The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test

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 March 23.)

Arcutis Biotherapeutics Inc ARQT
Bellerophon Therapeutics Inc BLPH (follow-on rally from Friday's news of FDA authorization of emergency use of inhaled nitric oxide delivery system to treat COVID-19)

Down In The Dumps

(Biotech stocks that hit 52-week lows March 23.)

Abbott Laboratories ABT
AbbVie Inc ABBV
ABIOMED, Inc. ABMD
Accelerate Diagnostics Inc AXDX
AcelRx Pharmaceuticals Inc ACRX
Acer Therapeutics Inc ACER
ADDEX THERAPEUT/ADR ADXN
Aerie Pharmaceuticals Inc AERI
Alterity Therapeutics Ltd ATHE
ANCHIANO THERAP/S ADR ANCN
Anixa Biosciences Inc ANIX
Antares Pharma Inc ATRS
Apyx Medical Corp APYX
Avanos Medical Inc AVNS
BIO-TECHNE Corp TECH
BioDelivery Sciences International, Inc. BDSI
BioSpecifics Technologies Corp. BSTC
Cumberland Pharmaceuticals, Inc. CPIX
DelMar Pharmaceuticals Inc DMPI
Edwards Lifesciences Corp EW
Erytech Pharma SA ERYP
Exicure Inc XCUR
GlaxoSmithKline plc GSK
Imv Inc IMV
Incyte Corporation INCY
Inspire Medical Systems Inc INSP
Intuitive Surgical, Inc. ISRG
Ionis Pharmaceuticals Inc IONS
Jazz Pharmaceuticals PLC JAZZ
Johnson & Johnson JNJ
Kindred Biosciences Inc KIN
LeMaitre Vascular Inc LMAT
Lumos Pharma Inc LUMO
Magenta Therapeutics Inc MGTA
Merck & Co., Inc. MRK
Merrimack Pharmaceuticals Inc MACK
Mesoblast limited MESO
Misonix Inc MSON
NanoVibronix Inc NAOV
Neovasc Inc NVCN
OptiNose Inc OPTN
Outlook Therapeutics Inc OTLK
Pacira Biosciences Inc PCRX
PDS Biotechnology Corp PDSB
Penumbra Inc PEN
PLx Pharma Inc PLXP
PRA Health Sciences Inc PRAH
Precipio Inc PRPO
Psychemedics Corp. PMD
Quest Diagnostics Inc DGX
Salarius Pharmaceuticals Inc SLRX
Sanofi SA SNY
Sellas Life Sciences Group Inc SLS
TherapeuticsMD Inc TXMD
Urogen Pharma Ltd URGN
Zoetis Inc ZTS

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Stocks In Focus

Milestone Pharma's Abnormal Heart Rhythm Drug Fails To Meet Primary Endpoint In Late-Stage Study

Milestone Pharmaceuticals Inc MIST said the Phase 3 study dubbed NODE-301 that evaluated its investigational therapy etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia, or SVT, did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm compared to placebo over the five-hour period following the study drug administration.

Top-line results from the study that evaluated a 70mg dose in 431 patients enrolled across 65 sites in the U.S. and Canada showed the median time to conversion of the treatment arm was 25 minutes compared to 45 minutes for the control arm, which was not statistically significant.

"We will continue to execute as prudently possible on the ongoing NODE studies, including NODE-301B, and look forward to reviewing these data with regulators," said Joseph Oliveto, CEO of Milestone.

The stock was falling 73.21% to $3.75 in Tuesday's premarket session.

Novartis' Zolgensma Found Efficacious In Long-Term Follow-Up Study

Novartis AG NVS released new data from the START long-term follow-up study of its SMA gene therapy Zolgensma, which showed a rapid, significant, clinically meaningful benefit, including prolonged event-free survival, motor milestone achievement and durability up to five years post-dosing.

In the STRIVE-US study, about 91% of the patients met the co-primary efficacy endpoint of event-free survival at 14 months and more than half of patients sitting for more than 30 seconds at 18 months of age.

The company also said interim data from the ongoing SPR1NT study continued to show patients achieving age-appropriate motor milestones when treated with Zolgensma presymptomatically.

Separately, the company's Sandoz generic unit said it has acquired the distribution rights in the U.S. for daptomycin 500mg injection and fosaprepitant 150mg for injection from BE Pharmaceuticals AG in a bid to grow its injectables portfolio and overall offerings in the hospital setting.

The stock was trading 4.87% higher at $74.11 in Tuesday's premarket session.

Novavax's Flu Vaccine Candidate Achieves Primary, Key Secondary End Points In Pivotal Late-Stage Study

Announcing top-line results of a pivotal Phase 3 study of NanoFlu, Novavax, Inc. NVAX said its recombinant quadrivalent seasonal influenza vaccine candidate with its Matrix-M adjuvant achieved all primary endpoints as well statistical significance in key secondary end points. The study evaluated the immunogenicity and safety of NanoFlu compared to Sanofi's Fluzone Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.

The company said it expects to submit a BLA under the FDA's accelerated approval pathway.

The stock was surging 46.56% to $15.77 in premarket trading Tuesday.

CytomX Announces Cancer Drug Collaboration With Astellas For Up To $1.6B

CytomX Therapeutics Inc CTMX and ASTELLAS PHARMA/ADR ALPMY announced a strategic collaboration agreement for the research and development of novel T-cell engaging bispecific antibodies targeting CD3 and tumor cell surface antigens for treating cancer using CytomX's Probody therapeutic technology platform as well as its proprietary bispecific formats and CD3 models.

Under the agreement, CytomX will be responsible for research and discovery activities up to clinical candidate selection, while Astellas will finance the activities. Astellas will then assume the responsibility for preclinical and clinical development as well as financing.

CytomX will receive an upfront cash payment of $80 million, and is also eligible to receive future preclinical, clinical and commercial milestones of over $1.6 billion. CytomX is also eligible to receive tiered royalties on global net sales in the high-single digits to mid-teens range.

Separately, CytomX announced the appointment of Carlos Campoy as its SVP and CFO.

GenMark Obtains BARDA Grant For COVID-19 Diagnostic Test Development, Approval

GenMark Diagnostics, Inc GNMK said the Biomedical Advanced Research and Development Authority has awarded it a grant up to $749,000 to fund the development and acquisition of FDA Emergency Use Authorization for its diagnostic panel that incorporates the new SARS-CoV-2 viral target into its existing ePlex Respiratory Pathogen panel.

The company said it expects the funding support to enable it to complete the development work necessary to request an EUA from the FDA for the ePlex RP2 Panel.

The stock was adding 5.42% to $4.47 in premarket trading Tuesday.

Qiagen Begins US Shipments Of Coronavirus Panel Test

Qiagen NVQGEN said it has begun shipments of its new QIAstat-Dx Respiratory SARS-CoV0-2 Panel Test to the U.S. to help diagnose infected persons. The shipments were in accordance with the new FDA policy announced March 16. The company said it will submit the EUA application to the FDA this week.

Qiagen shares were trading 3.31% higher to $39.36 in Tuesday's premarket session.

Cumberland Securing Supply Of Antibiotic For COVID-19-Related Pneumonia

Cumberland Pharma announced it is taking appropriate action to secure its supply chain for its potent antibiotic Vibativ injection to support the treatment of patients with hospital-acquired and ventilator-associated pneumonia associated with the outbreak of the COVID-19 disease.

The company said it will also make available special financing arrangements for hospitals and clinics to ensure supply. It is also sponsoring a national program with infectious disease experts to provide information on the management of complicated respiratory infections resulting from the novel coronavirus.

In premarket trading Tuesday, the stock was rising 11.85% to $4.06.

Applied DNA Files Patent Application For Coronavirus Diagnostic Assay

Applied DNA Sciences Inc APDN announced the filing of a provisional patent application with the U.S. Patent and Trademark Office for its diagnostic assay under development for SARS-CoV-2, the virus that causes COVID-19.

In premarket trading Tuesday, Applied DNA shares were rallying 12.56% to $4.48.

PDS Biotech CFO Quits

PDS Biotech said its CFO Andrew Saik has resigned from his position and as a director effective immediately to pursue other opportunities. The company said it has initiated a search to identify a successor.

The stock was moving up 5.26% to 30 cents in premarket trading Tuesday.

Urovant Appoints Jim Robinson As CEO

Urovant Sciences Ltd UROV said it has appointed Jim Robinson to the position of president and CEO, succeeding its founder Keith Katkin. Katkin, according to the company, will transition to an advisory role.

Offerings

Hoth Therapeutics Inc HOTH said it intends to offer shares of its common stock in a "best efforts" underwritten public offering.

The stock was slipping 16.84% to $3.11 in premarket trading Tuesday.

Baudax Bio Inc BXRX said it has commenced an underwritten public offering of its common stock, Series A warrants and Series B warrants. All the securities offered are being sold by Baudax.

The company said it intends to use the net proceeds for the commercial launch of Anjeso, pipeline development activities and general corporate purposes.

The stock was slumping 26.77% to $3.20 in premarket trading Tuesday.