The Daily Biotech Pulse: Moderna Ships COVID-19 Vaccine For Clinics, Mallinckrodt Strikes $1.6B Opioid Settlement

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 Feb. 24)

• Avadel Pharmaceuticals PLC AVDL
• Brainstorm Cell Therapeutics Inc BCLI
• Co-Diagnostics Inc CODX(received CE mark for its coronavirus test)
• COLLPLANT BIOTE/S ADR CLGN
• Gilead Sciences, Inc. GILD(reacted to a statement from WHO that its experimental drug remdesivir could be the one drug that may have efficacy)
• NGM Biopharmaceuticals Inc NGM( reacted to positive readout for its NASH drug)
• PAVmed Inc PAVM
• TELA Bio Inc TELA
• Zynex Inc. ZYXI

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Feb. 24)

• AcelRx Pharmaceuticals Inc ACRX
• Acorda Therapeutics Inc ACOR
• ADDEX THERAPEUT/ADR ADXN
• AngioDynamics, Inc. ANGO
• BioSig Technologies Inc BSGM
• Enanta Pharmaceuticals Inc ENTA
• Endologix, Inc. ELGX(announced debt restructuring)
• Enzo Biochem, Inc. ENZ
• Lantheus Holdings Inc LNTH
• MediciNova, Inc. MNOV
• Meridian Bioscience, Inc. VIVO
• Myriad Genetics, Inc. MYGN
• OncoSec Medical Inc ONCS
• Pacific Biosciences of California PACB
• Precipio Inc PRPO
• Pulse Biosciences Inc PLSE
• REDHILL BIOPHAR/S ADR RDHL
• Rhythm Pharmaceuticals Inc RYTM
• Sangamo Therapeutics Inc SGMO
• Sellas Life Sciences Group Inc SLS
• Sesen Bio Inc SESN
• Stealth BioTherapeutics Corp MITO
• SurModics, Inc. SRDX
• Taro Pharmaceutical Industries Ltd. TARO
• Theratechnologies Inc THTX
• TIZIANA LF SCIE/S ADR TLSA
• Tonix Pharmaceuticals Holding Corp TNXP
• Vanda Pharmaceuticals Inc. VNDA
• Zogenix, Inc. ZGNX

See Also: The Week Ahead In Biotech: Biopharma Earnings Pick Up Pace

Stocks In Focus

Moderna Ships First Batch COVID-19 Vaccine For Phase 1 Trials In U.S.

Moderna Inc MRNA said it has released the first batch of mRNA-1273, its first vaccine against the novel coronavirus, for human use. The company noted that vials having RNA-1273 have been shipped to the NIAID, a part of the National Institutes of Health, to be used in planned Phase 1 study in the U.S.

The stock rallied 18.34% to $22 in after-hours trading.

RedHill BioPharma To Buy Constipation Drug From AstraZeneca For Up To $67.5M

RedHill BioPharma is acquiring the global rights to Movantik, excluding Europe, Canada and Israel, from U.K. drug giant AstraZeneca plc AZN. Movantik is a peripherally acting mu-opioid receptor antagonist indicated for treating opioid-induced constipation. The acquisition is expected to close in the first quarter of 2020.

The agreement provides for RedHill making an upfront payment of $52.5 million to AstraZeneca upon closing and a further non-contingent payment of $15 million, 18 months post-closing. RedHill will also assume financial responsibility for sales-based royalty and potential milestone payments that AstraZeneca is liable to pay to Nektar Therapeutics NKTR.

RedHill expects to finance the Movantik acquisition by a non-dilutive, royalty-backed term loan from HealthCare Royalty Partners as part of the previously announced $115 million non-dilutive financing to support its U.S. commercial operations.

IMV Reports Positive Phase 2 Results For Ovarian Cancer Therapy

Imv Inc IMV released updated data from the Phase 2 study of its lead candidate DPX – Survivac in patients with advanced recurrent ovarian cancer, which showed that DPX-Survivac immunotherapy was active, durable and well tolerated.

Armed with the study results, the company said it plans to engage with the FDA on the design of a pivotal trial in ovarian cancer that might support an accelerated pathway.

In pre-market trading Tuesday, IMV shares were up 2.3% to $4.89.

Mallinckrodt Announces $1.6B Opioid Settlement Agreement

Mallinckrodt PLC MNK said it has reached an agreement in principle on terms of a global settlement that would resolve all opioid-related claims against the company, and its subsidiaries. The agreement provides for plaintiffs receiving $1.6 billion in structured payments to paid out in phases.

Separately, the company reported above-consensus fourth-quarter results.

In pre-market trading, Mallinckrodt shares were surging 31% to $5.50.

Roche Submits BLA For Subcutaneously Administered Fixed Dose Combination Regimen For Breast Cancer

Roche Holdings AG Basel ADR RHHBY said the FDA has accepted its BLA for the fixed-dose combo of Perjeta and Herceptin with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy for the treatment of eligible patients with HER2-positive breast cancer.

The company said the BLA was based on the results from the Phase 3 FeDeriCa study that showed non-inferior levels of Perjeta in blood and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.

Roche shares were seen edging up 0.14% to $42.60 in pre-market trading.

Acer Says Urea Cycle Disorder Drug Found Bioequivalent to Buphenyl

Acer Therapeutics Inc ACER said final data from Part B of its pivotal trial confirmed the bioavailability and bioequivalence of ACER-001 to Buphenyl. ACER-001 is a proprietary, taste-masked formulation of sodium phenylbutyrate, in development for the treatment of Urea Cycle Disorders.

The company said it plans to submit an NDA in early 2021, subject to additional capital and assuming successful completion of remaining non-clinical work and 12-month long-term stability data.

The stock added 1.84% to $4.99 in after-hours trading.

Earnings

Merit Medical Systems, Inc. MMSI reported fourth-quarter non-GAAP earnings per share of 40 cents, ahead of the 34-cent per share consensus estimate. Sales climbed 10.6% to $257.9 million. The company issued upbeat guidance for fiscal year 2020.

The stock rose 10.45% to $42.80 in after-hours trading.

Guardant Health Inc's GH fourth-quarter revenues climbed 91% to $62.9 million. The net loss per share narrowed from 30 cents to 27 cents, and was narrower than the consensus loss estimate of 31 cents per share. The 2020 revenue guidance was above estimates.

The stock slipped 7.46% to $78 in after-hours trading.

Orthofix Medical Inc OFIX reported fourth-quarter net sales of $121.5 million, up 0.3% year-over-year. The adjusted EPS was 51 cents, trialing the consensus estimate of 58 cents. The 2020 guidance was below estimates.

The stock moved down 14.15% to $38.60 in after-hours trading.

Clovis Oncology Inc CLVS reported net product revenues of $39.3 million, up 30% year-over-year. The net loss per share narrowed from $1.88 to $1.81, which however, was wider than the consensus loss estimate of $1.71 per share.

The stock slipped 9.07% to $9.02 in after-hours trading.

Tandem Diabetes Care Inc's TNDM fourth-quarter sales climbed 42.25% year-over-year to $108.40 million and EPS increased from 2 cents to 4 cents, while analysts estimated a loss of 5 cents per share.

The stock ended down 7.02% to $80.70 in after-hours trading.

Offerings

EXACT Sciences Corporation EXAS announced an underwritten public offering of $850 million aggregate principal amount of convertible senior notes due 2028. The company said it expects to use the net proceeds for general corporate purposes, including repayment or repurchase of debt, working capital and general corporate purposes.

The stock shed 7.28% to $88.60 in after-hours trading.

On The Radar

Earnings

• Avanos Medical Inc AVNS (before the market open)
• Strongbridge Biopharma plc SBBP (before the market open)
• Gamida Cell Ltd GMDA (before the market open)
• Vericel Corp VCEL (before the market open)
• MannKind Corporation MNKD (before the market open)
• Chimerix Inc CMRX (before the market open)
• Lantheus Holdings Inc LNTH (before the market open)
• Insmed Incorporated INSM (before the market open)
• Intercept Pharmaceuticals Inc ICPT (before the market open)
• Amarin Corporation plc AMRN (after the close)
• Adamas Pharmaceuticals Inc ADMS (after the close)
• Akcea Therapeutics Inc AKCA (after the close)
• Aclaris Therapeutics Inc ACRS (after the close)
• Iovance Biotherapeutics Inc IOVA (after the close)
• Insulet Corporation PODD (after the close)
• Nevro Corp NVRO (after the close)
• Exelixis, Inc. EXEL (after the close)
• GW Pharmaceuticals PLC- ADR GWPH (after the close)
• Inspire Medical Systems Inc INSP (after the close)
• Repro-Med Systems, Inc. KRMD (after the close)
• Veracyte Inc VCYT (after the close)
• MacroGenics Inc MGNX (after the close)
• Supernus Pharmaceuticals Inc SUPN (after the close)
• Paratek Pharmaceuticals Inc PRTK (after the close)
• Vanda Pharmaceuticals Inc. VNDA (after the close)
• Kura Oncology Inc KURA (after the close)
• Jazz Pharmaceuticals PLC JAZZ (after the close)