Benzinga | Aug 13, 2020 08:18AM EDT

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 (NASDAQ:ANNX)

* Cellular Biomedicine Group Inc (NASDAQ:CBMG) (announced a go-private deal)

* Fulgent Genetics Inc (NASDAQ:FLGT)

* Inari Medical Inc (NASDAQ:NARI)

* iTeos Therapeutics Inc (NASDAQ:ITOS)

* Orthopediatrics Corp (NASDAQ:KIDS)

* Penumbra Inc (NYSE:PEN)

* Shockwave Medical Inc (NASDAQ:SWAV) (reacted to second-quarter results)

Down In The Dumps

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

* Burning Rock Biotech Ltd (NASDAQ:BNR)

* Checkmate Pharmaceuticals Inc (NASDAQ:CMPI) (went public Friday)

* Entera Bio Ltd (NASDAQ:ENTX)

* Eyepoint Pharmaceuticals Inc (NASDAQ:EYPT)

* Iterum Therapeutics PLC (NASDAQ:ITRM) (announced commencement of a rights offering)

* Lantern Pharma Inc. (NASDAQ:LTRN)

* Legend Biotech Corp (NASDAQ:LEGN)

* Poseida Therapeutics, Inc. (NASDAQ:PSTX)

* Recro Pharma Inc (NASDAQ:REPH)

* Verrica Pharmaceuticals Inc (NASDAQ:VRCA)

Stocks In Focus

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

Novartis AG (NYSE: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 (NASDAQ: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 (NASDAQ: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. (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ:RDHL) (before the market open)

* Vascular Biogenics Ltd (NASDAQ:VBLT) (before the market open)

* PDS Biotechnology Corp (NASDAQ:PDSB) (before the market open)

* Zai Lab Ltd (NASDAQ:ZLAB) (before the market open)

* Veru Inc (NASDAQ:VERU) (before the market open)

* aTyr Pharma Inc (NASDAQ:LIFE) (after the market close)

* Caladrius Biosciences Inc (NASDAQ:CLBS) (after the market close)

* Dyadic International, Inc. (NASDAQ:DYAI) (after the market close)

* Myriad Genetics, Inc. (NASDAQ:MYGN) (after the market close)

* Histogen Inc (NASDAQ:HSTO) (after the market close)

* Lumos Pharma Inc (NASDAQ:LUMO) (after the market close)

* Viveve Medical Inc (NASDAQ:VIVE) (after the market close)

* Urovant Sciences Ltd (NASDAQ:UROV) (after the market close)

* Aptinyx Inc (NASDAQ:APTX) (after the market close)

* Navidea Biopharmaceuticals Inc (NYSE:NAVB) (after the market close)

* Reshape Lifesciences Inc (OTC:RSLS) (after the market close)

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