma industry veteran Tasos Konidaris as CFO, effective March 12. Konidaris will replace Todd Branning, who despite relinquishing office as CFO is available for the company through March 31.

The stock rose 1.54% to $3.30 in after-hours trading.

Flexion Appoints Melissa Layman As Chief Commercial Officer

Flexion Therapeutics Inc (NASDAQ: FLXN) announced the appointment of Melissa Layman as Chief Commercial Officer. Layman, according to the company, has 25 years of commercial experience within the life science industry.

"She combines deep and broad commercial expertise with important leadership experience and a strong track record of success. I am confident that she will make a very real difference for us and for patients on the journey to realizing the potential of ZILRETTA," said Michael Clayman, CEO of Flexion.

The stock rose 3.57% to $12.75 in after-hours trading.

Emergent Biosolutions To Begin Clinical Study Of COVID-19 Treatment In Q3

Emergent Biosolutions Inc (NYSE: EBS) has initiated development of two product candidates for the treatment and prevention of COVID-19 on its hyperimmune platforms.

The company said it has initiated plasma collection efforts for both human and equine platforms with the goal of manufacturing clinical material within the next four to five months in anticipation of beginning a clinical study as early as the third quarter of 2020.

The stock moved up 0.82% to $53.47 in after-hours trading.

Global Medical To Buy Back $200M Worth Of Shares

Globus Medical Inc (NYSE: GMED) said its board has authorized repurchase of $200 million of its common stock.

Earnings

Ovid Therapeutics Inc (NASDAQ: OVID) reported a net loss of 35 cents per share for the fourth quarter, narrower than the year-ago loss of 52 cents per share. Analysts expected a loss of 41 cents per share for the quarter.

The stock jumped 16.79% to $3.13 in after-hours trading.

Aquestive Therapeutics' revenues for the fourth quarter declined from $16.8 million in 2018 to $16.4 million in 2019. The net loss per share, however, narrowed from 56 cents to 48 cents per share. For the full year 2020, the company expects revenues of $35 million to $45 million, in line with the consensus estimate.

The stock gained 8.84% to $3.20 in after-hours trading.

Arcturus Therapeutics Ltd (NASDAQ: ARCT) reported a decline in its fourth-quarter revenues from $7.58 million in 2018 to $2.97 million in 2019. The net loss widened from 10 cents per share to 76 cents per share.

The stock moved up 6.95% to $14 in after-hours trading.

Offerings

Seelos Therapeutics Inc (NASDAQ: SEEL) said it has priced its underwritten public offering of 7.5 million shares at 60 cents per share. All the shares are to be offered by the company. The company expects to raise net proceeds of $3.9 million from the offering. The offering would close on or about March 16, Seelos said.

The stock plunged 17.95% to 64 cents in after-hours trading.

Close on heels of its decision to enter the fray to develop a treatment for COVID-19, Tiziana announced a follow-on offering of 3.33 million ADS representing 16.67 million shares at $3 per ADS for raising gross proceeds of about $10 million. The company expects the offering to close on March 16.

The stock added 6.33% to $4.20 in after-hours trading.

On The Radar

Earnings

Avadel Pharmaceuticals PLC (NASDAQ: AVDL) (before the market open)
Axsome Therapeutics Inc (NASDAQ: AXSM) (before the market open)
Aldeyra Therapeutics Inc (NASDAQ: ALDX) (before the market open)
Selecta Biosciences Inc (NASDAQ: SELB) (before the market open)
Polarityte Inc (NASDAQ: PTE) (before the market open)
Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) (before the market open)
Pieris Pharmaceuticals Inc (NASDAQ: PIRS) (before the market open)
Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
Provention Bio Inc (NASDAQ: PRVB) (before the market open)
Protalix Biotherapeutics Inc (NYSE: PLX) (before the market open)
Evofem Biosciences Inc (NASDAQ: EVFM) (before the market open)
China Biologic Products Holdings Inc (NASDAQ: CBPO) (before the market open)
Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) (before the market open)
Pieris Pharmaceuticals Inc (NASDAQ: PIRS) (before the market open)
X4 Pharmaceuticals Inc (NASDAQ: XFOR) (before the market open)
Polarityte Inc (NASDAQ: PTE) (before the market open)
Rubius Therapeutics Inc (NASDAQ: RUBY) (before the market open)
• Agenus Inc (NASDAQ: AGEN) (before the market open)
ADMA Biologics Inc (NASDAQ: ADMA) (after the close)
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) (after the close)
Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) (after the close)
Celcuity Inc (NASDAQ: CELC) (after the close)
Lineage Cell Therapeutics Inc (NYSE: LCTX) (after the close)
Chembio Diagnostics Inc (NASDAQ: CEMI) (after the close)
Harpoon Therapeutics Inc (NASDAQ: HARP) (after the close)
• Flexion (after the close)
Neoleukin Therapeutics Inc (NASDAQ: NLTX) (after the close)
Rockwell Medical Inc (NASDAQ: RMTI) (after the close)
Inovio Pharmaceuticals Inc (NASDAQ: INO) (after the close)
Savara Inc (NASDAQ: SVRA) (after the close)
Ocular Therapeutix Inc (NASDAQ: OCUL) (after the close)
Y-mAbs Therapeutics, Inc (NASDAQ: YMAB) (after the close)
Amphastar Pharmaceuticals Inc (NASDAQ: AMPH) (after the close)
CymaBay Therapeutics Inc (NASDAQ: CBAY) (after the close)
Adverum Biotechnologies Inc (NASDAQ: ADVM) (after the close)
Geron Corporation (NASDAQ: GERN) (after the close)
• CNS Pharmaceuticals (after the close)
Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) (after the close)
• Synlogic (after the close)

IPOs

Imara, a biopharma company that is developing therapies for rare hemoglobinopathies, priced its upsized IPO of 4.70 million shares at $16, the lower bound of the previously estimated price range of $16-$18. The company's shares will be listed on the Nasdaq under the ticker symbol IMRA.