The Daily Biotech Pulse: MediciNova Bags BARDA Contract, Lilly’s COVID-19 Antibody Cocktail Data, Bluebird Bio Refutes Blood Cancer Link
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 March 9)
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Amneal Pharmaceuticals, Inc. (NYSE: AMRX)
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AngioDynamics, Inc. (NASDAQ: ANGO)
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AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) ( announced a new-gen multi-cancer detection sensor)
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Axonics Modulation Technologies, Inc. (NASDAQ: AXNX)
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Bausch Health Companies Inc. (NYSE: BHC) (issued a pipeline update at a conference)
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Bolt Biotherapeutics, Inc. (NASDAQ: BOLT)
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Cullinan Oncology, Inc. (NASDAQ: CGEM)
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Five Prime Therapeutics, Inc. (NASDAQ: FPRX)
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IDEAYA Biosciences, Inc. (NASDAQ: IDYA)
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Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) (reacted to its fourth-quarter results)
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Second Sight Medical Products, Inc. (NASDAQ: EYES)
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Silverback Therapeutics, Inc. (NASDAQ: SBTX)
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Surmodics, Inc. (NASDAQ: SRDX)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows March 9)
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ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (moved lower in reaction to FDA communication regarding deficiencies in its regulatory application for dementia drug)
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Immunocore Holdings plc (NASDAQ: IMCR)
Stocks In Focus MediciNova Gets BARDA Contract to Study MN-166 For Chlorine Gas-induced Lung Damage
MediciNova, Inc. (NASDAQ: MNOV) said it has partnered with the BARDA to repurpose MN-166 as a potential medical countermeasure against chlorine gas-induced lung damage such as acute respiratory distress syndrome and acute lung injury. BARDA will provide funding for proof-of-concept studies of MN-166 in preclinical models of chlorine gas-induced acute lung injury.
MN-166 is the first compound to receive BARDA’s development support through the DRIVe ReDIRECT program, the company said.
The stock climbed 106.69% to $11.74 in after-hours trading.
Affimed to Continue Enrollment In The Mid-stage Blood Cancer Study Following Futility Analysis
Following a pre-planned futility analysis, Affimed N.V. (NASDAQ: AFMD) said it will continue enrollment in the Phase 2 REDIRECT trial, which is evaluating AFM13 as a monotherapy for the treatment of patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma.
The futility analysis demonstrated that the response rate in Cohort A achieved the predefined threshold for continuation of the study, the company said.
Evidence of anti-tumor response was observed in Cohort A as well as Cohort B, with complete and partial responses. The safety analysis was consistent with previously reported data from Affimed’s Phase 1 trials of AFM13, with infusion related reactions representing the main side effect.
Lilly Announces Additional Positive Phase 3 Data For Antibody Combo In Early-stage COVID-19 Patients
Eli Lilly and Company (NYSE: LLY) announced new data from the BLAZE-1 Phase 3 study, demonstrating bamlanivimab, 700 mg, and etesevimab,1400 mg, together significantly reduced COVID-19 related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19.
These results provide additional efficacy and safety data that support the use of the dose recently granted both emergency use authorization by the Food and Drug Administration and a positive scientific opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Bluebird Bio Says Analyses Prove Blood Cancer Incidence Not Tied to Its Investigational Sickle Cell Gene Therapy
bluebird bio, Inc. (NASDAQ: BLUE) said, based on the analyses completed to date, it is very unlikely the suspected unexpected serious adverse reaction of acute myeloid leukemia reported in its Phase 1/2 study of LentiGlobin gene therapy for sickle cell disease was related to the BB305 lentiviral vector.
The company said it has initiated engagement with regulators to begin the process of resuming clinical studies for sickle cell disease and β-thalassemia.
The stock was rallying 12.18% to $33.17 in premarket trading Wednesday.
Mallinckrodt Reaches Agreement With Lenders Regarding Restructuring Activities
Mallinckrodt plc (OTC: MNKKQ) said it has reached agreement with an ad hoc group of first lien term lenders holding approximately $1.3 billion of its outstanding loans to support its previously announced restructuring support agreement. The agreement, which is based on providing new term loans financing to replace the existing loans, resolves the open dispute between the company and the lenders as to how such lenders are to be treated under the restructuring plan and serves to extend near-term debt maturities.
Earnings
Outset Medical, Inc. (NASDAQ: OM) reported fourth-quarter net revenues of $17.2 million, up 143% year-over-year. The non-GAAP net loss per share narrowed from $20.91 to 60 cents. The company guided first-quarter revenues to $21 million to $22 million and full-year revenues to $89 million to $94 million.
The stock added 9.85% to $53.21 in after-hours trading.
Inari Medical, Inc.’s (NASDAQ: NARI) fourth-quarter revenues climbed from $38.7 million in 2019 to $48.7 million in 2020. The company reversed from a loss of 1 cent per share to a profit of 13 cents per share, well ahead of the consensus estimate for a profit of 1 cent per share. The company expects revenues of $54 million to $56 million for the first quarter and $225 million to $235 million for fiscal year 2021.
Analysts, on average, estimate revenues of $41.68 million for the first quarter and $181.5 million for 2021.
In after-hours trading, the stock was up 11.94% to $111.20.
Brickell Biotech, Inc. (NASDAQ: BBI) said its fourth-quarter revenues fell from $0.7 million in 2019 to $27,000 in 2020. The loss per share, however, narrowed from $1.38 to 15 cents, while analysts estimated a loss of 9 cents per share.
Cash and cash equivalents and marketable securities stood at $30.1 million as of Dec. 31, 2020, compared to $11.7 million as of Dec. 31, 2019.
The company also filed with the SEC a prospectus to offer securities to raise up to $150 million and another prospectus for the sale of shares worth $50 million by William Blair and Oppenheimer.
The stock slumped 11.48% to $1.08 in after-hours trading.
Offerings
Jounce Therapeutics, Inc. (NASDAQ: JNCE) said it has priced an underwritten public offering of 5 million shares of common stock at a public offering price of $11.25 per share, for raising gross proceeds of about $56.25 million.
The company said it expects to use the proceeds of the offering to fund ongoing and planned clinical trials, including the INNATE trial of JTX-8064, to fund R&D to advance Jounce’s pipeline, and for working capital and other general corporate purposes. All shares are being offered by Jounce.
In after-hours trading, the stock lost 4.48% to $11.30.
Xenon Pharmaceuticals Inc. (NASDAQ: XENE) priced its underwritten public offering of 4.324 million common shares and, in lieu of common shares to a certain investor, pre-funded warrants to purchase up to 1.081 million common shares, in accordance with its existing shelf registration statement.
The common shares are being offered at a public offering price of $18.50 per share and the pre-funded warrants are being offered at a price of $18.4999 per pre-funded warrant.
The gross proceeds to Xenon from the offering are expected to be approximately $100 million.
The stock moved down 5.19% to $19 in after-hours trading.
On The Radar Earnings
Bio-Path Holdings, Inc. (NASDAQ: BPTH) (before the market open)
Harvard Bioscience, Inc. (NASDAQ: HBIO) (before the market open)
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) (before the market open)
Clearside Biomedical, Inc. (NASDAQ: CLSD) (after the close)
DiaMedica Therapeutics Inc. (NASDAQ: DMAC) (after the close)
Flexion Therapeutics, Inc. (NASDAQ: FLXN) (after the close)
Harpoon Therapeutics, Inc. (NASDAQ: HARP) (after the close)
Lantern Pharma Inc. (NASDAQ: LTRN) (after the close)
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (after the close)
Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) (after the close)
Protagonist Therapeutics, Inc. (NASDAQ: PTGX) (after the close)
OrthoPediatrics Corp. (NASDAQ: KIDS) (after the close)
Ascendis Pharma A/S (NASDAQ: ASND) (after the close)
Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates
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