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)

• 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

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 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.