The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Hologic To Launch Coronavirus Test, Amarin's Strong Q1

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 April 29)

• Arvinas Inc ARVN
• Biondvax Pharmaceuticals Ltd – ADR BVXV
• Bio-Rad Laboratories, Inc. Class A Common StockBIO
• Capricor Therapeutics Inc CAPR( reacted to data that showed a 100% survival rate in COVID-19 patients treated with its CAP-1002 cell therapy)
• Cue Biopharma Inc CUE
• DexCom, Inc. DXCM(reacted to its quarterly results)
• Erytech Pharma SA ERYP(announced Fast Track Designation from the FDA for its cancer drug in pancreatic cancer)
• GenMark Diagnostics, Inc GNMK
• I-Mab ADR IMAB
• Immunomedics, Inc. IMMU
• Keros Therapeutics Inc KROS
• Masimo Corporation MASI(announced solid first-quarter results)
• Mersana Therapeutics Inc MRSN
• Zentalis Pharmaceuticals Inc ZNTL
• Zynex Inc. ZYXI(announced its first-quarter results)

None of the Nasdaq- or NYSE-listed biotech/medical device/diagnostics company hit 52-week lows Wednesday.

Stocks In Focus

Marker's Leukemia Drug Candidate Gets Orphan Drug Designation

Marker Therapeutics, Inc. MRKR said the FDA accorded Orphan Drug Designation to MT-401, its multi-tumor-associated antigen-specific T cell product for the treatment of patients with acute myeloid leukemia following allogenic stem cell transplant.

In after-hours trading, the stock rallied 23.79% to $2.81.

Evotec Unit to Work With Ology to Develop Antibodies Against Coronavirus

German biopharma Evotec SE EVOTF said its Seattle-based subsidiary Just-Evotec Biologics has entered into a partnership with Ology Bioservices for the evaluation and analytical characterisation of antibodies against SARS-CoV-2 – the virus that causes COVID-19.

The company noted this work was based on a contract awarded to Ology by the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies to develop, and manufacture monoclonal antibodies for the treatment and prevention of infections with SARS-CoV-2

FDA Approves an Expanded Indication For GlaxoSmithKline's Ovarian Cancer Drug

GlaxoSmithKline plc GSK announced FDA approval for its sNDA for Zejula as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status

The stock was up 1.51% to $42.48 in pre-market trading.

PDS Biotech Announces Expansion to Cancer Drug Collaboration With NCI

PDS Biotechnology Corp PDSB announced an expansion of its previously announced Cooperative Research and Development Agreement with the National Cancer Institute to include studies of PDS0103, a Versamune-based product incorporating novel mucin-1 epitopes developed by the NCI.

NCI is already evaluating PDS0101 in combination with two separate immune-modulating agents - NHS-IL12 and M7824 - in a phase 2 clinical trial in advanced HPV-associated cancers.

The stock was adding 2.61% to 97 cents in pre-market trading.

BeiGene, IGM, Atreca To Work On Coronavirus Treatment

Atreca Inc BCEL, Beigene Ltd BGNE and IGM Biosciences Inc IGMS announced plans to collaborate to develop novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19. The companies said work will commence immediately, with the financial and other terms to be finalized in the future.

In pre-market trading, BeiGene was edging up 0.42% to $162.30 and Atreca was advancing 3.57% to $18.

Offerings

NeoGenomics, Inc. NEO priced its proposed underwritten public offerings of 4.4 million newly issued shares at $28.50 per share. The company also said it's offering $175 million in aggregate principal amount of its 1.25% convertible senior notes due 2025.

The company also said underwriters of the common stock offering are also offering 1.065 million worth of shares of NeoGenomics borrowed from third parties.

The stock slid 4.90% to $29.50 in after-hours trading.

Syndax Pharmaceuticals Inc SNDX announced plans to offer shares of its common stock in an underwritten public offering. All the shares are being offered by the company.

In pre-market trading, the stock was adding 0.27% to $18.75.

Earnings

Vertex Pharmaceuticals Incorporated VRTX reported first-quarter revenues of $1.52 million, up from $858.44 million in the year-ago quarter. On a non-GAAP basis, earnings per share, or EPS, climbed from $1.14 to $2.56, ahead of the $1.84 per share consensus estimate. The company upwardly revised its full-year net product revenue guidance.

The stock was adding 2.97% to $258.50 in pre-market trading.

Hologic, Inc.'s HOLX second-quarter revenues fell 7.6% to $756.1 million, primarily reflecting Cynosure divestiture. The company reported non-GAAP EPS of 57 cents, in line with the consensus. The company withdrew its guidance for the second quarter and full year.

Separately, the company said it plans to launch a new Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its market-leading Panther system. The company expects to begin distributing a Research Use Only version of its test next week. It also plans to apply for Emergency Use Authorization with the FDA next week and register a CE Mark for diagnostic use in Europe later in May.

In pre-market trading, the stock was jumping 9.07% to $53.39.

Amarin Corporation plc's AMRN first-quarter revenues climbed 112% to $155 million. The net loss per share on a non-GAAP basis narrowed from 5 cents to 3 cents. The results trumped the consensus that called for a loss of 7 cents per share on revenues of $137.43 million.

Regarding the ANDA litigation, the company said hearing could happen in the third quarter or early fourth quarter, with a ruling likely in 2020 or in early 2021.

Amarin said it believes that it has a strong basis for appeal, which will be set out in its opening brief proposed for filing on May 12th.

In pre-market trading, Amarin shares were rallying 3.75% to $8.57.

On The Radar

Earnings

• Agios Pharmaceuticals Inc AGIO (before the market open)
• ABIOMED, Inc. ABMD (before the market open)
• Baxter International Inc BAX (before the market open)
• BIO-TECHNE Corp TECH (before the market open)
• Genocea Biosciences Inc GNCA (before the market open)
• Novocure Ltd NVCR (before the market open)
• Syneos Health Inc SYNH (before the market open)
• PRA Health Sciences Inc PRAH (before the market open)
• Lantheus Holdings Inc LNTH (before the market open)
• Iradimed Corp IRMD (before the market open)
• Concert Pharmaceuticals Inc CNCE (before the market open)
• Amgen, Inc. AMGN (after the close)
• Emergent Biosolutions Inc EBS (after the close)
• Insmed Incorporated INSM (after the close)
• Gilead Sciences, Inc. GILD (after the close)
• Seattle Genetics, Inc. SGEN (after the close)
• Natus Medical Inc NTUS (after the close)
• Illumina, Inc. ILMN (after the close)
• PTC Therapeutics, Inc. PTCT (after the close)
• LeMaitre Vascular Inc LMAT (after the close)
• ResMed Inc. RMD (after the close)
• Viking Therapeutics Inc VKTX (after the close)
• Silk Road Medical Inc SILK (after the close)
• Corvus Pharmaceuticals Inc CRVS (after the close)
• CareDx Inc CDNA (after the close)
• Tandem Diabetes Care Inc TNDM (after the close)
• Ekso Bionics Holdings Inc EKSO (after the close)