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The Daily Biotech Pulse: LogicBio Slapped With Clinical Hold, Agile Inks Debt Deal Ahead of Twirla Approval, Gilead Builds Stake In Sierra Oncology

Shanthi Rexaline

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 Feb. 10)

  • AbbVie Inc (NYSE: ABBV)
  • Allergan plc (NYSE: AGN) )(reacted to better-than-expected results and comments that its deal to be acquired by AbbVie is on track to close by the first quarter)
  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
  • Apellis Pharmaceuticals Inc (NASDAQ: APLS)
  • Aptose Biosciences Inc (NASDAQ: APTO)
  • Arcutis Biotherapeutics Inc (NASDAQ: ARQT)
  • Ascendis Pharma A/S (NASDAQ: ASND)
  • AtriCure Inc. (NASDAQ: ATRC)
  • ChemoCentryx Inc (NASDAQ: CCXI)
  • Co-Diagnostics Inc (NASDAQ: CODX)(announced sales of its new coronavirus test )
  • Cue Biopharma Inc (NASDAQ: CUE)
  • Deciphera Pharmaceuticals Inc (NASDAQ: DCPH)
  • DexCom, Inc. (NASDAQ: DXCM)
  • Esperion Therapeutics Inc (NASDAQ: ESPR)
  • Fulgent Genetics Inc (NASDAQ: FLGT)
  • GALAPAGOS NV/S ADR (NASDAQ: GLPG)
  • Insulet Corporation (NASDAQ: PODD)
  • Kodiak Sciences Inc (NASDAQ: KOD)(reacted to positive data readout from early-stage study of experimental drug to treat eye disorders)
  • Masimo Corporation (NASDAQ: MASI)
  • Novartis AG (NYSE: NVS)
  • Pacira Biosciences Inc (NASDAQ: PCRX)
  • Principia Biopharma Inc (NASDAQ: PRNB)
  • PTC Therapeutics, Inc (NASDAQ: PTCT)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • ResMed Inc. (NYSE: RMD)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Satsuma Pharmaceuticals Inc (NASDAQ: STSA)
  • Selecta Biosciences Inc (NASDAQ: SELB)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM)
  • TG Therapeutics Inc common stock (NASDAQ: TGTX)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
  • vTv Therapeutics Inc (NASDAQ: VTVT)( announced positive mid-phase readout for diabetes drug)
  • Zai Lab Ltd (NASDAQ: ZLAB)(announced China National Medical Products Administration's acceptance of NDA for omadacycline to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Feb. 10)

  • Acasti Pharma Inc (NASDAQ: ACST)(announced a delay in reporting of TRILOGY 2 topline results until the third quarter)
  • AngioDynamics, Inc. (NASDAQ: ANGO)
  • Bellerophon Therapeutics (NASDAQ: BLPH)
  • CASI Pharmaceuticals Inc (NASDAQ: CASI)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Enzo Biochem, Inc. (NYSE: ENZ)
  • Evolus Inc (NASDAQ: EOLS)
  • Galectin Therapeutics Inc. Common Stock (NASDAQ: GALT)
  • Happiness Biotech Group Ltd (NASDAQ: HAPP)
  • Meridian Bioscience, Inc. (NASDAQ: VIVO)
  • Moleculin Biotech Inc (NASDAQ: MBRX)
  • Pacific Biosciences of California (NASDAQ: PACB)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • Zogenix, Inc. (NASDAQ: ZGNX)

The Week Ahead In Biotech: SMID-Cap Earnings In The Spotlight

Stocks In Focus FDA Imposes Clinical Hold on LogicBio's IND For Metabolic Disorder Drug

LogicBio Therapeutics Inc (NASDAQ: LOGC) said the FDA has placed on hold its IND for LB-001, which is being evaluated for the treatment of methylmalonic acidemia, pending the resolution of certain clinical and non-clinical questions. The company said it expects the FDA questions to be provided in writing within 30 days.

The stock shed 25.84% to $7.75 in after-hours trading.

Mereo Receives Financing From Novartis, Aspire Capital

MEREO BIOPHARMA/ADR (NASDAQ: MREO) said it has entered into a $5 million convertible equity financing with Novartis, and also entered into a securities purchase agreement with institutional investor Aspire Capital Fund to sell up to $28 million worth of its ordinary shares exchangeable for ADSs.

Mereo shares advanced 5% to $2.10 in after-hours trading.

Seattle Genetics, Astellas Announce Positive Updated Results From Urothelial Cancer Drug

Seattle Genetics, Inc. (NASDAQ: SGEN) and ASTELLAS PHARMA/ADR (OTC: ALPMY) announced updated results from the Phase 1b/2 study of EV-103 in previously untreated patients with locally advanced, or metastatic urothelial cancer, who were ineligible for treatment with cisplatin-based chemotherapy. The results showed the experimental drug continued to meet outcome measures for safety and demonstrated encouraging clinical activity.

The data was measured after a median follow-up of 11.5 months.

The companies said the updated results will be presented during an oral session at the 2020 ASCO Genitourinary Cancers Symposium on Friday.

Exelixis' Solid Tumor Drug Shows Promise In Early-stage Study

Exelixis, Inc. (NASDAQ: EXEL) announced positive results from the metastatic castration-resistant prostate cancer cohort of COSMIC-02 Phase 1b trial of cobazanitib in combination with Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Tecentriq in patients with locally advanced or metastatic solid tumors.

The company said it would make an oral presentation of the data at the 2020 ASCO GU Symposium.

Novartis's Lung Cancer Drug Licensed From Incyte Granted Priority Review Designation

Novartis said the FDA has accepted and granted Priority Review to the NDA for capmatinib, a MET inhibitor being evaluated for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping mutated non-small cell lung cancer.

Capmatinib has been licensed to Novartis by Incyte Corporation (NASDAQ: INCY) under a 2009 agreement. The agreement granted Novartis exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

Pfizer Terminates Licensing Deal With Glycomimetics

GlycoMimetics Inc (NASDAQ: GLYC) said Pfizer Inc. (NYSE: PFE) notified it regarding the termination of a licensing agreement between the companies signed in 2011 regarding rivipansel and other products. Upon termination, GlycoMimetics will regain the rights to develop and commercialize the products, with Pfizer granting GlycoMimetics a non-exclusive license to the intellectual property developed by it in connection with its development of such products.

The move follows a failed late-stage trial of rivipansel in sickle cell disease reported by Pfizer in August.

GlycoMimetics shares added 4.65% to $4.50 in after-hours trading.

Gilead Picks About 10% Stake In Sierra

Gilead Sciences, Inc. (NASDAQ: GILD) disclosed in a filing with the SEC a 9.99% stake in Sierra Oncology Inc (NASDAQ: SRRA).

Gilead shares slipped 0.14% to $68.89 in after-hours trading, while Sierra Oncology shares rose 5.10% to $13.59.

Agile Reaches Agreement For $35M In Term Loans

Agile Therapeutics Inc (NASDAQ: AGRX) has entered into a senior secured term loan credit facility with Perceptive Advisors to provide it with, up to $35 million through term loans in three tranches. The company said it was already in possession of $5 million of the loan upon satisfaction of customary closing conditions, with $15 million to be made available if Twirla is approved and another $15 million upon achievement of certain revenue milestones.

The stock added 1% to $4.05 in after-hours trading.

KalVista Says Merck Opts Not to License Diabetic Macular Edema Drug

Kalvista Pharmaceuticals Inc (NASDAQ: KALV) said the option agreement between the company and Merck & Co., Inc. (NYSE: MRK) with regard to intravitreal diabetic macular edema candidate KVD001 and future oral DME molecules has expired, without Merck exercising the option to license.

KalVista now retains full ownership of all of its DME intellectual property in addition to its oral hereditary angioedema portfolio.

KalVista shares rose 0.51% to $15.75 in after-hours trading.

J&J Submits Regulatory Application For Darzalex Label Expansion

Johnson & Johnson's (NYSE: JNJ) Janssen said it has submitted an sBLA, seeking approval of Darzalex in combination with Kyprolis and dexamethasone for relapsed/refractory multiple myeloma.

The stock slipped 0.78% to $151.68 in after-hours trading.

Avrobio Presents Positive Data For Gene Therapies to Treat Cystinosis and Fabry's Disease

Avrobio Inc (NASDAQ: AVRO) presented at the 2020 WORLDSymposium updated data from a Phase 1/2 study of AVR-RD-04, an investigational gene therapy for cystinosis, which showed the first patient dosed with the therapy saw improvement across multiple measures. The company also said the Phase 1 and Phase 2 trials of AVR-RD-01 supported potential long-term engraftment and durable, endogenous production of functional enzyme in patients with Fabry disease.

The stock gained 2.25% to $26.80 in after-hours trading.

Offerings

Xeris Pharmaceuticals Inc (NASDAQ: XERS) has commenced an underwritten public offering of 6 million shares of its common stock. All the shares are being offered by the company.

The stock shed 7.53% to $5.65 in after-hours trading.

Revance said it intends to offer, subject to market conditions and other factors, $200 million aggregate principal amount of convertible senior notes due 2027 in a private placement to qualified institutional buyers.

The stock slipped 5.27% to $25.50 in after-hours trading.

Theravance Biopharma Inc (NASDAQ: TBPH) said it intends to offer $150 million worth of ordinary shares in an underwritten public offering.

The stock declined 3.60% to $29.48 in after-hours trading.

Moderna Inc (NASDAQ: MRNA) said it has commenced an underwritten public offering of $500 million worth of shares. The company said it intends to use the net proceeds for funding drug discovery and development in existing and new therapeutics areas.

Updating on its clinical program, Moderna said it expects to release Phase 2 data for its CMV vaccine in the third quarter, with the trial having enrolled more than 60% of the planned number. The company also said it is expanding investment in this core modality with three new development candidates.

The stock moved down 5.07% to $22.45 in after-hours trading.

Adverum Biotechnologies Inc (NASDAQ: ADVM), which reported positive early-stage data for its gene therapy candidate in the treatment of wet age-related macular degeneration, said it has commenced an underwritten public offering of $100 million worth of its common stock.

The stock lost 2.90% to $11.70 in after-hours trading.

Seelos Therapeutics Inc (NASDAQ: SEEL) said it has priced an underwritten public offering of 6.67 million shares at 75 cents per share. All shares are being sold by Seelos. The company expects to raise net proceeds of $4.3 million and the offering to close on or about Feb. 13.

The stock fell 1.69% to 84 cents in after-hours trading.

On The Radar Earnings

EXACT Sciences Corporation (NASDAQ: EXAS) (after the close)

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