The Daily Biotech Pulse: ASCO Abstracts Create Stock Ripples, Applied DNA's Coronavirus Test Receives EUA, Biopharmx Shareholders Vet Reverse Merger

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs May 13.)

• AstraZeneca plc AZN
• AtriCure Inc. ATRC
• BioXcel Therapeutics Inc BTAI
• Catalent Inc CTLT (announced a collaboration with Ennaid Therapeutics to develop an oral antiviral treatment targeted at COVID-19)
• Co-Diagnostics Inc CODX (reacted to disappointing sensitivity data reported by Abbott Laboratories ABT for its rapid molecular testing for SARS-CoV-2)
• CytomX Therapeutics Inc CTMX
• Forward Pharma A/S FWP (announced extended timing for patent appeal)
• Immunovant Inc IMVT
• Kala Pharmaceuticals Inc KALA
• Minerva Neurosciences Inc NERV
• Orgenesis Inc ORGS (announced a cell-based vaccine platform targeting COVID-19 and other existing and emerging viral diseases)
• Regeneron Pharmaceuticals Inc REGN
• Translate Bio Inc TBIO
• Zai Lab Ltd ZLAB (announced Chinese regulatory nod for its Optune in combination with temozolomide for the treatment of patients with newly diagnosed glioblastoma and Optune monotherapy for recurrent glioblastoma)
• Zentalis Pharmaceuticals Inc ZNTL

Down In The Dumps

(Biotech stocks that hit 52-week lows May 13.)

• Genfit SA GNFT
• Recro Pharma Inc REPH
• Sensus Healthcare Inc SRTS
• Sonnet Biotherapeutics Holdings Inc SONN

Stocks In Focus

ASCO Abstracts

A slew of biotechs reacted to publication of online abstracts that are set to be presented at the 2020 American Society of Clinical Oncology Annual Virtual Meeting May 29-31.

Updated safety and initial efficacy data for Arvinas Inc's ARVN Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer showed two patients with ongoing confirmed prostate-specific antigen responses, including one with an unconfirmed partial tumor response.

The stock was down 17.65% at $42 in Thursday's premarket session. 

Allogene Therapeutics Inc's ALLO abstract consisted of first data from its Phase 1 dose escalation ALPHA study of CAR-T cell therapy ALLO-501 in relapsed/refractory non-Hodgkin lymphoma.

Preliminary data on the first nine patients treated with escalating doses of ALLO-501 and a lower dose of ALLO-647 showed no dose limiting toxicities or graft-vs-host disease and a 78% overall response rate, with three complete responses and four partial responses.

The stock was up 22.01% at $37.80 in the premarket session. 

ImmunoGen, Inc.'s IMGN abstract consisted of initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin in patients with medium and high folate receptor alpha-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate.

The company said the combination showed promising anti-tumor activity and favorable tolerability, with a confirmed overall response rate of more than 60%.

The stock was trading 5.39% higher at $4.30 in the premarket session. 

MEI Pharma Inc MEIP announced updated data from a Phase 1b study of ME-401 in clinical development for the treatment of B-cell malignancies that showed treatment was generally well-tolerated, with an 83% overall response rate in patients with relapsed or refractory follicular lymphoma.

MEI shares were up 2.47% at $2.90 premarket Thursday.

MacroGenics Inc MGNX announced preliminary results from two of its studies.

The Phase 1 dose escalation and expansion clinical trial of MGD013 — in combination with margetuximab, its investigational Fc-engineered monoclonal antibody targeting HER-2 — suggested a response in approximately 40% of late-stage HER-2-positive tumors that compares favorably to low response rates for HER-2-directed agents and checkpoint blockades.

Separately, the company announced early results from an ongoing Phase 1 study of MGC018, an ADC directed against B7-H3, showing preliminary signals of anti-tumor effects, including prostate-specific antigen reductions of 50% or more in five of seven patients with late-stage prostate cancer.

The stock slumped 19.81% to $21.25 in after-hours trading.

See also: The Week Ahead In Biotech: Virtual Conference Presentations, Clovis PDUFA Date In The Spotlight

CytomX announced further details of oral and poster presentations to be made at the month end's ASCO meeting.

The stock was down 19.7% at $21.28 at the time of publication. 

Genocea Biosciences Inc GNCA announced updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neo-antigen vaccine candidate, which showed that seven of the eight patients enrolled have continued without progression with a median follow-up of over one year.

The stock was up 7.92% at $2.86 at the time of publication. 

Verona Pharma Receives Positive End-Of-Phase 2 Feedback From FDA

VERONA PHARMA P/S' ADR VRNA released details of the FDA's written response following the end-of-Phase 2 briefing package for nebulized ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease. The company said the response supported the continuation of its planned Phase 3 study. Verona expects to start the study in 2020.

Verona shares were up 22.28% at $4.61 at the time of publication. 

Sanofi's Hemolysis Drug Accepted For Priority Review

Sanofi SA SNY said the FDA granted priority review of its BLA for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease, or CAD. Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. The PDUFA date has been set for Nov. 13.

AIM ImmunoTech Gets FDA Nod For Starting Human Study of Combo Treatment In Cancer Patients With COVID-19

AIM ImmunoTech Inc AIM said the FDA authorized the first human trial assessing the safety and effectiveness of its lead asset, Ampligen, in combination with interferon alfa-2b, in cancer patients with COVID-19.

The stock was rallying by 36.17% to $3.20 in the premarket session. 

Illumima Marketing Chief To Depart

Illumina, Inc.'s ILMN global marketing head Omead Ostadan is leaving the company after more than a decade and is becoming president and COO of Seer Inc. effective June 29. 

Illumina shares were down 17.74% at $266.03 in the premarket session. 

Lilly, Innovent's Cancer Drug Aces Midphase Chinese Study In Esophageal Cancer

Hong Kong biotech Innovent Biologics announced along with Eli Lilly And Co LLY that the Phase 2 study of Tyvyt in China, dubbed ORIENT-2, met its primary endpoint of overall survival. The study evaluated Tyvyt monotherapy compared to chemotherapy as a second-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma.

Biopharmx Shareholders Approve Reverse Merger With Timber Pharma

Biopharmx Corp BPMX announced that all proposals related to its proposed merger with Timber Pharmaceuticals were approved by stockholders at a special meeting held May 13. The company said it expects the deal to close on or about May 18,, contingent upon customary closing conditions and regulatory approvals.

Upon closing of the transaction, the combined company will change its name to "Timber Pharmaceuticals, Inc." Its shares are expected to commence trading on the NYSE American market under the ticker symbol "TMBR."

The stock was roaring higher by 40.46% to 66 cents in premarket trading Thursday. 

Applied DNA's COVID-19 Diagnostic Assay Kit Receives Emergency Use Authorization

Applied DNA Sciences Inc APDN said the FDA has issued Emergency Use Authorization, or EUA, for its Linea COVID-19 RT-PCR test to be performed in clinical labs in the U.S. certified under Clinical Laboratory Improvement Amendments to perform high complexity tests.

Applied DNA shares were ripping 79.98% higher to $16 at the time of publication. 

Xeris Signs Distribution Deal Outside US For Low Blood Pressure Drug

Xeris Pharmaceuticals Inc XERS said it has signed an exclusive agreement with AIM-listed Clinigen Group to distribute its low blood pressure drug Gvoke outside of the U.S., where it is not currently licensed.

Gvoke has not yet been approved in Europe.

Immunic Gets Regulatory Nod For Phase 2 Study Of Coronavirus Drug 

Immunic Inc IMUX said it has received the first regulatory approval from Germany's BfArM to initiate a Phase 2 study of its selective oral DHODH inhibitor, IMU-838, in COVID-19.

The study is designed as a multicenter, randomized, placebo-controlled and double-blinded study, and it intends to study 230 patients with moderate COVID-19.

The company said it expects to dose the first patient later this month and make top-line data from the study available later this year.

In premarket trading Thursday, the stock was surging 19.84% to $12.20. 

Earnings

RA Medical Systems Inc RMED reported first-quarter revenue of $1.4 million, down from $1.7 million a year ago and lower than the $1.58-million consensus estimate.

The loss widened from $1.16 per share to 56 cents per share, while analysts estimated a loss of 34 cents per share.

The stock was declining 5.97% to 90 cents at the time of publication. 

Biocept Inc's BIOC first-quarter revenue rose 41% year-over-year to $1.4 million. The loss per share narrowed from 61 cents to 11 cents.

The stock was trading 4.83% higher to 46 cents in Thursday's premarket session. 

Offerings

Kiniksa Pharmaceuticals Ltd KNSA priced its 2.4-million-share common stock offering at $18.25 per share. The company expects to raise gross proceeds of $75 million from the offering. The offering would close May 18.

The stock was down 1% at $18.80 at the time of publication. 

Axcella Health Inc AXLA priced its underwritten public offering of 11 million shares of its common stock at $4.75 per share to raise gross proceeds of $52.3 million. The offering is expected to close May 18.

Axcella shares were down 0.56% at $5.31 premarket Thursday. 

On The Radar

• Earnings

• Vascular Biogenics Ltd VBLT (before the market open)
• Kaleido Biosciences Inc KLDO (before the market open)
• Biomx Inc PHGE (before the market open)
• Soliton Inc SOLY (before the market open)
• ImmuCell Corporation ICCC (before the market open)
• Galmed Pharmaceuticals Ltd GLMD (before the market open)
• Transenterix Inc TRXC (before the market open)
• Adaptimmune Therapeutics PLC – ADR ADAP (before the market open)
• Aptinyx Inc APTX (after the close)
• Aytu Bioscience Inc AYTU (after the close)
• Applied DNA (after the close)
• INmune Bio Inc INMB (after the close)
• Dare Bioscience Inc DARE (after the close)
• Navidea Biopharmaceuticals Inc NAVB (after the close)
• Thermogenesis Holdings Inc THMO (after the close)
• Eton Pharmaceuticals Inc ETON (after the close)
• Onconova Therapeutics Inc ONTX (after the close)
• TFF Pharmaceuticals Inc TFFP (after the close)
• Viveve Medical Inc VIVE (after the close)
• Salarius Pharmaceuticals Inc SLRX (after the close)
• Vermillion, Inc. VRML (after the close)
• Aptinyx Inc APTX (after the close)
• BioLife Solutions Inc BLFS (after the close)
• Co-Diagnostics (after the close)
• Capricor Therapeutics Inc CAPR (after the close)
• Dyadic International, Inc. DYAI (after the close)
• Thermogenesis Holdings Inc THMO (after the close)
• TFF Pharmaceuticals Inc TFFP (after the close)

Clinical Readouts

Caladrius Biosciences Inc CLBS will present at the Society for Cardiovascular Angiography and Intervention Virtual Conference, Scientific Sessions full data from the ESCaPE-CMD study of CLBS16 for the treatment of coronary microvascular dysfunction.

Constellation Pharmaceuticals Inc CNST said abstracts of a presentation due at the June 11-14 European Hematology Association meeting will be made available. The abstract pertains to an interim update from the MANIFEST Phase 2 study that is evaluating CPI-0610 in myelofibrosis.

Related Link: 5 Biopharmas Where BofA Would Put Its Money To Work