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The Daily Biotech Pulse: Amarin Gets Unanimous Backing For Vascepa Expansion, BeiGene's Blood Cancer Drug Gets Approval

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The Daily Biotech Pulse: Amarin Gets Unanimous Backing For Vascepa Expansion, BeiGene's Blood Cancer Drug Gets Approval

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 Nov. 14)

  • 10X Genomics Inc (NASDAQ: TXG)(IPOed Sept. 12)
  • 89bio Inc (NASDAQ: ETNB) (IPOed Nov. 11)
  • Bio-Rad Laboratories, Inc. Class A (NYSE: BIO)
  • Castle Biosciences Inc (NASDAQ: CSTL)
  • China Biologic Products Holdings Inc (NASDAQ: CBPO)(reacted to its third-quarter results)
  • Dicerna Pharmaceuticals Inc (NASDAQ: DRNA)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)(priced its debt offering)
  • IGM Biosciences Inc (NASDAQ: IGMS)
  • Kodiak Sciences Inc (NASDAQ: KOD)
  • Novo Nordisk A/S (NYSE: NVO)
  • Seattle Genetics, Inc. (NASDAQ: SGEN)
  • XOMA Corp (NASDAQ: XOMA)
  • XBiotech Inc (NASDAQ: XBIT)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 14)

  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • Altimmune Inc (NASDAQ: ALT) (reacted to its third-quarter results)
  • Auris Medical Holding Ltd (NASDAQ: EARS)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (priced its common stock offering)
  • Cellectar Biosciences Inc (NASDAQ: CLRB)
  • China SXT Pharmaceuticals Inc (NASDAQ: SXTC)
  • Cleveland BioLabs, Inc. (NASDAQ: CBLI)
  • Cocrystal Pharma Inc (NASDAQ: COCP)
  • CytomX Therapeutics Inc (NASDAQ: CTMX)
  • Diffusion Pharmaceuticals Inc (NASDAQ: DFFN)
  • Iterum Therapeutics PLC (NASDAQ: ITRM)
  • Leap Therapeutics Inc (NASDAQ: LPTX)(reacted to its decision to deprioritize a key mid-stage solid tumor candidate)
  • Lipocine Inc (NASDAQ: LPCN)(reacted to announcement concerning pricing of a common stock offering)
  • Marker Therapeutics (NASDAQ: MRKR)
  • Midatech Pharma PLC-ADR (NASDAQ: MTP)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Obseva SA (NASDAQ: OBSV)
  • Ocugen Inc (NASDAQ: OCGN)
  • Onconova Therapeutics Inc (NASDAQ: ONTX)
  • OpGen Inc (NASDAQ: OPGN)
  • Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP)
  • Oyster Point Pharma Inc (NASDAQ: OYST) (IPOed on Oct. 31)
  • PAVmed Inc (NASDAQ: PAVM)
  • Ritter Pharmaceuticals Inc (NASDAQ: RTTR)(reacted to its third-quarter results)
  • Savara Inc (NASDAQ: SVRA)
  • Salarius Pharmaceuticals Inc (NASDAQ: SLRX)
  • Sensus Healthcare Inc (NASDAQ: SRTS)
  • TELA Bio Inc (NASDAQ: TELA) (IPOed on Nov. 8)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • Unum Therapeutics Inc (NASDAQ: UMRX)
  • Verastem Inc (NASDAQ: VSTM)
  • Vistagen Therapeutics Inc (NASDAQ: VTGN)(flunked a mid-stage of a drug to be used as an adjunctive treatment for major depressive disorder)
  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)

Stocks In Focus

Amarin Gets Unanimous FDA Panel Backing For Vascepa Label Expansion

Amarin Corporation plc (NASDAQ: AMRN) said FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously, by a 16-0 margin, to recommend approval of label expansion for its fish oil pill Vascepa to add the indication of a reduction in cardiovascular events in high-risk patients.

The company said it plans to work with the FDA, as the latter completes its review of the application seeking label expansion for Vascepa to reflect REDUCE-IT results.

The stock was halted for trading Thursday morning in anticipation of the announcement.

BeiGene's Blood Cancer Drug Gets Accelerated FDA Approval

BeiGene Ltd (NASDAQ: BGNE) announced accelerated FDA approval for Brukinsa as a treatment option for mantle cell lymphoma in adult patients who have received at least one prior therapy.

Brukinsa is the first BeiGene-discovered product to be approved, the company said.

The company noted that the accelerated approval was based on the overall response rate, and continued approval for this indication hinges on verification and description of clinical benefit in a confirmatory trial.

BeiGene expects to make the drug available in the U.S. in the coming weeks.

The stock rose 3.36% to $203 in after-hours trading.

See Also: Biotech Stock On The Radar: Alkermes At A Crossroads

Regulatory Review of Agile's Twirla Extended

Agile Therapeutics Inc's (NASDAQ: AGRX) wait to move its Twirla contraceptive patch to the market isn't over yet. FDA had spurned Twirla application twice earlier, and following the company's third try, the FDA said it deemed it fit to extend the review period by three months. The new PDUFA goal date is Feb. 16, 2020.

The extension has come despite an Adcom panel, which met Oct. 30, voting 14 to 1 that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval.

The stock slumped 31.93% to $1.62 in after-hours trading.

Shionogi's Antibiotic For Urinary Tract Infection Clears The FDA Hurdle

SHIONOGI & CO L/ADR (OTC: SGIOY) said the FDA has approved its Fetroja in patients 18 years of age, or older, who have limited or no alternative treatment options, for treating complicated urinary tract infections, or cUTI, including pyelonephritis.

The company noted that the approval was got based on limited clinical safety and efficacy data, The company also said it expects to make Fetroja commercially available in early 2020.

Offerings

NextCure Inc (NASDAQ: NXTC) priced its public offering of 4.08 million shares at $36.75 per share. All the shares sold in the offering are being offered by the company. The company expects to raise gross proceeds of about $150 million from the offering. The offering is expected to close on or about Nov. 19.

Earnings

KemPharm Inc (NASDAQ: KMPH) reported revenues of $11.5 million for the third quarter of 2019 compared to no revenues in the year-ago period. The company reversed to a profit of 6 cents per share from a loss of 94 cents per share in the year-ago period. Analysts estimated a loss of 19 cents per share.

The stock soared 42.31% to 74 cents in after-hours trading.

Sellas Life Sciences Group Inc (NASDAQ: SLS) reported a narrower loss of $2.68 per share for the third quarter of 2019 compared to a loss of $26.75 per share in the year-ago period. Cash and cash equivalents totaled $9.1 million as of Sept. 30.

The stock advanced 17.50% to $7.25 in after-hours trading.

Zosano Pharma Corp's (NASDAQ: ZSAN) net loss per share narrowed from 68 cents in the third quarter of 2018 to 55 cents in the third quarter of 2019. The consensus estimate had called for a wider loss of 58 cents per share.

Cash, cash equivalents and marketable securities stood at $6.5 million as of Sept. 30, compared to $23 million as of Dec. 31, 2018.

The stock fell 11.17% to $1.75 in after-hours trading.

Plus Therapeutics Inc (NASDAQ: PSTV) reversed from a loss of $27.63 per share in the third quarter of 2018 to a profit of 3 cents per share in the third quarter of 2019. Cash, cash equivalents stood at $16.8 million as of Sept. 30, while debt principal balances were at $9.3 million.

The stock soared 23.43% to $2.95 in after-hours trading.

Titan Pharmaceuticals, Inc.'s (NASDAQ: TTNP) third quarter revenues declined from $1.7 million in 2018 to $0.9 million in 2019. The net loss per share narrowed from 64 cents to 18 cents. Analysts estimated a wider loss of 21 cents per share.

The company said its cash reserves and the $8.1 million of net cash proceeds from its public offering in October will be sufficient to fund its operations into the third quarter of 2020.

The stock plunged 14.49% to 16 cents in after-hours trading.

On The Radar

Earnings

 

 

Bio-Path Holdings Inc (NASDAQ: BPTH)

Posted-In: Biotech Earnings News Offerings FDA Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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