The Daily Biotech Pulse: PhaseBio Gets Breakthrough Therapy Designation, FDA Shoots Down Zogenix Epilepsy Regulatory Filing

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 on April 8)

• Alector Inc ALEC
• Denali Therapeutics Inc DNLI
• GENFIT S A/ADR GNFT
• Ionis Pharmaceuticals Inc IONS
• Moderna Inc MRNA
• NGM Biopharmaceuticals Inc NGM(began trading on the Nasdaq on Thursday)
• PDL BioPharma Inc PDLI
• ZEALAND PHARMA/S ADR ZEAL

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 8)

• Evoke Pharma Inc EVOK
• Obalon Therapeutics Inc OBLN
• Viveve Medical Inc VIVE

Related Link: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trial Readouts

Stock In Focus

PhaseBio's Reversal Agent For Astrazeneca's Anti-Clotting Drug Gets Breakthrough Therapy Designation

PhaseBio Pharmaceuticals Inc PHAS said the FDA granted Breakthrough Therapy designation for its PB2452, a novel reversal agent for AstraZeneca plc AZN's antiplatelet drug ticagrelor. The BTD was accorded based on the Phase 1 data, which showed PB2452 achieved immediate and sustained reversal of ticagrelor's antiplatelet effects.

The stock soared 34.45 percent to $16.90 in after-hours trading.

Chimerix Appoints Pharma IndustryVeteran Sherman as CEO

Chimerix Inc CMRX announced the appointment of former Endocyte CEO Michael Sherman as its CEO, effective immediately. Additionally, the company announced the appointment of Michael Andriole, also a former Endocyte executive, to the newly created position of Chief Business Officer.

The stock gained 7.66 percent to $2.25 in after-hours trading.

FDA Refuses to File Zogenix's Application For Epilepsy Drug

Zogenix, Inc. ZGNX said the FDA handed down a refusal to file letter regarding its NDA for Fintepla for treating seizures associated with Dravet syndrome.

The FDA determined the NDA was not sufficiently complete to permit a substantive review, primarily due to two reasons: non-submission of certain non-clinical studies for assessing chronic administration of the pipeline asset and an incorrect version of a clinical dataset, which prevented the completion of the review process required to support the filing.

Zogenix said it will seek immediate guidance, including a Type A meeting with the FDA to clarify and respond to the issues.

Zogenix stock slumped 31.53 percent to $35.50 in after-hours trading.

GW Pharmaceuticals PLC- ADR GWPH, which markets Epidiolex for treating Dravet syndrome, saw its shares rise 3.50 percent to $173.40 in after-hours trading.

Novartis Completes Alcon Spinoff

Novartis AG NVS completed the spinoff of the Alcon eye care devices business through a dividend-in-kind distribution to holders of Novartis shares and ADRs, with each holder receiving 1 Alcon share for every 5 Novartis shares or ADRs held on April 8, at the close of business.

The spin-off, according to Novartis, allows it to focus its capital allocation and management attention on medicines. The company said it is now well positioned to sustain top- and bottom-line growth and plans to improve innovative Medicines core margins in the mid-30s by 2022. Alcon shares will begin trading on the NYSE as well as the SIX Swiss Exchange on April 9 under the ticker symbol ALC.

The stock rose 1 percent to $94.93 in after-hours trading.

Offerings

Zosano Pharma Corp ZSAN commenced an underwritten public offering of its common shares, with all the shares to be sold by the company. The company said it intends to use the net proceeds to fund its ongoing development and preparation for potential commercialization of Qtrypta, and for working capital and general corporate purposes.

The stock plunged 21.22 percent to $4.01 in after-hours trading.

Homology Medicines Inc FIXX said it intends to offer $125 million worth of its common stock in an underwritten public offering. All the shares in the proposed offering are to be sold by Homology.

The stock fell 6.06 percent to $28.50 in after-hours trading.

GSK Unit ViiV Healthcare Says FDA Greenlights 2-Drug Regimen For HIV-1 Infection

ViiV Healthcare, majority owned by GlaxoSmithKline plc GSK, along with Pfizer Inc. PFE and Japan's SHIONOGI & CO L/ADR SGIOY said the FDA approved its Dovato, a complete, once-daily, single-tablet regimen of dolutegravir 50mg and lamivudine 300mg for treating HIV-1 infection in adults with no antiretroviral treatment history, and with no known resistant to dolutegravir or lamivudine.

"Dovato, a two-drug regimen (2DR), reduces exposure to the number of ARVs from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional DTG-based three-drug regimen," ViiV said.