Search This Blog

Monday, June 29, 2020

Inovio Analyst Downgrades Covid Vaccine Developer, Says Risk Higher After Rally

Inovio Pharmaceuticals Inc INO 5.7% shares have rallied strongly in late June, moving from $14.27 on June 19 to $31.25 on July 25, translating to a stellar gain of about 110%.
Much of the upside stemmed from a $71-million DoD contract award for its COVID-19 vaccine delivery device.
The Inovio Analyst: H.C. Wainwright analyst Raghuram Selvaraju downgraded Inovio from Buy to Neutral and removed the price target.
The Inovio Thesis: Inovio shares have risen 746.9% since Jan. 23, when it announced initial CEPI funding for its DNA vaccine against the novel coronavirus, compared to a mere 18.4% rise by the SPDR S&P Biotech XBI 0.1%, Selvaraju said in a Monday note. (See his track record here.)
Inovio’s COVID-19 vaccine candidate INO-4800 is now valued by the market at roughly $4 billion, the analyst said.
“We believe the risk/reward ratio for Inovio has increased significantly as many open questions remain, including the strength and duration of neutralizing antibodies and T cell responses that may be generated in human trials and the effective protection the vaccine may demonstrate in animal challenge studies.”
The skepticism is primarily due to the fact that there is no approved human vaccine for any type of coronavirus and that no DNA vaccines have been approved yet for human use, he said.
Selvaraju did not rule out upside from current levels. Any potential upside, hinges on the following, the analyst said:
  • Positive clinical data from human and animal challenge studies
  • Evidence that the immunity lasts sufficiently
  • Superiority of the DNA vaccine to competing vaccination approaches
  • Inovio’s ability to obtain market authorization, supply its vaccine sustainably and at an affordable price, while also enabling a reasonable profit margin
  • Long-term persistence of the pandemic itself
H.C. Wainwright noted that the interim Phase 1 readout of the DNA vaccine is due this month, with Phase 2/3 studies likely to start in summer.

Abbott, Tandem Diabetes to Develop Tech for Automated Insulin Delivery System

Abbott Laboratories has finalized a deal with Tandem Diabetes Care Inc. to work together on automated insulin delivery systems.
Abbott said the companies will develop and commercialize systems that combine its continuous glucose monitoring technology with Tandem’s insulin delivery systems to provide more options for people to manage their diabetes.
The companies first announced plans to work together in late 2019. The agreement covers technical development of device integration and associated commercial support activities.
Abbott and Tandem Diabetes Care will focus their initial commercial activities in the U.S. and Canada, with additional geographies considered in the future.

Seattle Genetics/Genmab conjugate shows positive effect in cervical cancer

Seattle Genetics (NASDAQ:SGEN) and collaboration partner Genmab A/S (NASDAQ:GMAB) announce positive topline results from a Phase 2 clinical trial, innovaTV 204, evaluating antibody-drug conjugate (ADC) tisotumab vedotin in patients with relapsed/refractory metastatic cervical cancer.
The objective response rate (ORR) was 24%. Median duration of response was 8.3 months.
The most common treatment-emergent adverse events (at least 20%) were alopecia (hair loss), epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye.
Detailed data will be submitted for presentation at a future medical conference.
The companies have been working together under an October 2011 agreement leveraging SGEN’s ADC technology with GMAB’s HuMax-TF antibody. Development costs and (eventual) profits are being equally shared.

Verrica hits pothole with U.S. application for lead candidate

Verrica Pharmaceuticals (NASDAQ:VRCA) announces that it has received a letter from the FDA related to its review of the company’s marketing application seeking approval of lead candidate VP-102 (cantharidin 0.7% topical solution) for the treatment of molluscum contagiosum, a contagious viral infection characterized by small bumps on the skin.
The agency cites deficiencies that “preclude discussion of labeling and post-marketing requirements” at this time but, giving the company a ray of hope, states that it has not made a final decision on the matter. Its action date is July 13.
The company says the letter does not specify any particular items but it has noted that the agency’s periodic requests for additional information have pertained to chemistry, manufacturing and control (CMC) aspects of the drug-device combination, adding that its ability to address the requests have been “significantly impacted” by COVID-19 disruptions.

Oncocyte strikes out with liquid biopsy lung nodule test

Oncocyte (NYSEMKT:OCX) announces unsuccessful results from a clinical validation study of DetermaDx, a liquid biopsy test aimed at determining whether a lung nodule is suspicious or benign.
The study failed to achieved the main endpoint of a statistically significant improvement in the diagnosis of intermediate-risk nodules, particularly in the 0.8 cm – 22 cm size range, compared to clinical factors used by doctors.
The company will cease further development of the test.
Management will host a conference call today at 5:00 pm ET to discuss the results.

FDA OKs Merck’s Keytruda for highly mutating forms of colorectal cancer

The FDA approves Merck’s (MRK +1.0%) PD-1 inhibitor Keytruda (pembrolizumab) for the first-line treatment of patients with unresectable/metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer, rapidly mutating forms of the disease that have poor prognoses.
The company says Keytruda is the first immunotherapy to receive the FDA nod for these patients in a first-line setting.

Luminex gets FDA warning letter

Luminex (LMNX -3.5%) receives a warning letter from the FDA resulting from inspections held at Texas facilities in February, and relates to the Company’s VERIGENE SP instrument and its hybridization heater in connection with FDA requirements.
The Company intends to submit a response within 15 business days.