The Daily Biotech Pulse: Lilly Raises Guidance, Medtronic Gets FDA Warning Letter, Decision Day For Calliditas, Genenta IPO

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

Vir Biotech Says COVID-19 Antibody Treatment Effective Against Omicron Variant

Vir Biotechnology, Inc. VIR announced that new preclinical data, published to the preprint server bioRxiv, demonstrated the impact of the significant antigenic shift of the new SARS-CoV-2 Omicron variant.
Data demonstrate that sotrovimab and five other preclinical mAbs, developed by Vir in conjunction with GlaxoSmithKline plc GSK retained their in vitro neutralizing activity against Omicron.

Vir shares were adding 4.28% to $48 in premarket trading.

AbbBVie's Rinvoq Gets Label Expansion To Treat Active Psoriatic Arthritis

AbbVie, Inc. ABBV announced that U.S. Food and Drug Administration approved Rinvoq for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.

The shares were up 0.71% at $128.20 in premarket trading.

Click here to access Benzinga's FDA Calendar

Lilly's Monoclonal Antibody Treatment Candidate Aces Late-State Maintenance Study In Ulcerative Colitis

Eli Lilly & Co., Inc. LLY announced that its mirikizumab met the primary endpoint of clinical remission and all key secondary endpoints at one year in LUCENT-2, a Phase 3 maintenance study evaluating the efficacy and safety of mirikizumab for the treatment of patients with moderately-to-severely active ulcerative colitis.

With these data, Lilly said it plans to submit a biologics license application to the FDA for mirikizumab in UC, followed by submissions to other regulatory agencies around the world in the first-half of 2022.

Separately, the company said at its investment community meeting, it is providing program updates and financial guidance. The company increased its 2021 revenue guidance to $28.0 billion-$28.3 billion and issued above-consensus guidance for 2022.

Lilly shares were rallying 5.06% to $262 in premarket trading.

Sanofi-GSK Say Single Booster Dose Of COVID-19 Vaccine Produced Strong Immune Response

Sanofi SNY and GlaxoSmithKline announced that a single booster dose of their recombinant adjuvanted COVID-19 vaccine candidate delivered consistently strong immune responses in a Phase 3 study.

Preliminary results from the VAT0002 clinical trial investigating the safety and immunogenicity of the booster showed neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine and for all age groups tested.

Sanofi shares were gaining 0.75% to $48.41 in premarket trading.

Pfizer Gets FDA Approval For Xeljanz In Active Ankylosing Spondylitis

Pfizer, Inc. PFE announced the FDA approved the supplemental new drug application for Xeljanz/Xeljanz XR for the treatment of adults with active ankylosing spondylitis, who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.

Pfizer shares were moving up 0.76% to $55.96 in premarket trading.

Atea to Test COVID-19 Antiviral Treatment As Monotherapy And In Combo

Atea Pharmaceuticals, Inc. AVIR announced an updated strategy for AT-527 by deciding to test its potential use as both a monotherapy and in combination.

Taking into account the changing COVID-19 landscape with the anticipated availability of new antiviral treatment regimens, the global Phase 3 MORNINGSKY trial will be closed out and the ongoing Phase 2 hospitalized trial will be further amended to expand enrollment to unvaccinated, high-risk outpatients, the company said.

The strategic collaboration with Roche Holding AG RHHBY will be terminated on February 10, 2022, it added.

Idera To Stop Idera Trials And Considers Out-licensing Arrangement

Idera Pharmaceuticals, Inc. IDRA said its clinical trials with tilsotolimod have not yet translated into a new treatment alternative for patients. However, given data support tilsotolimod's mechanism of action and encouraging safety profile result, the company said it will consider an out-licensing arrangement for tilsotolimod so that its full potential may continue to be explored on behalf of patients who do not respond to traditional immunotherapy.

The company also said it continues both to preserve cash and to identify and explore potential development or commercial-stage assets for Idera's portfolio.

The stock was sliding 17.24% to 72 cents in premarket trading.

Apellis-Sobi Announce European Regulatory Nod For Aspaveli In Paroxysmal Nocturnal Hemoglobinuria

Apellis Pharmaceuticals, Inc. APLS and Swedish Orphan Biovitrum AB announced that the European Commission has approved Aspaveli for the treatment of adults with paroxysmal nocturnal hemoglobinuria who are anemic after treatment with a C5 inhibitor for at least three months.

Merck's Pneumococcal Vaccine Gets The Nod In Europe

Merck MRK said the European Commission has approved Vaxneuvance, its pneumococcal 15-valent conjugate vaccine, for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

Medtronic Discloses FDA Warning Letter Regarding Its Diabetes Business Plant In California

Medtronic plc MDT said it received a warning letter from the FDA on Dec. 9 for ITS Northridge, California, facility, the headquarters for its diabetes business. The warning letter was issued following an inspection that concluded in July related to recalls of the MiniMed 600 series insulin infusion pump, and a remote controller device for MiniMed 508 and Paradigm pumps.

The warning letter focuses on the inadequacy of specific medical device quality system requirements at the Northridge facility in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events, the company said.

The stock was retreating 3.75% to $107.50 in premarket trading.

Tonix, NRx Pharma Gain On Index Inclusion

Tonix Pharmaceuticals Holding Corp. TNXP and NRx Pharmaceuticals NRXP announced separately that Nasdaq has added the companies to the Nasdaq Biotechnology Index NBI, effective December 20.

NRx shares were gaining 5.71% to $5.83 in premarket trading and Tonix was moving up 2.75% to 41.10 cents.

Offerings

Legend Biotech Corporation LEGN said that it intends to offer and sell $300 million of ADSs, each representing two ordinary shares, in an underwritten public offering. All ADSs to be sold in the proposed offering will be offered by Legend Biotech.

The stock was slipping 7.27% to $45.01 in premarket trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

On The Radar

PDUFA Dates

The FDA is set to rule on Calliditas Therapeutics AB (publ)'s CALT new drug application for Nefecon as a treatment option for IgA nephropathy.

Eagle Pharmaceuticals, Inc. EGRX has a Generic Drug User Fee Act date for its generic version of Vasostrict, which is marketed by Endo International Plc's ENDP Par unit.

Earnings

Enzo Biochem, Inc. ENZ (after the close)

IPOs

Italy-based Genenta Science S.p.A. GNTA, a clinical-stage biotechnology developing hematopoietic stem progenitor cell immuno-gene therapy for solid tumors, priced its upsized initial public offering of 2.4 million ADSs, each representing one ordinary share, at a public offering price of $11.50 per share.

Genenta also sold 720,114 ordinary shares reserved for subscription by its existing shareholders at a price of $11.50 per share.

The gross proceeds from the offering, including ordinary shares, are expected to be approximately $36 million. The shares are expected to begin trading on the Nasdaq under the ticker symbol "GNTA."