The FDA has approved Zogenix Inc.’s Fintepla (fenfluramine), an oral treatment for patients age 2 and older with seizures associated with Dravet syndrome, a rare, pediatric-onset form of epilepsy. The company’s stock (NASDAQ:ZGNX) dropped dramatically when the market opened Friday but recovered somewhat at midday to sag only about 3%. Dravet syndrome, which afflicts children, is life threatening, chronic and the seizures associated with it are severe. It also comes with an increased risk of sudden unexpected death. The price will vary from patient to patient, Ashish Sagrolikar, Zogenix’s executive vice president and chief commercial officer, said in Friday morning’s conference call, with an average list price based on dosing and patient weight expected to be $96,000 per year. The company will have a patient assistance program offering support based on patient needs, he added. There are anywhere from 6,000 to 8,000 Dravet syndrome patients in the U.S.

FDA issues CRL to Allergan and Molecular Partners

The FDA sent a complete response letter to Allergan plc, an Abbvie Inc. company, and Molecular Partners AG, of Zurich, Switzerland, regarding the BLA for Abicipar pegol, their VEGF-A inhibitor-Darpin therapy for patients with wet age-related macular degeneration. The FDA noted the rate of intraocular inflammation occurring after administering Abicipar pegol 2 mg/0.05 mL results in an unfavorable benefit-risk ratio. Abbvie said it will meet with the FDA to discuss the comments and determine next steps. Molecular Partners’ Darpin molecules come from naturally occurring binding proteins and have a high binding affinity. Molecular Partners’ stock (SIX:MOLN) dropped 31.47% Friday.

All change at the EMA as Cooke named new director while CHMP nods through remdesivir for COVID-19

DUBLIN – Emer Cooke, named this week as the next executive director of the EMA, is the first woman to lead the organization since its creation in 1994. She is due to take up the post in November, but her appointment must first be ratified by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). She is due to present a statement to the group on July 13. The imminent change of leadership at the agency comes at a critical time for drug regulation and public health in Europe – and everywhere else.

IPO market staying healthy; Akouos, Fusion price at $212.5M each

Sizeable IPOs fed the bank balance for a pair of biotechs: Boston-based Akouos Inc. and Fusion Pharmaceuticals Inc., of Hamilton, Ontario. Akouos sold 125 million shares at $17 each for $212.5 million in gross proceeds, and Fusion raked in the same amount via the same terms. Gene therapy-focused Akouos, which develops drugs for hearing disorders, was trading midday (NASDAQ:AKUS) at $22.94, up $5.94 or 34%. Working on next-generation radiopharmaceuticals, Fusion was expected to begin trading today under the ticker FUSN.

Artiva lands $78M financing series to back NK cell therapies pipeline

Artiva Biotherapeutics Inc., of San Diego, has secured $78 million in series A financing to support its development of off-the-shelf universal NK cells for use in combination with monoclonal antibody therapy and tumor targeting CAR-NK cell therapies. The company plans to move into the clinic this year with its first candidate, AB-101, in combination with an anti-CD20 monoclonal antibody for the treatment of relapsed refractory B-cell lymphoma. 5AM Ventures, Venbio Partners and RA Capital Management co-led the financing, joined by Medivate Partners, seed investors and Green Cross Holdings Corp.

China moves two more COVID-19 vaccines to trials, another one entering phase III

BEIJING – China this week approved both the country’s first mRNA vaccine candidate and its first recombinant protein subunit vaccine to begin clinical trials to fight COVID-19. China National Biotec Group’s vaccine is also entering phase III trials in Beijing, Wuhan and Abu Dhabi, the United Arab Emirates. The addition of these two vaccine candidates means China now has seven candidates in its trial pipeline for COVID-19. They include a viral vector-based vaccine and four inactivated vaccines, meaning that the country is adopting four different technologies in the vaccine race.

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Also in the news

Acceleron, Alimentiv, Allergan, Ascendis, Axsome, Basilea, BMS, Celltex, Citius, Daiichi Sankyo, DBV Technologies, Diversigen, Eisai, ERC Belgium, Erytech, Fennec, Helix, Hemogenyx, Highlight, Janssen, Leap, Medicinova, Molecular Partners, Novan, Novartis, Onconano, Philogen, Portage, Samsung Bioepis, Sarepta, Siga, Tela, Translate, Vaxart, Vertex, Xeris, Zogenix