The Daily Biotech Pulse: NASH Disappointment For Genfit, Novavax Lands $384M CEPI Funding For Coronavirus Vaccine, GW Pharma Earnings - Genfit (NASDAQ:GNFT), iShares Biotechnology ETF (NASDAQ:IBB)

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 May 11)

Acceleron Pharma Inc XLRN
Akebia Therapeutics Inc AKBA
Allogene Therapeutics Inc ALLO
Arcturus Therapeutics Ltd ARCT
AtriCure Inc. ATRC
Bio-Rad Laboratories, Inc. Class A Common Stock BIO
BioSig Technologies Inc BSGM
BIO-TECHNE Corp TECH (announced the release of the GMP Cloudz Human T Cell Activation Kit)
Cellect Biotechnology Ltd – ADR APOP (announced progress with respect to its ApoGraft technology and initiation of Phase 1/2 study)
ChemoCentryx Inc CCXI
Cue Biopharma Inc CUE
Cytokinetics, Inc. CYTK (announced FDA Fast Track designation for its lead drug candidate, omecamtiv mecarbil, which is being developed as a potential treatment for chronic heart failure with reduced ejection fraction)
CytomX Therapeutics Inc CTMX
DexCom, Inc. DXCM
Emergent Biosolutions Inc EBS
GENMAB A/S/S ADR GMAB
Halozyme Therapeutics, Inc. HALO
Horizon Therapeutics PLC HZNP
Immunomedics, Inc. IMMU
Immunovant Inc IMVT
Insulet Corporation PODD (reacted to first-quarter results)
Kiniksa Pharmaceuticals Ltd KNSA (announced positive results for its mavrilimumab in treating COVID-19 pneumonia and encouraging Phase 2 efficacy results for vixarelimab in diseases characterized by chronic pruritus)
MacroGenics Inc MGNX
Masimo Corporation MASI
Meridian Bioscience, Inc. VIVO
Minerva Neurosciences Inc NERV
Moderna Inc MRNA
Momenta Pharmaceuticals, Inc. MNTA
Natera Inc NTRA (announced positive Medicare coverage for the Prospera donor-derived cell-free DNA test)
Neubase Therapeutics Inc NBSE
OraSure Technologies, Inc. OSUR
ORIC Pharmaceuticals Inc ORIC
Qiagen NV QGEN
Quidel Corporation QDEL (FDA issued emergency use authorization for its COVID-19 antigen test)
Repligen Corporation RGEN
Seres Therapeutics Inc MCRB
Tandem Diabetes Care Inc TNDM
TG Therapeutics Inc common stock TGTX
Vertex Pharmaceuticals Incorporated VRTX - Vertex, along with Crispr Therapeutics AG CRSP, announced the receipt of the Regenerative Medicine Advanced Therapy designation for CTX001
West Pharmaceutical Services Inc. WST
Zai Lab Ltd ZLAB
Zentalis Pharmaceuticals Inc ZNTL
Zynex Inc. ZYXI

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 11)

Recro Pharma Inc REPH (reacted to first-quarter results)

Stocks In Focus

CymaBay Says Independent Expert Panel Recommends Lifting Of Clinical Hold On NASH Drug

CymaBay Therapeutics Inc CBAY said an independent expert panel that analyzed findings from its Phase 2b study of seladelpar in patients with non-alcoholic steatohepatitis, or NASH, concluded that there was no clinical, biochemical or histological evidence of seladelpar-induced liver injury in the study. The committee unanimously supported the lifting of the clinical hold imposed by the FDA and re-initiation of clinical development.

The company also reported a narrower loss for its first quarter.

The stock was trading 144.57% higher to $4.50 in Tuesday's premarket session.

NovaVax Announces CEPI Grant Of Up To $384M For Coronavirus Vaccine Program

Novavax, Inc. NVAX announced a grant of up to $384 million in funding by the Coalition for Epidemic Preparedness Innovations to help advance the clinical development of its SARS-CoV-2 vaccine and scale-up manufacturing.

Separately, the company reported better-than-expected first-quarter revenue and a narrower-than-expected loss per share.

The stock was jumping 48.12% to $36.29 in the premarket session.

Genfit's NASH Drug Fails To Meet Primary, Secondary Endpoints In Late-Stage NASH Study

Genfit SA GNFT said interim analysis of the RESOLVE-IT Phase 3 trial that evaluated once-daily, 120mg of elafibranor in adults with NASH did not meet the redefined primary endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients. The study also did not achieve statistical significance in the key secondary endpoints, including fibrosis improvement of at least one stage and changes in metabolic parameters.

The stock was falling by 66.31% to $7.31 in Tuesday's premarket session.

Acer To Work On COVID-19 Treatment

Acer Therapeutics Inc ACER said it has entered into a research collaboration agreement with the NIH's National Center for Advancing Translational Sciences to develop emetine hydrochloride as a potential treatment for patients with COVID-19 caused by infection with the SARS-CoV-2 virus.

The company expects to initiate an adaptive Phase 2/3 trial in the third quarter, contingent on IND submission and clearance.

The stock was rallying by 27.39% to $4 in Tuesday's premarket session.

Neurocrine Exercises Option To License Idorsia's Rare Pediatric Epilepsy Drug

Neurocrine Biosciences, Inc. NBIX said following the FDA's acceptance of its IND application, it has exercised the option to license the global rights to Idorsia's ACT-709478. Neurocrine said it plans to initiate a Phase 2 study of the T-type calcium channel blocker for the treatment of a rare pediatric epilepsy in the second half of 2020.

In premarket trading Tuesday, Neurocrine shares were up 3.9% to $118.

Sanofi's Multiple Myeloma Drug Aces Late-Stage Study

Sanofi SA SNY said its Phase 3 IKEMA trial that evaluated its sarclisa in patients with relapsed multiple myeloma met the primary endpoint. The company said the results were released early based on recommendation of an Independent Data Monitoring Committee.

Adamis To Re-Acquire US Commercialization Rights To Epinephrine Injection Products

Adamis Pharmaceuticals Corp ADMP said it is reacquiring from Novartis AG's NVS Sandoz unit the rights to its Symjepi — epinephrine injection 0.3mg — and epinephrine Injection 0.15mg, products that are currently marketed in the U.S. The company also said it has simultaneously entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC for the U.S. commercial rights for the Symjepi products, as well as its Zimhi, naloxone HCI Injection, USP, 5mg/0.5mL product candidate, for an upfront payment and potential regulatory and commercial milestones totaling up to $26 million.

Adamis shares were rising by 9.57% to 56 cents at the time of publication Tuesday.

Earnings

GW Pharmaceuticals PLC- ADR GWPH reported first-quarter revenues of $120.6 million, with $116.1 million in Epidiolex sales. Analysts had estimated revenues of $108.36 million. The loss narrowed from 14 cents per share to 2 cents per share.

The stock was up 9.93% at $120 at the time of publication Tuesday.

Pulse Biosciences Inc PLSE reported a wider loss of 57 cents per share compared to the consensus estimate of 47 cents per share.

The stock was up 1.36% at $11.90 at the time of publication.

Offerings

Protagonist Therapeutics Inc PTGX priced its upsized underwritten public offering of 7 million shares at $14 per share for generating gross proceeds of $98 million. The offering is expected to close on or about May 14.

In premarket trading, the stock was up 3.21% at $15.10.

Akebia Therapeutics Inc AKBA priced its underwritten public offering of 11 million shares at $12 per share for generating gross proceeds of $132 million. The offering is expected to close on or about May 14.

The stock was up 2.33% at $13.15 at the time of publication Tuesday.

Myokardia Inc MYOK said it has commenced a proposed underwritten public offering to sell $450 million in shares of its common stock.

The stock gained 1.65% to $98.50 in the premarket session.

AtriCure priced its underwritten offering of 3.98 million shares at $44 per share for generating gross proceeds of $175 million. The offering is expected to close on or about May 14. The stock was down 1.15% at $45.50 at the time of publication.

Quest Diagnostics Inc DGX said it has priced a public offering with a $550 million aggregate principal amount of its 2.8% senior notes due 2031 under Quest Diagnostics' shelf registration statement.

The stock was up 0.33% to $111.30 in the premarket session.

Bausch Health Companies Inc BHC said it has priced and upsized its previously announced offering of $1.5 billion, the aggregate principal amount of 6.25% senior notes due 2029. The size of the offering was increased by $250 million.

The stock was up 0.71% at $17 in Tuesday's premarket session.

Sutro Biopharma Inc STRO announced a proposed underwritten public offering in which it intends to offer and sell shares of its common stock. Separately, the company reported first-quarter results, showing a decline in its revenue from $8.6 million in 2019 to $7.2 million in 2020. The loss widened from 62 cents per share to 84 cents per share. The results trailed expectations.

The stock plunged 15.92% to $8.50 in after-hours trading.

On The Radar

Earnings

BioXcel Therapeutics Inc BTAI (before the market open)
DarioHealth Corp DRIO (before the market open)
Palatin Technologies, Inc. PT (before the market open)
InspireMD Inc NSPR (before the market open)
STRATA Skin Sciences Inc SSKN (before the market open)
BioNTech SE – ADR BNTX (before the market open)
aTyr Pharma Inc LIFE (after the close)
Adaptive Biotechnologies Corp ADPT (after the close)
Gossamer Bio Inc GOSS (after the close)
Catabasis Pharmaceuticals Inc CATB (after the close)
Curis, Inc. CRIS (after the close)
Clearpoint Neuro Inc CLPT (after the close)
OncoCyte Corp OCX (after the close)
Shockwave Medical Inc SWAV (after the close)
Turning Point Therapeutics Inc TPTX (after the close)
Opiant Pharmaceuticals Inc OPNT (after the close)
TapImmune Inc. common stock MRKR (after the close)
Cyclacel Pharmaceuticals Inc CYCC (after the close)
KemPharm Inc KMPH (after the close)
Osmotica Pharmaceuticals PLC OSMT (after the close)

Clinical Readouts

Genocea Biosciences Inc GNCA will host a KOL symposium with a live Q&A for analysts and investors to reflect on the progress of the T cell therapy landscape and provide an in-depth profile of GEN-011 – Genocea's neoantigen cell therapy.

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