The Daily Biotech Pulse: FDA Nod For Novartis, iRhythm CEO Quits Abruptly, Moderna Inks Vaccine Supply Agreements

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 June 1)

  • Anika Therapeutics, Inc. ANIK
  • Apellis Pharmaceuticals, Inc. APLS
  • GT Biopharma, Inc. GTBP
  • Lantheus Holdings, Inc. LNTH
  • Nemaura Medical Inc. NMRD
  • Paratek Pharmaceuticals, Inc. PRTK (announced FDA approval for expansion an oral-only formulation of Nuzyra to treat community-acquired bacterial pneumonia in adults)
  • PLx Pharma Inc. PLXP
  • Sesen Bio, Inc. SESN (announced addition to its senior management team)
  • Talaris Therapeutics, Inc. TALS
  • West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 1)

  • Aeglea BioTherapeutics, Inc. AGLE
  • Black Diamond Therapeutics, Inc. BDTX
  • Day One Biopharmaceuticals, Inc. DAWN (IPOed Thursday)
  • Immunovant, Inc. IMVT (announced its quarterly results and departure of its chief medical officer)
  • Impel NeuroPharma, Inc. IMPL
  • NuCana plc NCNA

Stocks In Focus

Novartis Gets FDA Nod For Cosentyx to Treat Plaque Psoriasis In Pediatric Population and Adolescents

Novartis AG NVS said the FDA approved its Cosentyx for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy.

This is the first approval for Cosentyx in a pediatric population in the U.S., the company noted.

Separately, the company announced 2-year positive results from the Phase 3 JUNIPERA study, demonstrating that Cosentyx significantly delayed time to flare vs placebo in pediatric patients with juvenile psoriatic arthritis and enthesitis-related arthritis – two subtypes of juvenile idiopathic arthritis.

Lilly Announces Positive Long-term Data For Arthritis Drug

Eli Lilly and Company LLY said it will present new data from Phase 3 studies that further demonstrated the long-term efficacy and safety profile of Taltz among patients with axial spondyloarthritis. These results are being presented at the virtual Annual European Congress of Rheumatology.

"Most patients treated with Taltz did not show bone damage progression of radiographic axial spondyloarthritis up to two years in the long-term extension of two Phase 3 studies," Lilly added.

iRhythm Announces Resignation of CEO Mike Coyle

iRhythm Technologies, Inc. IRTC announced that Mike Coyle has decided to resign from his position as president and chief executive officer and a member of the board, effective June 1, due to personal matters.

Douglas Devine, the company's chief Financial officer, has assumed the role of interim CEO while a search for a permanent CEO is conducted.

The stock slumped 13.55% to $65.92 in after-hours trading.

Lyra Out-licenses Rights to Rhinosinusitis In China

Lyra Therapeutics, Inc. LYRA and China's LianBio announced a strategic partnership and exclusive license agreement for the development and commercialization of LYR-210 in Greater China, South Korea, Singapore and Thailand.

LYR-210 is an anti-inflammatory, intra-nasal drug matrix in late-stage development that is designed to treat chronic rhinosinusitis, a debilitating inflammatory disease of the nasal passages.

Under the terms of the agreement, Lyra will receive an upfront payment of $12 million and is eligible to receive up to $135 million in future payments based upon the achievement of specified development, regulatory and commercialization milestones. Upon commercialization on a region-by-region basis, Lyra also will be entitled to receive low double-digit royalties based on net sales of LYR-210 in the licensed territories.

The stock was up 17.96% at $9 in premarket trading Wednesday.

Bristol-Myers Squibb's Opdivo-Yervoy Combo Therapy Snags Another Approval In Europe

Bristol-Myers Squibb Company BMY announced that the European Commission has approved Opdivo, plus Yervoy. for the first-line treatment of adults with unresectable malignant pleural mesothelioma.

Related Link: The Week Ahead In Biotech: ASCO Presentations Front And Center, FDA Decisions Due For Scynexis, Liminal And Alkermes

AC Immune Gains On Alzheimer's Disease Vaccine Candidate Update

AC Immune SA ACIU said it is completing a Phase 2 study of its first clinical candidate, ACI-24, in people with mild Alzheimer's disease, and is also advancing an optimized ACI-24 formulation, which demonstrates enhanced and sustained immunogenicity in non-human primate studies, particularly against key pathological forms of Abeta such as oligomeric and pyroglutamate Abeta.

"We are planning to file an Investigational New Drug (IND) application for the optimized ACI-24 formulation by year-end, followed by an accelerated clinical development in Down syndrome-related AD, with start of Phase 2 as early as 2022/23," the company said.

The shares were soaring 21.82% to $7.76 in premarket trading Wednesday.

Stealth Biotherapeutics's Rare Inherited Disease Treatment Candidate Gets Orphan Drug Designation In Europe

Stealth BioTherapeutics Corp MITO said the European Medicines Agency has granted orphan drug designation for elamipretide for the treatment of Barth syndrome, an ultra-rare genetic condition.

The designation, the company said, it with certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU Member States, and if approved, marketing exclusivity in the EU for 10 years.

The stock jumped 28.97% to $1.87 in after-hours trading.

Nanobiotix Announces CFO Change

Nanobiotix S.A. NBTX announced the appointment of Bart Van Rhijn, as chief financial officer and member of its executive board.

Van Rhijn brings proven capabilities, as the company prepares for the planned launch of its second clinical registration study for NBTXR3 in head and neck cancer, continued development in immunotherapy, and planned expansion across solid tumor types and therapeutic combinations, it added.

Philippe Mauberna, who previously served as CFO, is stepping down after eight years of service at the company.

Moderna Announces New Supply Agreements For Its COVID-19 Vaccine

Moderna, Inc. MRNA said it has entered into an additional agreement with Swiss CDMO Lonza to support drug substance manufacturing for its global supply chain. The agreement will establish a new production line at Lonza's Geleen site in the Netherlands, contributing to the supply of an additional 300 million doses of Moderna's updated booster variant vaccine candidate, if authorized, per year, at a 50-µg dose.

Separately, the company announced an agreement with Thermo Fisher Scientific TMO for fill/finish sterile manufacturing services and supply packaging for its COVID-19 vaccine.

Under the terms of the agreement, Thermo Fisher's commercial manufacturing site in Greenville, North Carolina will be used for aseptic fill/finish, labeling and packaging to support the production of hundreds of millions of doses of the Moderna COVID-19 vaccine. Production will begin in the third quarter of 2021.

On The Radar

Clinical Readouts

EULAR Virtual Conference Presentations

Kezar Life Sciences, Inc. KZR: Final data from MISSION Phase 1b trial, the 25-week safety and tolerability study investigating up to 75-mg weekly dosing of KZR-616 in 47 patients with systemic lupus erythematous (Wednesday, June 2, 4:30 p.m.)

Aurinia Pharmaceuticals Inc. AUPH: Supportive interim analysis of its AURORA 2 Phase 3 continuation study that is evaluating Lupkynis for the treatment of lupus nephritis

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

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