The Daily Biotech Pulse: AstraZeneca Faces Setback In Ovarian Cancer Study, Mallinckrodt To Explore COVID-19 Treatment, Imara IPO - AstraZeneca (NASDAQ:AZN), Teva Pharmaceutical Indus (NYSE:TEVA)

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

Stocks In Focus

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

AstraZeneca plc AZN and Merck & Co., Inc. 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 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 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 RHHBY for developing Venclyxto.

Clearside Confirms George Lasezkay As CEO

Clearside Biomedical Inc 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 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 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 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 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 GMED said its board has authorized repurchase of $200 million of its common stock.

Earnings

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

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