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

Down In The Dumps

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

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

Stocks In Focus

Amarin Gets Unanimous FDA Panel Backing For Vascepa Label Expansion

Amarin Corporation plc 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 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 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 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 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 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 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 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 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 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 BPTH