The Daily Biotech Pulse: Valneva Strikes Deal To Supply COVID Vaccine to Bahrain, TherapeuticsMD & Amneal Settle Patent Lawsuit, Reata Awaits Adcom

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

Stocks In Focus

EyePoint Announces Commercialization Agreement For Dexycu To Treat Post-Operative Inflammation

EyePoint Pharmaceuticals, Inc. EYPT and ImprimisRx, a wholly-owned subsidiary of Harrow Health, Inc. HROW, jointly announced the expansion of their commercial alliance in which ImprimisRx will assume responsibility for U.S. sales and marketing activities for Dexycu (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery in the U.S.

The amended agreement expands the commercial alliance previously established in August 2020 between the companies.

EyePoint will pay ImprimisRx a commission based on the net sales of Dexycu and will retain all commercial rights for it.

Valneva Announces COVID-19 Vaccine Supply Pact With Bahrain

Valneva SE VALN announced the signing of an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of its inactivated COVID-19 vaccine candidate VLA2001. This is the second purchase agreement Valneva has secured for VLA2001 since reporting positive data for its Phase 3 clinical trial Cov-Compare.

The stock was up 11.67% to $53.60 in premarket trading.

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Neurocrine Announces Positive Phase 3 Data For Valbenazine In Huntington's Disease

Neurocrine Biosciences, Inc. NBIX announced positive top-line data from its Phase 3 study evaluating the efficacy, safety and tolerability of valbenazine being investigated as a once-daily treatment in adults with chorea associated with Huntington disease.

The study met the primary endpoint of reduction in severity of chorea, the cardinal motor feature in Huntington disease.

The stock was up 3.34% at $85 in premarket trading.

Nuvation Gets FDA Nod To Study NUV-422 In Advanced Breast Cancer

Nuvation Bio Inc. NUVB announced that the U.S. Food and Drug Administration has cleared its investigational new drug application to evaluate NUV-422 for the treatment of advanced breast cancer.

The FDA accepted the company's first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme.

Sage-Biogen Report Positive Data For Depression Drug

Sage Therapeutics, Inc. SAGE and Biogen Inc. BIIB announced new data from the LANDSCAPE clinical program evaluating the efficacy and safety of zuranolone for the treatment of major depressive disorder, showing across the studies, zuranolone treatment led to improvements in depressive symptoms as well as in symptoms of elevated anxiety as early as Day 3, reaching statistical significance, followed by a stabilization of depressive symptoms through the follow-up period.

The data was presented at the American College of Neuropsychopharmacology Congress, being held in San Juan, Puerto Rico.

Sage shares were up 1.01% at $40 in premarket trading, while Biogen was edging up 0.17% at $227.22.

TherapeuticsMD, Amneal Settle Patent Litigation Over Bijuva

TherapeuticsMD, Inc. TXMD announced the settlement of the previously disclosed U.S. patent litigation for Bijuva with Amneal Pharmaceuticals, Inc. AMRX. Bijuva is an FDA-approved to treat moderate to severe vasomotor symptoms related to menopause.

Under the settlement agreement, TherapeuticsMD granted to Amneal a license to commercialize Amneal's generic version of Bijuva in the U.S., commencing on May 25, 2032, or earlier under certain circumstances.


Merck & Co., Inc. MRK priced its $8 billion public offering of five series of senior unsecured notes, due 2027, 2028, 2031, 2051and 2061.

Adicet Bio, Inc. ACET priced its underwritten public offering of 6.25 million shares of its common stock at a public offering price of $14 per share. The gross proceeds from the offering are expected to be $87.5 million.

The stock was pulling back by 1.66% to $14.25 in premarket trading.

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

On The Radar

Adcom Meeting

FDA's Cardiovascular And Renal Drugs Advisory Committee is scheduled to discuss Reata Pharmaceuticals, Inc.'s RETA NDA for bardoxolone methyl capsules for the proposed indication of slowing the progression of chronic kidney disease caused by Alport syndrome in patients 12 years of age and older.

Briefing documents released Monday showed that FDA staffers raised concerns over the clinical data submitted by the company regarding the estimated glomerular filtration rate, a key measure on kidney function and the primary endpoint of the trial that supported the new drug application submission.

Clinical Readouts

San Antonio Breast Cancer Symposium Presentations

Context Therapeutics Inc. CNTX: preliminary results from ONA-XR in postmenopausal women with PR+/HER2- early breast cancer

Zymeworks Inc. ZYME: new clinical data for zanidatamab, in combination with chemotherapy in heavily pretreated patients with HER2-positive breast cancer

Ambrx Biopharma Inc. AMAM: Phase 2 data for ARX788 in patients with HER2-positive metastatic breast cancer whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens as well as safety and anti-tumor activity of ARX788 in HER2-positive metastatic breast cancer patients whose disease is resistant/refractory to HER2 targeted agents

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