The Daily Biotech Pulse: Lilly Spikes On Alzheimer's Drug Regulatory Filing Plan, Applied Genetics, Arcus Issue Data Readouts, Adcom Test Awaits Incyte, Monte Rosa Prices 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 June 23)

AngioDynamics, Inc. ANGO
Arrowhead Pharmaceuticals, Inc. ARWR
Avid Bioservices, Inc. CDMO
Axonics, Inc. AXNX
Century Therapeutics, Inc. Common Stock IPSC (went public June 18)
Entera Bio Ltd. ENTX (announced positive mid-phase data for bone-building therapy)
Citius Pharmaceuticals, Inc. CTXR
Edwards Lifesciences Corporation EW
Intra-Cellular Therapies, Inc. ITCI
Intuitive Surgical, Inc. ISRG
Ironwood Pharmaceuticals, Inc. IRWD
Lantheus Holdings, Inc. LNTH
OrthoPediatrics Corp. KIDS
PAVmed Inc. PAVM
ResMed Inc. RMD
Vericel Corporation VCEL
West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 23)

4D Molecular Therapeutics, Inc. FDMT
AbCellera Biologics Inc. ABCL
Adicet Bio, Inc. ACET
Allogene Therapeutics, Inc. ALLO
Celyad Oncology SA CYAD
Cullinan Oncology, Inc. CGEM
ERYTECH Pharma S.A. ERYP
Gain Therapeutics, Inc. GANX
Galapagos NV GLPG (announced resignation of chief scientific officer)
Gemini Therapeutics, Inc. GMTX (declined despite reporting positive mid-stage data for drug to treat advanced retinal disorder)
Impel NeuroPharma, Inc. IMPL
IMV Inc. IMV
ORIC Pharmaceuticals, Inc. ORIC
Pharming Group N.V. PHAR

Stocks In Focus

Viatris Gets Favorable Decision On EpiPen Lawsuit

Viatris VTRS announced that the U.S. District Court for the District of Kansas ruled, in substantial part, in Mylan's favor on the company's summary judgment motion in a class action related to the EpiPen Auto-Injector.

The company said it is pleased with the court's decision to dismiss all of the plaintiffs' claims under the federal RICO statute, which include claims asserted against Mylan's former CEO Heather Bresch. The court also dismissed claims alleging that Mylan foreclosed branded competition through rebate arrangements with pharmacy benefit managers.

Arcus Announces Positive Phase 2 Data For Antibody Combo Treatment Option For Lung Cancer

Arcus Biosciences, Inc. RCUS said at the first interim analysis of the three-arm Phase 2 ARC-7 study, both arms with domvanalimab-based combinations showed encouraging clinical activity, when given as an initial treatment to people with metastatic, PD-L1≥50% non-small cell lung cancer.

The zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied by other companies in this setting. At the time of data cut off, no unexpected safety signals were observed.

All three arms of the ARC-7 trial, and the ongoing ARC-10 Phase 3 registrational study, will continue to enroll as planned, the company said.

Arcus also said its partner Gilead Sciences, Inc. GILD has an exclusive option to co-develop and co-commercialize domvanalimab and will make a decision regarding opting into the anti-TIGIT program later this year.

The stock was jumping 19.53% to $27.97 premarket Thursday.

Merck-AstraZeneca's Lynparza Conditionally Approved For Treating Prostate Cancer In China

Merck & Co., Inc. MRK and AstraZeneca PLC AZN said Lynparza has been granted conditional approval in China as monotherapy for the treatment of adult patients with germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, who have progressed following prior treatment that included a new hormonal agent.

In premarket trading, Merck shares were adding 0.46% to $75.93 and AstraZeneca was moving up 0.78% to $58.43.

Karyopharm Gets Up to $100M Financing For R&D

Karyopharm Therapeutics Inc. KPTI announced the expansion of its royalty agreement with entities managed by HealthCare Royalty Management, for up to $100 million in new financing to support the ongoing development and commercialization of Xpovio, and for the clinical development of other programs, including eltanexor.

Xpovio is marketed in the U.S. for multiple hematologic malignancy indications and has received conditional marketing authorization by the European Commission for patients with heavily pretreated multiple myeloma. Eltanexor is currently being investigated for the treatment of patients with refractory myelodysplastic syndrome.

The stock was up 4.54% to $10.82 in premarket trading.

Applied Genetic Reports Positive Phase 1/2 Data For Gene Therapy To Treat Inherited Color Blindness

Applied Genetic Technologies Corporation AGTC announced 12-month data for adult patients and low dose pediatric patients in its Phase 1/2 clinical trials evaluated AAV gene therapy for achromatopsia, showing biologic activity based on improvements in visual sensitivity in the treated area.

The safety profile of the ophthalmic gene therapy platform remained favorable, the company added.

Applied Genetic said it intends to advance the ACHM B3 trial to the next stage of clinical development, premised on the positive data. The path forward for ACHM A3 will be determined after additional pediatric patient data and pre-clinical studies are available and can be evaluated, it added.

The stock was up 6.95% at $4.46 in premarket trading.

Biogen-Eisai's Investigational Alzheimer's Disease Drug Gets Breakthrough Therapy Designation

Biogen, Inc. BIIB and Eisai Co., Ltd. ESALY announced that the FDA has granted breakthrough therapy designation for lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of Alzheimer's disease.

Roche's Wet AMD Therapy Accepted For Review With Priority Status

Roche Holding AG RHHBY announced that the FDA has accepted the company's biologics license application under priority review for a port delivery system with ranibizumab for the treatment of neovascular or wet age-related macular degeneration.

If approved, PDS would be a first-of-its-kind therapeutic approach, offering people living with nAMD an alternative to frequent eye injections of anti-vascular endothelial growth factor, the current standard of care, Roche said.

The FDA is expected to make a decision on approval by Oct. 23.

Lilly's Alzheimer's Therapy Gets Breakthrough Therapy Designation; Company To File BLA Later This Year

Eli Lilly and Company LLY said the FDA granted breakthrough therapy designation for donanemab, its investigational antibody therapy for Alzheimer's disease.

Lilly said it intends to submit a biologics license application for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ Phase 2 Study.

Lilly shares were up 8.25% to $235 in premarket trading.

4D Molecular Regains Full Rights to Gene Therapy To Treat Inherited Eye Disorder After Roche Terminates Licensing Deal

4D Molecular said it has received a notice of termination of the collaboration and license agreement by 4D-110 licensee Roche resulting in full rights to 4D-110 reverting to itself.

4D Molecular also reported positive preclinical data for 4D-110 in Choroideremia and 4D-125 for X-linked retinitis pigmentosa.

Neuronetics To Join Russell 2K Index

Neuronetics, Inc. STIM said the company will be added to the Russell 2000 Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, according to a preliminary list of additions posted June 4.

On The Radar

Adcom Meeting

FDA's Oncologic Drugs Advisory Committee is scheduled to meet between 10:30 a.m. and 2:30 p.m. to discuss Incyte Corporation's INCY biologics license application for retifanlimab as a treatment option for adult patients with locally advanced or metastatic squamous carcinoma of the anal canal, who have progressed on or who are intolerant of platinum-based chemotherapy.

Clinical Readouts

Fulcrum Therapeutics, Inc. FULC will present at the Facioscapulohumeral Muscular Dystrophy Society's International Research Congress data from its Phase 2b clinical trial of Losmapimod, a treatment for FSH muscular dystrophy that is intended to stop the expression of the DUX4 gene and slow the progression of symptoms.

Earnings

Aethlon Medical, Inc. AEMD (after the close)

IPO

Monte Rosa Therapeutics, Inc., a biotech developing a portfolio of small molecule precision medicines that employ the body's natural mechanisms to selectively degrade therapeutically relevant proteins, priced its initial public offering of 11.7 million shares of common stock at a public offering price of $19 per share. All of the shares are being offered by Monte Rosa. The shares are expected to begin trading on the Nasdaq under the ticker symbol "GLUE."

The gross proceeds of the offering are expected to be approximately $222.3 million.

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