The Daily Biotech Pulse: Mesoblast Awaits Adcom Test, BioCryst Rallies On Insider Buying, Sorrento Hits Back At Short Seller

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 12)

  • Annexon Inc ANNX
  • Cellular Biomedicine Group Inc CBMG (announced a go-private deal)
  • Fulgent Genetics Inc FLGT
  • Inari Medical Inc NARI
  • iTeos Therapeutics Inc ITOS
  • Orthopediatrics Corp KIDS
  • Penumbra Inc PEN
  • Shockwave Medical Inc SWAV (reacted to second-quarter results)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 12)

  • Burning Rock Biotech Ltd BNR
  • Checkmate Pharmaceuticals Inc CMPI (went public Friday)
  • Entera Bio Ltd ENTX
  • Eyepoint Pharmaceuticals Inc EYPT
  • Iterum Therapeutics PLC ITRM (announced commencement of a rights offering)
  • Lantern Pharma Inc. LTRN
  • Legend Biotech Corp LEGN
  • Poseida Therapeutics, Inc. PSTX
  • Recro Pharma Inc REPH
  • Verrica Pharmaceuticals Inc VRCA

Stocks In Focus

Novartis Files For Label Expansion For Self-Administered Allergic Asthma Drug

Novartis AG NVS said the FDA accepted the sBLA for a self-administration option for Xolair across all approved U.S. indications. If approved, Xolair pre-filled syringes would become available for either self-administration by select patients or administration by their caregivers, the company said.

A decision on approval is expected in the first quarter of 2021, Novartis said.

Xolair is approved for treating patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria.

The stock was edging up 0.88% to $85.68 in premarket trading Thursday.

Sorrento Denies Allegations By Hindenburg Regarding COVID-19 Diagnostic Test

Pushing back against allegations by Hindenburg Research, Sorrento Therapeutics Inc SRNE said a report published by the short seller regarding its COVID-19 diagnostic spit test includes false and/or misleading statements for the sole apparent purpose of negatively manipulating the company's stock price.

The company said in a press release that it has demanded through its counsel that Hindenburg cease and desist from illegal and wrongful activity and retract false and/or misleading statements. It also said it is contemplating legal action.

The stock was advancing 9.19% to $13.55 in premarket trading Thursday.

Heat Biologics Reports Positive Preclinical Results For COVID-19 Vaccine Candidate

Heat Biologics Inc HTBX reported preclinical data for its gp96-based COVID-19 vaccine candidate showing robust T-cell mediated immune response directed against the spike protein of SARS-CoV-2.The data was generated at the University of Miami Miller School of Medicine.

The stock was jumping 24.36% to $1.94 in premarket trading Thursday.

See also: The Week Ahead In Biotech: Bausch Health, Fennec Pharma FDA Decisions And Smid-cap Earning

BioCryst CFO Buys Shares

BioCryst Pharmaceuticals, Inc. BCRX shares reacted to a Form 4 filing by the company with the SEC regarding purchase of 54,000 of its shares by CFO Doyle Anthony.

The stock was up 5.29% to $4.18 premarket Thursday.

Earnings

Brickell Biotech Inc BBI said its second-quarter revenue fell from $2.6 million in 2019 to $600,000 in 2020. The loss per share narrowed from $6.48 to 43 cents.

The stock was moving down 4.39% to 85 cents in premarket trading Thursday.

Biocept Inc's BIOC second-quarter revenue declined from $1.2 million in 2019 to $917,000 in 2020. The net loss per share narrowed from 38 cents to 5 cents and was in line with estimates.

In premarket trading Thursday, the stock was trading 0.98% higher at $1.03. 

Eyenovia Inc EYEN said its net loss per share narrowed from 44 cents to 25 cents, with the loss per share coming in line with expectations.

The stock was moving down 6.86% to $4.75 in premarket trading Thursday.

Cyclacel Pharmaceuticals Inc CYCC reported a loss of 58 cents per share, narrower than the year-ago loss of $2.13 per share but wider than the consensus loss estimate of 47 cents per share.

The stock was shedding 6.36% to $4.27 in premarket trading Thursday.

On The Radar

Adcom Meeting

FDA's Oncology Drug Advisory Committee will discuss Thursday Mesoblast limited's MESO BLA for remestemcel-L for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. Briefing document released ahead of the meeting showed FDA staffers weren't convinced regarding the efficacy of the investigational therapy.

Earnings

  • RedHill Biopharma Ltd RDHL (before the market open)
  • Vascular Biogenics Ltd VBLT (before the market open)
  • PDS Biotechnology Corp PDSB (before the market open)
  • Zai Lab Ltd ZLAB (before the market open)
  • Veru Inc VERU (before the market open)
  • aTyr Pharma Inc LIFE (after the market close)
  • Caladrius Biosciences Inc CLBS (after the market close)
  • Dyadic International, Inc. DYAI (after the market close)
  • Myriad Genetics, Inc. MYGN (after the market close)
  • Histogen Inc HSTO (after the market close)
  • Lumos Pharma Inc LUMO (after the market close)
  • Viveve Medical Inc VIVE (after the market close)
  • Urovant Sciences Ltd UROV (after the market close)
  • Aptinyx Inc APTX (after the market close)
  • Navidea Biopharmaceuticals Inc NAVB (after the market close)
  • Reshape Lifesciences Inc RSLS (after the market close)

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates

Posted In: BiotechEarningsNewsPenny StocksFDA

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.