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)
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Alector Inc (NASDAQ: ALEC)
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Denali Therapeutics Inc (NASDAQ: DNLI)
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GENFIT S A/ADR (NASDAQ: GNFT)
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Ionis Pharmaceuticals Inc (NASDAQ: IONS)
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Moderna Inc (NASDAQ: MRNA)
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NGM Biopharmaceuticals Inc (NASDAQ: NGM)(began trading on the Nasdaq on Thursday)
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PDL BioPharma Inc (NASDAQ: PDLI)
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ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)
Down In The Dumps
(Biotech stocks hitting 52-week lows on April 8)
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Evoke Pharma Inc (NASDAQ: EVOK)
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Obalon Therapeutics Inc (NASDAQ: OBLN)
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Viveve Medical Inc (NASDAQ: 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 (NASDAQ: PHAS) said the FDA granted Breakthrough Therapy designation for its PB2452, a
novel reversal agent for AstraZeneca plc (NYSE: 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 (NASDAQ: 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. (NASDAQ: 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 (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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 (NASDAQ: 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 (NYSE: GSK), along with Pfizer Inc. (NYSE: PFE) and Japan's SHIONOGI & CO L/ADR (OTC: 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.
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